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 L i t t ’s

DRUG
ERUPTION
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REFERENCE MANUAL
17th
INCLUDING Edition
DRUG
18th INTERACTIONS
For personal use only.

15th EDITION
2012

Jerome Z. Litt, MD
Assistant Clinical Professor of Dermatology
Case Western Reserve University School of Medicine
Cleveland, Ohio, USA
 © Informa UK Limited
This edition is published in 2012 by Informa Healthcare, 119 Farringdon Road, London EC1R 3DA. Informa Healthcare is a trading
division of Informa UK Ltd. Registered Office: Informa House, 30–32 Mortimer Street, London W1W 7RE. Registered in England
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Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation
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For personal use only.

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 CONTENTS

Introduction v
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Drug profiles A–Z 1

For personal use only.

Descriptions of important reactions 579

Drugs that cause important reactions 585

Index of synonyms and trade names 621

iii
Downloaded from informahealthcare.com by Nyu Medical Center on 04/13/12
For personal use only.

To Vel – my Muse
 Author’s introductory note
Any drug has the potential to cause an adverse reaction. An adverse drug reaction (ADR) is an unwanted, unpleasant, noxious,
or harmful consequence associated with the use of a medication that has been administered in a standard dose by the proper
route, for the purpose of prophylaxis, diagnosis, or treatment. Death is the ultimate adverse drug event.
ADRs are a major problem in drug therapy. They are the most common of all iatrogenic illnesses that complicate 5–15% of
therapeutic drug courses, and are a leading cause of morbidity and mortality in healthcare. ADRs should therefore be con-
sidered in the differential diagnosis of a wide variety of medical disorders. Many more people – particularly the elderly – are
taking more and more prescription and over-the-counter medications. In addition, new drugs are appearing in the medical
marketplace on an almost daily basis. It is unsurprising, then, that more and more drug reactions and cutaneous eruptions are
emerging.
The FDA reports that 319,741 people in the United States were hospitalized as a result of serious adverse drug events in
2008, and of these cases, 15.6% – almost 50,000 – patients died. In fact, from January 2000 to June 2009 the FDA has
reported nearly 2 million cases of serious adverse drug events, of which 17% (336,448) have resulted in death. About 5% of
hospital admissions in the United States are estimated to be for the treatment of ADRs. Moreover, as many as one-third of all
emergency department and urgent care-center visits are drug related.
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Prevention, diagnosis and treatment of adverse drug events are becoming increasingly complex, and it is to be expected that
physicians in all specialties and medical students are often perplexed by the nature of ADRs. To this end, I now offer a new,
improved book that has evolved from the treasured drug eruption reference manual of previous editions. I hope that you will
find this new edition informative and valuable.
Enjoy!
Jerome Z. Litt, M.D.
January, 2012
For personal use only.

The Drug Eruptions & Reactions Manual (D.E.R.M.) – what’s new

This 18th edition has been revised and updated throughout to present a quick clinical reference guide to adverse drug
reactions (ADRs), side effects, drug interactions and other safety information for prescription and over-the-counter medica-
tions, including biologics and supplements. The full and comprehensive picture – from which our information derives – can be
found at our website database (www.drugeruptiondata.com), which is updated continually.
The aims of this book are:
1. To help medical practitioners make informed and safe decisions when diagnosing and prescribing, and also when
generally seeking information.
2. To help healthcare professionals remain pharmacovigilant.
3. To provide physicians, lecturers, educators, pharmacists and students with an easy-to-use and reliable quick reference
tool.
New to this Edition:
• Existing drug profiles have been updated throughout.
• Synonyms for drug generic names have been included for ease of quick reference.
• The number of reports for a reaction has been added (these references can be accessed by subscribers of our website pub-
lication: www.drugeruptiondata.com).
• The incidence of a reaction has been included where reported.
Drugs: This manual describes and catalogues the adverse side effects of more than 1000 prescribed and over-the-counter
generic drugs, as well as supplements and biologics. All drugs have also been indexed by their trade (brand) names for easy
accessibility, with synonyms included for ease of reference.
ADRs: Under each drug profile is a list of related adverse drug reactions. These adverse events have been classified under the
following categories:
Skin, Hair, Nails, Mucosal, Cardiovascular, Central Nervous System, Neuromuscular/Skeletal, Gastrointestinal/Hepatic,
Respiratory, Endocrine/Metabolic, Hematologic, Renal, Genitourinary, Otic, Ocular, Local, Other.

