Reporting a Side Effect: How to Report a Suspicion to the BfArM — in 10 Minutes

Ever since the new medicine you have been dizzy all the time, you have come out in a rash, or you no longer sleep. And then the thought: I have no way of knowing whether it really comes from that. That is precisely why it is called a suspected case report — you do not have to prove anything, you only have to describe. The report goes to the BfArM, Germany's federal institute for drugs and medical devices, or to the Paul-Ehrlich-Institut, takes around ten minutes online and can be anonymous if you wish. This guide shows you step by step how it works, what belongs in a good report — and what comes first when things are serious.

1. Why your report of all reports counts

Before a medicine reaches the market it is tested in trials — on a few hundred to a few thousand people. That is enough to pick up common side effects, but not to find rare ones: a reaction that affects one in ten thousand people treated will in all likelihood not show up at all in a trial with three thousand participants.

That is why safety testing does not end with approval; that is where it really begins. The technical term is pharmacovigilance — literally, watchfulness over medicines. What is meant is continuous observation under everyday conditions: in older people, in people with several conditions at once, in combination with five other preparations. In other words, in exactly the people who were often not included in the trials.^¹

Patient reports are especially valuable here: you describe what the side effect feels like in everyday life. That perspective is often missing from reports made by doctors — those contain a diagnosis, but not the fact that for four weeks you have not managed a flight of stairs without stopping. That is why patients in the EU are expressly allowed to approach the authorities directly.

2. A suspicion is enough — you do not have to prove anything

The most common thing that holds people back is: "Maybe the dizziness came from my circulation after all, and I don't want to report something that isn't right." That worry is unfounded: what is reported is a suspected case. Judging whether a connection is plausible is not your job — that is what the specialists at the authorities are there for.

• You do not need a diagnosis — "severe dizziness on standing up" is enough. Technical terms are not required.
• You do not need a practice to confirm it — you can report independently, even if your doctor sees the connection differently.
• An "uncertain" report is not a false report — unclear connections are built into the process. And you can stay anonymous: contact details are voluntary.

Nor is this about blame. A report is not a complaint against your practice, not a case against the manufacturer and not a claim for compensation — it is a data point for medicines safety.

3. Safety first: what cannot wait

Before we get to forms, the most important thing: reporting is never the first step when you are acutely unwell. The report can wait — a severe reaction cannot.

Once the emergency has been dealt with, the report is then especially valuable — severe and unexpected reactions are exactly the cases the system learns from. Note down as early as you can what happened and when.

4. The official route: nebenwirkungen.bund.de step by step

For some years now the two responsible German federal authorities have run a joint reporting portal: nebenwirkungen.bund.de ("side effects"). Behind it stand the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the Federal Institute for Drugs and Medical Devices) for most medicines and the PEI (Paul-Ehrlich-Institut) for vaccines and biomedicinal products. You do not have to know which of them is responsible — the portal forwards your report automatically.^²

1. Choose the reporting form for members of the public. There are separate routes for healthcare professionals and for patients. Take the patient route — it is written in everyday language and does not ask for technical terms.
2. Enter the product and the active substance. Ideally both: the brand name from the pack and the active substance underneath it. With a generic the manufacturer matters too, because products with the same active substance differ in their excipients.
3. Add the batch number if you have it to hand. It is printed on the carton and on the blister, usually as "Ch.-B." (Charge, the German for batch) or "Lot" — not a mandatory field, but valuable with quality problems and with vaccines.
4. Give the dose and the period. How much, how often, since when — and whether you are still taking the medicine.
5. Describe the reaction. In your own words: what happened, when it began, how long it lasted. Everyday language is expressly welcome.
6. List your other medicines. Everything else you take — including over-the-counter products, supplements and herbal preparations. Many reactions only arise from a combination.
7. Name your existing conditions and background details. Age, sex, approximate weight, and any known conditions of the kidneys, liver or heart.
8. Contact details: voluntary. You can report anonymously; with an address the institute can follow up if it needs to.
9. Submit it and keep the confirmation. You receive an acknowledgement of receipt with a reference number — save it in case you want to add something later.

Reckon on around ten minutes if you have the pack and your medication list to hand. The biggest time sink is the concomitant medication — which is exactly why a well-kept medication list or medication plan pays off.

5. What makes a good report: the timeline

If there is one thing you do particularly carefully, make it the sequence of events. For assessing a suspected case, "what happened when?" matters more than any turn of phrase.

The honest problem with all this: after three weeks hardly anyone still knows whether the rash began on the Tuesday or the Thursday. That is exactly why keeping an ongoing record is half the battle — it turns a vague feeling into a solid timeline. It is worth its weight in gold for your next appointment too: Prepare for a doctor's appointment.

6. The easier route: through your practice or pharmacy

You do not have to fill in the form yourself. Doctors and pharmacies are required under their professional codes to report suspected cases that come to their attention to the drug commissions of their professions, which pass them on to the authorities. So one sentence at your next appointment is enough.

