4-1OAS Cutaneous Drug Hypersensitivity Reaction in Korean Children: An Analysis of KAERS Database on 2012-2013

Thursday, 15 October 2015: 11:00 - 11:15
Room R2 ABC (Floor 3) (Coex Convention Center)

Eui Jun Lee, MD , Department of Pediatrics, Seoul National University Hospital, Seoul, South Korea

Dongin Suh, MD , Department of Pediatrics, Seoul National University Hospital, Seoul, South Korea

Hwa Jin Cho, MD , Department of Pediatrics, Chonnam National University Hospital, Gwangju, South Korea

Sung-Il Woo, MD , Pediatic SIG, Korea Institute of Drug Safety and Risk Management, Seoul, South Korea

Eun Hee Chung, MD , Department of Pediatrics, National Medical Center, Seoul, South Korea

Soo Youn Chung , Korea Institute of Drug Safety and Risk Management, Gyeonggi-do, South Korea


Since a large proportion of adverse drug reaction (ADR) affects the skin, investigations of cutaneous drug hypersensitivity reaction (DHR) are important to evaluate their impact in dermatology and health care in generals as well as their burden for affected patients. However, little is known about the characteristics of drug-induced cutaneous reactions in Korean children.


We analyzed Individual Case Safety Reports (ICSRs) of cutaneous adverse reactions kept in the Korea Adverse Event Reporting System (KARES). From January 2012 to December 2013, cases of cutaneous DHR were selected and analyzed regarding the age, gender, causative agents, and fatal cases. Based on the WHO-UMC causality assessment system, cases that assessed as ‘unlikely’, ‘unclassified’ or ‘unassessable’ were excluded.


A total of 2,577 cases were identified. 1406 cases were male (54.6%), and mean age was 5.97 ± 6.48 years. The most common agent was vancomycin (6.1%), followed by amoxicillin (4.0%), ampicillin (4.0%). The most common adverse reaction was rash (29.2%), followed by urticaria (20.8%), itching (14.0%). Among the ‘certain’ cases by WHO-UMC causality assessment system, the most common agent was acetylsalicylic acid (13.5%), followed by paracetamol (6.7%), iopromide (5.6%).

There were 55 cases of serious ADR. Among the serious ADRs, Acute generalized exanthematous pustulosis (AGEP) was most common (37 cases), followed by Steven-Johnson Syndrome (SJS, 14 cases), Toxic Epidermal Necrolysis (TEN, 2 cases), and Drug reaction with Eosinophilia and Systemic Symptoms (DRESS, 2 cases). Paracetamol was most common causes of serious ADRs (5 cases).


The brief analysis of ICSRs-KARES ADR report reveals that the antibiotics and commonly used antipyretics were most common causative agent of cutaneous reaction. More active reporting about cutaneous DHRs should be encouraged to indicate unlabeled ADRs.