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Bupropion side effects: what 98,116 FDA adverse event reports show

Bupropion Hydrochloride · 1,189 reaction terms · 428,785 drug–reaction co-reports · data 2026-09-14
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Drug class

Aminoketone antidepressant

FDA label, Indications wording

Who reports

98,116 reports · 51% serious · 4,722 with death outcome · 73% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1. INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets, USP (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient.

FDA label, Indications and Usage

What it is

Bupropion is an aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring.

PubChem CID 444 (ChEBI)

Boxed warning

SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. ( 5.1 ) • Monitor for worsening and emergence of suicidal thoughts and behaviors.

FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 1Labeled (related wording) 4Reporting / coding artifact 3Lab value / disease marker 5Not in label — unassessed 27
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,149 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Temperature regulation disorder49963.2
57.2–69.8ROR 63.5 · χ² 23,418 / p <1e-300
48.7 EB05 45.2 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious n=492 · ♀ 100% (drug 73%)not reported in cached trials
Stool analysis abnormal6745.9
35.3–59.8ROR 46.0 · χ² 2,380 / p <1e-300
37.5 EB05 30.6 · IC025 +4.5
3/3 methods agree
Reporting / coding artifact♀ 0% (drug 73%) · 100% consumernot reported in cached trials
Ejection fraction10345.6
36.9–56.4ROR 45.6 · χ² 3,654 / p <1e-300
37.4 EB05 31.7 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=103 · ♀ 100% (drug 73%)not reported in cached trials
Sensitisation12140.0
32.9–48.6ROR 40.0 · χ² 3,831 / p <1e-300
33.6 EB05 28.9 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=120 · ♀ 100% (drug 73%)not reported in cached trials
Retinitis18125.9
22.2–30.2ROR 25.9 · χ² 3,834 / p <1e-300
23.1 EB05 20.4 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=181 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Polycystic ovaries13920.7
17.4–24.6ROR 20.7 · χ² 2,349 / p <1e-300
18.9 EB05 16.4 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=136 · ♀ 100% (drug 73%)not reported in cached trials
Food allergy62119.1
17.6–20.7ROR 19.2 · χ² 9,732 / p <1e-300
17.6 EB05 16.4 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=598 · ♀ 100% (drug 73%)not reported in cached trials
Postictal state8218.3
14.6–23.0ROR 18.3 · χ² 1,219 / p 2e-267
16.9 EB05 14.0 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=81not reported in cached trials
Joint destruction12117.8
14.8–21.5ROR 17.9 · χ² 1,758 / p <1e-300
16.5 EB05 14.1 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=121 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Rheumatoid factor positive41516.5
14.9–18.2ROR 16.6 · χ² 5,587 / p <1e-300
15.4 EB05 14.1 · IC025 +3.8
3/3 methods agree
Lab value / disease markerserious n=414 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Lupus vulgaris8315.9
12.8–19.9ROR 16.0 · χ² 1,067 / p 2e-234
14.8 EB05 12.3 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=83 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Obstructive sleep apnoea syndrome9215.0
12.2–18.5ROR 15.0 · χ² 1,110 / p 1e-243
14.0 EB05 11.7 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=88 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Oesophageal spasm11814.6
12.1–17.5ROR 14.6 · χ² 1,381 / p <1e-300
13.6 EB05 11.6 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=114 · ♀ 100% (drug 73%)NCT01601704: 1/4,450 (0.0%) control (serious AE)
Bone erosion21713.9
