Elsevier Radarweg 29, PO Box 211, 1000 AE Amsterdam, Netherlands The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom 50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States First edition 2016 Copyright © 2016 Elsevier B.V All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein) Notices Knowledge and best practice in this field are constantly 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Zoe Kruze Acquisition Editor: Zoe Kruze Editorial Project Manager: Shellie Bryant Production Project Manager: Surya Narayanan Jayachandran Cover Designer: Victoria Pearson Esser Typeset by SPi Global, India Contributors Alexander Accinelli School of Pharmacy and Health Professions, University of Maryland at Eastern Shore, Princess Anne, MD, USA Teresa DeLellis Department of Pharmacy Practice, College of Pharmacy, Natural and Health Sciences, Manchester University, Fort Wayne, IN, USA Asima N Ali Campbell University CPHS, Buies Creek; Wake Forest Baptist Health—Internal Medicine OPD Clinic, Winston-Salem, NC, USA Rahul Deshmukh Department of Pharmaceutical Sciences, College of Pharmacy, Rosalind Franklin University of Medicine and Science, North Chicago, Il, USA Laura J Baumgartner Department of Clinical Sciences, Touro University California College of Pharmacy, Vallejo, CA, USA Sujana Dontukurthy NY, USA Robert D Beckett Manchester University College of Pharmacy, Natural, and Health Sciences, Fort Wayne, IN, USA Kirk Evoy College of Pharmacy, The University of Texas at Austin, Austin; School of Medicine, University of Texas Health Science Center San Antonio, Pharmacotherapy Education and Research Center, San Antonio, TX, USA Renee A Bellanger Department of Pharmacy Practice, University of the Incarnate Word, Feik School of Pharmacy, San Antonio, TX, USA New York Methodist Hospital, Brooklyn, Jingyang Fan Department of Pharmacy Practice, SIUE School of Pharmacy, Edwardsville, IL, USA Nicholas T Bello Department of Animal Sciences, School of Environmental and Biological Sciences, Rutgers, The State University of New Jersey, New Brunswick, NJ, USA Elizabeth Flockton Royal Liverpool Hospital, Liverpool, United Kingdom Cynthia E Franklin Department of Pharmaceutical Sciences, University of the Incarnate Word, Feik School of Pharmacy, San Antonio, TX, USA Skye Bickett Medical Librarian Assistant Director of Library Services, PCOM, Suwanee, GA, USA Lynn Frendak Department of Pharmacy, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA Adrienne T Black 3E Company, Warrenton, VA, USA Alison Brophy Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway; Saint Barnabas Medical Center, Livingston, NJ, USA Jason C Gallagher Temple University, Philadelphia, PA, USA Nidhi Gandhi Department of Pharmacy Practice, PCOM School of Pharmacy, Suwanee, GA, USA Maria Cardinale Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway; Saint Peter’s University Hospital, New Brunswick, NJ, USA Tatsuya Gomi Department of Radiology, Ohashi Medical Center, Toho University, Tokyo, Japan Saira B Chaudhry Ernest Mario School of Pharmacy, RutgersThe State University of New Jersey, Piscataway, NJ, USA Joshua P Gray Department of Science, United States Coast Guard Academy, New London, CT, USA James Chue Clinical Trials and Research Program, Edmonton, AB, Canada Andrew L Griffiths Asthma & Allergy Group, Swansea University Medical School, Institute of Life Science 1, Swansea University, Swansea, United Kingdom Pierre Chue University of Alberta, Edmonton, AB, Canada Karyn I Cotta Department of Pharmaceutical Sciences, South University School of Pharmacy, Savannah, GA, USA Kristopher G Hall Department of Pharmaceutical Sciences, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA Bryony Coupe Asthma & Allergy Group, Swansea University Medical School, Institute of Life Science 1, Swansea University, Swansea, United Kingdom Makoto Hasegawa Department of Radiology, Ohashi Medical Center, Toho University, Tokyo, Japan Kendra M Damer Butler University College of Pharmacy and Health Sciences, Indianapolis, IN, USA Christopher S Holaway Department of Pharmacy Practice, PCOM School of Pharmacy, Suwanee, GA, USA Gwyneth A Davies Asthma & Allergy Group, Swansea University Medical School, Institute of Life Science 1, Swansea University, Swansea, United Kingdom Sandra L Hrometz Department of Pharmaceutical Sciences, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA v vi CONTRIBUTORS I-Kuan Hsu Department of Clinical Sciences, Touro University California College of Pharmacy, Vallejo, CA, USA Cassandra Maynard Department of Pharmacy Practice, SIUE School of Pharmacy, Edwardsville, IL, USA Eric J Ip Department of Clinical Sciences, Touro University California College of Pharmacy, Vallejo, CA, USA Renee McCafferty Department of Pharmacy Practice, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA Jason Isch PGY2 Ambulatory Care, Saint Joseph Health System, Mishawaka, IN, USA Abhishek Jha Royal Liverpool Hospital, Liverpool, United Kingdom Dayna S McManus Department of Pharmacy Services, YaleNew Haven Hospital, Yale University, New Haven, CT, USA Carrie M Jung Butler University College of Pharmacy and Health Sciences; Eskenazi Health, Indianapolis, IN, USA Calvin J Meaney Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY, USA Allison Kalstein USA Philip B Mitchell School of Psychiatry, University of New South Wales; Black Dog Institute, Sydney, NSW, Australia New York Methodist Hospital, Brooklyn, NY, Spinel Karas Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY, USA Sipan Keshishyan Department of Pharmacy Practice, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA Madan K Kharel School of Pharmacy and Health Professions, University of Maryland at Eastern Shore, Princess Anne, MD, USA Nicole Kiehle Department of Pharmacy, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA Vladlena Kovalevskaya Department of Pharmaceutical Sciences, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA Justin G Kullgren Department of Pharmacy, The Ohio State University Wexner Medical Center, Columbus, OH, USA Dirk W Lachenmeier Chemisches und Veterin€aruntersuchungsamt (CVUA) Karlsruhe, Karlsruhe, Germany Bonnie Lau Department of Clinical Sciences, Touro University California College of Pharmacy, Vallejo; Department of Emergency Medicine, Kaiser Permanente Santa Clara Medical Center, Santa Clara; Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, CA, USA Tina C Lee University of the Incarnate Word Feik School of Pharmacy, San Antonio, TX, USA Linda Lim College of Pharmacy, The University of Texas at Austin, Austin; School of Medicine, University of Texas Health Science Center San Antonio, Pharmacotherapy Education and Research Center, San Antonio, TX, USA Tristan Lindfelt Department of Clinical Sciences, Touro University California College of Pharmacy, Vallejo, CA, USA Mei T Liu Jersey City Medical Center, Jersey City, NJ, USA Megan E Maroney Rutgers University Ernest Mario School of Pharmacy, Piscataway, NJ, USA Ashley Martinelli Department of Pharmacy, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA Mark Martinez Department of Pharmacy Practice, PCOM School of Pharmacy, Suwanee, GA, USA Dianne May University of Georgia College of Pharmacy on Augusta University Campus, Augusta, GA, USA Vicky V Mody Department of Pharmaceutical Sciences, PCOM School of Pharmacy, Suwanee, GA, USA Kaitlin Montagano Department of Pharmaceutical Sciences, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA Toshio Nakaki Department of Pharmacology, Teikyo University School of Medicine, Tokyo, Japan Anjan Nan Department of Pharmaceutical Sciences, University of Maryland Eastern Shore School of Pharmacy, Princess Anne, MD, USA Diane Nguyen Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA John D Noti Allergy and Clinical Immunology Branch, Health Effects Laboratory Division, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Morgantown, WV, USA Igho J Onakpoya Nuffield Department of Primary Care Health Sciences, Oxford, United Kingdom Michael G O’Neil Department of Pharmacy Practice, Drug Diversion, Pain Management and Substance Abuse Specialist, South College School of Pharmacy, Knoxville, TN, USA Yekaterina Opsha Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway; Saint Barnabas Medical Center, Livingston, NJ, USA Sreekumar Othumpangat Allergy and Clinical Immunology Branch, Health Effects Laboratory Division, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Morgantown, WV, USA Harish Parihar Department of Pharmacy Practice, PCOM School of Pharmacy, Suwanee, GA, USA Deepa Patel Department of Pharmacy Practice, PCOM School of Pharmacy, Suwanee, GA, USA Punam B Patel Department of Clinical Sciences, Touro University California College of Pharmacy, Vallejo, CA, USA Michelle M Peahota Infectious Diseases, Thomas Jefferson University Hospital, Philadelphia, PA, USA Alan Polnariev College of Pharmacy, University of Florida, Gainesville, FL, USA Hanna Raber College of Pharmacy, The University of Utah, Salt Lake City, UT, USA Sushma Ramsinghani Department of Pharmaceutical Sciences, University of the Incarnate Word, Feik School of Pharmacy, San Antonio, TX, USA vii CONTRIBUTORS Sidhartha D Ray Department of Pharmaceutical Sciences, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA David Reeves Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Butler University; Department of Pharmacy, St Vincent Indianapolis Hospital, Indianapolis, IN, USA Jonathan Smithson School of Psychiatry, University of New South Wales; Black Dog Institute, Sydney, NSW, Australia Brian Spoelhof Department of Pharmacy, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA