Drug Safety Information for DORAL (Quazepam)

FDA Safety-related Labeling Changes for DORAL (QUAZEPAM) Rx Drug: Safety Information Link

Adverse Drug Reactions for DORAL* (Quazepam)

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 DORAL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pyrexia	52
2	Alanine aminotransferase increased	31
3	Insomnia	31
4	Blood creatine phosphokinase increased	29
5	Depressed level of consciousness	28
6	Suicide attempt	27
7	Aspartate aminotransferase increased	26
8	Rhabdomyolysis	24
9	Somnolence	23
10	Fall	23
11	Dizziness	23
12	Hepatic function abnormal	22
13	Altered state of consciousness	20
14	Decreased appetite	20
15	Nausea	19
16	Loss of consciousness	19
17	Depression	18
18	Condition aggravated	18
19	Completed suicide	18
20	Rash	18

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

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

	Reason	# of FDA Reports
1	Insomnia*	622
2	Schizophrenia	113
3	Product used for unknown indication	84
4	Depression	66
5	Schizophrenia, paranoid type	63
6	Schizophrenia, disorganised type	32
7	Bipolar disorder	28
8	Suicide attempt	18
9	Panic disorder	16
10	Ill-defined disorder	12

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

Types of Adverse Events for DORAL

Total Reports Filed with FDA: 2562

Number of FDA Adverse Event Reports by Patient Age for DORAL

Total Reports Filed with FDA: 2562*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Quazepam (Quazepam, Doral)

Charts are based on 2562 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.

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.