Effexor XRvenlafaxine
According to the FDA label: Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ).
75,568 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Effexor XR in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 6,383 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Nausea 6,128 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 5,169 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 5,132 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Depression 4,434 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Dizziness 4,381 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Anxiety 4,309 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Pain 3,930 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Off Label Use 3,520 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Insomnia 3,447 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 3,319 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Malaise 3,169 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Vomiting 3,126 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 3,012 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Drug Withdrawal Syndrome 3,007 reports
The set of symptoms that can occur when a medication the body has gotten used to is stopped or reduced.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 52,436 |
| Male | 18,199 |
| Unknown | 281 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,178 |
| 18-34 | 6,633 |
| 35-49 | 12,213 |
| 50-64 | 16,385 |
| 65-74 | 6,629 |
| 75+ | 4,127 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Effexor XR. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 34,556 |
| Non-Serious | 24,344 |
| Hospitalization | 21,237 |
| Death | 5,063 |
| Life-Threatening | 3,173 |
| Disability | 2,828 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Effexor XR. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 2,404 |
| 2005 | 2,827 |
| 2006 | 2,585 |
| 2007 | 2,459 |
| 2008 | 2,415 |
| 2009 | 2,745 |
| 2010 | 4,160 |
| 2011 | 3,673 |
| 2012 | 4,408 |
| 2013 | 3,653 |
| 2014 | 3,529 |
| 2015 | 4,697 |
| 2016 | 5,188 |
| 2017 | 4,024 |
| 2018 | 4,039 |
| 2019 | 4,056 |
| 2020 | 3,430 |
| 2021 | 2,965 |
| 2022 | 3,114 |
| 2023 | 2,975 |
| 2024 | 3,038 |
| 2025 | 2,578 |
| 2026 (partial) | 605 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Effexor XR
In FDA adverse event reports that mention Effexor XR, these medications appeared most often in the same report.
- Gabapentin (8,154 reports)
- Quetiapine (6,511 reports)
- Levothyroxine (6,022 reports)
- Clonazepam (6,004 reports)
- Acetaminophen (5,869 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026