Lisa V Stottlemyer Wilmington VA Medical Center, Wilmington, DE; Pennsylvania College of Optometry, Elkins Park, PA, USA Lucia Rivera Lara Departments of Neurology, Anesthesiology, and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA Kalee Swanson Department of Pharmaceutical Sciences, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA Nicholas Robinson Manchester University College of Pharmacy, Natural, and Health Sciences, Fort Wayne, IN, USA Fred R Tejada School of Pharmacy and Health Professions, University of Maryland at Eastern Shore, Princess Anne, MD, USA Lauren K Roller Department of Clinical Sciences, Touro University California College of Pharmacy, Vallejo, CA, USA Kelan L Thomas Touro University California College of Pharmacy, Vallejo, CA, USA Lucia Rose Infectious Diseases, Cooper University Hospital, Camden, NJ, USA Sonia Thomas Department of Pharmacy Practice, PCOM School of Pharmacy, Suwanee, GA, USA Audrey Rosene Manchester University College of Pharmacy, Natural, and Health Sciences, Fort Wayne, IN, USA Sara N Trovinger Department of Pharmacy Practice, Manchester University College of Pharmacy, Natural and Health Sciences, Fort Wayne, IN, USA Christina Seeger University of the Incarnate Word, Feik School of Pharmacy, San Antonio, TX, USA Kirby Welston AU Medical Center/University of Georgia College of Pharmacy, Augusta, GA, USA Mona U Shah Department of Pharmacy, Falls Church, VA, USA Andrea L Wilhite Manchester University College of Pharmacy, Natural, and Health Sciences, Fort Wayne, IN, USA Ajay N Singh Department of Pharmaceutical Sciences, South University School of Pharmacy, Savannah, GA, USA Zhiqian Wu Department of Pharmaceutical Sciences, PCOM School of Pharmacy, Suwanee, GA, USA Michel R Smith School of Pharmacy and Health Professions, University of Maryland at Eastern Shore, Princess Anne, MD, USA Joel Yarmush USA Thomas Smith Manchester University College of Pharmacy, Fort Wayne, IN, USA New York Methodist Hospital, Brooklyn, NY, Matthew R Zahner Drug Safety and Research Development, Pfizer, Groton, CT, USA Preface Side Effects of Drugs: Annual (SEDA) is a yearly publication focused on existing, new and evolving side effects of drugs encountered by a broad range of healthcare professionals including physicians, pharmacists, nurse practitioners, and advisors of poison control centers This 37th edition of SEDA includes analyses of the side effects of drugs using both clinical trials and case-based principles which include encounters identified during bedside clinical practice over the 18 months since the previous edition SEDA seeks to summarize the entire body of relevant medical literature into a single volume with dual goals of being comprehensive and of identifying emerging trends and themes in medicine as related to side effects and adverse drug effects (ADEs) With a broad range of topics authored by practicing clinicians and scientists, SEDA is a comprehensive and reliable reference to be used in clinical practice The majority of the chapters include relevant case studies that are not only peer-reviewed but also have a forwardlooking, learning-based focus suitable for practitioners as well as students in training The nationally known contributors believe this educational resource can be used to stimulate an active learning environment in a variety of settings Each chapter in this volume has been reviewed by the editor, experienced clinical educators, actively practicing clinicians and scientists to ensure the accuracy and timeliness of the information The overall objective is to provide a framework for further understanding the intellectual approaches in analyzing the implications of the case studies and their appropriateness when dispensing medications, as well as interpreting adverse drug reactions (ADRs), toxicity and outcomes resulting from medication errors This issue of SEDA is the first to include perspectives from pharmacogenomics/pharmacogenetics and personalized medicine Due to the advances in science, the genetic profiles of patients must be considered in the etiology of side effects, especially for medications provided to very large populations This marks the first phase of genome-based personalized medicine, in which side effects of common medications are linked to polymorphisms in one or more genes A focus on personalized medicine should lead to major advances for patient care and awareness among clinicians to deliver the most effective medication for the patient This modality should considerably improve ‘appropriate medication use’ and enable the clinicians to pre-determine “good versus the bad responders”, and help reduce ADRs Overall, clinicians will have a better control on ‘predictability and preventability’ of ADEs induced by certain medications Over time, it is anticipated that pharmacogenetics and personalized medicine will become an integral part of the practice sciences SEDA will continue to highlight the genetic basis of side effects in future editions The collective wisdom, expertise and experience of the editor, authors and reviewers were vital in the creation of a volume of this breadth Reviewing the appropriateness, timeliness and organization of this edition consumed an enormous amount of energy by the authors, reviewers and the editor, which we hope will facilitate the flow of information inter-professionally among health practitioners, professionals in training, and students, and will ultimately improve patient care Scanning for accuracy, rebuilding and reorganizing information between each edition is not an easy task; therefore, the editor had the difficult task of accepting or rejecting information The editor will consider this undertaking worthwhile if this publication helps to provide better patient care; fulfills the needs of the healthcare professionals in sorting out side effects of medications, medication errors or adverse drug reactions; and stimulates interest among those working and studying medicine, pharmacy, nursing, physical therapy, chiropractic, and those working in the basic therapeutic arms of pharmacology, toxicology, medicinal chemistry and pathophysiology Editor of this volume gratefully acknowledge the leadership provided by the former editor Prof J.K Aronson, all the contributors and reviewers, and will continue to maintain the legacy of this publication by building on their hard work The editor would also like to extend special thanks for the excellent support and assistance provided by Ms Zoe Kruze (Publisher, serials and series) and Ms Shellie Bryant (Editorial Project Manager) during the compilation of this work Sidhartha D Ray Editor xvii Special Reviews in SEDA 38 Chapter – Lithium Susceptibility Factors Chapter – Anti-Inflammatory and Antipyretic Analgesics and Drugs Used in Gout Special Review – New Drug Approval: Lesinurad Chapter 11 – Neuromuscular Blocking Agents and Skeletal Muscle Relaxants Neuromuscular Blockers: Reversal Agents Chapter 12 – Drugs That Affect Autonomic Functions or the Extrapyramidal System Dopamine Receptor Agonists • Piribedil and impulse control disorders Chapter 14 – Antihistamines (H1 Receptor Antagonists) Special Review – RX: Pharmacogenetics • Rupatadine & other antihistamines 26 83 108 119 144 Chapter 15 – Drugs That Act on the Respiratory Tract Olodaterol Monoclonal Antibodies in the Treatment of Asthma Chapter 25 – Antifungal Drugs Special Review – Drug–Drug Interactions and Pharmacogenomics of the Azoles Antifungal 157,161 Chapter 33 – Drugs that Affect Blood Coagulation, Fibrinolysis and Hemostasis Special Review – Idarucizumab 375 Chapter 34 – Gastrointestinal Drugs Proton-Pump Inhibitors (PPIs) 10 Chapter 36 – Drugs That Act on the Immune System: Immunosuppressive and Immunostimulatory Drugs Special Review – Association of Genetic Factors and Adverse Effects of Thiopurines 11 Chapter 43 – Cytostatic Agents—Tyrosine Kinase Inhibitors Utilized in the Treatment of Solid Malignancies Special Review – Skin 12 Chapter 44 – Radiological Contrast Agents and Radiopharmaceuticals Special Review – B-Raf Inhibitors • Vemurafenib and Dabrafenib 13 Chapter 45 – Drugs Used in Ocular Treatment Special Review on Pharmacogenetics • Gadolinium accumulation xix 249 379 418 487 498 509 Table of Essays, Annuals 1–37 SEDA Author Country Title M.N.G Dukes The Netherlands The moments of truth K.H Kimbel Germany Drug monitoring: why care? L Lasagna USA Wanted and unwanted drug effects: The need for perspective M.N.G Dukes The Netherlands The van der Kroef syndrome J.P Griffin, P.F D’Arcy UK Adverse reactions to drugs—the information lag I Bayer Hungary Science vs practice and/or practice vs science E Napke Canada Adverse reactions: some pitfalls and postulates M.N.G Dukes Denmark The seven pillars of foolishness W.H.W Inman UK Let’s get our act together 10 S Van Hauen Denmark Integrated medicine, safer medicine and “AIDS” 11 M.N.G Dukes Denmark Hark, hark, the fictitious dogs bark 12 M.C Cone Switzerland Both sides of the fence 13 C Medawar UK On our side of the fence 14 M.N.G Dukes, E Helsing Denmark The great cholesterol carousel 15 P Tyrer UK The nocebo effect—poorly known but getting stronger 16 M.N.G Dukes Denmark Good enough for Iganga? 