Reporting Side Effects: A Beginner-Friendly Start
Reporting Side Effects: the few things that matter most, and the mistakes that catch people out early.
The FDA MedWatch program, through which anyone can report a suspected reaction.
Key takeaways
- Who can report: anyone, including patients and caregivers
- What to report: any suspected reaction, even if you are unsure
- Most useful single change: Report anything you suspect, without waiting to be certain.
- Commonest mistake: Assuming someone else will have reported it.
- See a doctor if any of the signs under "When to speak to a doctor" below apply to you.
Why bother
Safety signals for medicines are often found after approval, from reports, and patients can report directly rather than through a clinician.
Start here
Two things, and nothing else until both feel routine.
- Report anything you suspect, without waiting to be certain
- Include what you were taking, the dose and the timing
Then add these
Once the first two are automatic, these are worth adding.
- Tell your doctor or pharmacist as well as reporting
- Keep the product packaging and lot number if you can
The numbers, in one place
| Measure | Figure |
|---|---|
| Who can report | anyone, including patients and caregivers |
| What to report | any suspected reaction, even if you are unsure |
| Covers | medicines, medical devices, dietary supplements and cosmetics |
| Vaccines | reported separately through VAERS |
| Run by | the FDA |
Common early mistakes
- Assuming someone else will have reported it
- Waiting for proof of causation before reporting
- Continuing a medicine you suspect is harming you without advice
Related topics
- Vaccine Side Effects: What Published Guidance Supports (Vaccinations)
- The Evidence on Cancer Treatment Side Effects, Without the Hype (Cancer Awareness)
- What the Guidance Really Says About Statins (Heart Health)
- Vaccination: What the Evidence Actually Says (Immunity)
Where to go next
- Reporting Side Effects: The Questions People Actually Ask
- Reporting Side Effects at a Glance
- Reporting Side Effects — the reference entry
- Medicines Safety: The Complete Guide
- The Evidence on Taking Medicines Correctly, Without the Hype
- Acetaminophen Dosing Limits: What Published Guidance Supports
When to speak to a doctor
Reporting is not a substitute for treatment. Call 911 for swelling of the lips or tongue, difficulty breathing, collapse, a widespread blistering rash, or any severe reaction. Contact your doctor urgently about stopping the medicine for yellowing of the skin, severe abdominal pain, or unusual bleeding.
Where this comes from
- FDA — MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- CDC — Vaccine Adverse Event Reporting System (VAERS)
How this page was put together
Every figure, recommendation and warning above is taken from the guidance named in Where this comes from. Nothing on this page is inferred, summarized or generalized beyond what those bodies publish: where they give a number, it is their number, and where they are silent, so are we. Pages are rebuilt whenever the underlying record changes. Sign-off by a named clinician, where it has happened, is shown at the top of the page along with the date.
Medical disclaimer
This article is general information, not medical advice. It cannot account for your own history, medication or circumstances. Always speak to your doctor, pharmacist or another qualified health professional before making changes that affect your treatment, and never delay seeking medical advice because of something you have read here. In an emergency, call 911.
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