This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older [see Warnings and Precautions ( 5.1 )] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.1 )] . NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation [see Warnings and Precautions ( 5.2 )]. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion trea...
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Bupropion , a substance that is chemically related to certain amphetamines, is authorised for smoking cessation. It is no more effective than nicotine , but can cause neuropsychiatric disorders (including aggressiveness, depression and suicidal thoughts), potentially severe allergic reactions (including angioedema and Stevens-Johnson syndrome), addiction, and congenital heart defects in children exposed to the drug in utero ( Prescrire Int n° 126, 131; Rev Prescrire n° 221, 377). When a drug is needed to help with smoking cessation, nicotine is a better choice, despite its limitations. Urology
Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Smoking cessation) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Bupropion hydrochloride extended-release tablets, USP (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM ) . The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14 )] . The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies ( 14 )] . • Bupropion hydrochloride extended-release tablets, USP (SR), are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
• Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. • Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see Warnings and Precautions ( 5.3 )]. • Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.3 )] . • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (SR) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (SR) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (SR) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (SR) within 14 days of discontinuing treatment w...
• Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg. Discontinue if seizure occurs. ( 4 , 5.3 , 7.3 ) • Hypertension: Bupropion hydrochloride extended-release tablets (SR) can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ( 5.4 ) • Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms. ( 5.5 ) • Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. ( 5.6 ) • Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.7 ) 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression...
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in adolescents and young adults [see Boxed Warning , Warnings and Precautions ( 5.1 )] • Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see Boxed Warning , Warnings and Precautions ( 5.2 )] • Seizure [see Warnings and Precautions ( 5.3 )] • Hypertension [see Warnings and Precautions ( 5.4 )] • Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] • Psychosis and other neuropsychiatric reactions [see Warnings and Precautions ( 5.6 )] • Angle-closure glaucoma [see Warnings and Precautions ( 5.7 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence greater than or equal to 5% and greater than or equal to 2% more than placebo rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation, myalgia, sweating, rash, and anorexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis Laboratories FL, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or Error! H...
RECENT MAJOR CHANGES Warnings and Precautions, Angle-Closure Glaucoma ( 5.7 ) 08/2014
Source: FDA SPL label for Bupropion Hydrochloride SR (Proficient Rx LP), effective 20220501. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 10,697 | 10,132 | 9,245 | 8,967 | 8,535 | 8,941 | 8,424 | 4,711 |
2,223 reports blaming this drug for every million Medicare prescriptions filled, which is 0.8× the typical drug on this site. (21,823 reports in 2024–2026, against 9,815,715 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 11/2023 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications |
| 10/2023 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications |
| 05/2023 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications; during stability testing |
| 12/2022 | Class II | Amerisource Health Services LLC | Failed Impurities/Degradation Specifications |
| 04/2022 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle. |
| 04/2022 | Class III | SUN PHARMACEUTICAL INDUSTRIES INC | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle. |
| 03/2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| 09/2018 | Class III | InvaGen Pharmaceuticals, Inc. | Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size. |
| 03/2018 | Class III | InvaGen Pharmaceuticals, Inc. | Failed Dissolution Specifications; during stability testing |
| 03/2018 | Class III | InvaGen Pharmaceuticals, Inc. | Failed Dissolution Specifications; during stability testing |
| 12/2016 | Class III | Sun Pharmaceutical Industries, Inc. | Failed Dissolution Specifications; 18 month stability time point |
| 09/2016 | Class III | Sun Pharmaceutical Industries, Inc. | Failed Dissolution Specifications |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $219,060 in payments to US physicians and hospitals tied to this drug across 9,138 transactions (Aplenzin $202,787, Wellbutrin $16,273).
No pending federal MDL names this drug or its brands.
Settlements of $100M+ in which this drug (Wellbutrin) was a named product, as recorded by the Department of Justice. A settlement resolves allegations; civil settlements are not admissions and not findings of wrongdoing. They are shown because off-label promotion cases describe how the evidence many prescribers saw was shaped.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Bupropion XL | 6,831,216 | $25 |
| Bupropion HCl SR | 2,256,886 | $20 |
| Bupropion HCl | 702,514 | $24 |
| Wellbutrin XL | 18,653 | $4,390 |
| Wellbutrin SR | 6,091 | $853 |
| Forfivo XL | 355 | $667 |
No same-class alternatives found in RxClass.