Published: 2017-11-23

Profile of cutaneous adverse drug reactions of carbamazepine

Meenakshi B., Nirmala Devi P., Radha M., Abdul Rahuman M. B., Shantaraman K.


Background: Carbamazepine, a commonly used antiepileptic drug is known to produce adverse effects including dangerous reactions like cutaneous hypersensitivity reactions such as drug induced hypersensitivity syndrome (DHS), Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The FDA released a warning that serious and potentially fatal skin reactions may occur after carbamazepine in patients positive for the HLA-B*1502 allele which occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. This study profiles the cutaneous adverse drug reactions reported in this institute over a period of 3 years.

Methods: This retrospective study was conducted at Tirunelveli Medical College Hospital by analysing patient case records based on adverse drug reactions reported between August 2014 and July 2017 in the adverse drug reaction monitoring centre. The age, gender, diagnosis, type of cutaneous ADR, duration of treatment, seriousness of reaction and outcome were recorded and analysed.

Results: Among the total 25 reactions 36% were benign and 64% were severe reactions. According to Pharmaco vigilance Program of India 80% of the reactions were serious and 20% non serious. The commonest benign skin reaction was maculopapular eruption. SJS and TEN were the two very serious reactions which affected 8 patients totally. Exfoliative dermatitis was reported in 7 patients and Drug Hypersensitivity Syndrome (DHS) in one patient.

Conclusions: Severe cutaneous reactions occur after carbamazepine and prevention of ADR requires prediction of predisposition which requires special studies of HLA or genomic assessment. These are the issues of interest for future research.


Carbamazepine, Cutaneous adverse drug reactions, DHS, SJS, TEN

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James O. McNamara. Pharmacotherapy of epilepsies Goodman & Gillman’s The Pharmacological basis of Therapeutics 12th Edition; Laurence Brunton McGraw Hill; 2011:583-607.

Sekula P, Dunant A, Mockenhaupt M, Naldi L, Bouwes Bavinck JN, Halevy S, et al. Regi SCAR study group. Comprehensive survival analysis of a cohort of patients with StevensJohnson syndrome and toxic epidermal necrolysis. J Investig Dermatol. 2013;133:1197-204. [PubMed]

Garcia JB, Ferro LS, Carvalho AB, da Rocha RM, de Souza LM, James W. Patterson Cutaneous drug reactions. Patterson Weedon’s skin Pathology. 4th Edition; 596-610.

Information for Healthcare Professionals: Dangerous or Even Fatal Skin Reactions - Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics) Available at:

Safety of Medicines. A guide to detecting and reporting adverse drug reactions. Why health professionals need to take action. Available at:

Elias A, Madhusoodanan S, Pudukkadan D, Antony JT. Angioedema and maculopapular eruptions associated with carbamazepine administration. CNS Spectr. 2006 May;11(5):352-4.

Michael R. Ardern-Jone, Haur YL. Benign Cutaneous Adverse Reactions to drugs. Rook’s Text book of Dermatology Volume 4 Editors. Christopher Griffiths, Jonathan Barker, Tanya Bleiker, Robert Chalmers, Daniel Creamer. 9th Edition; 2010:118.1-118.17.

Walsh S, Haur YL, Creamer D. Severe Cutaneous Adverse Reactions to Drugs. Rook’s Text book of Dermatology Volume 4 Editors. Christopher Griffiths, Jonathan Barker, Tanya Bleiker, Robert Chalmers, Daniel Creamer. 9th Edition; 2010:119.1-119.23.

Knowles SR, Shapiro LE, Shear NH. Anticonvulsant hypersensitivity syndrome: Incidence, prevention and management. Drug Saf. 1999;21:489-501.

Shear NH, Sandra R. Knowles. Cutaneous reactions to drugs. Fitzpatrick’s Dermatology in General Medicine Lowell A. Goldsmith, Stephen I. Katz, Barbara A. Gilchrest, Army S. Paller, David J. Leffell, Klaus Wolff. 8th Edition. 2008;1:449-457.

James WD, Berger TG, Elston DM. Contact Dermatitis and drug eruptions Andrews’ Disease of the skin. Clinical Dermatology 12th Edition; 2016:90-135.

Mark McCormack. HLA-A3101 and Carbamazepine-Induced Hypersensitivity Reactions in Europeans. N Engl J Med. 2011 Mar 24;364(12):1134-43.

Valeyrie-Allanore L, Jean-Claude R. Chapter 40 Epidermal necrolysis and Toxic epidermal necrolysis. Fitzpatrick’s Dermatology in General Medicine. Lowell A. Goldsmith, Stephen I. Katz, Barbara A. Gilchret, Amy S. Paller, David J. Leffell, Klaus Wolff 8th Edition; 2012:439-448.

Viard I, Wehrli P, Bullani R, Schneider P, Holler N, Salomon D, et al. Inhibition of toxic epidermal necrolysis by blockade of CD95 with human intravenous immunoglobulin, Science. 1998 Oct 16;282(5388):490-3.

James WD, Berger TG, Elston DM, Neuhaus IM. Bullous Reactions: Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. Andrews Diseases of the skin. Clinical Dermatology 12th Edition; 2016:115-117.

Mockenhaupt M, Messenheimer J, Tennis P, Schlingmann J. Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis in new users of antiepileptics. Neurology. 2005 Apr 12;64(7):1134-8.

Chung WH, Hung SI, Hong HS, Hsih MS, Yang LC, Ho HC, et al. Medical genetics: a marker for Stevens-Johnson syndrome. Nature. 2004 Apr 1;428(6982):486.

Mehta TY, Prajapati LM, Mittal B, Joshi CG, Sheth JJ, Patel DB, et al. Association of HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome among Indians. Indian J Dermatol Venereol Leprol. 2009 Nov-Dec;75(6):579-82.

Chang CC, Too CL, Murad S, Hussein SH. Association of HLA-B*1502 allele with carbamazepine-induced toxic epidermal necrolysis and Stevens-Johnson syndrome in the multi-ethnic Malaysian population. Int J Dermatol. 2011 Feb;50(2):221-4.