Drug Safety Information for DESYREL (Trazodone hydrochloride)

FDA Safety-related Labeling Changes for DESYREL (TRAZODONE HYDROCHLORIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for DESYREL* (Trazodone 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 DESYREL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*2497
2Drug ineffective*2060
3Fatigue*1965
4Depression1944
5Pain1913
6Headache*1840
7Anxiety1702
8Insomnia*1701
9Dizziness*1661
10Dyspnoea1573
11Vomiting1517
12Diarrhoea1471
13Completed suicide1370
14Fall1321
15Asthenia1302
16Diabetes mellitus1261
17Toxicity to various agents1151
18Weight increased1145
19Type 2 diabetes mellitus1034
20Arthralgia994

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

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

Reason # of FDA Reports
1Product used for unknown indication19304
2Insomnia*13548
3Depression*9694
4Sleep disorder*9381
5Anxiety*1137
6Sleep disorder therapy999
7Bipolar disorder731
8Pain512
9Antidepressant therapy385
10Ill-defined disorder366

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


Types of Adverse Events for DESYREL

Total Reports Filed with FDA: 187626


Number of FDA Adverse Event Reports by Patient Age for DESYREL

Total Reports Filed with FDA: 187626*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Trazodone hydrochloride (Molipaxin, Thombran, Trazon, Desyrel, Trialodine, Trazodona, Trazodone hcl, Deprax, Novo-trazodone, Apo-trazodone, Trittico, Trazodone, Ratio-trazodone, Oleptro)

Charts are based on 187626 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 DESYREL 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.