v
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 Drug interactions: As with previous editions, D.E.R.M. 18th edition contains details of many severe, hazardous drug–drug
interactions. Only clinically significant drug interactions that have been reported to trigger potential harm and that could be
life-threatening have been included. These interactions are predictable and well documented in controlled studies; they
should be avoided.
Various generic drugs have been eliminated from the print copy because either they have been withdrawn from the market-
place or they are rarely, if ever, prescribed today. These drug profiles (together with all the information in this book) are
available to subscribers on our website: www.drugeruptiondata.com.

Where has all this data come from?

Several reference works were consulted in the course of compiling the very first few editions of this manual. These included:
(2002): Stockley IH, Stockley’s Drug Interactions, Pharmaceutical Press, London and Chicago.
(1998): Kauppinen K et al, Skin Reactions to Drugs, CRC Press, Boca Raton.
(1996): Bruinsma W, A Guide to Drug Eruptions, The File of Medicines, PO Box 21, 1474 HJ Oosthuizen, Netherlands.
(1994): Goldstein S & Wintroub BU, Adverse Cutaneous Reactions to Medication, CoMedica, New York.
(1992): Zürcher K & Krebs A, Cutaneous Drug Reactions, Karger, Basel.
Downloaded from informahealthcare.com by Nyu Medical Center on 04/13/12

(1992): Breathnach SM & Hintner H, Adverse Drug Reactions and the Skin, Blackwell, Oxford.
(1988): Bork K, Cutaneous Side Effects of Drugs, WB Saunders, Philadelphia.
Now, the majority of the information in this Manual has been gleaned from the millions of citations assembled under PubMed®
by the U.S. National Library of Medicine® (NLM).
Journal article evidence for many of the reactions listed comes from the J Am Acad Dermatol, Arch Dermatol, Cutis, Int J
Dermatol, Contact Dermatitis, Br J Dermatol, JAMA, Lancet, BMJ, Aust J Dermatol, N Engl J Med, Ann Intern Med, and many other
For personal use only.

prominent and easily accessible journals. The allusions to the incidence of many of the listed ADRs are obtained from these
peer reviewed and published articles. The journal citations can be found on the database (www.drugeruptiondata.com).
Online resources such as the FDA (U.S. Food and Drug Administration) and the eMC (Electronic Medicines Compendium)
as well as the prescribing information and package inserts for various products have also been referred to when compiling
drug profiles.
A number of drug profiles have been researched by the Editorial team at Informa Healthcare.
We are continuously adding to Litt’s D.E.R.M. database (the online ADR checking tool from which the D.E.R.M. printed
book is created) and we welcome any ADR related observations that you may have. Please email us with observations at
[email protected]. All relevant input will be catalogued, and you will be given appropriate attribution and
recognition on our website: www.drugeruptiondata.com.

A note on ADRs
Adverse drug reactions are the most common iatrogenic illness, complicating, at times, up to 15% of therapeutic drug
courses. Despite the frequency and sometimes life-threatening nature of ADRs, they remain underreported and thus are an
underestimated cause of morbidity and mortality.
In a study conducted in 1998, Lazarou et al1 found that more than 2 million Americans become seriously ill every year from
reactions to drugs that were correctly prescribed and taken, and that 106,000 Americans die annually from those side effects.
The authors calculated a 0.13% incidence of fatal ADRs in patients admitted to hospital, and 0.19% in patients developing an
ADR while in hospital. The authors concluded that ADRs may rank from the fourth to the sixth leading cause of death.
In the UK Pirmohamed et al2 analysed hospital admissions related to ADRs in 2004, and suggested a 0.15% incidence of
fatal ADRs, similar to the US figure of Lazarou et al. The authors of the UK study concluded the true rate of death taking

