Hypersensitivity Reactions in Serious Adverse Events Reported for Paracetamol in the EudraVigilance Database, 2007⁻2018.

ABSTRACT: Paracetamol is a popular and easily available drug which is used world-wide as analgesic, antipyretic agent. Hypersensitivity reactions to this drug involve a wide range of symptoms of various importance for patient management. The EudraVigilance (EV) database serves as a system for monitoring adverse events (AE) due to drug intake. We retrospectively recorded AE reports for "paracetamol" reported from 1 January 2007 to 1 October 2018 which fulfilled the category of "serious" in EV. For further analysis the retrieved AE reports were selected according to the keywords corresponding to hypersensitivity symptoms. We included in the study 4589 AE reports with 9489 particular AEs. 24.2% of all the AE reports concerned children. The most often reported symptoms were "angioedema," "rash" and "urt

SUBMITTER: Popiolek I 

PROVIDER: S-EPMC6473647 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature