82/100 · Critical
Manufactured by Aurobindo Pharma Limited
Venlafaxine Hydrochloride Adverse Events: High Seriousness and Diverse Reactions
273,078 FDA adverse event reports analyzed
Last updated: 2026-05-12
VENLAFAXINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 273,078 FDA adverse event reports, VENLAFAXINE HYDROCHLORIDE has a safety score of 82 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 HYDROCHLORIDE include DRUG INEFFECTIVE, NAUSEA, FATIGUE, HEADACHE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VENLAFAXINE HYDROCHLORIDE.
Venlafaxine Hydrochloride has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 273,078 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 74.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (74.1%) among total reports.
Diverse range of reactions including suicidal ideation, depression, and drug interactions. Significant number of reports related to weight changes and sexual dysfunction.
Patients taking Venlafaxine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Venlafaxine Hydrochloride can interact with other drugs, and patients should be warned about the risk of drug interactions and overdose. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Venlafaxine Hydrochloride received a safety concern score of 82/100 (high concern). This is based on a 74.1% serious event ratio across 128,021 classified reports. The score accounts for 273,078 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: 84,349, Male: 33,489, Unknown: 414. The most frequently reported age groups are age 53 (2,435 reports), age 58 (2,008 reports), age 60 (2,002 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 128,021 classified reports for VENLAFAXINE HYDROCHLORIDE:
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 Hydrochloride can interact with other drugs, and patients should be warned about the risk of drug interactions and overdose.
If you are taking Venlafaxine Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, headache, dizziness. 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. Avoid abrupt discontinuation of the medication to prevent withdrawal symptoms. 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.
Regulatory oversight is ongoing, with frequent updates on safety concerns and warnings.
The FDA has received approximately 273,078 adverse event reports associated with Venlafaxine Hydrochloride. 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 Hydrochloride include Drug Ineffective, Nausea, Fatigue, Headache, Dizziness. By volume, the top reported reactions are: Drug Ineffective (9,710 reports), Nausea (8,839 reports), Fatigue (8,007 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 Hydrochloride.
Out of 128,021 classified reports, 94,890 (74.1%) were classified as serious and 33,131 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 Hydrochloride break down by patient sex as follows: Female: 84,349, Male: 33,489, Unknown: 414. 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 Hydrochloride adverse events are: age 53: 2,435 reports, age 58: 2,008 reports, age 60: 2,002 reports, age 54: 1,962 reports, age 56: 1,896 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 Hydrochloride adverse event reports is Aurobindo Pharma Limited. 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 Hydrochloride include: Depression, Anxiety, Off Label Use, Pain, 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 Hydrochloride 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 Hydrochloride has a safety concern score of 82 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 (74.1%) among total reports.
Key safety signals identified in Venlafaxine Hydrochloride's adverse event data include: Suicidal ideation and completed suicides are key safety signals.. Drug interactions and overdose are frequent.. Serious reactions such as death and acute kidney injury are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Venlafaxine Hydrochloride can interact with other drugs, and patients should be warned about the risk of drug interactions and overdose. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Venlafaxine Hydrochloride.
Patients should strictly follow prescribed dosages and report any unusual symptoms to their healthcare provider. Avoid abrupt discontinuation of the medication to prevent withdrawal symptoms.
Venlafaxine Hydrochloride has 273,078 adverse event reports on file with the FDA. Diverse range of reactions including suicidal ideation, depression, and drug interactions. The volume of reports for Venlafaxine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates on safety concerns and warnings. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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