Health Professionals

The information in this section is for health providers, such as doctors, pharmacists, nurses, medical assistants, etc. and not present as medical advice to health professionals.

NPRA Recent Updates, Safety Alert & DHPCs

Angiotensin II Receptor Blockers (ARBs): Risk of Intestinal Angioedema
published on 2025-05-28

[Updated] Statins: Risk of Inducing or Aggravating Myasthenia Gravis
published on 2025-05-26

Isotretinoin: Risk of Sacroiliitis and Urethritis
published on 2025-05-26

Enoxaparin: Risk of Acute Generalised Exanthematous Pustulosis (AGEP)
published on 2025-05-21

Azathioprine: Risk of Non-Cirrhotic Portal Hypertension (NCPH) / Portosinusoidal Vascular Disease (PVSD)
published on 2025-05-20

Viewl All Recent Updates

28May

Safety Alerts 2025Seksyen Farmakovigilans

Angiotensin II Receptor Blockers (ARBs): Risk of Intestinal Angioedema

27May

Safety Alerts 2025Seksyen Farmakovigilans

[Updated] Statins: Risk of Inducing or Aggravating Myasthenia Gravis

26May

Safety Alerts 2025Seksyen Farmakovigilans

Isotretinoin: Risk of Sacroiliitis and Urethritis

View All Safety Alerts

IMBRUVICA®(Ibrutinib): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use
published on 2023-11-29

GLYPRESSIN® (Terlipressin): Serious or Fatal Respiratory Failure and Sepsis/Septic Shock in Patients with Type 1 Hepatorenal Syndrome (Type 1 HRS)
published on 2023-06-13

ALECENSA® (Alectinib): Risk of Haemolytic Anaemia (New Warning and Precaution and Dose Modification Guidance)
published on 2022-09-28

MAVENCLAD® (Cladribine): Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring
published on 2022-06-13

TECENTRIQ® (Atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
published on 2021-04-22

Reporting ADR/AEFI by Healthcare Professionals

Please report ALL suspected Adverse Drug Reactions (ADRs) (including those for traditional products) and Adverse Events Following Immunisation (AEFIs) to the National Centre for Adverse Drug Reactions Monitoring.
Do not hesitate to report if some details are not known.The identities of Reporter, Patient and Institution will remain confidential.

Reporting by Healthcare Professionals

Quality Reporting

Please use this form to report for quality reporting of registered product (e.g. quality, efficacy, labelling, packaging) NOT related to ADRs.

Quality Reporting of Registered Product Form [PDF]

Products Search

Search Pharmaceutical, Complimentary & Alternative Products that registered with National Pharmaceutical Regulatory Agency, NPRA. You may also search cosmetic products notified with NPRA

Search Products

Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia

This report provides summarised updates on adverse events following immunisatAion (AEFIs) of COVID-19 Vaccines in Malaysia.

To receive the latest safety issues including COVID-19 Vaccines AEFI Summary Report, you may join the NPRA Safety Information Mailing List by submitting details of your name, profession and workplace through email to fv@npra.gov.my (please put in NPRA Safety Mailing List as the subject of your email).

The summary report is only available in English.

View AEFIs Report of COVID-19 Vaccines in Malaysia

Newsletter : MADRAC Bulletin

The MADRAC Bulletin provides information on the activities of the Malaysian Adverse Drug Reactions Advisory Committee, which meets bimonthly and advises the Drug Control Authority (DCA) on local and international drug safety issues.

View All MADRAC Bulletin

REAKSI Drug Safety News

This publication provides information and recommendations to healthcare professionals to enhance communication of drug safety updates, raise
awareness of adverse drug reactions reported, and stimulate additional adverse drug reaction reporting.

View All REAKSI Drug Safety News

Health Professionals Information

Consumer Reporting of Side Effects to Medicines or Vaccines

To report a suspected side effect or adverse drug reaction (ADR) to any medicine (including prescription, over-the-counter, traditional product, health supplement, etc.)
or adverse event following immunisation (AEFI) to any vaccine.

e-Brochures

Easy-to-read guides or information on medicinal products and cosmetics, including their safe use and how to report side effects or product quality issues.

Online Public Engagement

This page is available for public consultation and will present new proposals or amendments to the draft law (including laws, policies, regulations, etc.). The draft will appear on this page within 14 working days. The public is encouraged to provide comments and views on the NPRA during this period.

Vaccine Lot Release Certificate

Search Vaccine Lot Release

Plasma Products Lot Release

Search Plasma Products Lot Release

Safety Information

Cancellation of Registered Complementary & Alternative Product

Produk-produk ini didapati mengandungi bahan kimia, termasuk racun berjadual yang tidak dibenarkan dalam Produk Komplementari dan Alternatif. Penggunaan produk-produk ini yang dicampurpalsu dengan bahan kimia seperti yang telah dikesan boleh menyebabkan kesan advers serius.

Adulterated Poducts ( Unregistered )

NPRA telah menerima laporan kesan sampingan berkaitan produk-produk yang tersenarai di bawah dan hasil ujian yang telah dijalankan mendapati bahawa produk-produk ini telah dicampurpalsu dengan bahan terlarang atau racun berjadual.

Cancellation of Notified Cosmetic Products

Produk-produk ini telah didapati mengandungi bahan larangan, termasuk racun berjadual yang tidak dibenarkan dalam produk kosmetik. Penggunaan produk kosmetik yang dicampurpalsu dengan bahan kimia seperti yang telah dikesan boleh menyebabkan kesan advers serius.