Safety Profile: coenzyme Q10

Source: OpenFDA CAERS Database
Report Count: 45 adverse event reports
Date Range: 2006 - 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
NAUSEA	5
Dyspnoea	4
RASH	4
CHEST PAIN	3
LIVER FUNCTION TEST ABNORMAL	3
VOMITING	3
PRURITUS	3
Dizziness	2
COLD SWEAT	2
GASTROOESOPHAGEAL REFLUX DISEASE	2

Reported Outcomes

Outcome	Count
Other Serious or Important Medical Event	28
Hospitalization	13
Visited a Health Care Provider	13
Visited Emergency Room	7
Other Serious Outcome	6

Notable Signals

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

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