HealthRX.com · Printable symptom log
Suspected MOTS-c reaction record for your clinician and a MedWatch report
Fill this in after a possible reaction to a product sold as MOTS-c: what the label says, what happened and when, and what else was going on that week. These are the details a clinician needs to sort out the cause, and the details FDA's MedWatch form asks for.
What the product label says
Photograph the label and keep the container if it is safe to do so.
Product name as printed
Stated ingredient and salt formfree base, acetate, or not stated
Other active ingredients listedmulti-peptide blends change the question
Concentration, and how it was mixed
Lot number and beyond-use or expiry date
Pharmacy or seller
The event
Date and time of the last usemark it if this is an estimate
Amount used and route
When the first symptom started
What happened, in order
Tests or treatment received
Outcome so farrecovered, recovering, not recovered
What else was going on that week
A coincidence or another medicine is often the better explanation. Write it down before memory fades.
| Date | Other medicines or supplements | Food, alcohol or exercise changes | Illness or other injections |
|---|---|---|---|
What FDA's MedWatch instructions say
- You can report a suspected reaction without being certain the product caused it.[1]
- Include the lot number whenever you know it.[1]
- If exact dates are unknown, give your best estimate.[1]
- FDA counts a reaction as serious when it leads to death, is life-threatening, causes a new or longer hospital stay, causes disability or permanent damage, causes a birth defect, or is another important medical event.[1]
- Keep the product if you can: examining it is often critical to evaluating the problem.[1]
Why your report matters for this product
- Compounders under section 503A generally do not report adverse events to FDA, so FDA may not learn of a reaction unless someone submits a report.[2]
- FDA is concerned that injected MOTS-c could provoke immune reactions because peptides can clump together (aggregate) and may carry peptide-related impurities.[3]
Questions for the clinician
- Could this be a reaction to an impurity, a clumped (aggregated) peptide or contamination rather than to MOTS-c itself?
- Do any of my other medicines or conditions explain it better?
- Should anything be tested now, while the reaction is still present?
- Should I stop the product, and how would we know whether it was related?
- Will you file the MedWatch report, or should I?
Sources for the facts on this sheet
- U.S. Food and Drug Administration. Instructions for Completing Form FDA 3500. Accessed 2026-10-18. https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500
- U.S. Food and Drug Administration. FDA Briefing Document: MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026. Accessed 2026-10-18. https://www.fda.gov/media/193347/download
- U.S. Food and Drug Administration. July 23, 2026 Meeting of the Pharmacy Compounding Advisory Committee: FDA Presentations (MOTS-c (free base) and MOTS-c acetate). Accessed 2026-10-18. https://www.fda.gov/media/193773/download
This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.