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Drug · FAERS side-effect profile with label screen

Bupropion side effects: what 44,278 FDA adverse event reports show

Bupropion · 1,192 reaction terms · 189,263 drug–reaction co-reports · data 2026-09-14
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Drug class

Aminoketone antidepressant

FDA label, Indications wording

Who reports

44,278 reports · 72% serious · 8,963 with death outcome · 66% 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

11. DESCRIPTION Bupropion hydrochloride extended-release tablets (XL), is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.

FDA label, Description section

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 (related wording) 6Reporting / coding artifact 1Lab value / disease marker 6Outcome field, not a reaction 1Not in label — unassessed 26
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. 1,152 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
Ejection fraction139148.0
122.3–179.0ROR 148.4 · χ² 15,290 / p <1e-300
110.9 EB05 96.2 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious n=139 · ♀ 100% (drug 66%)not reported in cached trials
Sensitisation180145.7
123.3–172.2ROR 146.3 · χ² 19,598 / p <1e-300
110.0 EB05 97.1 · IC025 +6.2
3/3 methods agree
Not in label — unassessedserious n=179 · ♀ 100% (drug 66%)not reported in cached trials
Postmortem blood drug level increased5482.8
62.0–110.6ROR 82.9 · χ² 3,637 / p <1e-300
68.8 EB05 54.8 · IC025 +5.0
3/3 methods agree
Lab value / disease markerserious n=54 · 100% cliniciannot reported in cached trials
Polycystic ovaries17860.4
51.7–70.6ROR 60.7 · χ² 9,159 / p <1e-300
53.3 EB05 47.1 · IC025 +5.3
3/3 methods agree
Not in label — unassessedserious n=178 · ♀ 100% (drug 66%)not reported in cached trials
Asthma exercise induced3349.6
34.7–71.0ROR 49.7 · χ² 1,377 / p <1e-300
43.9 EB05 32.7 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=33 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Temperature regulation disorder19145.3
39.1–52.5ROR 45.5 · χ² 7,501 / p <1e-300
41.2 EB05 36.5 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=187 · ♀ 94% (drug 66%)not reported in cached trials
Electrocardiogram qrs complex prolonged44645.2
41.0–49.8ROR 45.6 · χ² 17,527 / p <1e-300
41.2 EB05 38.1 · IC025 +5.1
3/3 methods agree
Lab value / disease markerserious n=446 · 100% cliniciannot reported in cached trials
Retinitis14344.3
37.3–52.6ROR 44.4 · χ² 5,488 / p <1e-300
40.3 EB05 35.1 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=143 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Factor v leiden mutation3342.7
29.9–61.0ROR 42.8 · χ² 1,194 / p 6e-262
38.4 EB05 28.6 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=33 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Psychiatric decompensation16142.5
36.2–50.0ROR 42.7 · χ² 5,945 / p <1e-300
38.9 EB05 34.1 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=159 · ♀ 0% (drug 66%) · 91% cliniciannot reported in cached trials
Obstructive sleep apnoea syndrome9835.7
29.1–43.8ROR 35.8 · χ² 3,038 / p <1e-300
33.0 EB05 27.9 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=98 · ♀ 100% (drug 66%)not reported in cached trials
Ejection fraction abnormal7631.2
24.7–39.3ROR 31.2 · χ² 2,052 / p <1e-300
29.1 EB05 24.0 · IC025 +4.2
3/3 methods agree
Lab value / disease markerserious n=76 · ♀ 100% (drug 66%)not reported in cached trials
