OBJECTIVES: The main objective of this study was to assess the knowledge, attitude of participants towards ADR and to determine the common barriers towards reporting an ADR in Malaysia. METHODS: A descriptive, cross-sectional study was carried out for a period of 3 months in an area of Cheras, Malaysia. The data was collected by a self-administered questionnaire which consisted of 3 sections. RESULTS: Among the 400 respondents, 144 (36%) were male and 256 (64%) were female. The majority of the respondents were Chinese (n=227, 57%). About (n=243, 60.75%) participants reflect inadequate knowledge about what is an ADR. A significant number of the participants (n=333, 83%) were unaware of the ADR reporting center in Malaysia and about (n=344, 86%) stated that they were not aware of the ADR reporting procedure. Participants considered that inadequate knowledge regarding drugs (n=395, 87.4%), their unawareness of reporting procedure (n=320, 80%) and proper access to ADR reporting form (n=299, 75%), could be the main reasons for under-reporting. CONCLUSIONS: As the main loophole for under-reporting an ADR is the lack of public awareness about the reporting centre and its procedure. So there is a dire need that MADRAC should make certain modifications to the existing ADR reporting system in order to identify the aspects to overcome the problems of the present layman reporters. It must also ensure that a separate ADR reporting form for consumers using layman language should be made available apart from encouraging the healthcare professionals to motivate their patients to report ADRs.