What the label lists and what reports show
Bupropion and dextromethorphan side effects
Bupropion and dextromethorphan's FDA label: “Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.” FAERS holds 3,287 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (308 reports).
- No generic listed
- Boxed warning
Check it at the source: the bupropion and dextromethorphan FDA label on DailyMed (effective August 17, 2026, Axsome Therapeutics, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of AUVELITY?AUVELITY may cause serious side effects, including: See “ What is the most important information I should know about AUVELITY ” Seizures. There is a risk of seizures during treatment with AUVELITY. The risk is higher in people who: take higher doses of AUVELITY have certain medical problems take AUVELITY with certain other medicines or alcohol Do not take AUVELITY with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with AUVELITY, stop taking AUVELITY and call your healthcare provider right away. Do not take AUVELITY again if you have a seizure. Increases in blood pressure (hypertension). Your healthcare provider should check your blood pressure before you start taking and during treatment with AUVELITY. Manic episodes. Manic episodes may happen in people with bipolar disorder who take AUVELITY. […]
Source: FDA drug label, Axsome Therapeutics, Inc., effective August 17, 2026 (SPL set dcefda7c-9a68-278e-e053-2995a90aec79), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.
Table 2: Adverse Reactions Occurring in ≥2% of Adult Patients with MDD Treated with AUVELITY and More Frequently than in Patients Treated with Placebo in a 6-Week Placebo-Controlled Study (Study 1)
| Adverse Reaction | AUVELITY (N=162) % | Placebo (N=164) % |
|---|---|---|
| Dizziness | 16 | 6 |
| Nausea | 13 | 9 |
| Headache | 8 | 4 |
| Diarrhea | 7 | 3 |
| Somnolence | 7 | 3 |
| Dry mouth | 6 | 2 |
| Sexual dysfunction a | 6 | 0 |
| Hyperhidrosis | 5 | 0 |
| Anxiety | 4 | 1 |
| Constipation | 4 | 2 |
| Decreased appetite | 4 | 1 |
| Insomnia | 4 | 2 |
| Arthralgia | 3 | 0 |
| Fatigue b | 3 | 2 |
| Paraesthesia c | 3 | 0 |
| Vision blurred | 3 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Seizure [see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Hypertension [see Warnings and Precautions ( 5.3 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )] Psychosis and Other Neuropsychiatric Reactions [see Warnings and Precautions ( 5.5 )] Angle-closure Glaucoma [see Warnings and Precautions ( 5.6 )] Dizziness [see Warnings and Precautions ( 5.7 )] Serotonin Syndrome [see Warnings and Precautions ( 5.8 )] Embryo-fetal Toxicity [see Warnings and Precautions ( 5.9 )] Hyponatremia [see Warnings and Precautions ( 5.10 )] MDD: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis. (6.1) Agitation associated with dementia due to Alzheimer’s disease: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness and dyspepsia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Axsome Therapeutics, Inc., effective August 17, 2026 (SPL set dcefda7c-9a68-278e-e053-2995a90aec79), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,287 reports list bupropion and dextromethorphan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 33 are coded as a death and 179 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,091, against a median of 2 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bupropion and dextromethorphan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions