What the label lists and what reports show
Bupropion side effects
Bupropion's FDA label: “Most common adverse reactions (incidence ≥5% and ≥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 …” FAERS holds 140,269 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 nausea (9,800 reports).
- Generic listed
- Boxed warning
Check it at the source: the bupropion FDA label on DailyMed (effective June 21, 2024); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of bupropion hydrochloride extended-release tablets (SR)?Bupropion hydrochloride extended-release tablets (SR) can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of bupropion hydrochloride extended-release tablets (SR). The most common side effects of bupropion hydrochloride extended-release tablets (SR) include: If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime. Tell your healthcare provider right away about any side effects that bother you. These are not all the possible side effects of bupropion hydrochloride extended-release tablets (SR). For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Epic Pharma, LLC at 1-888-374-2791.
Source: FDA drug label, Epic Pharma LLC, effective June 21, 2024 (SPL set 9fb44e96-6160-4a4a-90cb-91764c0dcd89), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5% and ≥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.
Table 4: Adverse Reactions in Placebo-Controlled Trials in Patients with MDD
This table is printed in the Aplenzin label published by Bausch Health US, LLC of March 4, 2026; the label quoted above does not print one.
| Body System/Adverse Reaction | Placebo (n=385) | Bupropion HCl Sustained-Release 300 mg/day Equivalent to 348 mg/day bupropion HBr (n=376) | Bupropion HCl Sustained-Release 400 mg/day Equivalent to 464 mg/day bupropion HBr (n=114) |
|---|---|---|---|
| Headache | 23% | 26% | 25% |
| Infection | 6% | 8% | 9% |
| Abdominal pain | 2% | 3% | 9% |
| Asthenia | 2% | 2% | 4% |
| Chest pain | 1% | 3% | 4% |
| Pain | 2% | 2% | 3% |
| Palpitation | 2% | 2% | 6% |
| Migraine | 1% | 1% | 4% |
| Hot flashes | 1% | 1% | 3% |
| Dry mouth | 7% | 17% | 24% |
| Nausea | 8% | 13% | 18% |
| Constipation | 7% | 10% | 5% |
| Diarrhea | 6% | 5% | 7% |
| Anorexia | 2% | 5% | 3% |
| Vomiting | 2% | 4% | 2% |
| Dysphagia | 0% | 0% | 2% |
| Myalgia | 3% | 2% | 6% |
| Arthralgia | 1% | 1% | 4% |
| Arthritis | 0% | 0% | 2% |
| Insomnia | 6% | 11% | 16% |
| Dizziness | 5% | 7% | 11% |
| Agitation | 2% | 3% | 9% |
| Anxiety | 3% | 5% | 6% |
| Tremor | 1% | 6% | 3% |
| Nervousness | 3% | 5% | 3% |
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 greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in adolescents and young adults [see Boxed Warning and Warnings and Precautions (5.1) ] • Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see 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 ≥5% and ≥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 Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Epic Pharma LLC, effective June 21, 2024 (SPL set 9fb44e96-6160-4a4a-90cb-91764c0dcd89), via openFDA; the full label on DailyMed
What do FAERS reports show?
140,269 reports list bupropion among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13,386 are coded as a death and 33,199 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. Of the 18 reactions below, 11 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: 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