Safety Profile - melatonin
Safety Profile: melatonin
Source: OpenFDA CAERS Database
Report Count: 50 adverse event reports
Date Range: 2005 - 2024
IMPORTANT DISCLAIMER: These are voluntary adverse event reports and do not establish causation. The FDA cautions that "generally only a small fraction of adverse events associated with any product is reported." Multiple products and reactions may be listed in a single report with no way to conclude which product caused which reaction.
Most Commonly Reported Reactions
| Reaction | Report Count |
|---|---|
| Dyspnoea | 6 |
| Nausea | 5 |
| Urticaria | 4 |
| Vomiting | 4 |
| Constipation | 3 |
| Dizziness | 3 |
| Diarrhoea | 3 |
| Pruritus | 3 |
| HEADACHE | 3 |
| NAUSEA | 3 |
Reported Outcomes
| Outcome | Count |
|---|---|
| Other Serious or Important Medical Event | 28 |
| Hospitalization | 14 |
| Visited Emergency Room | 13 |
| Visited a Health Care Provider | 13 |
| Disability | 7 |
Notable Signals
The following adverse reactions have been reported 5 or more times:
- Dyspnoea (6 reports)
- Nausea (5 reports)
Understanding This Data
The Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) is a database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. Reports are submitted by:
- Healthcare professionals (physicians, pharmacists, nurses)
- Consumers (patients, family members)
- Manufacturers (when they receive serious adverse event reports)
Key Limitations:
- Voluntary reporting - Not all adverse events are reported
- No causation established - Reports describe associations, not causation
- Multiple products - A single report may list multiple products
- No dose information - Reports may not specify dosage or duration
- Reporting bias - Serious events are more likely to be reported
FDA Guidance
For more information on how to interpret CAERS data, visit: - CFSAN Adverse Event Reporting System - FDA's CAERS Database Information