17 M.N.G Dukes Denmark The mists of tomorrow 18 R.D Mann UK Databases, privacy, and confidentiality—the effect of proposed legislation on pharmacoepidemiology and drug safety monitoring 19 A Herxheimer UK Side effects: Freedom of information and the communication of doubt 20 E Ernst UK Complementary/alternative medicine: What should we about it? 21 H Jick USA Thirty years of the Boston Collaborative Drug Surveillance Program in relation to principles and methods of drug safety research 22 J.K Aronson, R.E Ferner UK Errors in prescribing, preparing, and giving medicines: Definition, classification, and prevention 23 K.Y Hartigan-Go, J.Q Wong Philippines Inclusion of therapeutic failures as adverse drug reactions 24 IPalmlund UK Secrecy hiding harm: case histories from the past that inform the future 25 L Marks UK The pill: untangling the adverse effects of a drug 26 D.J Finney UK From thalidomide to pharmacovigilance: a Personal account 26 L.L.Iversen UK How safe is cannabis? 27 J.K Aronson UK Louis Lewin—Meyler’s predecessor 27 H Jick USA The General Practice Research Database 28 J.K Aronson UK Classifying adverse drug reactions in the twenty-first century 29 M Hauben, A Bate USA/Sweden Data mining in drug safety 30 J.K Aronson UK Drug withdrawals because of adverse effects 31 J Harrison, P Mozzicato USA MedDRA®: The Tale of a Terminology 32 K Chan Australia Regulating complementary and alternative medicines xxi xxii TABLE OF ESSAYS, ANNUALS 1–37 SEDA Author Country Title 33 Graham Dukes Norway Third-generation oral contraceptives: time to look again? 34 Yoon K Loke UK An agenda for research into adverse drug reactions 35 J.K Aronson UK Observational studies in assessing benefits and harms: Double standards? 36 J.K Aronson UK Mechanistic and Clinical Descriptions of Adverse Drug Reactions Definitive (Between-the-Eyes) Adverse Drug Reactions 37 Sidhartha D Ray USA ADRs, ADEs and SEDs: A Bird’s Eye View Abbreviations The following abbreviations are used throughout the SEDA series 2,4-Dimethoxyamfetamine 3,4-Dimethoxyamfetamine Lamivudine (dideoxythiacytidine) Attention deficit hyperactivity disorder Adenosine diphosphate Antinuclear antibody Antineutrophil cytoplasmic antibody Acellular pertussis Acute physiology and chronic health evaluation (score) Activated partial thromboplastin time American Society of Anesthesiologists Anti-Saccharomyces cerevisiae antibody The area under the concentration versus time curve from zero to infinity The area under the concentration versus time curve from zero to time x The area under the concentration versus time curve from zero to the time of the last sample The area under the concentration versus time curve during a dosage interval Anthrax vaccine adsorbed Zidovudine (azidothymidine) Bacillus Calmette Guérin Twice a day (bis in die) Bispectral index Body mass index Continuous ambulatory peritoneal dialysis Cluster of differentiation (describing various glycoproteins that are expressed on the surfaces of T cells, B cells and other cells, with varying functions) CI Confidence interval Maximum (peak) concentration after a dose Cmax Maximum (peak) concentration after a dose at steady state Css.max Minimum (trough) concentration after a dose at steady state Css.min COX-1 and COX-2 Cyclo-oxygenase enzyme isoforms and CT Computed tomography CYP (e.g CYP2D6, CYP3A4) Cytochrome P450 isoenzymes D4T Stavudine (didehydrodideoxythmidine) DDC Zalcitabine (dideoxycytidine) DDI Didanosine (dideoxyinosine) DMA Dimethoxyamfetamine; see also 2,4-DMA, 3,4-DMA DMMDA 2,5-Dimethoxy-3,4-methylenedioxyamfetamine DMMDA-2 2,3-Dimethoxy-4,5-methylenedioxyamfetamine DTaP Diphtheria + tetanus toxoids + acellular pertussis DTaP-Hib-IPV-HB Diphtheria + tetanus toxoids + acellular pertussis + IPV + Hib + hepatitis B (hexavalent vaccine) DT-IPV Diphtheria + tetanus toxoids + inactivated polio vaccine DTP Diphtheria + tetanus toxoids + pertussis vaccine DTwP Diphtheria + tetanus toxoids + whole cell pertussis eGFR Estimated glomerular filtration rate ESR Erythrocyte sedimentation rate FDA (US) Food and Drug Administration Forced expiratory volume in s FEV1 FTC Emtricitabine FVC Forced vital capacity G6PD Glucose-6-phosphate dehydrogenase GSH Glutathione GST Glutathione S-transferase HAV Hepatitis A virus Hemoglobin A1c HbA1c HbOC Conjugated Hib vaccine (Hib capsular antigen polyribosylphosphate covalently linked to the nontoxic diphtheria toxin variant CRM197) HBV Hepatitis B virus 2,4-DMA 3,4-DMA 3TC ADHD ADP ANA ANCA aP APACHE aPTT ASA ASCA AUC AUC0!x AUC0!t AUCτ AVA AZT BCG bd BIS BMI CAPD CD [4, 8, etc] xxiii xxiv HDL, LDL, VLDL Hib HIV hplc HPV HR HZV ICER Ig (IgA, IgE, IgM) IGF INN INR IPV IQ [range], IQR JE LABA MAC MCV4 MDA MDI MDMA MenB MenC MIC MIM MMDA MMDA-2 MMDA-3a MMR MMRV MPSV4 MR MRI NMS NNRTI NNT, NNTB, NNTH NRTI NSAIDs od OMIM OPV OR OROS PCR PMA PMMA PPAR ppb PPD ppm PRP-CRM PRP-D-Hib PT PTT QALY qds ROC curve RR RT-PCR SABA SMR SNP SNRI SSRI ABBREVIATIONS High-density lipoprotein, low-density lipoprotein, and very low density lipoprotein (cholesterol) Haemophilus influenzae type b Human immunodeficiency virus High-performance liquid chromatography Human papilloma virus Hazard ratio Herpes zoster virus vaccine Incremental cost-effectiveness ratio Immunoglobulin (A, E, M) Insulin-like growth factor International Nonproprietary Name (rINN ¼ recommended; pINN ¼ provisional) International normalized ratio Inactivated polio vaccine Interquartile [range] Japanese encephalitis vaccine Long-acting beta-adrenoceptor agonist Minimum alveolar concentration 4-valent (Serogroups A, C, W, Y) meningococcal Conjugate vaccine 3,4-Methylenedioxyamfetamine Metered-dose inhaler 3,4-Methylenedioxymetamfetamine Monovalent serogroup B meningoccocal vaccine Monovalent serogroup C meningoccocal conjugate vaccine Minimum inhibitory concentration Mendelian Inheritance in Man (see http://www.ncbi.nlm.nih.gov/omim/607686) 3-Methoxy-4,5-methylenedioxyamfetamine 2-Methoxy-4,5-methylendioxyamfetamine 2-Methoxy-3,4-methylendioxyamfetamine Measles + mumps + rubella Measles + mumps + rubella + varicella 4-Valent (serogroups A, C, W, Y) meningococcal polysaccharide vaccine Measles + rubella vaccine Magnetic resonance imaging Neuroleptic malignant syndrome Non-nucleoside analogue reverse transcriptase inhibitor Number needed to treat (for benefit, for harm) Nucleoside analogue reverse transcriptase inhibitor Nonsteroidal anti-inflammatory drugs Once a day (omne die) Online Mendelian Inheritance in Man (see http://www.ncbi.nlm.nih.gov/omim/607686) Oral polio vaccine Odds ratio Osmotic-release oral system Polymerase chain reaction Paramethoxyamfetamine Paramethoxymetamfetamine Peroxisome proliferator-activated receptor Parts per billion Purified protein derivative Parts per million See HbOC Conjugated Hib vaccine(Hib capsular antigen polyribosylphosphate covalently Linked to a mutant polypeptide of diphtheria toxin) Prothrombin time Partial thromboplastin time Quality-adjusted life year Four times a day (quater die summendum) Receiver-operator characteristic curve Risk ratio or relative risk Reverse transcriptase polymerase chain reaction Short-acting beta-adrenoceptor agonist Standardized mortality rate Single nucleotide polymorphism Serotonin and noradrenaline reuptake inhibitor Selective serotonin reuptake inhibitor 548 anaphylaxis adrenaline, 115 cefazolin, 220 cobalamins, 357 influenza vaccines, 310 iron salts, 198 methocarbamol, 112 thiamine, 359 ANCA-positive vasculitis propylthiouracil, 446 anemia artemether–lumefantrine, 256 artesunate, 258–259 ciprofloxacin, 232 clozapine, 41 continuous renal replacement therapy (CRRT), 525 cyclophosphamide, 408 daratumumab, 399 levamisole, 297, 299 nivolumab, 401–402 pembrolizumab, 133 ribavirin, 270 sofosbuvir, 272–273 temsirolimus, 417 valganciclovir, 263 angina amiodarone, 167 misoprostol, 429 angioedema alteplase, 371–372 haloperidol, 43 nevirapine, 137 angioneurotic oedema thiamine, 359–360 ankle arthritis levamisole, 297 ankle pain levamisole, 297 anorexia artesunate, 258 dihydroartemisinin–piperaquine, 256 methylphenidate, 3–4 olanzapine, 43 telavancin, 234 anticholinergic initiation olanzapine, 43 risperidone, 35 anuric acute renal failure albendazole, 296 anxiety aripiprazole, 38 epoprostenol, 428 evolocumab, 475–476 mefloquine, 259 quetiapine, 45 aphasia apixaban, 370 appetite asenapine, 39 risperidone, 46 appetite decreases enfuvirtide, 276 nivolumab, 401–402 posaconazole, 247 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS application site erythema rivastigmine, 7–8 arrhythmia aripiprazole, 39 clarithromycin, 237 fingolimod, 411 ziprasidone, 47 arterial calcification warfarin, 365 arterial hypertension eplerenone, 189 arthralgia alirocumab, 475 betamethasone, 134 bevacizumab, 398 calcipotriol, 134 combination therapy, 205 enfuvirtide, 276 evolocumab, 400, 475 levamisole, 303 melatonin, 464 primaquine, 257 arthritis combination therapy, 205 aseptic meningitis eltrombopag, 395 aspartate aminotransferase (AST) albendazole, 255 asthenia everolimus, 410 nivolumab, 401–402 quetiapine, 45 retigabine, 63 risperidone, 46 vismodegib, 131 asthma antihistamines, 144 folic acid, 358 mepolizumab, 401 ataxia gabapentin, 56–57 lithium, 22–24 atopic dermatitis antihistamines, 144 azathioprine, 130–131 betamethasone, 130–131 crisaborole, 131 JNJ-39758979, 131 tacrolimus, 131 UR-1505, 131 atrial fibrillation clozapine, 41 vismodegib, 131 atrioventricular block ticagrelor, 374 vitamin A, 355–356 atrophic plaques levamisole, 303 attention deficit lithium, 22 auditory hallucinations aripiprazole, 38 autism antidepressants drugs, 14 autoimmune diseases cyclophosphamide, 407 autoimmune hepatitis albendazole, 255, 296 B back pain alirocumab, 474–475 barbiturates, 55 enfuvirtide, 276 evolocumab, 475–476 mepolizumab, 401 primaquine, 257 systemic glucocorticoids, 426 basal cell carcinoma vismodegib, 131 behavioral disturbance perampanel, 61 bilateral mydriasis fentanyl, 73 bilateral vision loss, acute topiramate, 63 bilirubin elevation octreotide, 445 bipolar disorder lithium, 