85/100 · Critical
Manufactured by Pfizer Laboratories Div Pfizer Inc
High Safety Concerns with Varenicline Tartrate, Particularly for Mental Health and Suicide-Related Reactions
167,559 FDA adverse event reports analyzed
Last updated: 2026-05-12
VARENICLINE TARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 167,559 FDA adverse event reports, VARENICLINE TARTRATE 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 VARENICLINE TARTRATE include NAUSEA, DEPRESSION, ABNORMAL DREAMS, ANXIETY, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VARENICLINE TARTRATE.
Varenicline Tartrate 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 167,559 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Nausea, Depression, Abnormal Dreams. Of classified reports, 40.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Significant reports of depression, suicidal ideation, and suicide attempts, indicating potential mental health risks.
Nausea and vomiting are common gastrointestinal side effects. Drug interactions and intolerances are reported, necessitating careful monitoring. Serious adverse events, including chest pain and myocardial infarction, are notable but less frequent. Weight changes and mood swings are also commonly reported.
Patients taking Varenicline Tartrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Varenicline Tartrate can interact with other drugs, and patients should be monitored for adverse reactions. Patients with a history of mental health issues should be closely observed. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Varenicline Tartrate received a safety concern score of 85/100 (high concern). This is based on a 40.6% serious event ratio across 79,201 classified reports. The score accounts for 167,559 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: 45,796, Male: 25,889, Unknown: 427. The most frequently reported age groups are age 58 (809 reports), age 55 (792 reports), age 60 (761 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 79,201 classified reports for VARENICLINE TARTRATE:
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.
Varenicline Tartrate can interact with other drugs, and patients should be monitored for adverse reactions. Patients with a history of mental health issues should be closely observed.
If you are taking Varenicline Tartrate, here are important things to know. The most commonly reported side effects include nausea, depression, abnormal dreams, anxiety, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening mental health symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug interactions and intolerances. 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 has issued warnings about the potential for serious mental health effects, including suicidal ideation and depression. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of mental health is
The FDA has received approximately 167,559 adverse event reports associated with Varenicline Tartrate. 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 Varenicline Tartrate include Nausea, Depression, Abnormal Dreams, Anxiety, Drug Ineffective. By volume, the top reported reactions are: Nausea (14,427 reports), Depression (8,667 reports), Abnormal Dreams (7,824 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Varenicline Tartrate.
Out of 79,201 classified reports, 32,170 (40.6%) were classified as serious and 47,031 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 Varenicline Tartrate break down by patient sex as follows: Female: 45,796, Male: 25,889, Unknown: 427. 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 Varenicline Tartrate adverse events are: age 58: 809 reports, age 55: 792 reports, age 60: 761 reports, age 53: 758 reports, age 52: 746 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 Varenicline Tartrate adverse event reports is Pfizer Laboratories Div Pfizer 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 Varenicline Tartrate include: Insomnia, Vomiting, Suicidal Ideation, Headache, Feeling Abnormal. 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 Varenicline Tartrate 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.
Varenicline Tartrate 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. Significant reports of depression, suicidal ideation, and suicide attempts, indicating potential mental health risks.
Key safety signals identified in Varenicline Tartrate's adverse event data include: Suicidal ideation and suicide attempts. Depression and depressive mood. Drug interactions and intolerances. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Varenicline Tartrate can interact with other drugs, and patients should be monitored for adverse reactions. Patients with a history of mental health issues should be closely observed. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Varenicline Tartrate.
Patients should report any new or worsening mental health symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug interactions and intolerances.
Varenicline Tartrate has 167,559 adverse event reports on file with the FDA. Nausea and vomiting are common gastrointestinal side effects. The volume of reports for Varenicline Tartrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings about the potential for serious mental health effects, including suicidal ideation and depression. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of mental health is For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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