Drug Safety Information for VIIBRYD (Vilazodone hydrochloride)

Safety-related Labeling Changes for VIIBRYD (VILAZODONE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for VIIBRYD* (Vilazodone 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 VIIBRYD
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea464
2Nausea393
3Insomnia365
4Anxiety265
5Headache245
6Dizziness240
7Paraesthesia214
8Off label use205
9Feeling abnormal185
10Suicidal ideation183
11Depression182
12Fatigue180
13Drug ineffective149
14Hallucination147
15Tremor136
16Weight increased127
17Vomiting120
18Somnolence116
19Agitation116
20Abnormal dreams112

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

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

Reason # of FDA Reports
1Depression5844
2Product used for unknown indication664
3Anxiety586
4Major depression510
5Antidepressant therapy114
6Bipolar disorder96
7Obsessive-compulsive disorder78
8Post-traumatic stress disorder62
9Panic attack35
10Stress34

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


Types of Adverse Events for VIIBRYD

Total Reports Filed with FDA: 12022


Number of FDA Adverse Event Reports by Patient Age for VIIBRYD

Total Reports Filed with FDA: 12022*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Vilazodone hydrochloride (Viibryd)

Charts are based on 12022 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 VIIBRYD 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.