21–22, 27 birth defects methimazole, 447 bladder cancer vismodegib, 131 blastomyces dermatitidis infliximab, 397 bleeding aripiprazole, 39 eptifibatide, 372–373 ticagrelor, 374 blepharitis erlotinib, 484–485 blepharospasm botulinum toxin, 110 bloating pain opioids, 71 blood creatinine increase combination therapy, 205 blood disorders tacrolimus, 416 blood transfusion eptifibatide, 373 blurred vision carbamazepine, 55–56 chlorpheniramine, 147 crizotinib, 486 gabapentin, 57 primaquine, 257 zonisamide, 66 BMI increase diencephalon, 35 olanzapine, 35 body ache albendazole, 295 clozapine, 40–41 bone disease antidepressant drugs, 14–15 cyclophosphamide, 408 bone loss levothyroxine, 444 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS bone pain filgrastim-sndz, 395 posaconazole, 247 bowel incontinence lithium, 22–23 bradyarrhythmia timolol, 174–175 bradycardia lithium, 21–22 neostigmine, 108 bradykinesia piribedil, 119–120 breast cancer acetaminophen, 77 hormone replacement therapy, 434 breath difficulty melatonin, 464 breath shortness hydroxyzine, 148 mycophenolate mofetil, 413 brittleness voriconazole, 248 bronchitis mepolizumab, 401 bronchoconstriction midazolam, 29 bronchospasm neostigmine, 108 bruising sodium hypochlorite, 214 bullae phenytoin, 62 bullous eruption tetracaine, 103 burning benzocaine, 100 chlorpheniramine, 147 5-fluorouracil, 130 tretinoin, 129 C cancer dipeptidyl peptidase-4 (DPP-4) inhibitors, 456 HMG-CoA reductase inhibitors, 473–474 cardiac arrest adrenaline, 115–116 lidocaine, 101 cardiac arrhythmias caffeine, 515 cardiac complications adrenaline, 115–116 antidepressant drugs, 12–14 secukinumab, 403 cardiogenic shock tramadol, 74 cardiomyopathy clozapine, 41 cobalt, 197 ranolazine, 176 cardiovascular death dipeptidyl peptidase-4 inhibitors, 454–456 cardiovascular disease cyclophosphamide, 408 hormone replacement therapy (HRT), 434 niacin, 470–471 cardiovascular toxicity dantrolene, 109–110 cataracts HMG-CoA reductase inhibitors, 472 catecholamine-dependent shock brentuximab, 398 catheter-related bloodstream infections parenteral nutrition, 362 cellulitis oritavancin, 135, 234 vancomycin, 135 cerebellar ataxia deferiprone, 207 cerebral hemorrhage ipilimumab, 132 cervical cancer azathioprine, 418 cervical dystonia quetiapine, 45 chest pain dobutamine, 118 epoprostenol, 428 oxytocin, 465 rituximab, 403 CHF See congestive heart failure chills brentuximab, 398 epoprostenol, 428 levamisole, 297 meropenem, 217–218 misoprostol, 429 primaquine, 257 cholangiocarcinoma praziquantel, 304 choreoathetosis lithium, 24 chronic kidney disease cidofovir, 261 chronic liver disease propranolol, 174 chronic lung disease systemic glucocorticoids, 427 chronic obstructive pulmonary disease apremilast, 133 glycopyrronium, 124 chronic renal dysfunction lithium, 25 chronic urticaria antihistamines, 144 cirrhosis albendazole, 295–296 telaprevir, 269–270 clinical myocarditis influenza vaccines, 309–310 clonus fentanyl, 73 cognitive impairment lithium, 22 cold phenylephrine, 117 colitis pembrolizumab, 133 conduction disturbances amphetamine and amphetamine derivates, 549 confluent pruriginous maculopapular eruption telaprevir, 269–270 confusion artesunate, 258 ertapenem, 217 gabapentin, 57 levamisole, 298 lithium, 24 metoprolol, 173–174 olanzapine, 43 telavancin, 234 timolol, 174–175 congenital malformation aripiprazole, 37 olanzapine, 37 quetiapin, 37 risperidone, 37 congestive heart failure axitinib, 480 pazopanib, 480 sorafenib, 480 sunitinib, 480 vandetanib, 480 conjunctival hyperemia bimatoprost, 429 5-fluorouracil, 129–130 conjunctivitis afatinib, 484–485 constipation alvimopan, 71–72 bile acid sequestrants, 469 cariprazine, 40 clozapine, 40–41 duloxetine, 17 isavuconazole, 249 loxapine, 43 melatonin, 464 mycophenolate mofetil, 414 octreotide, 445 opioids, 71 paliperidone, 44 promethazine, 388 contusion evolocumab, 475 COPD exacerbation roflumilast, 161 corneal micro-deposits amiodarone, 166 corneal opacities chlorpromazine, 40 coronary artery disease adrenaline, 115 zolpidem, 30 coronary syndrome, acute vitamin A, 355 cough aclidinium bromide, 158–159 daratumumab, 399 dihydroartemisinin–piperaquine, 256 EGFR, 483 glycopyrronium, 124 hydroxyzine, 148 iloprost, 428 indacaterol, 118 isavuconazole, 249 550 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS cough (Continued) loxapine, 43 nivolumab, 402 thrombopoietin receptor agonists, 347 vilanterol, 158 cranial neuropathy vincristine, 251 Crohn’s disease secukinumab, 403 cryoprecipitate, 341 crystalluria amoxicillin, 218 cutaneous events brentuximab, 399 cutaneous leucocytoclastic vasculitis proprotein convertase subtilisin/kexin type 9, 474 cutaneous skin reactions lithium, 27 cyanosis dapsone gel, 526 CYP2D6 activity decrease metoprolol, 173–174 cystic fibrosis voriconazole, 247–248 cystic lesions vemurafenib, 132 cytokine release syndrome brentuximab, 398–399 cytomegalo virus infection azathioprine, 418 tacrolimus, 416 D dark tea-colored urine quinacrine, 257 death aluminum, 193 caffeine, 515 clozapine, 40 digoxin, 165–166 ephedrine, 116 erythrocytes, 336 glycopyrronium, 124 mycophenolate mofetil, 414 poliovirus vaccines, 320 systemic glucocorticoids, 427 deep vein thrombosis brentuximab, 136 fondaparinux, 371 idarucizumab, 375 dehydration brentuximab, 136 colchicine, 82 delirium idarucizumab, 400 delutions metoprolol, 173–174 dementia amisulpride, 37 aripiprazole, 36–37 lithium, 22–23 olanzapine, 36 quetiapine, 36 risperidone, 36–37 sulpiride, 37 depression dantrolene, 109–110 levamisole, 297 mefloquine, 259 melatonin, 464 oxcarbazepine, 60 paliperidone, 44 perampanel, 61 ribavirin, 270 dermatitis chromium, 196 ipilimumab, 132 vitamin B6, 358 dermatitis neglecta lithium, 25–26 diabetes alirocumab, 474 HMG-CoA reductase inhibitors, 472 rituximab, 403 tacrolimus, 416 zolpidem, 30 diabetes mellitus cyclosporine, 410 risperidone, 35–36 tacrolimus, 416 diaphoresis rituximab, 403 diarrhea afatinib, 135–136 apremilast, 133–134, 137 armodafinil, 5–6 axitinib, 479 cabozantinib, 479–480 calcitonin, 463 ceftaroline, 221–222 combination therapy, 205 cyclophosphamide, 408 cyclosporine, 409 deferasirox, 206 EGFR, 482–483 elotuzumab, 399–400 epoprostenol, 428 eprosartan, 180 erlotinib, 483–484 eslicarbazepine, 56 evolocumab, 475 gefitinib, 483–484 histamine-2 receptor antagonists (H2RAs), 379 iloprost, 428 interleukin-2, 396 levamisole, 296–297 losartan, 180 methotrexate, 135–136 misoprostol, 429 mycophenolate mofetil, 413–414 nimotuzumab, 402 nivolumab, 132–133, 401–402 olmesartan, 180–181 oral methylnaltrexone, 71–72 pazopanib, 479 pembrolizumab, 133 promethazine, 388 regorafenib, 479 roflumilast, 161 selexipag, 429–430 sorafenib, 479 sunitinib, 479–480 systemic glucocorticoids, 426 tacrolimus, 416 telavancin, 234 vandetanib, 479 vilazodone, 18 vismodegib, 131 vitamin B6, 359 diffuse alveolar hemorrhage alemtuzumab, 398 diffuse erythema dihydrocodeine, 72–73 diplopia crizotinib, 486 disorientation olanzapine, 43 dizziness abacavir, 274–275 alirocumab, 475 atazanavir, 275 bupivacaine, 101 carbamazepine, 55–56 chlorpheniramine, 147 droxidopa, 117 enfuvirtide, 276 eslicarbazepine, 56 evolocumab, 475–476 fingolimod, 411–412 gabapentin, 56–57 iloperidone, 43 lacosamide, 57 levetiracetam, 58 melatonin, 464 methocarbamol, 112 olanzapine, 43 perampanel, 61–62 phenytoin, 62 pramipexole, 124 retigabine, 63 ropinirole, 119 rotigotine, 119 selexipag, 429–430 skeletal muscle relaxants, 109–110 zonisamide, 66 downbeat nystagmus lithium, 24 drooling aripiprazole, 38 drowsiness aripiprazole, 38 doxylamine, 147–148 gabapentin, 57 levosulpiride, 43 loxapine, 43 melatonin, 464 methocarbamol, 112 skeletal muscle relaxants, 109–110 drug allergy terbinafine, 243 dry cough warfarin, 366 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS dry eye symptoms bimatoprost, 429 dry mouth aclidinium bromide, 158–159 iloperidone, 43 loxapine, 43 oxybutynin, 125 quetiapine, 45 skeletal muscle relaxants, 109–110 solifenacin, 125 vilanterol, 158 dryness tretinoin, 129 dysarthria levamisole, 298 lithium, 22–24 olanzapine, 43 dysgeusia loxapine, 43 nivolumab, 402 vismodegib, 131 dyskinesia levodopa, 123 olanzapine, 35 risperidone, 35 ropinirole, 119 rotigotine, 119 ziprasidone, 35 dyskinetic movements aripiprazole, 39 dyslipidemia mycophenolate mofetil, 413–414 niacin, 470–471 tacrolimus, 416 dyspepsia alvimopan, 71–72 bile acid sequestrants, 469 cariprazine, 40 cyclosporine, 409 evolocumab, 475–476 lurasidone, 43 methocarbamol, 112 mycophenolate mofetil, 414 promethazine, 388 dysphagia botulinum toxin, 110–111 levamisole, 298 lithium, 22–23 dysphonia salmeterol, 158 dyspnea alpha1 antitrypsin (AAT), 340 botulinum toxin, 110–111 brentuximab, 398 dabigatran, 369 everolimus, 410 iloprost, 428 indacaterol, 118 levamisole, 297 nivolumab, 402 ticagrelor, 374 vemurafenib, 488 vilanterol, 158 warfarin, 366 dysregulation syndrome piribedil, 120 dysrhythmias amphetamine and amphetamine derivates, dystonia botulinum toxin, 110 escitalopram, 16 olanzapine, 43 risperidone, 46 dysuria quetiapine, 45 E edema anegrelide, 372 atenolol, 173 levamisole, 297 midazolam, 29 pembrolizumab, 133 quetiapine, 46 subcutaneous immunoglobulin, 344 systemic glucocorticoids, 427 ejaculatory dysfunction risperidone, 46 elective termination human papillomavirus vaccine, 308 electrolyte abnormalities vincristine, 251 electrolyte balance sulfonylureas, 461 elevations in liver function tests brentuximab, 399 emesis vitamin B6, 359 encephalopathy colchicine, 82 metformin, 460 end-stage renal disease (ESRD) lithium, 25 sitagliptin, 456 enuresis risperidone, 46 valproic acid, 64 eosinophilia clozapine, 41–42 