1. (1998) Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA
279(15), 1200
2. (2004) Pirmohamed M, James S, Meakin S+. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ
329(7456), 15

vi
 into account all ADRs (those causing admission, and those occurring while patients are in hospital) was greater than 10,000
a year.
Finally, in a study of prevalence, incidence, direct costs and avoidability of ADRs in France, Lagnaoui et al3 found that out of
444 hospital admissions to an internal medicine department over 4 months, 156 ADRs occurred in 116 patients (26.1% of all
admissions); 95 (21.4%) of these had ADRs at admission, which were the reason for admission in 32 (7.2%) cases. Twenty-
one patients (4.7%) presented with 26 ADRs during hospitalization. According to this study, 80% of ADRs could be con-
sidered preventable.
1. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.
http://www.ncbi.nlm.nih.gov/pubmed/9555760
2. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC443443/
3. Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct
costs and avoidability. http://www.ncbi.nlm.nih.gov/pubmed/10877014
ADRs can be very broadly classified as immunologic or non-immunologic, and can have a wide ranging effect on patients.
ADRs have also been classified into these six types:
• Dose-related, e.g. digoxin toxicity
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• Non-dose-related, e.g. immunological reactions

• Dose-related and time-related, e.g. corticosteroids
• Time-related, e.g. tardive dyskinesia
• Withdrawal, e.g. opiate or beta-blocker withdrawal
• Unexpected failure of therapy, e.g. inadequate dose of an oral contraceptive
The incidence and severity of ADRs are influenced by a number of factors:
For personal use only.

1. Patient-related factors:
• Age – geriatric, pediatric, adolescent . . . Older patients are taking more medications—hence more of a possibility of
developing reactions; pediatric patients have more delicate skins; hormonal changes occur in adolescents . . . All these
factors play roles in the development of possible adverse reactions.
• Sex – male or female – and if the latter, then pregnant/breast-feeding/ menopausal . . .
• Disease – not only the disease being treated, but also other pre-existing health conditions and comorbid diseases. For
example, atopic patients are at increased risk for serious allergic reactions. Also, there would be an increased risk for
hypersensitivity drug reactions if the patient has asthma or lupus erythematosus.
• Genetics – a patient could have abnormal drug metabolism by cytochrome P450 due to inheriting abnormal alleles.
• Geography – Patients living in sunny climes could develop photoxicities from photosensitizing drugs more readily than
those who inhabit cooler, less sunny climates.

2. Drug-related factors:
• Type/class of drug. For example, there is a heightened risk of hypersensitivity with the use of beta-blockers.
• Duration of therapy – the longer a patient maintains the therapy, the greater the possibility that he/she could develop a
reaction.
• Dosage – the greater the dosage, the more likely an adverse side effect.
• Bioavailability – the extent to and rate at which the drug enters systemic circulation, thereby accessing the site of action.
• Interactions with other drugs – for example, synergistic QT prolongation can occur when two QT prolonging agents, such
as erythromycin + ritonavir, are used together.
• Route of administration – intramuscular, intravenous and topical administrations are more likely to cause hypersensitivity
reactions; oral medications are less likely to result in drug hypersensitivity.

3. (2000) Lagnaoui R, Moore N, Fach J+. Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence,
direct costs and avoidability. Eur J Clin Pharmacol 56(2) 181

vii
 With all the facts listed both in this section and in the “introductory note,” one would have thought that prevention, diagnosis
and treatment of ADRs were complex enough . . . Unfortunately, the situation is further complicated by the variety of ways in
which we talk about adverse drug reactions! The terms “drug allergy,” “drug hypersensitivity,” and “drug reaction” are often
used interchangeably. Drug allergy specifically refers to a reaction mediated by IgE; drug hypersensitivity is an immune-
mediated response to a drug agent in a sensitized patient; and drug reactions comprise all adverse events related to drug
administration, regardless of etiology.

Vigilance at point of care:

While the possibilities for adverse drug reactions seem endless, we must be on the lookout for any new medication(s) the
patient might be taking. A thorough, detailed history of all medications must be made in order to elicit any remote possibility
that the drug in question might be the culprit for the side effect. People do not often realize that the common over-the-
counter analgesics – aspirin, Tylenol, Advil, Motrin, Naprosyn, and others – are actually medications. Herbals and supple-
ments such as St. John’s Wort, ginkgo biloba, and echinacea can be responsible for various hypersensitivity reactions. For
instance, St. John’s Wort, in particular, interacts adversely with SSRIs and tricyclic antidepressants.
Listen to your patients! They will often tell you what you need to know when it comes to adverse effects of medication.
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Contents of the book, and how to use them

