FLUMAZENIL

N/A

Manufactured by Baxter Healthcare Corporation

2,155 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FLUMAZENIL

FLUMAZENIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Baxter Healthcare Corporation. The most commonly reported adverse reactions for FLUMAZENIL include INTENTIONAL OVERDOSE, DRUG INEFFECTIVE, TOXICITY TO VARIOUS AGENTS, COMA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUMAZENIL.

Top Adverse Reactions

INTENTIONAL OVERDOSE102 reports
DRUG INEFFECTIVE88 reports
TOXICITY TO VARIOUS AGENTS88 reports
COMA69 reports
OFF LABEL USE69 reports
INTENTIONAL PRODUCT MISUSE61 reports
DRUG DEPENDENCE57 reports
PRODUCT USE ISSUE55 reports
HYPOTENSION54 reports
DEPRESSED LEVEL OF CONSCIOUSNESS52 reports
SEIZURE47 reports
DRUG WITHDRAWAL CONVULSIONS44 reports
SOMNOLENCE42 reports
OVERDOSE39 reports
SUICIDE ATTEMPT33 reports

Report Outcomes

Out of 816 classified reports for FLUMAZENIL:

Serious 93.5%Non-Serious 6.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female392 (52.5%)
Male348 (46.6%)
Unknown7 (0.9%)

Reports by Age

Age 3824 reports
Age 4821 reports
Age 7020 reports
Age 3719 reports
Age 3417 reports
Age 2416 reports
Age 3216 reports
Age 5316 reports
Age 6216 reports
Age 7316 reports
Age 4215 reports
Age 4715 reports
Age 8115 reports
Age 5214 reports
Age 6513 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.