Generic name
Bupropion hcl: adverse event reports filed with FDA
3,164 reports list it as a suspect or interacting product, 2004–2021. Class: Aminoketone.
- 3,164
- reports as suspect product
- 0% of all reports · about 141 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 74.3%
- marked serious by the reporter
- 57.6% across the class
- 31.8%
- record death among outcomes, as reported
- 1,005 reports · not verified by FDA
Between January 2004 and September 2021, 3,164 adverse event reports received by FDA list bupropion hcl, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (5,899) are left out of every figure here.
In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 141 reports a year and 0% of the 20,646,523 reports in the database, and 4.5% of the reports for the aminoketone class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded completed suicide (21.3%), depression (11.9%) and drug ineffective (11.5%). A report can list several reactions, so shares add to more than 100%; 576 different terms appear across these reports. Completed suicide is recorded in 21.3% of these reports, a larger share than in the median aminoketone drug (3.1%).
74.3% of the reports are marked serious by the reporter (57.6% across the class); 31.8% record death among the outcomes and 14.2% record hospitalisation, as reported. 31.6% of the reports came from physicians, and the largest patient age group is 18 to 44 (36.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
Reactions recorded in the reports
share of Bupropion hcl reports recording the termmedian drug in aminoketone
- Completed suicidedeath by suicide21.3%674
- Depressionlow mood11.9%375
- Drug ineffectivethe medicine did not work as expected11.5%364
- Product substitution issuea problem after switching products7.5%238
- Anxietyanxiety6.8%215
- Cardiac arrestthe heart stopped6.5%207
- Poisoning6.1%193
- Respiratory arrestbreathing stopped5.7%180
- Therapeutic response unexpected with drug substitution5.5%173
- Headachehead pain5.1%160
- Suicidal ideationthoughts of suicide4.8%152
- Insomniadifficulty sleeping4.4%138
- Nauseafeeling sick4.2%134
- Convulsion4.1%130
- Agitationrestlessness4%126
- Drug toxicity3.7%116
- Dizzinesslight-headedness or unsteadiness3.5%111
- Cardio-respiratory arrestthe heart and breathing stopped3.5%110
- Condition aggravatedthe condition being treated got worse3.4%109
- Overdosea dose above the recommended amount3.4%108
- Feeling abnormalfeeling odd or not right3.4%107
- Tremorshaking3%94
- Product quality issuea problem with the product itself2.9%91
- Drug interactionan interaction between medicines2.8%89
- Deaththe patient died; cause not stated by this term2.5%80
- Multiple drug overdose2.5%80
- Fatiguetiredness2.5%79
- Irritabilityirritability2.5%78
- Toxicity to various agentspoisoning or toxic effect of one or more substances2.3%72
Top 30 of 576 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the aminoketone class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 70,951 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 86.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Depression | 872 | 27.6% |
| Major depression | 135 | 4.3% |
| Smoking cessation therapy | 102 | 3.2% |
| Anxiety | 76 | 2.4% |
| Bipolar disorder | 38 | 1.2% |
| Attention deficit/hyperactivity disorder | 28 | 0.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 3,164 reports.
In context
| Measure | Bupropion hcl | Aminoketone | All reports |
|---|---|---|---|
| Reports as suspect product | 3,164 | 70,951 | 20,646,523 |
| Share of that pool | — | 4.5% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 74.3% | 57.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 318 | 165 | 91 |
| Hospitalisation recorded, per 1,000 reports | 142 | 205 | 213 |
| Consumer-filed share | 28.8% | 49.3% | 45.8% |
| Top term, share of reports | Completed suicide 21.3% | median 3.1% | 0.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the aminoketone class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Bupropion hydrochloride | generic | 23,187 | 1,027 | 58.1% |
| Bupropion | generic | 20,232 | 1,958 | 88% |
| Wellbutrin | brand | 13,341 | 224 | 30.3% |
| Naltrexone hydrochloride and bupropion hydrochloride | generic | 8,062 | 763 | 32.3% |
| Auvelity | brand | 2,965 | 918 | 19.8% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Bupropion hcl reports
How many adverse event reports has FDA received for Bupropion hcl?
3,164 reports list Bupropion hcl as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 5,899 list it only as a concomitant medication.
What reactions are recorded in Bupropion hcl reports?
completed suicide (21.3%), depression (11.9%), drug ineffective (11.5%), product substitution issue (7.5%) and anxiety (6.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Bupropion hcl was responsible.
How serious are the reports?
74.3% are marked serious by the reporter. Among the outcomes recorded, 31.8% of reports include death and 14.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (31.6%), consumer or non-health professional (28.8%) and other health professional (18.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Bupropion hcl rising?
0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Bupropion hcl was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Bupropion hcl?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Bupropion hcl as a suspect or interacting product; reports listing it only as a concomitant medication (5,899) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.