A duplicate report, incidentally, is not a problem: if you report and your practice does so as well, the cases are merged during evaluation. Better reported twice than not at all.^³

7. Report it or put up with it? An honest dividing line

Not every inconvenience has to be reported — and not every one has to be endured. Both are legitimate.

What usually needs no report

If the package leaflet lists a side effect as "common", if it is mild and if it disappears after a few days, it is already known to the system: mild nausea in the first week, loose stools while on antibiotics, headaches at the start of treatment. You can recognise this from the frequency categories — how to read them is explained in Understanding the package leaflet.

What should be reported

• Anything unexpected: a reaction that is not in the package leaflet at all — the most valuable reason to report there is.
• Anything severe: hospital admission, lasting impairment, inability to work, a life-threatening situation.
• Anything persistent: whatever is no better after weeks, although the leaflet calls it "temporary".
• Anything with new products and after a switch: with recently approved medicines the evidence is thin; suddenly different symptoms after a change of product can be down to the excipients or to the way the substance is released.

"Putting up with it" does not mean doing nothing, either. Even a known side effect is a good reason to talk to your practice about alternatives, the dose or the timing — especially with symptoms that put you at risk in everyday life, such as dizziness from medications or tiredness at the wheel, see Medications and driving.

8. What happens after your report

Your report does not disappear into a drawer. It goes through a defined process:

1. Recording and plausibility check. The case is entered into a database and coded using internationally standardised terms — which makes it comparable with reports from other countries.
2. Transfer to the European database. Reports from Germany feed into the shared system of the European Medicines Agency. That makes rare patterns visible across borders too.^⁴
3. Signal detection. Specialists and statistical methods look for anomalies: does a reaction occur more often with one active substance than would be expected?
4. Assessment. A signal is examined — literature, studies, the reports in detail. Sometimes the suspicion is not confirmed.
5. Action. If it is confirmed, consequences follow: additions to the product and patient information, warnings, restrictions on use and, in extreme cases, suspension of the marketing authorisation.

You may know the most visible outcome from the news: the Rote-Hand-Brief ("red hand letter") — the circular with which manufacturers inform healthcare professionals about newly identified risks, recognisable by the red hand on the letterhead. Every one of these letters stands at the end of a chain that began with individual suspected case reports.

9. Special cases: vaccinations, pregnancy and breastfeeding

Vaccines: the PEI is responsible

For vaccines and other biomedicinal products it is not the BfArM that is responsible but the Paul-Ehrlich-Institut. Through the joint portal you do not have to make that distinction yourself — your report is allocated for you. Two details matter particularly here: the batch number, which you will find in your vaccination record, and the exact date of vaccination.^⁵

For context: the usual vaccine reactions such as pain at the injection site, tiredness or a slight fever in the first one to two days are known and documented. What should above all be reported are reactions that go beyond that in nature, severity or duration. More under Vaccinations for adults and Vaccines and medications.

Pregnancy and breastfeeding: embryotox as well

There is a particularity here: alongside the report to the authorities, feedback to embryotox, the pharmacovigilance centre at the Charité in Berlin, is worthwhile. It systematically follows up the use of medicines in pregnancy and while breastfeeding — including uneventful courses. Without reports on uncomplicated use, the evidence stays thin for everybody else. Practical pointers are under Medications during pregnancy; for breastfeeding, embryotox is likewise the first port of call.

Children and older people

For both groups the evidence is thinner — which makes reports weigh more. In children, weight and age are particularly important (Medications for children); in older people, it is the concomitant medication (Medications in old age).

10. "It won't make any difference anyway" — three objections fact-checked

• "That has been known for ages." Perhaps — but perhaps not in this form, this duration or this combination. And even with known reactions the frequency counts: it is recalculated continuously, and that takes reports.
• "A single report changes nothing." On its own, no — as part of a pattern, yes. That is exactly how signal detection works: a statistical signal emerges from many independent individual observations. Every report that is never sent is missing from that calculation.
• "My practice already does that." Sometimes it does, often it does not — time pressure is real. Do ask. And if you are unsure: duplicate reports are merged.

Specialists assume that side effects are reported considerably less often than they actually occur. That is the real weak point of the system — and the only one you can do something about directly.

11. And for you personally: the consequence of the side effect

The report serves the public good. For you personally it changes nothing at first — which is why a second step belongs with it:

• Write down what happened — active substance, reaction, date. This note is relevant with every future prescription and every hospital admission.
• Mention it actively — with every new prescription, in every pharmacy, before every procedure. It matters before operations too, see Medications before surgery.
• Have an alternative looked at — within the same substance group there are often better-tolerated options; the choice is made by the treating practice. This also matters during a supply shortage, when you are given a different product.

And if the symptom stays: take it seriously. A reported side effect is not a treated side effect.

12. How brite helps you with reporting

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