Drug Safety Information for VENLAFAXINE HYDROCHLORIDE (Venlafaxine hydrochloride)

Safety-related Labeling Changes for EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) Rx Drug: FDA Link

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

Adverse Drug Reactions for VENLAFAXINE HYDROCHLORIDE* (Venlafaxine 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 VENLAFAXINE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*3836
2Drug ineffective3453
3Depression3420
4Dizziness*3135
5Anxiety3117
6Headache*3067
7Drug withdrawal syndrome2982
8Fatigue*2855
9Insomnia*2439
10Pain2332
11Vomiting2218
12Suicidal ideation2103
13Feeling abnormal2076
14Malaise1999
15Diarrhoea1965
16Dyspnoea1960
17Fall1928
18Completed suicide1881
19Drug interaction1832
20Asthenia1789

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

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

Reason # of FDA Reports
1Depression*68323
2Product used for unknown indication23501
3Anxiety*6427
4Major depression*3444
5Bipolar disorder*2082
6Hot flush*1947
7Antidepressant therapy1019
8Fibromyalgia*845
9Panic attack*758
10Anxiety disorder*738

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


Types of Adverse Events for VENLAFAXINE HYDROCHLORIDE

Total Reports Filed with FDA: 283466


Number of FDA Adverse Event Reports by Patient Age for VENLAFAXINE HYDROCHLORIDE

Total Reports Filed with FDA: 283466*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Venlafaxine hydrochloride (Venlafaxine, Dobupal, Venlafaxina, Effexor, Vandral, Trevilor, Efexor, Effexor xr)

Charts are based on 283466 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.

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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.