Safety Profile - vitamin C

source active confidence: low 2026-04-09
#safety #fda #adverse-events #caers

Safety Profile: vitamin C

Source: OpenFDA CAERS Database
Report Count: 50 adverse event reports
Date Range: 2004 - 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
Nausea 6
Pain 4
ASTHENIA 3
Abdominal pain upper 3
DYSPNOEA 3
Constipation 3
Diarrhoea 3
CHOKING 3
VOMITING 3
Abdominal pain 3

Reported Outcomes

Outcome Count
Other Serious or Important Medical Event 26
Hospitalization 12
Visited Emergency Room 11
Other Outcome 7
Visited a Health Care Provider 7

Notable Signals

The following adverse reactions have been reported 5 or more times:

  • Nausea (6 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:

  1. Voluntary reporting - Not all adverse events are reported
  2. No causation established - Reports describe associations, not causation
  3. Multiple products - A single report may list multiple products
  4. No dose information - Reports may not specify dosage or duration
  5. 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