FDA Adverse Events Reports (FAERS) Summary for EFFEXOR

These tables and charts are based on 63,369 total reports for EFFEXOR (VENLAFAXINE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 61,208 pharmaceutical company-submitted and non-U.S. FAERS reports and 2,161 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 2,161 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch EFFEXOR summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with EFFEXOR (reported in FAERS Database)

 Side Effect# of FDA Reports
1NAUSEA4919
2DRUG INEFFECTIVE4561
3FATIGUE4101
4DEPRESSION3898
5HEADACHE3822
6ANXIETY3776
7DIZZINESS3665
8PAIN3102
9INSOMNIA2941
10DRUG WITHDRAWAL SYNDROME2922
11FEELING ABNORMAL2664
12MALAISE2621
13DIARRHEA2594
14VOMITING2517
15FALL2465
16SUICIDAL IDEATION2347
17SHORTNESS OF BREATH2228
18WEIGHT INCREASED2133
19LACK OF STRENGTH AND ENERGY (ASTHENIA)2081
20OFF LABEL USE1861

Latest Known Outcomes for Reactions Reported for EFFEXOR

Latest Known Outcome for Reported ReactionsNumber of Cases
1Unknown Outcome25343
2Patient has not recovered/symtoms have not resolved10815
3Patient recovered10467
4Patient is recovering/symptoms resolving4476
5Patient died1419
6Patient has recovered but has consequent health issues271

Yearly FDA Adverse Event Reports (Table)

YearNumber of Reports
20031
20042379
20052824
20062581
20072439
20082285
20092565
20103995
20113458
20124203
20133575
20143480
20154494
20164996
20173538
20183500
20193212
20202448
20211735
20221531
20231358
20241183
20251080
2026509

Reports by Patient Age Group (Table)

Age GroupNumber of Reports
0-10429
11-201020
21-303044
31-405103
41-507621
51-609388
61-706940
71-803360
81-901286
91+144

Based on 38335 reports that included a patient age.

EFFEXOR Total Reports

 Male    Female    Unknown    Total  
 14927    45140    3302    63,369  

Top Countries Reporting

 Country  Number of Reports
United States  31237
France  2467
Canada  2286
Japan  727
Italy  219
Australia  180
Brazil  153
United Kingdom  145
Switzerland  109
10 EU  76

Outcomes for Reports

Serious: 40107
Not Serious: 23257
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications      
Product used for unknown indication
Migraine
Depression
Premenstrual dysphoric disorder
Panic attack

Top Companies Reporting

   MYLAN

Safety-Related FDA Updates

FDA Approval Date: 1993-12-28

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for EFFEXOR reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.