Drugs › Serotonin and norepinephrine reuptake inhibitor
Generic name
Venlafaxine hcl: adverse event reports filed with FDA
8,401 reports list it as a suspect or interacting product, 2004–2026. Class: Serotonin and norepinephrine reuptake inhibitor.
- 8,401
- reports as suspect product
- 0% of all reports · about 373 a year
- 15
- reports, 12 months to June 2026
- 26 in the 12 months before
- 67.3%
- marked serious by the reporter
- 66.4% across the class
- 16.3%
- record death among outcomes, as reported
- 1,366 reports · not verified by FDA
8,401 adverse event reports received by FDA list venlafaxine hcl, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 7,395 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 15 reports listed it, down 42% from 26 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 373 reports a year and 0% of the 20,646,523 reports in the database, and 4.9% of the reports for the serotonin and norepinephrine reuptake inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (18.4%), completed suicide (8.3%) and nausea (5.5%). A report can list several reactions, so shares add to more than 100%; 1,124 different terms appear across these reports. Drug ineffective is recorded in 18.4% of these reports, a larger share than in the median serotonin and norepinephrine reuptake inhibitor drug (10.4%).
67.3% of the reports are marked serious by the reporter (66.4% across the class); 16.3% record death among the outcomes and 24.9% record hospitalisation, as reported. 36.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (30.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Venlafaxine hcl reports recording the termmedian drug in serotonin and norepinephrine reuptake inhibitor
- Drug ineffectivethe medicine did not work as expected18.4%1,545
- Completed suicidedeath by suicide8.3%696
- Nauseafeeling sick5.5%459
- Drug interactionan interaction between medicines5.4%452
- Headachehead pain5%416
- Dizzinesslight-headedness or unsteadiness4.9%408
- Depressionlow mood4.5%381
- Anxietyanxiety4.3%365
- Feeling abnormalfeeling odd or not right4.2%352
- Malaisegeneral feeling of being unwell4.2%352
- Drug hypersensitivityan allergic-type reaction to a medicine4.1%347
- Fatiguetiredness3.8%318
- Overdosea dose above the recommended amount3.5%297
- Suicide attempta suicide attempt3.3%275
- Intentional overdosea deliberate overdose3.2%266
- Insomniadifficulty sleeping3.2%265
- Somnolencedrowsiness3.1%264
- Vomitingbeing sick3%251
- Suicidal ideationthoughts of suicide2.9%241
- Cardiac arrestthe heart stopped2.8%238
- Tremorshaking2.8%236
- Toxicity to various agentspoisoning or toxic effect of one or more substances2.7%230
- Withdrawal syndrome2.7%229
- Hyperhidrosisexcessive sweating2.6%222
- Maternal exposure during pregnancythe mother took the medicine during pregnancy2.6%220
- Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor2.5%206
- Condition aggravatedthe condition being treated got worse2.4%201
- Off label useused for a purpose or in a way not on the label2.4%198
- Tachycardiafast heart rate2.3%193
- Diarrhoealoose or frequent stools2.3%190
Top 30 of 1,124 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 12 drugs in the serotonin and norepinephrine reuptake inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 171,115 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 53.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Depression | 1,932 | 23% |
| Anxiety | 345 | 4.1% |
| Major depression | 158 | 1.9% |
| Bipolar disorder | 87 | 1% |
| Anxiety disorder | 45 | 0.5% |
| Antidepressant therapy | 42 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 8,401 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Venlafaxine hcl reports |
|---|---|---|
| Mirtazapine | 393 | 4.7% |
| Effexor | 319 | 3.8% |
| Diazepam | 282 | 3.4% |
| Lorazepam | 281 | 3.3% |
| Gabapentin | 268 | 3.2% |
| Alprazolam | 254 | 3% |
| Quetiapine | 237 | 2.8% |
| Clonazepam | 220 | 2.6% |
| Acetaminophen | 206 | 2.5% |
| Olanzapine | 189 | 2.2% |
Other products listed in reports where Venlafaxine hcl is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Venlafaxine hcl | Serotonin and norepinephrine reuptake inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 8,401 | 171,115 | 20,646,523 |
| Share of that pool | — | 4.9% | 0% |
| Reports, latest 12 months | 15 | — | 1,332,454 |
| Marked serious | 67.3% | 66.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 163 | 102 | 91 |
| Hospitalisation recorded, per 1,000 reports | 249 | 241 | 213 |
| Consumer-filed share | 36.3% | 41.4% | 45.8% |
| Top term, share of reports | Drug ineffective 18.4% | median 10.4% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the serotonin and norepinephrine reuptake inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Cymbalta | brand | 52,279 | 346 | 52.3% |
| Venlafaxine | generic | 29,752 | 2,345 | 93.8% |
| Venlafaxine hydrochloride | generic | 19,464 | 1,026 | 80% |
| Duloxetine | generic | 16,103 | 1,529 | 85.5% |
| Effexor | brand | 13,079 | 36 | 60.1% |
| Desvenlafaxine succinate | generic | 12,414 | 59 | 29.6% |
| Duloxetine hydrochloride | generic | 8,245 | 787 | 82.5% |
| Pristiq | brand | 5,941 | 81 | 41.8% |
| Savella | brand | 2,909 | 34 | 29.4% |
| Desvenlafaxine | generic | 1,436 | 135 | 78.9% |
| Fetzima | brand | 1,092 | 75 | 53.1% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Venlafaxine hcl reports
How many adverse event reports has FDA received for Venlafaxine hcl?
8,401 reports list Venlafaxine hcl as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 15 of them arrived in the latest 12 months. Another 7,395 list it only as a concomitant medication.
What reactions are recorded in Venlafaxine hcl reports?
drug ineffective (18.4%), completed suicide (8.3%), nausea (5.5%), drug interaction (5.4%) and headache (5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Venlafaxine hcl was responsible.
How serious are the reports?
67.3% are marked serious by the reporter. Among the outcomes recorded, 16.3% of reports include death and 24.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (36.3%), physician (28.7%) and other health professional (19.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Venlafaxine hcl rising?
15 reports in the 12 months to June 2026, down 42% from 26 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Venlafaxine hcl was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Venlafaxine hcl?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Venlafaxine hcl as a suspect or interacting product; reports listing it only as a concomitant medication (7,395) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.