Table of Contents
Pharmacy, Volume 7, Issue 1 (March 2019)
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Cover Story (view full-size image) Paracetamol is a readily available analgesic and antipyretic agent, which can induce a wide [...] Read more. Paracetamol is a readily available analgesic and antipyretic agent, which can induce a wide spectrum of hypersensitivity reactions. We recorded serious adverse events (AE) related to paracetamol hypersensitivity reported to the EudraVigilance (EV) database from 2007 to 2018. EV is the European system for collecting information about drug AE. We identified 4589 AE reports with 9489 particular AE. The most often reported symptoms were “angioedema”, “rash”, “urticaria” and “oedema” located in the head, neck or respiratory tract. A total of 58 AE reports had fatal outcomes: 9 Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) cases; 10 anaphylactic reactions; 21 cases of hepatic failure; and 18 cases defined as “other reasons”. SJS/TEN prodromes and symptoms appeared in 286 of the AE reports. For patient safety, it is vital to identify early warning signs of severe AE. View this paper