Drug Safety Information for BELSOMRA (Suvorexant)

Safety-related Labeling Changes for BELSOMRA (SUVOREXANT) Rx Drug: FDA Link

Adverse Drug Reactions for BELSOMRA* (Suvorexant)

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 BELSOMRA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective367
2Nightmare104
3Abnormal dreams93
4Somnolence77
5Headache67
6Feeling abnormal59
7Insomnia56
8Hallucination35
9Nausea32
10Poor quality sleep28
11Dizziness26
12Wrong technique in drug usage process25
13Palpitations24
14Middle insomnia23
15Anxiety22
16Fatigue19
17Sleep paralysis18
18Agitation16
19Adverse event14
20Tremor14

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

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

Reason # of FDA Reports
1Insomnia1455
2Sleep disorder42
3Sleep disorder therapy14
4Circadian rhythm sleep disorder7
5Poor quality sleep6
6Middle insomnia6
7Depression2
8Suicide attempt2
9Product used for unknown indication1

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


Types of Adverse Events for BELSOMRA

Total Reports Filed with FDA: 1828


Number of FDA Adverse Event Reports by Patient Age for BELSOMRA

Total Reports Filed with FDA: 1828*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Suvorexant (Belsomra)

Charts are based on 1828 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 BELSOMRA Reviews and Review Summary .

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.

Visit   DrugInformer.com more on BELSOMRA's side effects.