82/100 · Critical
Manufactured by Zydus Lifesciences Limited
Bupropion Adverse Events: High Concern for Suicidality and Depression
93,974 FDA adverse event reports analyzed
Last updated: 2026-05-12
BUPROPION is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Zydus Lifesciences Limited. Based on analysis of 93,974 FDA adverse event reports, BUPROPION 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 BUPROPION include COMPLETED SUICIDE, DRUG INEFFECTIVE, TOXICITY TO VARIOUS AGENTS, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPROPION.
Bupropion 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 93,974 adverse event reports for this medication, which is primarily manufactured by Zydus Lifesciences Limited.
The most commonly reported adverse events include Completed Suicide, Drug Ineffective, Toxicity To Various Agents. Of classified reports, 71.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Suicidal ideation and completed suicide are among the most serious adverse events reported.
Depression and fatigue are common, indicating potential mood-related side effects. Overdose and intentional misuse are significant risks, especially in psychiatric conditions.
Patients taking Bupropion should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bupropion can cause serious adverse events such as suicidal ideation and depression, and should be used with caution in patients with a history of psychiatric disorders. Drug interactions, particularly with monoamine oxidase inhibitors, are also a co This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Bupropion received a safety concern score of 82/100 (high concern). This is based on a 71.5% serious event ratio across 41,763 classified reports. The score accounts for 93,974 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: 24,397, Male: 12,560, Unknown: 133. The most frequently reported age groups are age 54 (1,114 reports), age 53 (830 reports), age 59 (723 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 41,763 classified reports for BUPROPION:
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.
Bupropion can cause serious adverse events such as suicidal ideation and depression, and should be used with caution in patients with a history of psychiatric disorders. Drug interactions, particularly with monoamine oxidase inhibitors, are also a co
If you are taking Bupropion, here are important things to know. The most commonly reported side effects include completed suicide, drug ineffective, toxicity to various agents, fatigue, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of depression, suicidal ideation, and mood changes. Avoid abrupt discontinuation of bupropion to prevent withdrawal symptoms and potential exacerbation of psychiatric conditions. 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 bupropion for safety, particularly for suicidality and depression. Healthcare providers should closely monitor patients and consider alternative treatments if adverse events occur.
The FDA has received approximately 93,974 adverse event reports associated with Bupropion. 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 Bupropion include Completed Suicide, Drug Ineffective, Toxicity To Various Agents, Fatigue, Nausea. By volume, the top reported reactions are: Completed Suicide (4,408 reports), Drug Ineffective (3,504 reports), Toxicity To Various Agents (3,113 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Bupropion.
Out of 41,763 classified reports, 29,854 (71.5%) were classified as serious and 11,909 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 Bupropion break down by patient sex as follows: Female: 24,397, Male: 12,560, Unknown: 133. 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 Bupropion adverse events are: age 54: 1,114 reports, age 53: 830 reports, age 59: 723 reports, age 57: 709 reports, age 60: 704 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 Bupropion adverse event reports is Zydus Lifesciences 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 Bupropion include: Off Label Use, Headache, Depression, Pain, Overdose. 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 Bupropion 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.
Bupropion 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. Suicidal ideation and completed suicide are among the most serious adverse events reported.
Key safety signals identified in Bupropion's adverse event data include: High number of reports related to completed suicide and suicidal ideation.. Multiple reports of depression and mood disturbances.. Significant number of adverse events related to overdose and intentional misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Bupropion can cause serious adverse events such as suicidal ideation and depression, and should be used with caution in patients with a history of psychiatric disorders. Drug interactions, particularly with monoamine oxidase inhibitors, are also a co Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bupropion.
Patients should be closely monitored for signs of depression, suicidal ideation, and mood changes. Avoid abrupt discontinuation of bupropion to prevent withdrawal symptoms and potential exacerbation of psychiatric conditions.
Bupropion has 93,974 adverse event reports on file with the FDA. Depression and fatigue are common, indicating potential mood-related side effects. The volume of reports for Bupropion reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor bupropion for safety, particularly for suicidality and depression. Healthcare providers should closely monitor patients and consider alternative treatments if adverse events occur. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with BUPROPION:
Drugs related to BUPROPION based on therapeutic use, drug class, or shared indications: