Consumer Reporting of Side Effects
(Note: If you are a Healthcare Professional, please click here to report a medicinal problem or adverse drug reaction.)
Please report any side effects to medicines or vaccines [adverse events following immunisation (AEFI)] that you or someone you care for has experienced to the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. Your reports help improve the safe use of medicines in Malaysia.
A side effect (or adverse drug reaction –ADR) is defined as any unintended effect of a medicine which occurs at the normal dose used. Please report any side effect you find troubling, even if you are not certain it is due to the medicine or vaccine.
For further information on Vaccine Safety, please click here.
How to Report?
You may report directly to the NPRA using the ConSERF form below. This form is used to report a suspected side effect to any medicine (prescription, over-the-counter, or traditional products, health supplements, vaccines, etc.).
(i) Submit your report directly online, or
(ii) Download and print out the form, complete the details yourself, and submit it to us by email, fax or post at the address stated below.
Please provide as many details as possible to ensure your report is useful. Your details will remain confidential and will not be passed on to any person outside NPRA without your permission. You will only be personally contacted if we need additional information related to your report.
You are encouraged to consult your healthcare provider (such as a doctor or pharmacist) before submitting your report. Your healthcare provider may be able to provide further clinical information based on your medical records that can help us evaluate your report.
Consumer Side Effect Reporting Form [Online Reporting]
For enquiries on reporting side effects/ AEFI, or to submit your report please contact:
Pusat Pasca Pendaftaran Produk & Kawalan Kosmetik
Bahagian Regulatori Farmasi Negara (NPRA)
Lot 36, Jalan Universiti,
46200 Petaling Jaya, Selangor.
Tel. No.: 03-7801 8464/8470
Fax. No.: 03-7956 7151