terbinafine, 243–244 episodic memory deficit lithium, 22 epistaxis idarucizumab, 375 nivolumab, 402 eruption cetirizine, 146 erythema afamelanotide, 134 ipilimumab, 132 levamisole, 297 polyhexamethylene biguanidine, 213 rotigotine, 119 systemic glucocorticoids, 427 water-soluble intravascular iodinated contrast agents, 493–494 erythema, eyelid bimatoprost, 429 erythema, flagellate trastuzumab, 137 erythema multiforme sorafenib, 136 erythematous micropapular lesions, face labetalol, 173 erythematous papules pembrolizumab, 133 erythematous pruritic skin rashes deferasirox, 207 esophagitis sirolimus, 415 ESRD See end-stage renal disease etastatic malignant melanoma vemurafenib, 132 euphoria gabapentin, 56–57 exanthema melatonin, 464 exostoses voriconazole, 248 expulsion hormonal contraceptives, 438 extra hepatic portal vein obstruction propranolol, 174 extra-pyramidal symptoms (EPS) aripiprazole, 38 olanzapine, 43 eye, anatomical parts of mefloquine, 259 eye disorders isavuconazole, 130 eyelashes erlotinib, 484–485 eyelid edema 5-fluorouracil, 129–130 eye pain topiramate, 63 eye pruritus bimatoprost, 429 F facial acneiform eruption sorafenib, 136 facial erythema vemurafenib, 132 facial paralysis dofetilide, 170 failed abortion abortifacients, 439 Fanconi syndrome vemurafenib, 488 fasting glucose risperidone, 35 fatal obstruction clozapine, 41 fat embolism syndrome (FES) vitamin E, 360 fatigue afatinib, 135–136 aripiprazole, 38 artesunate, 258 axitinib, 479 barbiturates, 55 cabozantinib, 479–480 551 552 fatigue (Continued) chlorpheniramine, 147 cyclosporine, 409 daratumumab, 399 droxidopa, 117 EGFR, 483 elotuzumab, 399–400 everolimus, 410 evolocumab, 400, 475 gabapentin, 56–57 hepatitis B vaccine, 308 hyperbilirubinemia, 480 hypophosphatemia, 480 Japanese encephalitis, 318–319 levetiracetam, 58 melatonin, 464 methotrexate, 135–136 nivolumab, 132–133, 401–402 pazopanib, 479 pembrolizumab, 133 perampanel, 61–62 pertussis vaccines, 326–327 pneumococcal vaccines, 329 posaconazole, 247 pramipexole, 124 praziquantel, 304 quinacrine, 257 regorafenib, 479 retigabine, 63 ribavirin, 270 risperidone, 46 rotigotine, 119 sofosbuvir, 271–272 sorafenib, 479 sunitinib, 479–480 temsirolimus, 417 vandetanib, 479 vismodegib, 131 zonisamide, 66 febrile seizures influenza vaccines, 312 fever albendazole, 295 amphotericin, 244 anakinra, 396 artesunate, 258 brentuximab, 398 carbamazepine, 55–56 clozapine, 40–42 daratumumab, 399 dihydrocodeine, 72–73 enfuvirtide, 276 epoprostenol, 428 erythrocytes, 337 human papillomavirus vaccine, 308 hydroxyurea, 208 hydroxyzine, 149 influenza vaccines, 312 interferon beta, 396 interleukin-2, 396 labetalol, 173 lamotrigine, 138 levamisole, 296–297, 303 levetiracetam, 59 meropenem, 217–218 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS misoprostol, 429 phenytoin, 62 pneumococcal vaccines, 330–331 praziquantel, 304 primaquine, 257 promethazine, 388 rituximab, 403 terbinafine, 243 flagellate erythema trastuzumab, 137 flank pain vitamin C, 516 flatulence alvimopan, 71–72 ibuprofen, 79 melatonin, 464 oral methylnaltrexone, 71–72 systemic glucocorticoids, 426 flu-like symptoms epoprostenol, 428 flushing epoprostenol, 428 iloprost, 428 niacin, 470–471 folliculocentric eruption vemurafenib, 132 fracture antidepressant drugs, 14–15 clarithromycin, 175 fungal pneumonia eltrombopag, 395 G gait disorders piribedil, 119–120 galactorrhea paliperidone, 45 gastritis rufinamide, 63 gastroesophageal reflux disease clozapine, 40–41 gastrointestinal bleeding antidepressant drugs, 11 gastrointestinal diarrhea enfuvirtide, 276 gastrointestinal discomfort deferiprone, 207 gastrointestinal disorders tacrolimus, 416 gastrointestinal disturbances azathioprine, 417 glucagon-like peptide-1 agonists, 457 levosulpiride, 43 liraglutide, 457 gastrointestinal hemorrhage aluminum, 193 gastrointestinal intolerance cyclophosphamide, 407 gastrointestinal toxicity cyclophosphamide, 408 vincristine, 251 generalized exanthematous pustulosis, acute labetalol, 173 genetic predisposition cyclophosphamide, 407 genital vasculitis vitamin A, 356 genotoxicity nitrous oxide, 90 gestational diabetes mellitus insulin, 454 gingival enlargement amlodipine, 175 nitrendipine, 175 gingival hyperplasia cyclosporine, 409 gingivitis eltrombopag, 395 glomerulonephritis levamisole, 302–303 glucose elevation diencephalon, 35 gonorrhea levamisole, 297 gout arsenic, 194–195 grade mucositis sirolimus, 415 granulocytes, 338–339 gross hematuria bevacizumab, 398 Grover disease dabrafenib, 132 vemurafenib, 132 Guillain–Barre syndrome systemic glucocorticoids, 427 gynecomastia nebivolol, 174 risperidone, 46 H hair loss amiodarone, 169 azathioprine, 418 hallucinations dantrolene, 109–110 ropinirole, 119 hand–foot skin reactio vemurafenib, 132 hand foot syndrome axitinib, 479 cabozantinib, 479, 481 pazopanib, 479 regorafenib, 479 sorafenib, 479 sunitinib, 479–480 vandetanib, 479 Hashimoto thyroiditis lithium, 27 HDL-cholesterol reductions diencephalon, 35 olanzapine, 35 headache aclidinium bromide, 158–159 albendazole, 295 alpha1 antitrypsin (AAT), 340 apremilast, 133 aripiprazole, 38 armodafinil, 5–6 azathioprine, 417 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS barbiturates, 55 betamethasone, 134 brexpiprazole, 40 calcipotriol, 134 carbamazepine, 55–56 ceftolozane, 222 droxidopa, 117 enfuvirtide, 276 epoprostenol, 428 eslicarbazepine, 56 evolocumab, 400, 475 fingolimod, 411–412 5-fluorouracil, 129–130 gabapentin, 56–57 hepatitis B vaccine, 308 histamine-2 receptor antagonists (H2RAs), 379 iloprost, 428 isavuconazole, 130, 249 Japanese encephalitis, 318–319 lacosamide, 57 levetiracetam, 58 levocetirizine, 149 melatonin, 464 mepolizumab, 401 nifedipine, 175 oritavancin, 135, 234 oxantel–albendazole pamoate, 256–257 paliperidone, 44 pertussis vaccines, 327 phenylephrine, 117 pneumococcal vaccines, 327–330 pramipexole, 124 praziquantel, 304 primaquine, 257 promethazine, 388 rituximab, 403 rotigotine, 119 selexipag, 429–430 sofosbuvir, 271–272 somatropin, 463–464 subcutaneous immunoglobulin, 344 systemic glucocorticoids, 426 tacrolimus, 416 telbivudine, 270–271 umeclidinium, 160 vancomycin, 135 vilanterol, 158 zonisamide, 66 headedness albendazole, 295 head injuries warfarin, 366 heartburn melatonin, 464 heat/burning sensation See also burning UR-1505, 131 heavy head melatonin, 464 hematemesis clozapine, 40–41 hematological toxicity boceprevir, 265 iodine-131, 445–446 hematoma bemiparin, 367 idarucizumab, 375 hematuria idarucizumab, 375 vitamin C, 516 warfarin, 366 hemidystonia prochlorperazine, 45 hemiparesis apixaban, 370 hemodialysis eplerenone, 189 hemoglobinuria erythrocytes, 337 hemolysis artesunate, 258 hemolytic anemia albendazole, 296 metaxalone, 112 hemolytic anemia, acute ceftriaxone, 222 hemophagocytosis deferiprone, 207 hemorrhage abortifacients, 439 hemorrhagic cystitis cyclophosphamide, 408 hemorrhoidal hemorrhage vismodegib, 131 hepatic dysfunction sirolimus, 415 hepatitis systemic glucocorticoids, 427 vismodegib, 131 hepatobiliary disorders isavuconazole, 130 hepatotoxicity azathioprine, 417 brentuximab, 399 cyclosporine, 409 dantrolene, 109–110 HDS, 516 leflunomide, 413 metaxalone, 112 methimazole, 446 herpes keratitis cyclosporine, 409 herpes zoster infection cyclophosphamide, 407 leflunomide, 413 tacrolimus, 416 hiccups aripiprazole, 39 promethazine, 388 high-grade fever clonidine, 182–183 hirsutism cyclosporine, 409 hives cefazolin, 220 H1N1 virus infection corticotrophins, 425 hyperaldosteronism mycophenolate mofetil, 414 hyperalgesia fentanyl, 73 hyperammonemic encephalopathy glutamine, 361–362 hyperbilirubinemia cyclophosphamide, 408 hypercalcemia lithium, 24 vitamin A, 356 vitamin D, 360 hypercalciuria vitamin D supplement, 526 hypercholesterolemia cyclosporine, 409 temsirolimus, 417 hyperemia oxybutynin, 125 hypereosinophilia allopurinol, 81 lamotrigine, 138 hyperglycemia aripiprazole, 37 budesonide, 154 chlorpromazine, 37 ciprofloxacin, 231 clozapine, 37 cyclosporine, 409 daratumumab, 399 elvitegravir, 274 everolimus, 410 haloperidol, 37 ibuprofen, 79 levofloxacin, 231 moxifloxacin, 231 nivolumab, 402 olanzapine, 37 prochlorperazine, 37 quetiapine, 37 risperidone, 37 somatostatin, 466 somatropin, 463–464 hyperhidrosis oral methylnaltrexone, 71–72 hyperkalemia barium, 195 cefepime, 221 eplerenone, 184 nicorandil, 176 propranolol, 174 spironolactone, 189 tacrolimus, 417 hyperkinesia paliperidone, 44 hyperlipidemia aripiprazole, 37 blonanserin, 37 clozapine, 37 everolimus, 410 lisinopril, 179–180 olanzapine, 37 paliperidone, 37 perospirone, 37 quetiapine, 37 risperidone, 37 tacrolimus, 416 zotepine, 37 553 554 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS hyperparathyroidism lithium, 24 hyperphosphatemia continuous renal replacement therapy, 525 hyperpigmentation cyclophosphamide, 408 hyperprolactinemia aripiprazole, 39 paliperidone, 44–45 quetiapine, 45 risperidone, 46 hyperreflexia fentanyl, 73 hypersalivation/drooling benzalkonium chloride, 214 hypersensitivity allopurinol, 81 anaplastic lymphoma kinase, 485 azathioprine, 418 ceftriaxone, 223 cefuroxime, 224 cephalexin, 224 contrast media, 497 crizotinib, 485 filgrastim-sndz, 395 vitamin A, 356 ziprasidone, 47 hypertension adrenaline, 115 alirocumab, 474–475 amphetamine and amphetamine derivates, anegrelide, 372 atenolol, 173 axitinib, 479–480 bevacizumab, 398 budesonide, 154 cabozantinib, 479–480 cediranib, 480 corticotrophins, 425 cyclosporine, 409 droxidopa, 117 ephedrine, 116 eprosartan, 180 everolimus, 410 hydrochlorothiazide, 183–184 infliximab, 397–398 labetalol, 173 lisinopril, 179–180 metoprolol, 173–174 mycophenolate mofetil, 414 nebivolol, 