Analysis of docetaxel adverse drug reactions: A retrospective study based on iraqi pharmacovigilance center database

Abstract

Docetaxel is a chemotherapeutic agent approved for management of various cancers, but the occurrence of significant adverse drug reactions may affect the drug use and overall effectiveness in clinical practice. The purpose of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions. Most of the adverse drug reactions were related to “skin and subcutaneous tissue disorders” (26.7%), followed by “respiratory, thoracic and mediastinal disorders” (20.8%), “gastrointestinal disorders” (17.4%) and “general disorders and administration site conditions” (10.6%). The majority of these reactions with possible causality (68.6%), severity level 3 according to Hartwig’s Severity Assessment (55.5%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition, the most common outcome of adverse drug reactions was recovered / resolved (46.19%).