Drug-induced dysphagia: Analysis of age and time of onset profiles using a Japanese pharmacovigilance database

OBJECTIVES: To investigate differences in drug-induced dysphagia profiles among causative drugs, with a focus on reporting risk, patient age, and time to onset. BACKGROUND: Drug-induced dysphagia is one of several causes of dysphagia. However, its detailed profile, including differences among drugs and age groups, has not yet been thoroughly examined. MATERIALS AND METHODS: Data were obtained from the Japanese Adverse Drug Event Report Database. Reports submitted between April 2004 and October 2021 were analyzed. The 10 drugs with the highest number of reports of drug-induced dysphagia were selected as the target drugs. Reporting odds ratios were calculated to evaluate the association between each drug and dysphagia. The primary endpoint was the reporting odds ratio, while age distribution and time to onset were secondary outcomes. RESULTS: A total of 756,965 reports were analyzed. All target drugs were associated with drug-induced dysphagia. Cevimeline was identified as a novel finding because dysphagia was not observed during clinical trials. For most drugs, dysphagia occurred within approximately 25 days of administration. In contrast, paroxetine and milnacipran were associated with dysphagia even after long-term use. The age distribution of reported cases differed by drug, suggesting drug-specific differences in susceptible age groups. CONCLUSION: Drug-induced dysphagia profiles differ among drugs, particularly in terms of timing of onset and patient age distribution. Therefore, clinicians should consider both the causative drug and the patient's age when monitoring for dysphagia.