Pharmacovigilance and adverse events associated with losartan potassium

Abstract

Objective: To analyze the profile of adverse events associated with the use of losartan potassium in Brazil between 2018 and 2023. Methods: Descriptive cross-sectional study with a quantitative approach, using secondary data obtained from the VigiMed platform, from 01/01/2018 to 02/04/2023. Results: 18 notifications were recorded, involving patients aged between 24 and 90. The majority (88%) belonged to generation X, 50% were female and 50% male. In 55% of cases, the drug was withdrawn, 94% used the 50mg dose, and 72% reported using it twice a day. Notifications were made by pharmacists in 50% of cases, 77% of which were spontaneous. The most cited adverse event (11%) was dose omission; in terms of severity, 33% reported another clinically significant effect and 50% of the cases were considered resolved. Conclusion: The results indicated that the patients belonged to generation X, suggesting that advanced age is a more significant risk factor than gender, given that the proportion between men and women was equivalent. Although pharmacists play an essential role in reporting these events, only a proportion of reactions are actually reported, compromising the identification of signs of drug safety.