Safety Profile - protein powder
Safety Profile: protein powder
Source: OpenFDA CAERS Database
Report Count: 50 adverse event reports
Date Range: 2007 - 2025
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 |
|---|---|
| DIARRHOEA | 5 |
| NAUSEA | 5 |
| VOMITING | 5 |
| DYSPNOEA | 4 |
| Dizziness | 4 |
| Nausea | 4 |
| Chest pain | 3 |
| Gastrointestinal disorder | 3 |
| PAIN | 3 |
| Abdominal pain upper | 3 |
Reported Outcomes
| Outcome | Count |
|---|---|
| Other Serious or Important Medical Event | 33 |
| Hospitalization | 15 |
| Visited a Health Care Provider | 12 |
| Other Serious Outcome | 10 |
| Visited Emergency Room | 10 |
Notable Signals
The following adverse reactions have been reported 5 or more times:
- DIARRHOEA (5 reports)
- NAUSEA (5 reports)
- VOMITING (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