Comparison of patient-reported adverse drug reactions with pharmacovigilance records in gastrointestinal disorders.

Adverse drug reactions (ADRs) are frequently under-recognized in patients with gastrointestinal disorders. Differences may exist between patient-reported experiences and formal pharmacovigilance records. Therefore, it is of interest to evaluate self-reported ADRs among 265 adults receiving treatment for gastrointestinal conditions and compared findings with regional pharmacovigilance data from the same period. A structured and pretested survey collected demographic, clinical and ADR-related information. Overall, 51.7% reported at least one ADR, most commonly abdominal discomfort (27.2%), nausea (21.9%) and headache (17.4%). Awareness of formal ADR reporting systems was low, with only 38.5% having heard of such systems and 25.7% knowing how to report. Concordance between patient reports and pharmacovigilance data was high for gastrointestinal and central nervous system reactions but lower for severe and dermatological reactions. Female gender, higher education and poly-pharmacy were significantly associated with increased ADR reporting (p < 0.05). Thus, gaps in awareness of ADR reporting support integration of patient-reported outcomes into pharmacovigilance systems.