85/100 · Critical
Manufactured by Alembic Pharmaceuticals Inc.
Venlafaxine Adverse Events: High Seriousness and Diverse Reactions
151,835 FDA adverse event reports analyzed
Last updated: 2026-05-12
VENLAFAXINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. Based on analysis of 151,835 FDA adverse event reports, VENLAFAXINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for VENLAFAXINE include DRUG INEFFECTIVE, NAUSEA, TOXICITY TO VARIOUS AGENTS, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VENLAFAXINE.
Venlafaxine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 151,835 adverse event reports for this medication, which is primarily manufactured by Alembic Pharmaceuticals Inc..
The most commonly reported adverse events include Drug Ineffective, Nausea, Toxicity To Various Agents. Of classified reports, 84.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (84.1%) indicates significant safety concerns.
Diverse range of reactions, including suicidal ideation and attempts, necessitates careful monitoring. Overdose and intentional misuse are common, highlighting the need for patient education.
Patients taking Venlafaxine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Venlafaxine can interact with other drugs, including other antidepressants, and may increase the risk of serotonin syndrome. Patients should avoid alcohol and other CNS depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Venlafaxine received a safety concern score of 85/100 (high concern). This is based on a 84.1% serious event ratio across 68,147 classified reports. The score accounts for 151,835 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 41,672, Male: 19,396, Unknown: 168. The most frequently reported age groups are age 53 (1,519 reports), age 60 (1,159 reports), age 58 (1,106 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 68,147 classified reports for VENLAFAXINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Venlafaxine can interact with other drugs, including other antidepressants, and may increase the risk of serotonin syndrome. Patients should avoid alcohol and other CNS depressants.
If you are taking Venlafaxine, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, toxicity to various agents, fatigue, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and report any unusual symptoms to their healthcare provider. Inform healthcare providers about all other medications and supplements to avoid potential drug interactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Venlafaxine safety. Healthcare providers should report adverse events to the FDA's MedWatch program.
The FDA has received approximately 151,835 adverse event reports associated with Venlafaxine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Venlafaxine include Drug Ineffective, Nausea, Toxicity To Various Agents, Fatigue, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (5,508 reports), Nausea (4,297 reports), Toxicity To Various Agents (4,264 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Venlafaxine.
Out of 68,147 classified reports, 57,309 (84.1%) were classified as serious and 10,838 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Venlafaxine break down by patient sex as follows: Female: 41,672, Male: 19,396, Unknown: 168. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Venlafaxine adverse events are: age 53: 1,519 reports, age 60: 1,159 reports, age 58: 1,106 reports, age 54: 1,094 reports, age 59: 1,046 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Venlafaxine adverse event reports is Alembic Pharmaceuticals Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Venlafaxine include: Headache, Completed Suicide, Drug Interaction, Dizziness, Diarrhoea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Venlafaxine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Venlafaxine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (84.1%) indicates significant safety concerns.
Key safety signals identified in Venlafaxine's adverse event data include: High number of serious adverse events (57,309 out of 68,147 total outcomes).. Multiple reports of suicidal ideation and attempts, including completed suicides.. Significant number of drug interactions and warnings, especially with other antidepressants.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Venlafaxine can interact with other drugs, including other antidepressants, and may increase the risk of serotonin syndrome. Patients should avoid alcohol and other CNS depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Venlafaxine.
Patients should strictly follow prescribed dosages and report any unusual symptoms to their healthcare provider. Inform healthcare providers about all other medications and supplements to avoid potential drug interactions.
Venlafaxine has 151,835 adverse event reports on file with the FDA. Diverse range of reactions, including suicidal ideation and attempts, necessitates careful monitoring. The volume of reports for Venlafaxine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Venlafaxine safety. Healthcare providers should report adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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