Drug Safety Information for FLURAZEPAM Hydrochloride (Flurazepam hydrochloride)

Adverse Drug Reactions for FLURAZEPAM Hydrochloride* (Flurazepam hydrochloride)

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 FLURAZEPAM Hydrochloride
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Suicide attempt134
2Completed suicide124
4Toxicity to various agents110
5Confusional state101
10Drug ineffective*95
14Drug abuse83
16Intentional overdose77
17Drug interaction76

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

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

Reason # of FDA Reports
1Product used for unknown indication1260
2Sleep disorder714
5Suicide attempt80
7Ill-defined disorder67
8Sleep disorder therapy53
10Intentional overdose44

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

Types of Adverse Events for FLURAZEPAM Hydrochloride

Total Reports Filed with FDA: 11983

Number of FDA Adverse Event Reports by Patient Age for FLURAZEPAM Hydrochloride

Total Reports Filed with FDA: 11983*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Flurazepam hydrochloride (Flurazepam, Dalmadorm, Staurodorm, Dormodor, Apo-flurazepam, Fluracepam, Dalmane)

Charts are based on 11983 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.

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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.

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