Drug specific antibody8330.6
24.5–38.2ROR 30.7 · χ² 2,204 / p <1e-300
28.6 EB05 23.8 · IC025 +4.3
3/3 methods agree
Lab value / disease markerserious n=83 · ♀ 100% (drug 66%)not reported in cached trials
Lupus vulgaris7130.0
23.6–38.1ROR 30.0 · χ² 1,842 / p <1e-300
28.0 EB05 23.0 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=71 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Anti-cyclic citrullinated peptide antibody3929.3
21.2–40.5ROR 29.4 · χ² 977 / p 7e-215
27.3 EB05 20.9 · IC025 +3.8
3/3 methods agree
Lab value / disease markerserious n=39 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Nephrectomy8629.1
23.4–36.2ROR 29.2 · χ² 2,170 / p <1e-300
27.3 EB05 22.8 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=84 · ♀ 100% (drug 66%)not reported in cached trials
Completed suicide (death by suicide)4,61427.4
26.7–28.2ROR 30.5 · χ² 111,396 / p <1e-300
26.0 EB05 25.3 · IC025 +4.6
3/3 methods agree
Outcome field, not a reactionserious PRR 20.8 · 99% cliniciannot reported in cached trials
Serotonin syndrome88923.0
21.6–24.6ROR 23.5 · χ² 17,856 / p <1e-300
22.0 EB05 20.8 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious PRR 17.8 · 94% cliniciannot reported in cached trials
Oesophageal spasm8422.6
18.1–28.1ROR 22.6 · χ² 1,631 / p <1e-300
21.5 EB05 17.9 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=84 · ♀ 100% (drug 66%)NCT01601704: 1/4,450 (0.0%) control (serious AE)
Rhinitis allergic19421.6
18.7–24.9ROR 21.7 · χ² 3,621 / p <1e-300
20.6 EB05 18.3 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=192 · ♀ 95% (drug 66%)not reported in cached trials
Brugada syndrome4421.2
15.7–28.7ROR 21.3 · χ² 792 / p 1e-174
20.2 EB05 15.6 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=44 · 100% cliniciannot reported in cached trials
Granuloma skin3520.8
14.9–29.2ROR 20.9 · χ² 614 / p 8e-136
19.8 EB05 14.8 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=35 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Foetal death21620.5
17.9–23.5ROR 20.6 · χ² 3,829 / p <1e-300
19.7 EB05 17.6 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=216 · ♀ 100% (drug 66%)not reported in cached trials
Food allergy29719.3
17.2–21.7ROR 19.5 · χ² 4,944 / p <1e-300
18.6 EB05 16.9 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=288 · ♀ 100% (drug 66%)not reported in cached trials
Bone erosion13618.9
15.9–22.4ROR 18.9 · χ² 2,195 / p <1e-300
18.1 EB05 15.7 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious n=136 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Areflexia10318.8
15.5–22.9ROR 18.9 · χ² 1,655 / p <1e-300
18.1 EB05 15.3 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=102 · ♀ 87% (drug 66%) · 100% cliniciannot reported in cached trials
Rheumatoid factor positive22018.7
16.4–21.4ROR 18.8 · χ² 3,534 / p <1e-300
18.0 EB05 16.1 · IC025 +3.9
3/3 methods agree
Lab value / disease markerserious n=220 · ♀ 100% (drug 66%) · 96% cliniciannot reported in cached trials
Distributive shock8318.4
14.8–23.0ROR 18.5 · χ² 1,301 / p 4e-285
17.7 EB05 14.7 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=83 · ♀ 43% (drug 66%) · 100% cliniciannot reported in cached trials
Pupil fixed6217.4
13.5–22.4ROR 17.4 · χ² 909 / p 6e-200
16.7 EB05 13.5 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=62 · 100% cliniciannot reported in cached trials
Hyperreflexia11916.6
13.9–20.0ROR 16.7 · χ² 1,674 / p <1e-300
