Background Drug regulatory authorities promote patient safety by, among other ways, monitoring adverse drug events (ADEs). Reporting of ADEs in Uganda is below the average for a well-performing system. Enhancing patients’ understanding of and involving them in reporting ADEs improves drug safety and treatment outcome monitoring. The objective of this study was to describe the knowledge, attitude, and practice of patients and healthcare workers regarding ADEs and ADEs reporting.

Methods A cross-sectional survey was carried out among 1034 respondents from randomly selected households and 327 health workers at health facilities in the Iganga Mayuge Health and Demographic Surveillance Site (IMHDSS). The IMHDSS, located in Uganda, covers 90,000 people living in 17,000 households.

Results Over half of respondents (59%) sought treatment from private drug shops, 37% from either clinic, health center or hospital, while 4% sought treatment from herbalists, friends or relatives. Over half (56%) were aware of ADEs, 57% expressed willingness to report an ADE while 43% did not know what to do when it occurs. Almost half (46%) could not differentiate between an ADE and the symptoms, and for those who could, the majority (76%) were willing to report it. Only 34% had ever reported an ADE when it occurred to them. Of those who reported, 43% had their drugs changed, 31% were only counseled while 11.5% continued taking the same medication. Among healthcare workers, 95% knew about ADEs, but only 35% had ever reported. Reasons for not reporting were: fear of being victimised or sued (35%); lack of adequate knowledge about ADE (26%); 20% thought it would disappear shortly; and 14% did not find it necessary to report.

Conclusion Patients seek their treatment from private providers. Patients want to report ADEs, but they do not have adequate knowledge. Healthcare workers’ reasons for not reporting are subjective. Dedicated pharmacovigilance-related interventions at community level would improve community members’ knowledge and hence ADE reporting rate.