This book has three parts.
1. The A–Z
The major portion of the manual – the body of the work – lists in alphabetical order the 1000+ generic drugs and
For personal use only.

supplements, and the adverse reactions that can arise from their use. The half-life is noted for each drug profile. A note
outlining hazardous interactions appears alongside those drugs for which severe/hazardous drug interactions are
reported. Information about the pregnancy category into which the drug falls has also been included.
The number of reports is given for each reaction in square brackets. The incidence of the most important reactions is
given in parentheses where indicated in a report. For example, the profile for Amoxicillin begins:
Skin
Acute generalized exanthematous pustulosis (AGEP) [17]
Anaphylactoid reactions/Anaphylaxis [10]
Angioedema (1–10%) [4]
This means that we have 17 articles referring to occurrence of AGEP; 10 articles mentioning the occurrence of
anaphylaxis; and 4 articles talking of angioedema, as reactions to Amoxicillin within the Skin category. All these articles
appear on the website www.drugeruptiondata.com together with links to the article abstracts on PubMed. Addition-
ally, the incidence of angioedema as a reaction has been reported (usually in the full prescribing information) as
between 1 and 10%.
Later in the Amoxicillin profile is an entry for:
Ecchymoses
If there are no numbers after an entry it indicates that the reaction has been reported in the full prescribing
information (without an incidence) or has been recorded anecdotally.
On some occasions, there are very few or no adverse reactions to a specific drug. These drugs are still included in the
manual as there is a positive significance in negative findings.

2. Important eruptions / reactions

i) This section of the manual includes a description of important eruption and reaction patterns. Over 40 eruptions/
reactions are described here in alphabetical order, from Acanthosis nigricans to Xerostomia.
ii) Following this section are lists of ALL drugs that have been found to cause these important eruptions/reactions. This
section is a quick look-up tool for drugs that cause important reaction patterns.

viii
 (Descriptions of several other reactions, and lists of drugs associated with these reactions, can be found on our
website – www.drugeruptiondata.com.)

3. The Index
The final part of the manual is an index of trade/brand names and their corresponding generic drugs or synonyms
(noted in italic). If you need to look up a trade name, use this index to find the corresponding generic name so that you
can then look-up the relevant generic drug profile entry in the A–Z section of the book. Synonyms are included for
ease of reference.

Notes on style and conventions

Drug information
• The Generic drug name is at the top of each drug profile. A listing of synonyms (where applicable) follows.
• Trade (Brand) name(s) are then listed alphabetically. When there are many trade names, the ten (or so) most commonly
recognized ones are listed.
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• Following the trade names is – in parentheses – the latest name of the pharmaceutical company that is marketing the
drug. Many of the names of the companies have changed from earlier editions of this manual because of acquisitions,
mergers, and other factors in the pharmaceutical industry.
• Next appears the Half-life of each drug, when known.
• On occasion, an important or pertinent Note (most often pertaining to potentially severe drug–drug interactions) will
follow.
For personal use only.

Where known and when applicable, pregnancy category ratings (as per the US FDA) have been included within each drug
profile. The FDA-assigned pregnancy categories are explained as follows:

Category A
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and
there is no evidence of risk in later trimesters).

Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled
studies in pregnant women.

Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies
in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or
studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk
based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in
pregnant women clearly outweigh potential benefits.

ix
 Reactions
• These are the Adverse Reactions to the particular generic drug. They are classified into seventeen different categories:
Skin, Hair, Nails, Mucosal, Cardiovascular, Central Nervous System, Neuromuscular/Skeletal, Gastrointestinal/Hepatic,
Respiratory, Endocrine/Metabolic, Hematologic, Renal, Genitourinary, Otic, Ocular, Local, Other.
• Within each category, the reactions are listed alphabetically. Thus, the order of listing does not reflect severity or frequency
in any way. The number of articles reporting the reaction is noted in square brackets. The incidence of the listed ADRs is
recorded in percentages in parentheses where known.
• The terminology used to list reaction patterns has been simplified as far as possible by eliminating, for the most part, tags
such as “like” (as in “-Psoriasis-like”), “-reactivation,” “-syndrome,” “-dissemination,” “-iform,” etc.
• The number of references reporting the ADR is recorded in square brackets.
Downloaded from informahealthcare.com by Nyu Medical Center on 04/13/12
For personal use only.

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