OBJECTIVES: To analyse the pattern and patient’s clinical characteristics of reported Adverse Drug Reactions (ADRs) in Malaysia.

METHODS: All ADR reports received by the National ADR Monitoring Centre from January to December 2015 were retrospectively reviewed. The compiled data was analysed and coded. WHO Anatomical Therapeutic and Chemical (ATC) classification system was used to determine the class of drugs. Types of ADRs were coded based on the Medical Dictionary for Regulatory Activities (MedDRA) terminology. ADRs due to immunization, over-the-counter (OTC) and traditional products were excluded. Descriptive analyses were conducted to summarize demographic data, patient's clinical and ADR characteristics, causality assessment and comorbidity.

RESULTS: Result shows that most reported ADR in year 2015 mostly occurred among Malay, female and in the age group between 46 to 65 years. Out of 5,707 reported cases analysed, 18.8% (n=1,073) of them were due to antibacterial drugs for systemic use (J01). The causality for most of the ADRs reported were classified as C3 i.e. might occur within reasonable time and may be due to concurrent disease or other drugs. In terms of specific drug causing ADR, amlodipine ranked as the drugs with the most frequent ADR (282 cases). Based on preferred term of MedDRA terminology, the top five most reported ADR were urticaria (6.9%), rash maculo-papular (6.5%), itching (5.6%), pruritus (3.9%) and dizziness (3.1%). There were 33 ADR-related deaths with more than 50% caused by imatinib.

CONCLUSIONS: The number of ADR reported in Malaysia for year 2015 is still low compare to the other countries. Due to spontaneous ADR reporting in Malaysia, detailed intention and quality information reported by healthcare professionals and consumers are needed to facilitate in reducing ADR incidences in the future.