Drug Safety Information for TRIAZOLAM (Triazolam)

Safety-related Labeling Changes for HALCION (TRIAZOLAM) Rx Drug: FDA Link

Adverse Drug Reactions for TRIAZOLAM* (Triazolam)

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 TRIAZOLAM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia224
2Drug ineffective205
3Overdose205
4Insomnia*194
5Nausea184
6Dizziness183
7Suicide attempt181
8Vomiting*159
9Somnolence*158
10Decreased appetite156
11Dyspnoea151
12Diarrhoea151
13Fall149
14Malaise142
15Loss of consciousness138
16Headache*135
17Pain129
18Pneumonia127
19Depressed level of consciousness124
20Depression113

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

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

Reason # of FDA Reports
1Insomnia*3928
2Product used for unknown indication1743
3Sleep disorder*1073
4Ill-defined disorder215
5Depression209
6Cataract operation164
7Sleep disorder therapy136
8Suicide attempt116
9Anxiety*111
10Bipolar i disorder85

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


Types of Adverse Events for TRIAZOLAM

Total Reports Filed with FDA: 21988


Number of FDA Adverse Event Reports by Patient Age for TRIAZOLAM

Total Reports Filed with FDA: 21988*


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

Charts are based on 21988 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 TRIAZOLAM 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.