174 pazopanib, 479 regorafenib, 479–480 rocuronium, 107 sorafenib, 479 sunitinib, 479–480 tacrolimus, 415–416 telmisartan, 181 vandetanib, 479 zolpidem, 31 zopiclone, 31 hyperthermia benzalkonium chloride, 214 oxybutynin, 125 hyperthyroidism lithium, 25 hypertonia deferiprone, 207 fentanyl, 73 hypertrichosis cyclosporine, 409 everolimus, 411 hypertriglyceridemia nivolumab, 402 quetiapine, 45 temsirolimus, 417 hypervitaminosis vitamin A, 356 hypesthesia epoprostenol, 428 hypnotic activity melatonin, 464 hypocalcemia cyclosporine, 409 foscarnet, 262 hypoesthesia oral asenapine, 39 hypoglycemia diazoxide, 183 insulin, 454 levofloxacin, 233 timolol, 174–175 venlafaxine, 17 hypokalemia acetazolamide, 185 amphotericin, 244 corticotrophins, 425 cyclosporine, 409 foscarnet, 262 isavuconazole, 249 salbutamol, 158 hypomagnesemia foscarnet, 262 proton-pump inhibitors, 380–381 tacrolimus, 415–416 hypomania loxapine, 43 hyponatremia acetazolamide, 185 corticotrophins, 425 losartan, 180 pembrolizumab, 133 hypophosphatemia cyclosporine, 409 gadolinium, 197 hypopituitarism pembrolizumab, 133 hypotension amphetamine and amphetamine derivates, anegrelide, 372 bevacizumab, 398 bupivacaine, 100 chlorpheniramine, 147 clarithromycin, 237 epoprostenol, 428 erythrocytes, 336 lithium, 21–22 midazolam, 29 nitroglycerin, 176 olanzapine, 43 phenylephrine, 117 promethazine, 150 succinylcholine, 106 hypotensive shock interleukin-2, 396 hypothyroidism arsenic, 194 iodine-131, 446 nivolumab, 401–402 I incomplete abortion abortifacients, 439 increased appetite aripiprazole, 38 increases in alanine aminotransferase nivolumab, 401–402 infection abortifacients, 439 azathioprine, 417 belatacept, 407 clopidogrel, 373 cyclophosphamide, 407–408 etanercept, 134 everolimus, 410 fingolimod, 411 isavuconazole, 130 leflunomide, 413 oritavancin, 135 tacrolimus, 416 infertility cyclophosphamide, 407 infestations isavuconazole, 130 inflammatory eruptions everolimus, 411 influenza combination therapy, 205 eltrombopag, 395 evolocumab, 475–476 inhaled corticosteroids, 153 phenylephrine, 117 injection-related reaction mepolizumab, 401 injection-site pain aripiprazole, 38 evolocumab, 476 paliperidone, 44 insomnia aripiprazole, 38 armodafinil, 5–6 cyclosporine, 409 elvitegravir, 274 gabapentin, 56–57 metoprolol, 173–174 paliperidone, 44 pramipexole, 124 primaquine, 257 quetiapine, 45 sofosbuvir, 272 systemic glucocorticoids, 426 interstitial fibrosis everolimus, 411 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS intertriginous erythema clozapine, 40–41 intestinal perforation levodopa, 123 intracranial bleeding warfarin, 366 intracranial hemorrhage antidepressant drugs, 11–12 enoxaparin, 367 intracranial hypertension fentanyl, 73 iodine deficiency dietary iodine, 445 ionized hypercalcemia continuous renal replacement therapy (CRRT), 525 ionized hypocalcemia continuous renal replacement therapy (CRRT), 525 ipilimumab dabrafenib, 132 irritation betamethasone, 130–131 perampanel, 61–62 ischemic colitis clozapine, 40–41 quetiapine, 45 ischemic stroke clopidogrel, 383 itching betamethasone, 130–131 chlorpheniramine, 147 niacin, 470–471 systemic glucocorticoids, 427 UR-1505, 131 water-soluble intravascular iodinated contrast agents, 493–494 itchy eruptions carbamazepine, 55–56 J jaundice deferasirox, 207 methocarbamol, 112 jaw pain epoprostenol, 428 iloprost, 428 selexipag, 429–430 joint pain albendazole, 295 K keratoacanthomas vemurafenib, 132 Kounis syndrome adrenaline, 115 amiodarone, 167 L labile mood clozapine, 42 laryngitis ibuprofen, 79 lassitude risperidone, 46 LDL-cholesterol risperidone, 35 left atrial thrombus idarucizumab, 375 left ventricular ejection fraction tacrolimus, 416 left ventricular ejection fraction (LVEF) fingolimod, 412 lethargy azathioprine, 417 leucocytoclastic vasculitis hydroxyurea, 208 leucopenia foscarnet, 262 methocarbamol, 112 quetiapine, 45–46 leukocytopenia nimotuzumab, 402 leukocytosis enalapril, 179 labetalol, 173 terbinafine, 243–244 leukoencephalopathy levamisole, 420 leukopenia clozapine, 36, 40–41 cyclophosphamide, 408–409 daratumumab, 399 inosine triphosphate pyrophosphohydrolase, 418 leflunomide, 413 levamisole, 296 pembrolizumab, 133 temsirolimus, 417 lichenoid eruptions chlorpromazine, 40 limb pain evolocumab, 400, 475 lipid emulsion infusion aluminum, 194 lipoatrophy fingolimod, 412 liposarcoma vismodegib, 131 listeria meningitis enfuvirtide, 275–276 liver cytolysis albendazole, 296 liver failure, acute deferasirox, 206 liver hydatid cyst albendazole, 296 liver injury acetaminophen, 78 clopidogrel, 373 loose stools solithromycin, 235 loss of appetite quinacrine, 257 loss of balance phenytoin, 62 loss of consciousness filgrastim-sndz, 395 loss of corneal glycols, 528 lower extremities zolpidem, 31 lower extremity weakness bupivacaine, 101 lumbar pain meropenem, 217–218 lung dysfunction aluminum, 193 lupus etanercept, 134 lymphadenopathy enfuvirtide, 276 lamotrigine, 138 lymphatic disorders tacrolimus, 416 lymphoblastic leukemia, acute methotrexate, 418 lymphocele tacrolimus, 416 lymphoma clozapine, 41 etanercept, 134 lymphopenia elotuzumab, 399–400 everolimus, 411 mercaptopurine, 419 M macular edema fingolimod, 411 maculopapular rash nevirapine, 137 maculopapular rashes water-soluble intravascular iodinated contrast agents, 493–494 malaise carbamazepine, 55–56 malaria artesunate, 258 male fertility impacts cyclosporine, 410 malignancy belatacept, 407 cyclophosphamide, 407 malignant hyperthermia (MH) succinylcholine, 106 mania paliperidone, 45 melanoma dabrafenib, 132–133 ipilimumab, 132 nivolumab, 132–133 pembrolizumab, 133 vemurafenib, 132 memory loss lithium, 22–23 memory problems oxcarbazepine, 60 menstrual disturbances aripiprazole, 38 metabolic abnormalities everolimus, 410 olanzapine, 43 metabolic syndrome clozapine, 37 555 556 metabolic syndrome (Continued) olanzapine, 37 quetiapin, 37 metallic taste methocarbamol, 112 metastatic colon cancer bevacizumab, 398 metastatic melanoma nivolumab, 132–133 mild dehydration levamisole, 296 mild diarrhea octreotide, 445 mild gastrointestinal disorders isavuconazole, 249 mild hypotension melatonin, 464 vitamin K, 360–361 mild thrombocytopenia deferiprone, 207 miosis neostigmine, 108 miscarriage antidepressant drugs, 12 moderate sinus tachycardia aripiprazole, 38 mood and morbid barbiturates, 55 mood disturbance perampanel, 61 mortality See also death clopidogrel, 382–383 eptifibatide, 372 indacaterol, 118 olanzapine, 36 quetiapine, 36 risperidone, 36 mortality risk haloperidol, 42 movement disorders lithium, 24 risperidone, 46 mucosal inflammation nivolumab, 402 mucositis temsirolimus, 417 multiple sclerosis fingolimod, 411–412 systemic glucocorticoids, 427 muscle cramp tacrolimus, 416 muscle pain pneumococcal vaccines, 327–328 muscle spasms elotuzumab, 399–400 evolocumab, 475 vismodegib, 131 musculoskeletal chest pain atazanavir, 275 musculoskeletal extremity pain enfuvirtide, 276 musculoskeletal pain epoprostenol, 428 posaconazole, 247 myalgia INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS alirocumab, 474 artesunate, 258 bevacizumab, 398 cholesteryl ester transfer protein inhibitors, 469–470 epoprostenol, 428 evolocumab, 475–476 HMG-CoA reductase inhibitors, 472 levamisole, 303 nivolumab, 401–402 paliperidone, 45 pembrolizumab, 133 pneumococcal vaccines, 330 myasthenia asenapine, 39 myeloid leukemia, acute isavuconazole, 130 myelosuppression cyclophosphamide, 407 myelotoxicity hydroxyurea, 208 mycophenolate mofetil, 413 myocardial damage ephedrine, 116–117 myocardial infarction apremilast, 133 clopidogrel, 382–383 ephedrine, 116 eptifibatide, 372 idarucizumab, 375 misoprostol, 429 tacrolimus, 416 ticagrelor, 374 myocardial ischaemia adrenaline, 115–116 myocardial ischemia adrenaline, 115 myocarditis asenapine, 39 clozapine, 41 lithium, 21–22 myoclonic jerks piperacillin, 219 myoclonic movements lithium, 22–23 myoclonus clozapine, 41 myopathy HMG-CoA reductase inhibitors, 472 N nail effects EGFR, 482–483 nail toxicity everolimus, 411 nasal congestion enfuvirtide, 276 nasal polyposis arsenic, 194 nasopharyngitis alirocumab, 474–475 apremilast, 133–134 atazanavir, 275 bile acid sequestrants, 469 evolocumab, 475–476 fingolimod, 411–412 glycopyrronium, 124 hepatitis B vaccine, 308 melatonin, 464 paliperidone, 44 systemic glucocorticoids, 426 tacrolimus, 416 thrombopoietin receptor agonists, 347 vilanterol, 158 nausea amphotericin, 244 apremilast, 133–134, 137 aripiprazole, 38 armodafinil, 5–6 axitinib, 479 azathioprine, 417 bile acid sequestrants, 469 cabozantinib, 479 calcitonin, 463 cariprazine, 40 carvedilol, 181 ceftaroline, 221–222 clozapine, 250 combination therapy, 205 deferasirox, 206–207 delafloxacin, 135 droxidopa, 117 dulaglutide, 457 elvitegravir, 274 enfuvirtide, 276 epoprostenol, 428 eslicarbazepine, 56 evolocumab, 475 exenatide, 457 fentanyl, 73 gabapentin, 56–57 halogenated vapours, 87 hydrochlorothiazide, 183–184 ibuprofen, 79 iloprost, 428 lacosamide, 57 levamisole, 297 liraglutide, 457 lornoxicam, 79–80 losartan, 180 lurasidone, 43 melatonin, 464 mepolizumab, 401 methocarbamol, 112 methylphenidate, 3–4 mycophenolate mofetil, 414 neostigmine, 108 nimotuzumab, 402 nivolumab, 401–402 octreotide, 445 ondansetron, 388 opioids, 71 oral methylnaltrexone, 71–72 oritavancin, 135, 234 pazopanib, 479 posaconazole, 247 pramipexole, 124 quinacrine, 257 regorafenib, 479 ribavirin, 270 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS ropinirole, 119 rotigotine, 119 selexipag, 429–430 sofosbuvir, 272 solithromycin, 235 sorafenib, 479 subcutaneous immunoglobulin, 344 sugammadex, 108 sunitinib, 479–480 systemic glucocorticoids, 426 