65/100 · Elevated
Manufactured by Bausch Health US LLC
Bupropion Hydrochloride Adverse Events: Moderate Safety Concerns
208,986 FDA adverse event reports analyzed
Last updated: 2026-05-12
BUPROPION HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US LLC. Based on analysis of 208,986 FDA adverse event reports, BUPROPION HYDROCHLORIDE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for BUPROPION HYDROCHLORIDE include DRUG INEFFECTIVE, NAUSEA, FATIGUE, HEADACHE, DEPRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUPROPION HYDROCHLORIDE.
Bupropion Hydrochloride has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 208,986 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us Llc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 50.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and fatigue are the most common side effects, with over 7,000 reports each.
Serious adverse events, including suicidal ideation and death, account for nearly 51% of all reports. Drug interactions and overuse are significant concerns, with over 1,700 reports each.
Patients taking Bupropion Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bupropion Hydrochloride can interact with other medications, and patients should inform their healthcare providers of all drugs they are taking. Overuse or misuse can lead to serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Bupropion Hydrochloride received a safety concern score of 65/100 (elevated concern). This is based on a 50.9% serious event ratio across 95,513 classified reports. The score accounts for 208,986 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 63,452, Male: 23,917, Unknown: 271. The most frequently reported age groups are age 54 (1,728 reports), age 58 (1,542 reports), age 59 (1,449 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 95,513 classified reports for BUPROPION 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.
Bupropion Hydrochloride can interact with other medications, and patients should inform their healthcare providers of all drugs they are taking. Overuse or misuse can lead to serious adverse events.
If you are taking Bupropion Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, headache, depression. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed dosages and do not alter the medication without consulting a healthcare provider. Inform your healthcare provider about any pre-existing conditions or other medications you are taking. 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 the safety of Bupropion Hydrochloride and has issued several warnings, including those related to suicidal ideation and serious infections.
The FDA has received approximately 208,986 adverse event reports associated with Bupropion 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 Bupropion Hydrochloride include Drug Ineffective, Nausea, Fatigue, Headache, Depression. By volume, the top reported reactions are: Drug Ineffective (9,292 reports), Nausea (7,517 reports), Fatigue (6,919 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 Hydrochloride.
Out of 95,513 classified reports, 48,633 (50.9%) were classified as serious and 46,880 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 Hydrochloride break down by patient sex as follows: Female: 63,452, Male: 23,917, Unknown: 271. 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 Hydrochloride adverse events are: age 54: 1,728 reports, age 58: 1,542 reports, age 59: 1,449 reports, age 48: 1,416 reports, age 53: 1,387 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 Hydrochloride adverse event reports is Bausch Health Us Llc. 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 Hydrochloride include: Anxiety, Pain, Dizziness, Insomnia, Off Label Use. 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 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.
Bupropion Hydrochloride has a safety concern score of 65 out of 100 (elevated 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. Nausea and fatigue are the most common side effects, with over 7,000 reports each.
Key safety signals identified in Bupropion Hydrochloride's adverse event data include: Suicidal ideation and completed suicides are key safety signals, especially in older adults.. Over 1,100 reports of serious infections and pneumonia highlight potential immunosuppressive effects.. Over 1,100 reports of drug interactions and contraindications indicate a need for careful monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Bupropion Hydrochloride can interact with other medications, and patients should inform their healthcare providers of all drugs they are taking. Overuse or misuse can lead to serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bupropion Hydrochloride.
Always follow prescribed dosages and do not alter the medication without consulting a healthcare provider. Inform your healthcare provider about any pre-existing conditions or other medications you are taking.
Bupropion Hydrochloride has 208,986 adverse event reports on file with the FDA. Serious adverse events, including suicidal ideation and death, account for nearly 51% of all reports. The volume of reports for Bupropion Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Bupropion Hydrochloride and has issued several warnings, including those related to suicidal ideation and serious infections. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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