Drug Safety Information for ROMAZICON (Flumazenil)

Adverse Drug Reactions for ROMAZICON* (Flumazenil)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ROMAZICON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Convulsion38
2Coma36
3Pyrexia29
4Depressed level of consciousness28
5Hypotension25
6Unresponsive to stimuli24
7Somnolence22
8Hypoxia19
9Toxicity to various agents17
10Overdose16
11Cardiac arrest16
12Drug interaction16
13Tachycardia13
14Death13
15Loss of consciousness13
16Suicide attempt13
17Drug ineffective12
18Bradycardia12
19Oxygen saturation decreased12
20Renal failure12

* This side effect also appears in "Top 10 Side Effects of ROMAZICON " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ROMAZICON
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication266
2Reversal of sedation105
3Sedation86
4Diagnostic procedure35
5Toxicity to various agents33
6Overdose29
7Delayed recovery from anaesthesia24
8Somnolence13
9Anaesthesia reversal11
10Respiratory rate decreased11

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ROMAZICON

Total Reports Filed with FDA: 2026


Number of FDA Adverse Event Reports by Patient Age for ROMAZICON

Total Reports Filed with FDA: 2026*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Flumazenil (Anexate, Romazicon, Lanexat, Flumazenil)

Charts are based on 2026 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ROMAZICON Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.