Generic name
Bupropion hydrochloride: adverse event reports filed with FDA
23,187 reports list it as a suspect or interacting product, 2004–2026. Class: Aminoketone. Also reported as Bupropion Hydrochloride Xl, Bupropion Hcl Xl, Bupropion Hydrochloride Extended Release Sr.
- 23,187
- reports as suspect product
- 0.1% of all reports · about 1,031 a year
- 1,027
- reports, 12 months to June 2026
- 1,865 in the 12 months before
- 58.1%
- marked serious by the reporter
- 57.6% across the class
- 10.8%
- record death among outcomes, as reported
- 2,495 reports · not verified by FDA
23,187 adverse event reports received by FDA list bupropion hydrochloride, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 51,762 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 1,027 reports listed it, down 45% from 1,865 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 1,031 reports a year and 0.1% of the 20,646,523 reports in the database, and 32.7% 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.
The MedDRA terms listed most often are drug ineffective (13.4%), depression (8.2%) and headache (7.9%). A report can list several reactions, so shares add to more than 100%; 1,902 different terms appear across these reports. Drug ineffective is recorded in 13.4% of these reports, a larger share than in the median aminoketone drug (10%).
58.1% of the reports are marked serious by the reporter (57.6% across the class); 10.8% record death among the outcomes and 20% record hospitalisation, as reported. 54.7% of the reports came from consumers, and the largest patient age group is 18 to 44 (22.1%). 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
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Bupropion hydrochloride reports recording the termmedian drug in aminoketone
- Drug ineffectivethe medicine did not work as expected13.4%3,104
- Depressionlow mood8.2%1,895
- Headachehead pain7.9%1,838
- Drug hypersensitivityan allergic-type reaction to a medicine7.2%1,679
- Anxietyanxiety6.7%1,551
- Fatiguetiredness5.7%1,315
- Nauseafeeling sick5.7%1,314
- Completed suicidedeath by suicide5.4%1,262
- Overdosea dose above the recommended amount5.2%1,207
- Drug interactionan interaction between medicines5.1%1,171
- Insomniadifficulty sleeping4.9%1,144
- Off label useused for a purpose or in a way not on the label4.8%1,121
- Painpain, site not specified4.6%1,068
- Dizzinesslight-headedness or unsteadiness4.6%1,058
- Toxicity to various agentspoisoning or toxic effect of one or more substances4.5%1,037
- Hyperhidrosisexcessive sweating4.4%1,020
- Intentional overdosea deliberate overdose4.1%957
- Feeling abnormalfeeling odd or not right4%921
- Suicidal ideationthoughts of suicide3.9%904
- Hypertensionhigh blood pressure3.8%874
- Rashskin rash3.8%872
- Asthmaasthma3.7%865
- Product substitution issuea problem after switching products3.7%854
- Hypersensitivityan allergic-type reaction3.6%829
- Convulsion3.3%776
- Tremorshaking3.3%759
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease3.1%727
- Seizurea fit or convulsion3.1%726
- Constipationconstipation3.1%713
- Agitationrestlessness2.8%658
Top 30 of 1,902 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. 73.3% 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 | 5,016 | 21.6% |
| Bipolar disorder | 443 | 1.9% |
| Anxiety | 423 | 1.8% |
| Major depression | 413 | 1.8% |
| Smoking cessation therapy | 397 | 1.7% |
| Ill-defined disorder | 254 | 1.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 23,187 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Bupropion hydrochloride reports |
|---|---|---|
| Gabapentin | 1,323 | 5.7% |
| Clonazepam | 1,003 | 4.3% |
| Quetiapine fumarate | 954 | 4.1% |
| Zopiclone | 952 | 4.1% |
| Venlafaxine hydrochloride | 936 | 4% |
| Quetiapine | 874 | 3.8% |
| Actemra | 862 | 3.7% |
| Orencia | 859 | 3.7% |
| Albuterol | 801 | 3.5% |
| Rituximab | 754 | 3.3% |
Other products listed in reports where Bupropion hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Bupropion hydrochloride | Aminoketone | All reports |
|---|---|---|---|
| Reports as suspect product | 23,187 | 70,951 | 20,646,523 |
| Share of that pool | — | 32.7% | 0.1% |
| Reports, latest 12 months | 1,027 | — | 1,332,454 |
| Marked serious | 58.1% | 57.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 108 | 165 | 91 |
| Hospitalisation recorded, per 1,000 reports | 200 | 205 | 213 |
| Consumer-filed share | 54.7% | 49.3% | 45.8% |
| Top term, share of reports | Drug ineffective 13.4% | median 10% | 6.3% |
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 | generic | 20,232 | 1,958 | 88% |
| Wellbutrin | brand | 13,341 | 224 | 30.3% |
| Naltrexone hydrochloride and bupropion hydrochloride | generic | 8,062 | 763 | 32.3% |
| Bupropion hcl | generic | 3,164 | 0 | 74.3% |
| 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 hydrochloride reports
How many adverse event reports has FDA received for Bupropion hydrochloride?
23,187 reports list Bupropion hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,027 of them arrived in the latest 12 months. Another 51,762 list it only as a concomitant medication.
What reactions are recorded in Bupropion hydrochloride reports?
drug ineffective (13.4%), depression (8.2%), headache (7.9%), drug hypersensitivity (7.2%) and anxiety (6.7%). 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 hydrochloride was responsible.
How serious are the reports?
58.1% are marked serious by the reporter. Among the outcomes recorded, 10.8% of reports include death and 20% 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?
consumer or non-health professional (54.7%), other health professional (21.4%) and physician (15.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Bupropion hydrochloride rising?
1,027 reports in the 12 months to June 2026, down 45% from 1,865 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 hydrochloride 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 hydrochloride?
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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (51,762) 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.