Brand name · Dextromethorphan hydrobromide, bupropion hydrochloride
Auvelity: adverse event reports filed with FDA
2,965 reports list it as a suspect or interacting product, 2021–2026. Class: Aminoketone.
- 2,965
- reports as suspect product
- 0% of all reports · about 604 a year
- 918
- reports, 12 months to June 2026
- 1,023 in the 12 months before
- 19.8%
- marked serious by the reporter
- 57.6% across the class
- 0.8%
- record death among outcomes, as reported
- 24 reports · not verified by FDA
2,965 adverse event reports received by FDA list the brand name Auvelity (dextromethorphan hydrobromide, bupropion hydrochloride) as a suspect or interacting product, from August 2021 to June 2026. A further 322 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, 918 reports listed it, down 10% from 1,023 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 604 reports a year and 0% of the 20,646,523 reports in the database, and 4.2% 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 reactions recorded most often are dizziness (10%), feeling abnormal (8.7%) and anxiety (6.5%). A report can list several reactions, so shares add to more than 100%; 413 different terms appear across these reports. Dizziness is recorded in 10% of these reports, a larger share than in the median aminoketone drug (5.3%).
19.8% of the reports are marked serious by the reporter (57.6% across the class); 0.8% record death among the outcomes and 4.1% record hospitalisation, as reported. 51.1% of the reports came from consumers, and the largest patient age group is 18 to 44 (16.5%). 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 Auvelity reports recording the termmedian drug in aminoketone
- Dizzinesslight-headedness or unsteadiness10%296
- Feeling abnormalfeeling odd or not right8.7%259
- Anxietyanxiety6.5%193
- Drug ineffectivethe medicine did not work as expected6.3%186
- Inappropriate schedule of product administrationthe product was taken at the wrong times6%179
- Off label useused for a purpose or in a way not on the label5%149
- Nauseafeeling sick5%147
- Therapy interrupted4.8%142
- Fatiguetiredness4.7%138
- Depressionlow mood4.5%134
- Headachehead pain4.2%126
- Tremorshaking3.9%117
- Insomniadifficulty sleeping3.4%100
- Somnolencedrowsiness3.3%97
- Suicidal ideationthoughts of suicide3.2%96
- Withdrawal syndrome3.2%96
- Hyperhidrosisexcessive sweating3.2%95
- Brain fog2.7%80
- Malaisegeneral feeling of being unwell2.5%73
- Product use issuea problem in how the product was used2.4%72
- Dissociation2.4%70
- Tinnitusringing in the ears2.3%68
- Blood pressure increaseda raised blood pressure reading2.1%63
- Euphoric mood2.1%63
- Loss of therapeutic response2%60
- Agitationrestlessness1.7%51
- Vision blurredblurred vision1.7%51
- Vomitingbeing sick1.7%51
- Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor1.7%50
Top 30 of 413 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. 99.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Major depression | 933 | 31.5% |
| Depression | 246 | 8.3% |
| Bipolar disorder | 13 | 0.4% |
| Anxiety | 11 | 0.4% |
| Post-traumatic stress disorder | 3 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,965 reports.
In context
| Measure | Auvelity | Aminoketone | All reports |
|---|---|---|---|
| Reports as suspect product | 2,965 | 70,951 | 20,646,523 |
| Share of that pool | — | 4.2% | 0% |
| Reports, latest 12 months | 918 | — | 1,332,454 |
| Marked serious | 19.8% | 57.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 8 | 165 | 91 |
| Hospitalisation recorded, per 1,000 reports | 41 | 205 | 213 |
| Consumer-filed share | 51.1% | 49.3% | 45.8% |
| Top term, share of reports | Dizziness 10% | median 5.3% | 2.4% |
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% |
| Bupropion hcl | generic | 3,164 | 0 | 74.3% |
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 Auvelity reports
How many adverse event reports has FDA received for Auvelity?
2,965 reports list Auvelity as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 918 of them arrived in the latest 12 months. Another 322 list it only as a concomitant medication.
What reactions are recorded in Auvelity reports?
dizziness (10%), feeling abnormal (8.7%), anxiety (6.5%), drug ineffective (6.3%) and inappropriate schedule of product administration (6%). 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 Auvelity was responsible.
How serious are the reports?
19.8% are marked serious by the reporter. Among the outcomes recorded, 0.8% of reports include death and 4.1% 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 (51.1%), physician (16.8%) and not given (16.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Auvelity rising?
918 reports in the 12 months to June 2026, down 10% from 1,023 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 Auvelity 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 Auvelity?
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 Auvelity as a suspect or interacting product; reports listing it only as a concomitant medication (322) 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.