www.ijbcp.com International Journal of Basic & Clinical Pharmacology | January 2019 | Vol 8 | Issue 1 Page 27 IJBCP International Journal of Basic & Clinical Pharmacology Print ISSN: 2319-2003 | Online ISSN: 2279-0780 Original Research Article Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India Vijaya Chandra Reddy Konda 1 , Sree Surya Durga Devi Pilla 2 , A. Surekha 3 , K. R. Subash 1 *, K. Umamaheswara Rao 1 INTRODUCTION According to World Health Organization (WHO), an adverse reaction to drug is one that is noxious, unintended and occurs at doses normally used in man. 1 Adverse drug reactions (ADRs) are associated with prolonged hospitalization, increased morbidity and mortality. 2,3 ADRs resulted in substantial increase in costs for the healthcare sector. 4 Cutaneous ADR is any undesirable change in the structure or function of the skin, its appendages or mucous membranes, encompassing all adverse events related to drug eruption, regardless of the etiology. 5 Skin reactions are one of the most frequently reported ADRs and are responsible for about 3% of all disabling injuries during hospitalization. 6 The Pharmacovigilance Programme of India (PvPI) is launched in 2010 with a broad objective to safe guard the ABSTRACT Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs. Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability. Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti- inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication. Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients. Keywords: Adverse drug reaction monitoring centre, Cutaneous adverse drug reactions, Causality, Pharmacovigilance DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20185085 1 Department of Pharmacology, 2 ADR Monitoring Centre, 3 Department of Dermatology, Sri Venkateswara Institute of Medical Sciences, Sri Padmavathi Medical College for Women, Tirupati, Andhra Pradesh, India Received: 26 November 2018 Accepted: 01 December 2018 *Correspondence to: Dr. K. R. Subash, Email: subbu2207@yahoo.com Copyright: © the author(s), publisher and licensee Medip Academy. This is an open- access article distributed under the terms of the Creative Commons Attribution Non- Commercial License, which permits unrestricted non- commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.