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) Latest Known Outcomes for Reactions Reported for EFFEXOR
Based on 38335 reports that included a patient age.
Side Effect # of FDA Reports 1 NAUSEA 4919 2 DRUG INEFFECTIVE 4561 3 FATIGUE 4101 4 DEPRESSION 3898 5 HEADACHE 3822 6 ANXIETY 3776 7 DIZZINESS 3665 8 PAIN 3102 9 INSOMNIA 2941 10 DRUG WITHDRAWAL SYNDROME 2922 11 FEELING ABNORMAL 2664 12 MALAISE 2621 13 DIARRHEA 2594 14 VOMITING 2517 15 FALL 2465 16 SUICIDAL IDEATION 2347 17 SHORTNESS OF BREATH 2228 18 WEIGHT INCREASED 2133 19 LACK OF STRENGTH AND ENERGY (ASTHENIA) 2081 20 OFF LABEL USE 1861 Latest Known Outcome for Reported Reactions Number of Cases 1 Unknown Outcome 25343 2 Patient has not recovered/symtoms have not resolved 10815 3 Patient recovered 10467 4 Patient is recovering/symptoms resolving 4476 5 Patient died 1419 6 Patient has recovered but has consequent health issues 271 Yearly FDA Adverse Event Reports (Table)
Year Number of Reports 2003 1 2004 2379 2005 2824 2006 2581 2007 2439 2008 2285 2009 2565 2010 3995 2011 3458 2012 4203 2013 3575 2014 3480 2015 4494 2016 4996 2017 3538 2018 3500 2019 3212 2020 2448 2021 1735 2022 1531 2023 1358 2024 1183 2025 1080 2026 509 Reports by Patient Age Group (Table)
Age Group Number of Reports 0-10 429 11-20 1020 21-30 3044 31-40 5103 41-50 7621 51-60 9388 61-70 6940 71-80 3360 81-90 1286 91+ 144
EFFEXOR Total Reports
| Male | Female | Unknown | Total |
|---|---|---|---|
| 14927 | 45140 | 3302 | 63,369 |
Top Countries Reporting
| Country | Number of Reports | |
|---|---|---|
| 1 | United States | 31237 |
| 2 | France | 2467 |
| 3 | Canada | 2286 |
| 4 | Japan | 727 |
| 5 | Italy | 219 |
| 6 | Australia | 180 |
| 7 | Brazil | 153 |
| 8 | United Kingdom | 145 |
| 9 | 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 | |
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.
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.
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.
Safety-Related FDA Updates
Notes
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.
