Report your persistent side effects to drug regulatory agencies

Global health & drug regulatory agencies

If you are experiencing an adverse reaction, either while ON the drug or experiencing persistent or worsening health problems AFTER stopping use of the drug, please report it to the appropriate health agency below.

It is extremely important that reports of adverse events (either directly from you or through your doctor) reach national regulatory bodies. This is vital to generate appropriate awareness about people suffering from persistent side effects. The more people that submit reports of persistent side effects, the more national and supranational agencies will take notice of the problem, and are thus more likely to investigate the effects caused by the drugs. As well as much needed acknowledgement of the situation, it is hoped this will lead to changes in advice to doctors regarding prescription, adequate warning on labeling and other regulatory changes regarding usage.

If you have not submitted an adverse reaction report yet, please do so — today.

Click here for a list of EU/EEA regulatory agencies

Click here for all regulatory agencies in Europe

Click here for all regulatory agencies WORLDWIDE

USA

FDA – U.S. Food & Drug Administration
Phone: 1-800-332-1088
Report Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Report by Mail (download & print form): https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf
Mail to: MedWatch,  5600 Fishers Lane, Rockville, MD 20852-9787

UK

MHRA – National Yellow Card Information Service
Phone: 0808 100 3352
E-mail: pharmacovigilance@mhra.gsi.gov.uk
Report Online: https://yellowcard.mhra.gov.uk/
Mail to: MHRA, CHM FREEPOST, London SW8 5BR

Italy

AIFA – Italian Medicines Agency / Agenzia Italiana del Farmaco
Phone / Contatti: 06 59784351
Fax: 06 59784142
Address: Via del Tritone, 181, 00187 Rome (Roma), Italy1. Citizens Adverse Events Reporting Form / Scheda di segnalazione per i cittadini: http://www.agenziafarmaco.it/sites/default/files/tipo_file07d6.pdf

2. Spedire una copia del modello di scheda per i cittadini compilato a uno dei seguenti recapiti:
a) in busta chiusa all’indirizzo postale AIFA (Agenzia Italiana del Farmaco) – Ufficio Farmacovigilanza – Via del Tritone, 181 – 00187 Roma ;
b) oppure via fax al numero 06 59784142;
Per ulteriori informazioni puoi contattare il numero telefonico 06 59784351.

Australia

Therapeutic Goods Administration
Phone: 1300 134 237
Fax: 02 6203 1616
Email:
Report online: https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase
Report by mail (download & print form): http://www.tga.gov.au/adr/bluecard.pdf
Mail to: Medicines Safety Monitoring, Reply Paid 100, WODEN ACT 2606

Canada

Health Canada – MedEffect Adverse Reaction reporting
Phone: 1-866-234-2345
Fax: 1-866-678-6789
Email: cadrmp@hc-sc.gc.ca
Report online: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html#a1
Report by mail (download & print form): http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/report-declaration/ar-ei_form-eng.pdf
Mail to (addresses): http://www.hc-sc.gc.ca/contact/dhp-mps/hpfb-dgpsa/cvro-brcv-eng.php

If you would like to report your side effects to the manufacturer of Propecia:

Merck

  • USA Merck National Service Center – Adverse Event reporting: 1-800-444-2080
  • Worldwide contacts: www.merck.com/contact/
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