Reporting side effects: official routes and useful information

Care comes before the form

For severe or sudden warning signs, arrange medical help immediately. Do not wait for an acknowledgement or a reply from a regulator. Examples include sudden loss of sight, severe breathing problems or intense persistent abdominal pain.

For less urgent symptoms, your treating team is still the right place for questions about further use. Submitting a form does not tell you whether a particular treatment should continue in your circumstances. Ask specifically for an individual assessment when unsure.

What a suspected reaction report means

You do not need to prove the cause yourself. Describe what happened and when, as factually as possible. Clinical examination can investigate other explanations alongside the report. Reporting and medical assessment serve different purposes.

The number of publicly available reports does not establish your personal probability of harm; among other limitations, a reliable comparison group is missing. Avoid treating individual reports as a league table of supposedly safe or dangerous products.

Prepare a short factual record

Have the packaging or your medicine list available. Gather information you actually know, and mark uncertainty instead of inventing a date or a finding. If a relative helps, make clear whose experience is being reported.

• Medicine name, active ingredient and formulation; batch number if available.
• When use began, symptom onset, what happened and how it developed.
• Other medicines used at the same time, relevant examinations and their results.
• Professionals already involved and any existing report reference, where requested.

Choose the official reporting service

The language of this article does not determine the responsible authority. Use the country relevant to the treatment event. If something happens while travelling, a pharmacy or regulator can help clarify the route. The sources below link to official starting points.

• Germany: the joint BfArM and Paul-Ehrlich-Institut patient portal nebenwirkungen.bund.de.
• Switzerland: Swissmedic’s online reporting form for patients and relatives.
• Austria: the BASG online reporting service for human medicine adverse effects.
• France: the government health-event reporting portal, linked through Service Public.
• Italy: AIFA’s service for reporting suspected adverse drug reactions.
• Spain: AEMPS and the NotificaRAM portal for suspected medicine reactions.

Keep track after submitting

Save any confirmation or case reference offered by the service. If new test results become available, use the same reference for follow-up where possible and follow the portal’s instructions. This helps connect additional information with the original case.

Do not post medical records, packaging containing personal details or your health history in website comments. Discuss ongoing care directly with the treating team. A report does not mean the regulator will create your personal treatment plan or provide an individual diagnosis.