United States · Consumer reporting
Prepare GLP-1 notes for an FDA MedWatch report
Organize the product details and event timeline you already know, then use the FDA’s official reporting process.
Use your diary to reconstruct the event
A personal GLP-1 record can help you describe a suspected side effect or product problem without relying entirely on memory. Start with what happened and when. Add the product name exactly as shown on the packaging, relevant recorded administration dates and what you did next. Keep observations separate from conclusions about why the event happened.
Get appropriate medical help for urgent or concerning symptoms. Preparing or submitting a MedWatch report is separate from getting care and does not tell you whether to continue, stop or change a medicine.
Choose the FDA’s consumer reporting route
The FDA's Report a Problem page provides an online voluntary reporting route and links to Form FDA 3500B for patients and consumers. Start there to reach the current official options. A personal CSV is a preparation aid, not the FDA form and not a supported automatic submission method.
The current Form FDA 3500B covers adverse events, product problems and medication-use errors for relevant products. It asks people to provide what they know even when some information is missing. Its instructions also explain privacy, images and follow-up. Read those instructions before sharing a completed report.
Make two short records: product and event
For the product record, copy the name, presentation, manufacturer and batch or lot if available. Keep a reference to packaging images rather than uploading them to an unrelated website. Distinguish a printed expiration date from the date you received or first used the product.
For the event record, use a sequence of dated notes. Include the first observation, later changes, effects on your day and contacts with health professionals. If a date is approximate, say so. When you describe a conversation, identify who gave the advice and when; do not present your own interpretation as their instruction.
MedWatch preparation worksheet
Download blank worksheet (CSV)
Print this page to write by hand, or open the CSV in a spreadsheet. Leave unknown details blank. This worksheet does not submit information.
| Field | My notes |
|---|---|
| Exact product, formulation and manufacturer | |
| Lot or batch and packaging image location | |
| Dates of relevant recorded administrations | |
| Event description and onset | |
| Later changes and impact on daily activities | |
| Other products or context to discuss | |
| Healthcare contact and advice received | |
| Official report date and acknowledgement |
Check for avoidable ambiguity
Illustrative example: “The symptom began on Friday; the time is approximate. I called my care team on Saturday.” Keep the month in words if a numeric date could be read two ways. If you have several products, identify which record you mean instead of writing only “my injection.” These examples show writing technique, not a real patient's outcome.
A blank field is more honest than an invented lot number or a guessed measurement. If you later find the missing packaging or receive clarification, keep a dated note with your copy. Follow the official instructions for any additional information.
After submission, save the acknowledgement where you can find it. The FDA form explains that reporting does not establish that a product caused the event. Continue your care conversation separately; neither a diary entry nor a report reference is a diagnosis.