telaprevir, 269–270 telavancin, 234 vancomycin, 135 vandetanib, 479 vilazodone, 18 vismodegib, 131 vortioxetine, 17–18 water-soluble intravascular iodinated contrast agents, 493–494 zonisamide, 66 necrolysis cyclophosphamide, 408 sulfasalazine, 138 necrosis levamisole, 299–300 necrotic keratinocytes zoledronic acid, 139 necrotizing ischemic colitis quetiapine, 45 nephrocalcinosis vitamin D supplement, 526 nephrogenic diabetes insipidus lithium, 25 nephrogenic systemic fibrosis (NSF) gadolinium, 197 gadolinium salts, 497–498 nephropathy lithium, 25, 27 nephrotoxicity amphotericin, 244 cidofovir, 261 tacrolimus, 415 telavancin, 234 nervous system disorders tacrolimus, 416 neuroleptic malignant syndrome aripiprazole, 36 haloperidol, 36 neurological symptoms ephedrine, 116 neuro-ophthalmic events mefloquine, 259 neuropathy disulfiram, 527 neurotoxicity cefepime, 221 neutropenia afatinib, 135–136 brentuximab, 136 ceftaroline, 222 clozapine, 40–41 cyclophosphamide, 408 daratumumab, 399 deferiprone, 207 elotuzumab, 399–400 isavuconazole, 130 levamisole, 296, 299–300 mercaptopurine, 419 methotrexate, 136 nivolumab, 132–133 quetiapine, 45–46 ribavirin, 270 temsirolimus, 417 valganciclovir, 263 neutrophilia clozapine, 41 terbinafine, 243–244 nightmares melatonin, 464 nivolumab dabrafenib, 132–133 nocturnal enuresis aripiprazole, 39 nocturnal hypersalivation clozapine, 40 non-cardiac chest pain alirocumab, 475 nonfollicular pustules dihydrocodeine, 72–73 nonmelanoma skin cancer avagacestat, 137 non-ST- segment elevation idarucizumab, 375 NSF See nephrogenic systemic fibrosis numbness bupivacaine, 101 nystagmus gabapentin, 57 lithium, 24 O obesity lisinopril, 179–180 obsessive compulsive symptoms clozapine, 41 ocular irritation bimatoprost, 429 oculogyric crisis bupivacaine, 101 onychomycosis terbinafine, 243 opioid-induced constipation (OIC) opioids, 71 opportunistic infections etanercept, 134 optic neuritis systemic glucocorticoids, 427 oral candidiasis glycopyrronium bromide, 159 oral ulceration benzalkonium chloride, 214 oral ulcers everolimus, 411 oromandibular dystonia botulinum toxin, 110 oropharyngeal discomfort salmeterol, 158 oropharyngeal pain evolocumab, 475–476 557 osinophilia vancomycin, 235 osteoarthritis pain flare diclofenac, 79 osteomyelitis oritavancin, 135 osteonecrosis silver nitrate, 201–202 ostraceous psoriasis lithium, 25–26 ower adaptive scores clozapine, 42 oxidative damage aluminum, 193 P pain alirocumab, 474 chlorhexidine, 212 clozapine, 40–41 erythrocytes, 337 evolocumab, 475 5-fluorouracil, 129–130 ingenol mebutate, 129 prochlorperazine, 388 subcutaneous immunoglobulin, 344 voriconazole, 248 pain, breast nebivolol, 174 painful discoloration levamisole, 297 painful erythematous papules interferon beta, 396 painful rashes levamisole, 297 pain in extremities iloprost, 428 palpitations anegrelide, 372 budesonide, 154 chlorpheniramine, 147 clozapine, 250 melatonin, 464 telavancin, 234 pancreatitis cabozantinib, 481 canagliflozin, 458–459 cyclophosphamide, 407 dipeptidyl peptidase-4 (DPP-4) inhibitors, 456 ezetimibe, 470 methimazole, 446–447 pancreatitis, 481 pancreatitis, acute digoxin, 165 levamisole, 299 pancytopenia clozapine, 41 panniculitis fingolimod, 412 papillomas vemurafenib, 132 paradoxical pinpoint pupils asenapine, 40 558 paralysis glycols, 528 paralytic ileus clozapine, 40–41 paresthesia asenapine, 39 primaquine, 257 parkinsonism aripiprazole, 38 levodopa, 123 parotitis clozapine, 40–41 patches atenolol, 173 pazopanib pancreatitis, 481 peeling, skin tretinoin, 129 pemphigus vulgaris rituximab, 403 perianal ulcers everolimus, 411 pericardial effusion clozapine, 42 pericarditis clozapine, 42 influenza vaccines, 309–310 periorbital edema clozapine, 40–41 periostitis voriconazole, 248–249 peripheral edema nifedipine, 175 nivolumab, 401–402 peripheral neuropathy cyclophosphamide, 408 vincristine, 251 persistent pulmonary hypertension of the newborn (PPHN) antidepressant drugs, 14 pharyngeal pain enfuvirtide, 276 pharyngitis mepolizumab, 401 salmeterol, 158 phobic anxiety mefloquine, 259 photoallergic contact dermatitis chlorpromazine, 40 photophobia crizotinib, 486 photopsia crizotinib, 486 photosensitivity cyclophosphamide, 408 dabrafenib, 132 tretinoin, 129 vemurafenib, 132 pityriasis atenolol, 173 pityriasis lichenoides (PL) influenza vaccines, 313–314 pityriasis rosea clozapine, 40–41 plaque psoriasis INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS secukinumab, 403 PML See progressive multifocal leukoencephalopathy pneumonia ceftriaxone, 222 daratumumab, 399 elotuzumab, 400 eltrombopag, 395 fluticasone, 153–155 glycopyrronium bromide, 159 histamine-2 receptor antagonists (H2RAs), 379 inhaled corticosteroids, 153 mycophenolate mofetil, 414 olanzapine, 37 risperidone, 37 tacrolimus, 416 pneumonitis everolimus, 410–411 nivolumab, 401–402 pembrolizumab, 133 sirolimus, 415 polycystic ovarian syndrome hydrochlorothiazide, 183–184 polymorphism cyclophosphamide, 408–409 leflunomide, 413 mercaptopurine, 419 poly-substance abuse levamisole, 297 ponatinib pancreatitis, 481 post delirium sedation syndrome olanzapine, 43 posterior reversible encephalopathy syndrome lithium, 23 postpartum hemorrhage antidepressant drugs, 12 post-transplant lymphoproliferative disorder belatacept, 407 premature delivery thiopurine, 418 PRES See posterior reversible encephalopathy syndrome priapism clozapine, 40–42 quetiapine, 46 pro-arrhythmic activity lithium, 21–22 proctitis nimotuzumab, 402 progressive multifocal leukoencephalopathy fingolimod, 411 prolactin elevation asenapine, 40 risperidone, 35 prolonged thrombocytopenia bevacizumab, 398 prophylaxis cefuroxime, 224 ertapenem, 217 prostatic hyperplasia glycopyrronium, 124 proteinuria deferasirox, 206 deferiprone, 207 everolimus, 411 mycophenolate mofetil, 413 temsirolimus, 417 pruritic rash levamisole, 297 quinacrine, 257 pruritus 5-fluorouracil, 129–130 hydroxyzine, 148 ingenol mebutate, 129 ipilimumab, 132 niacin, 470 nivolumab, 132–133, 401–402 polyhexamethylene biguanidine, 213 primaquine, 257 proprotein convertase subtilisin/kexin type 9, 474 ribavirin, 270 rotigotine, 119 water-soluble intravascular iodinated contrast agents, 493–494 pseudolithiasis ceftriaxone, 223 Pseudomonas aeruginosa infection tigecycline, 226 pseudo-pheochromocytoma clozapine, 40–41 pseudo-Stauffer’s syndrome asenapine, 39 pseudotumor cerebri vitamin A, 357 pseuodohypoaldosteronism systemic glucocorticoids, 427 psoriasiform plaques hydroxyurea, 208 psoriasis acetaminophen, 78 apremilast, 133–134 betamethasone, 134 BI 655066, 134 calcipotriol, 134 etanercept, 134 infliximab, 134 methotrexate, 133 nivolumab, 402 psoriatic arthritis secukinumab, 403 psychiatric disorders tacrolimus, 416 psychosis aripiprazole, 38 cabergoline, 118–119 caffeine, 515 metoprolol, 173–174 timolol, 174–175 psychotic disorder aripiprazole, 38 mefloquine, 259 ptosis botulinum toxin, 110–111 pulmonary edema idarucizumab, 400 oxytocin, 465 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS pulmonary embolism American ginseng, 515–516 idarucizumab, 375 warfarin, 366 pulmonary oedema, acute adrenaline, 116 pulmonary thromboembolism clozapine, 40–41 olanzapine, 43 pulmonary toxicity amiodarone, 167–168 dantrolene, 109–110 pulmonary veno-occlusive disease cyclophosphamide, 408 punctate keratitis bimatoprost, 429 purple retiform rash levamisole, 303 purpuric skin eruptions amlodipine, 175 pustular rash nevirapine, 137 pustules interferon beta, 396 pyrexia combination therapy, 205 dabrafenib, 132, 489 isavuconazole, 249 systemic glucocorticoids, 426 tacrolimus, 416 trametinib, 489 vemurafenib, 132 pyrronium glycopyrronium bromide, 159 Q QTc interval axitinib, 480 cabozantinib, 480 pazopanib, 480 sorafenib, 480 sunitinib, 480 vandetanib, 480 QTc prolongation aripiprazole, 38–39 risperidone, 46 QT prolongation amisulpride, 36 droperidol, 42 olanzapine, 43 risperidone, 36 thioridazine, 36 ziprasidone, 36 R radiation dermatitis nimotuzumab, 402 radio necrosis iodine-131, 446 rash abacavir, 274–275 afatinib, 135–136 bevacizumab, 136 cefazolin, 220 cinchocaine, 101 delafloxacin, 135 dihydroartemisinin–piperaquine, 256 EGFR, 482–483 erlotinib, 483 everolimus, 410 evolocumab, 475–476 ipilimumab, 132 isavuconazole, 130 lamotrigine, 58 leflunomide, 413 levamisole, 299 levosulpiride, 43 lithium, 25 mepolizumab, 401 methotrexate, 135–136 nivolumab, 401–402 sofosbuvir, 272 temsirolimus, 417 terbinafine, 243 vancomycin, 235 rash, delayed-type proprotein convertase subtilisin/kexin type 9, 474 redness anakinra, 396 reduced visual acuity crizotinib, 486 regorafenib pancreatitis, 481 renal dysfunction everolimus, 410 renal epithelial cell damage everolimus, 411 renal failure enfuvirtide, 275–276 renal failure, acute clozapine, 41 famciclovir, 264 infliximab, 397–398 renal insufficiency tacrolimus, 416 renal toxicity cyclophosphamide, 408 lithium, 25 respiratory cough enfuvirtide, 276 respiratory distress colchicine, 82 respiratory distress syndrome, acute gadolinium, 197 respiratory dysfunction arsenic, 194 mercury, 200 respiratory insufficiency ipilimumab, 132 respiratory tract infection apremilast, 133 retinal atrophy aripiprazole, 39 rhabdomyolysis ezetimibe, 469–470 HMG-CoA reductase inhibitors, 472 paliperidone, 45 tacrolimus, 416 rheumatoid arthritis (RA) levothyroxine, 444 systemic glucocorticoids, 425–426 rhinitis mepolizumab, 401 tacrolimus, 416 thrombopoietin receptor agonists, 347 rhinitis allergy antihistamines, 145–146 daratumumab, 399 rhinorrhea tacrolimus, 416 right ventricular failure idarucizumab, 400 rigidity piribedil, 119–120 rust-colored spots amlodipine, 175 S Schamberg’s disease amlodipine, 175 schistosomiasis praziquantel, 304 schizophrenia paliperidone, 44 scleral icterus quinacrine, 257 sedation aripiprazole, 38 asenapine, 39 clozapine, 40–41 loxapine, 43 lurasidone, 43 olanzapine, 43 perampanel, 61 quetiapine, 45 risperidone, 46 seizures amphetamine and amphetamine derivates, caffeine, 515 cefepime, 221 clozapine, 40–41 dantrolene, 109–110 lithium, 22–23 melatonin, 464 vincristine, 251 self-harm antidepressant drugs, 15–16 semantic fluency deficit lithium, 22 sepsis enfuvirtide, 275–276 serious infections brentuximab, 399 serotonin syndrome aripiprazole, 39 fentanyl, 73 serum creatinine elevation combination therapy, 205 deferasirox, 207 deferiprone, 207 serum creatinine level increase cyclosporine, 409 temsirolimus, 417 559 560 severe abdominal pain losartan, 180 severe arthropathy deferiprone, 207 severe edema infliximab, 397–398 loop diuretics, 185 severe hypercalcemia vitamin D supplement, 526 severe hypertension clonidine, 182–183 severe pain halogenated vapours, 87 shivering fentanyl, 73 short-term memory loss lithium, 22–24 sialorrhea aripiprazole, 39 clozapine, 40–41 sinus congestion enfuvirtide, 276 sinusitis alirocumab, 475 evolocumab, 475–476 mepolizumab, 401 sinusoidal obstructive syndrome sirolimus, 415 skin cancer belatacept, 407 etanercept, 134 folic acid, 357–358 skin disorders telaprevir, 135 skin eruption hydroxyzine, 149 skin hyperpigmentation bimatoprost, 429 skin lesions influenza vaccines, 311 levamisole, 303 skin necrosis fingolimod, 412 skin pigmentation chlorpromazine, 40 skin rash abacavir, 274–275 deferasirox, 207 lamotrigine, 138 phenytoin, 62 telavancin, 234 skin stings primaquine, 257 sleep disturb oxcarbazepine, 60 sleep disturbance clozapine, 42 sleepiness antihistamines, 143–144 gabapentin, 56–57 melatonin, 464 oxcarbazepine, 60 sleeping difficulties melatonin, 464 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS sleep walking melatonin, 464 small bowel wall thickening enalapril, 179 small intestinal hemorrhage vismodegib, 131 somnambulism zaleplon, 30 somnolence aripiprazole, 38 asenapine, 39 carbamazepine, 55–56 gabapentin, 57 histamine-2 receptor antagonists (H2RAs), 379 lacosamide, 57 lurasidone, 43 melatonin, 464 olanzapine, 43 paliperidone, 44 perampanel, 61–62 phenytoin, 62 quetiapine, 45 retigabine, 63 ropinirole, 119 spinal cord infarction systemic glucocorticoids, 426 spondylitis secukinumab, 403 spongiosis atenolol, 173 spongiotic dermatitis pembrolizumab, 133 spontaneous abortion/stillbirths See also miscarriage antidepressant drugs, 12 barbiturates, 55 human papillomavirus vaccine, 308 thiopurine, 418 squamous cell carcinoma vemurafenib, 132 stent thrombosis bivalirudin, 368 clopidogrel, 373, 382–383 Stevens–Johnson syndrome clozapine, 42 nevirapine, 137 sorafenib, 136 stomach pain ceftriaxone, 223 stomatitis afatinib, 135–136 cyclophosphamide, 408 EGFR, 482–483 everolimus, 410–411 methotrexate, 135–136 nivolumab, 402 salmeterol, 158 stroke amiodarone, 166 antidepressant drugs, 16 ephedrine, 116 misoprostol, 429 systemic glucocorticoids, 426 zolpidem, 30 stuttering clozapine, 41 subcutaneous tissue disorders isavuconazole, 130 sudden death fingolimod, 411 sudden-onset dystonia asenapine, 40 suicide antidepressant drugs, 15–16 arsenic, 194 suicide attempt aripiprazole, 36 clozapine, 36 haloperidol, 36 quetiapine, 36 risperidone, 36 supra-ventricular tachycardia clozapine, 41 sweating/hot flash melatonin, 464 primaquine, 257 Sweet’s syndrome azathioprine, 418 swelling anakinra, 396 pramocaine, 102 sodium hypochlorite, 214 swelling, breast nebivolol, 174 swelling of arms/legs melatonin, 464 syncope carbamazepine, 55–56 ticagrelor, 374 systolic blood pressure belatacept, 407 T tachycardia amphetamine and amphetamine derivates, clonidine, 182–183 dapsone gel, 526 doxylamine, 147–148 epoprostenol, 428 lithium, 25 lornoxicam, 79–80 melatonin, 464 rocuronium, 107 succinylcholine, 106 tachysystole misoprostol, 429 Takotsubo cardiomyopathy ranolazine, 176 Takotsubo syndrome adrenaline, 115 tardive dyskinesia amisulpride, 37 aripiprazole, 37 clozapine, 37 olanzapine, 37 risperidone, 37 ziprasidone, 37 tardive dystonia aripiprazole, 39 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS tear film dysfunction erlotinib, 484–485 tearing 5-fluorouracil, 129–130 temporal–spatial disorientation lithium, 22–23 teratogenicity lithium, 26 methimazole, 447 throat swelling vemurafenib, 488 thrombocytopenia bivalirudin, 368 ciprofloxacin, 232 clozapine, 41 continuous renal replacement therapy (CRRT), 525 cyclophosphamide, 408 daratumumab, 399 deferiprone, 207 eptifibatide, 373 everolimus, 410 levamisole, 299–300 mycophenolate mofetil, 413 piperacillin, 219–220 quetiapine, 45–46 ribavirin, 270 temsirolimus, 417 thrombocytopenia, acquired bivalirudin, 368 thrombocytosis clozapine, 41 thromboembolism hormonal contraceptives, 438 thrombotic microangiopathy sirolimus, 415 thyroid disorders lithium, 24–25 thyroid dysfunction amiodarone, 168–169 thyrotoxicosis lithium, 25 water-soluble intravascular iodinated contrast agents, 494 tingling niacin, 470 UR-1505, 131 tiredness oxcarbazepine, 60 tongue ulceration benzalkonium chloride, 214 tonic–clonic movements bupivacaine, 100 tonic–clonic seizure barbiturates, 55 lidocaine, 102 transaminitis brentuximab, 136 transient ischemic attacks misoprostol, 429 transient morning pseudoneutropenia aripiprazole, 39 transient myopia, acute aripiprazole, 39 trauma levamisole, 299 tremor aripiprazole, 38 cariprazine, 40 cyclosporine, 409 fentanyl, 73 gabapentin, 57 lithium, 23–25 loxapine, 43 paliperidone, 44 risperidone, 46 tacrolimus, 415–416 triglycerides flupenthixol, 42 troponin elevation clozapine, 41 tuberculosis cyclophosphamide, 407 etanercept, 134 inhaled corticosteroids, 153 tubular atrophy everolimus, 411 T-wave inversions ranolazine, 176 type II diabetes lisinopril, 179–180 U ulcers with sores on cheeks levamisole, 303 unsteadiness gabapentin, 57 oxcarbazepine, 60 perampanel, 61 upper abdominal pain deferasirox, 206 evolocumab, 475–476 upper extremities zolpidem, 31 upper respiratory tract infection alirocumab, 475 apremilast, 133–134 aripiprazole, 38 evolocumab, 475–476 mepolizumab, 401 pneumococcal vaccines, 328 thrombopoietin receptor agonists, 347 vilanterol, 158 urinary incontinence clozapine, 40–41 urinary tract infection alirocumab, 474–475 apremilast, 133 rivastigmine, 7–8 type sodium-glucose cotransporter inhibitors, 458 urticaria fingolimod, 412 vemurafenib, 488 urticarial aggravation chlorpheniramine, 147 uterine perforation abortifacients, 439 uveitis secukinumab, 403 V valvular heart disease cabergoline, 118–119 vandetanib pancreatitis, 481 vasculitis clozapine, 41 levamisole, 297–298, 300–302 venous thromboembolism clozapine, 41 ventricular arrhythmia clotiapine, 36 haloperidol, 36 olanzapine, 36 prochlorperazine, 36 quetiapine, 36 risperidone, 36 sulpiride, 36 thioridazine, 36 verrucal keratosis dabrafenib, 132 vemurafenib, 132 vertigo gabapentin, 56–57 methocarbamol, 112 retigabine, 63 viral infection mepolizumab, 401 viral upper respiratory tract infection glycopyrronium, 124 visceral leishmaniasis fingolimod, 412 visual acuity mefloquine, 259 moxifloxacin, 234 visual disturbances dantrolene, 109–110 vigabatrin, 65 visual hallucinations ertapenem, 217 lithium, 22–23 visual impairment crizotinib, 486 visual loss cobalt, 197 vitamin D deficiency levothyroxine, 444 vitiligo afamelanotide, 134 UVB therapy, 134 vitreous floaters crizotinib, 486 vomiting amphotericin, 244 apremilast, 137 aripiprazole, 38 calcitonin, 463 cariprazine, 40 carvedilol, 181 ceftaroline, 221–222 clozapine, 250 561 562 vomiting (Continued) deferasirox, 206–207 delafloxacin, 135 dihydroartemisinin–piperaquine, 256 epoprostenol, 428 eslicarbazepine, 56 everolimus, 410 fentanyl, 73 halogenated vapours, 87 hydrochlorothiazide, 183–184 iloprost, 428 lacosamide, 57 levamisole, 297 losartan, 180 lurasidone, 43 melatonin, 464 methocarbamol, 112 misoprostol, 429 mycophenolate mofetil, 414 neostigmine, 108 nimotuzumab, 402 ondansetron, 388 opioids, 71 oral methylnaltrexone, 71–72 oritavancin, 135, 234 pneumococcal vaccines, 329 promethazine, 388 INDEX OF ADVERSE EFFECTS AND ADVERSE REACTIONS rufinamide, 63 solithromycin, 235 sugammadex, 108 telavancin, 234 vancomycin, 135 zonisamide, 66 vortex keratopathy amiodarone, 166 vulval abscesses filgrastim-sndz, 395 W waist circumference flupenthixol, 42 warmth niacin, 470 weakness primaquine, 257 weight gain amisulpride, 36 aripiprazole, 36, 38 asenapine, 36 brexpiprazole, 40 clozapine, 36, 38, 40–42 iloperidone, 36 lurasidone, 36, 43 olanzapine, 36, 38 paliperidone, 36, 44 quetiapine, 36 risperidone, 36, 46 sertindole, 36 ziprasidone, 36, 47 weight loss aripiprazole, 38 HDS, 517 loxapine, 43 roflumilast, 161 ropinirole, 119 vismodegib, 131 wheal reaction systemic glucocorticoids, 427 wheeze iloprost, 428 word-finding difficulty lithium, 24 worsening ulcerative colitis systemic glucocorticoids, 426 wound dehiscence bemiparin, 367 X xerostomia paliperidone, 44 ... USA Preface Side Effects of Drugs: Annual (SEDA) is a yearly publication focused on existing, new and evolving side effects of drugs encountered by a broad range of healthcare professionals including... neuromuscular blockers Analysis of ADEs, ADRs, Side Effects and Toxicity Terminology A recent report suggested that ADEs and/or side effects of drugs occur in approximately 30% of hospitalized patients... the etiology of side effects, especially for medications provided to very large populations This marks the first phase of genome-based personalized medicine, in which side effects of common medications