If you have experienced a suspected adverse drug reaction (ADR), you can report it to your country's medicines regulator or pharmacovigilance program. These agencies collect reports to help identify potential medication safety problems and protect the public.
You do not need to prove that a medication caused your symptoms before submitting a report. Report what happened, including when the medication was started or changed and when symptoms began.
NORTH AMERICA
United States 🇺🇸
Canada 🇨🇦
UNITED KINGDOM AND IRELAND
United Kingdom 🇬🇧
Ireland 🇮🇪
- Agency: Health Products Regulatory Authority (HPRA)
- Website: https://www.hpra.ie/
- Search the site for Report a side effect or Human medicines to find the current reporting route.
AUSTRALIA AND NEW ZEALAND
Australia 🇦🇺
New Zealand 🇳🇿
- Agency: Centre for Adverse Reactions Monitoring (CARM)
- Website: https://nzphvc.otago.ac.nz/
- Look for consumer reporting instructions for suspected adverse reactions.
EUROPE
For countries in the European Union, the European Medicines Agency (EMA) provides information about reporting suspected side effects. Reports are generally submitted through the relevant national system.
For other European countries, consult the national medicines regulator or use the EMA website to identify the appropriate reporting arrangements.
ASIA
India 🇮🇳
- Agency: Indian Pharmacopoeia Commission (IPC)
- Program: Pharmacovigilance Program of India (PvPI)
- Website and reporting forms: https://www.ipc.gov.in/PvPI/adr.html
- Toll-free helpline listed by PvPI: 1800-180-3024
Japan 🇯🇵
- Agency: Pharmaceuticals and Medical Devices Agency (PMDA)
- Website: https://www.pmda.go.jp/english/
- Look for drug safety information and adverse drug reaction reporting.
Singapore 🇸🇬
- Agency: Health Sciences Authority (HSA)
- Website: https://www.hsa.gov.sg/
- Search for Report adverse events or Adverse drug reactions.
Malaysia 🇲🇾
- Agency: National Pharmaceutical Regulatory Agency (NPRA)
- Website: https://www.npra.gov.my/
- Look for consumer adverse drug reaction reporting.
Philippines 🇵🇭
- Agency: Food and Drug Administration (FDA)
- Website: https://www.fda.gov.ph/
- Look for adverse drug reaction reporting or pharmacovigilance.
AFRICA
South Africa 🇿🇦
- Agency: South African Health Products Regulatory Authority (SAHPRA)
- Website: https://www.sahpra.org.za/
- Look for adverse drug reaction reporting forms and current submission instructions.
Other African countries
Reporting systems vary by country. Consult your national medicines regulator or Ministry of Health to find the current pharmacovigilance contact.
CENTRAL AND SOUTH AMERICA
Brazil 🇧🇷
Mexico 🇲🇽
- Agency: Federal Commission for the Protection against Sanitary Risks (COFEPRIS)
- Website: https://www.gob.mx/cofepris
- Search for farmacovigilancia and consumer reporting instructions.
For Argentina, Chile, Colombia, and other countries in the region, contact the national medicines regulator or Ministry of Health for the current reporting system.
IF YOUR COUNTRY IS NOT LISTED
The World Health Organization (WHO) maintains information about countries participating in its Program for International Drug Monitoring.
Select your country and follow the information available to identify its national pharmacovigilance centre or medicines regulator. Participation in the WHO programme does not necessarily mean that a country has a public online reporting form.
What information should you include?
Before submitting a report, gather as much of the following information as you can:
- Medication name, including the brand and generic name if known.
- Dose, dates started and stopped, and any dose changes.
- Date symptoms began and a description of what happened.
- Other medications and supplements taken at the time.
- Whether the medication was reduced, stopped, or continued.
- Any medical treatment received and the outcome so far.
You can report a suspected reaction even if you are uncertain about its cause. Describe the facts as accurately as possible, without feeling that you must establish a definite connection.
Important safety reminder⚠️
Reporting an ADR is not a substitute for medical assessment. If you experience a severe or potentially life-threatening reaction, seek urgent medical attention rather than waiting to complete a report. Do not abruptly stop or change a regularly taken psychiatric medication without appropriate medical guidance, unless emergency clinicians direct you otherwise.
Disclaimer: This resource is for educational and peer-support purposes. Reporting systems, eligibility, telephone numbers, and submission procedures may change. Check the official agency website for the latest instructions before submitting a report.
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