12.1–15.9ROR 13.9 · χ² 2,422 / p <1e-300
13.0 EB05 11.6 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=216 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Foetal death28812.5
11.1–14.1ROR 12.5 · χ² 2,869 / p <1e-300
11.8 EB05 10.7 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=288 · ♀ 100% (drug 73%)not reported in cached trials
Red blood cell sedimentation rate abnormal12812.4
10.4–14.8ROR 12.4 · χ² 1,254 / p 5e-275
11.6 EB05 10.0 · IC025 +3.2
3/3 methods agree
Lab value / disease markerserious n=126 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Pre-existing condition improved34112.2
10.9–13.6ROR 12.2 · χ² 3,290 / p <1e-300
11.5 EB05 10.5 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=188not reported in cached trials
Coeliac disease53012.1
11.1–13.3ROR 12.2 · χ² 5,115 / p <1e-300
11.5 EB05 10.7 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious PRR 15.5 · ♀ 100% (drug 73%)NCT01601704: 2/4,450 (0.0%) control
Immunodeficiency77211.8
10.9–12.7ROR 11.9 · χ² 7,198 / p <1e-300
11.2 EB05 10.5 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious PRR 13.7 · ♀ 100% (drug 73%)not reported in cached trials
Electrocardiogram qrs complex prolonged26411.6
10.2–13.1ROR 11.6 · χ² 2,408 / p <1e-300
11.0 EB05 9.9 · IC025 +3.2
3/3 methods agree
Lab value / disease markerserious n=264 · 100% cliniciannot reported in cached trials
Hostility13111.4
9.6–13.6ROR 11.4 · χ² 1,173 / p 2e-257
10.8 EB05 9.3 · IC025 +3.1
3/3 methods agree
Labeled adverse reaction
exact term
serious n=102not reported in cached trials
Gambling disorder13411.0
9.3–13.1ROR 11.1 · χ² 1,153 / p 4e-253
10.4 EB05 9.0 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=107not reported in cached trials
Grand mal convulsion45810.9
10.0–12.0ROR 11.0 · χ² 3,923 / p <1e-300
10.4 EB05 9.6 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 11.9not reported in cached trials
Bursitis57010.5
9.7–11.5ROR 10.6 · χ² 4,685 / p <1e-300
10.1 EB05 9.4 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 13.0 · ♀ 94% (drug 73%)NCT01601704: 1/4,455 (0.0%) on Bupropion (serious AE)
Tongue biting9510.2
8.3–12.6ROR 10.2 · χ² 745 / p 2e-164
9.6 EB05 8.0 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=86not reported in cached trials
Medication residue11810.0
8.4–12.1ROR 10.1 · χ² 909 / p 5e-200
9.5 EB05 8.1 · IC025 +2.9
3/3 methods agree
Not in label — unassessed76% consumernot reported in cached trials
Product odour abnormal4569.8
8.9–10.7ROR 9.8 · χ² 3,425 / p <1e-300
9.3 EB05 8.6 · IC025 +3.1
3/3 methods agree
Reporting / coding artifact–not reported in cached trials
Psychiatric decompensation859.7
7.8–12.0ROR 9.7 · χ² 625 / p 3e-138
9.1 EB05 7.5 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=84 · ♀ 0% (drug 73%) · 100% cliniciannot reported in cached trials
Drug tolerance2159.4
8.2–10.8ROR 9.4 · χ² 1,538 / p <1e-300
8.9 EB05 8.0 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=190not reported in cached trials
Diabetic neuropathy2089.3
8.1–10.7ROR 9.3 · χ² 1,463 / p <1e-300
8.8 EB05 7.9 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=202not reported in cached trials
Rhinitis allergic1859.2
8.0–10.7ROR 9.3 · χ² 1,295 / p 6e-284
8.8 EB05 7.8 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=176not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive2949.2
8.2–10.3ROR 9.2 · χ² 2,046 / p <1e-300
8.8 EB05 7.9 · IC025 +2.9
3/3 methods agree
Lab value / disease markerserious PRR 10.0 · ♀ 100% (drug 73%) · 100% cliniciannot reported in cached trials
Sleep apnoea syndrome7919.2
8.5–9.9ROR 9.2 · χ² 5,520 / p <1e-300
8.8 EB05 8.3 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious PRR 11.2not reported in cached trials
Therapeutic response unexpected with drug substitution1688.8
7.6–10.3ROR 8.8 · χ² 1,113 / p 3e-244
8.4 EB05 7.4 · IC025 +2.8
3/3 methods agree
Reporting / coding artifactserious n=97not reported in cached trials
Drug screen false positive1098.6
7.1–10.4ROR 8.6 · χ² 699 / p 3e-154
8.1 EB05 6.9 · IC025 +2.7
3/3 methods agree
Lab value / disease marker100% consumernot reported in cached trials
Compulsive shopping808.6
6.8–10.7ROR 8.6 · χ² 505 / p 3e-112
8.0 EB05 6.6 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=60 · 100% consumernot reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Bupropion as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Drug ineffective (drug did not work)9,4841.5
1.5–1.6ROR 1.6 · χ² 1,919 / p <1e-300
1.5 EB05 1.5 · IC025 +0.6Reporting / coding artifactserious PRR 1.9not reported in cached trials
Nausea7,7512.1
2.1–2.2ROR 2.2 · χ² 4,656 / p <1e-300
2.1 EB05 2.1 · IC025 +1.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.4NCT01601704: 1/4,455 (0.0%) on Bupropion (serious AE)
Headache6,9772.4
2.3–2.5ROR 2.5 · χ² 5,786 / p <1e-300
2.4 EB05 2.3 · IC025 +1.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.1NCT01601704: 1/4,450 (0.0%) control (serious AE)
Depression6,3226.1
5.9–6.2ROR 6.4 · χ² 26,198 / p <1e-300
5.9 EB05 5.8 · IC025 +2.5
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 6.3NCT01601704: 1/4,450 (0.0%) control (serious AE)
Anxiety5,6464.3
4.2–4.4ROR 4.5 · χ² 14,173 / p <1e-300
4.2 EB05 4.1 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.5NCT01601704: 26/4,455 (0.6%) on Bupropion; 8/4,450 (0.2%) control
Pain5,2811.8
1.8–1.9ROR 1.9 · χ² 2,072 / p <1e-300
1.8 EB05 1.8 · IC025 +0.8Labeled adverse reaction
exact term
serious PRR 2.4NCT01601704: 2/4,455 (0.0%) on Bupropion; 3/4,450 (0.1%) control (serious AE)
Dizziness5,0532.2
2.1–2.2ROR 2.2 · χ² 3,274 / p <1e-300
2.2 EB05 2.1 · IC025 +1.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.5NCT01601704: 4/4,455 (0.1%) on Bupropion; 1/4,450 (0.0%) control (serious AE)
Off label use (used outside approved label)4,5371.1
1.1–1.1ROR 1.1 · χ² 58 / p 1e-14
1.1 EB05 1.1 · IC025 +0.1Reporting / coding artifactserious PRR 1.5not reported in cached trials
Insomnia (trouble sleeping)4,5133.7
3.6–3.8ROR 3.8 · χ² 8,684 / p <1e-300
3.6 EB05 3.5 · IC025 +1.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.7 · 72% consumerNCT01601704: 38/4,455 (0.9%) on Bupropion; 16/4,450 (0.4%) control
Diarrhoea (diarrhea)3,6381.2
1.2–1.2ROR 1.2 · χ² 135 / p 1e-31
1.2 EB05 1.2 · IC025 +0.2Labeled adverse reaction
exact term
serious PRR 1.4NCT01601704: 35/4,455 (0.8%) on Bupropion; 21/4,450 (0.5%) control
Vomiting3,4321.6
1.5–1.6ROR 1.6 · χ² 717 / p 3e-158
1.6 EB05 1.5 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 1.8NCT01601704: 2/4,455 (0.0%) on Bupropion (serious AE)
Rash3,4131.7
1.6–1.7ROR 1.7 · χ² 967 / p 1e-212
1.7 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 2.1NCT01601704: 10/4,455 (0.2%) on Bupropion; 3/4,450 (0.1%) control
Dyspnoea (shortness of breath)3,2341.2
1.2–1.3ROR 1.2 · χ² 134 / p 3e-31
1.2 EB05 1.2 · IC025 +0.2Labeled adverse reaction
exact term
serious PRR 1.4NCT01601704: 1/4,455 (0.0%) on Bupropion; 1/4,450 (0.0%) control (serious AE)

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Bupropion ↔ Seizures.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Bupropion?

In FDA FAERS, the most frequently co-reported reaction terms for Bupropion are nausea, fatigue, headache, depression, anxiety, pain. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Bupropion have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. ( 5.1 ) • Monitor for worsening and emergence of suicidal thoughts and behaviors.

Do FAERS signals prove that Bupropion causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.