Safety Profile - iron

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

Safety Profile: iron

Source: OpenFDA CAERS Database
Report Count: 50 adverse event reports
Date Range: 2003 - 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
VOMITING 7
MALAISE 4
Pyrexia 4
DIARRHOEA 3
Sepsis 3
Diarrhoea 3
Nausea 3
Vomiting 3
FEELING OF BODY TEMPERATURE CHANGE 2
ASTHENIA 2

Reported Outcomes

Outcome Count
Other Serious or Important Medical Event 30
Hospitalization 18
Visited a Health Care Provider 9
Visited Emergency Room 8
Required Intervention 6

Notable Signals

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

  • VOMITING (7 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