Keywords
Pharmacovigilance
Causality Assessment
How to Cite
Abstract
Introduction: An adverse drug reaction (RAM) refers to a harmful and unintended response that occurs when administering doses normally used in humans to prevent, diagnose, treat, or modify a physiological function. Objective: To analyze the causality of RAM using the Naranjo algorithm in patients hospitalized at a teaching hospital in Paraguay. Methods: An observational, descriptive, and cross-sectional study using convenience sampling. Adult patients hospitalized in the departments of internal medicine, surgery, traumatology, urology, otorhinolaryngology, and hematology at the Hospital de Clínicas of the National University of Asunción between March and May 2021 were included. Data were collected through patient interviews and medical record review using the RAM notification form. Causality was assessed using the Naranjo algorithm. Results: Twenty-four suspected cases of RAM were identified. Of these, 8 (33.3%) were classified as probable, 13 (54.2%) as possible, and 3 (12.5%) as doubtful; none were considered definitive. The most common active ingredients classified as probable were omeprazole 40 mg and rituximab (8.3% each). Was the drug most frequently associated with possible reactions (12.5%) was vancomycin 1 g. The most reported RAM was diarrhea (16.7%). The most affected system was the gastrointestinal (54%), being more prevalent in women (58%) and in the 18-40 age group (50%). Conclusions: The predominant RAM were possible, especially in young women, with gastrointestinal reactions being the most frequent.
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