16.0 EB05 13.8 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=118 · 100% cliniciannot reported in cached trials
Bezoar4515.9
11.8–21.5ROR 16.0 · χ² 595 / p 1e-131
15.3 EB05 11.8 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=45 · 100% cliniciannot reported in cached trials
Rebound acid hypersecretion9615.3
12.5–18.7ROR 15.3 · χ² 1,226 / p 7e-269
14.7 EB05 12.4 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=96not reported in cached trials
Exposure via ingestion7915.1
12.1–18.9ROR 15.1 · χ² 994 / p 2e-218
14.6 EB05 12.0 · IC025 +3.4
3/3 methods agree
Reporting / coding artifactserious n=77 · 100% cliniciannot reported in cached trials
Pulseless electrical activity12514.6
12.2–17.4ROR 14.6 · χ² 1,522 / p <1e-300
14.1 EB05 12.1 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=125not 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 (1 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
Completed suicide (death by suicide)4,61427.4
26.7–28.2ROR 30.5 · χ² 111,396 / p <1e-300
26.0 EB05 25.3 · IC025 +4.6
3/3 methods agree
Outcome field, not a reactionserious PRR 20.8 · 99% cliniciannot reported in cached trials
Toxicity to various agents3,68710.6
10.3–11.0ROR 11.5 · χ² 31,641 / p <1e-300
10.4 EB05 10.1 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious PRR 8.6 · 97% cliniciannot reported in cached trials
Drug ineffective (drug did not work)3,6691.3
1.3–1.4ROR 1.3 · χ² 303 / p 4e-68
1.3 EB05 1.3 · IC025 +0.3Reporting / coding artifactserious PRR 1.9not reported in cached trials
Nausea2,4371.5
1.4–1.5ROR 1.5 · χ² 371 / p 7e-83
1.5 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
serious PRR 1.5NCT01601704: 1/4,455 (0.0%) on Bupropion (serious AE)
Off label use (used outside approved label)2,4351.3
1.3–1.4ROR 1.3 · χ² 206 / p 4e-47
1.3 EB05 1.3 · IC025 +0.3Reporting / coding artifactserious PRR 1.5not reported in cached trials
Headache2,3521.8
1.7–1.9ROR 1.8 · χ² 827 / p 3e-182
1.8 EB05 1.7 · IC025 +0.8Labeled adverse reaction
exact term
serious PRR 2.1NCT01601704: 1/4,450 (0.0%) control (serious AE)
Depression2,2324.7
4.5–4.9ROR 4.9 · χ² 6,420 / p <1e-300
4.6 EB05 4.5 · IC025 +2.1
3/3 methods agree
Labeled — boxed warning
synonym match
serious PRR 4.3NCT01601704: 1/4,450 (0.0%) control (serious AE)
Pain2,0451.6
1.5–1.6ROR 1.6 · χ² 441 / p 3e-98
1.6 EB05 1.5 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 1.6NCT01601704: 2/4,455 (0.0%) on Bupropion; 3/4,450 (0.1%) control (serious AE)
Overdose1,9354.3
4.1–4.4ROR 4.4 · χ² 4,828 / p <1e-300
4.2 EB05 4.1 · IC025 +2.0
3/3 methods agree
Reporting / coding artifactserious PRR 4.2 · 91% cliniciannot reported in cached trials
Anxiety1,7402.9
2.8–3.0ROR 3.0 · χ² 2,180 / p <1e-300
2.9 EB05 2.8 · IC025 +1.5
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.8NCT01601704: 26/4,455 (0.6%) on Bupropion; 8/4,450 (0.2%) control
Drug interaction1,7355.2
5.0–5.5ROR 5.4 · χ² 5,900 / p <1e-300
5.2 EB05 5.0 · IC025 +2.3
3/3 methods agree
Reporting / coding artifactserious PRR 4.4 · ♀ 35% (drug 66%)not reported in cached trials
Dizziness1,6671.6
1.5–1.7ROR 1.6 · χ² 369 / p 1e-82
1.6 EB05 1.5 · IC025 +0.6Labeled adverse reaction
exact term
serious PRR 1.6NCT01601704: 4/4,455 (0.1%) on Bupropion; 1/4,450 (0.0%) control (serious AE)
Seizure1,6647.0
6.6–7.3ROR 7.2 · χ² 8,395 / p <1e-300
6.9 EB05 6.6 · IC025 +2.7
3/3 methods agree
Labeled — boxed warning
exact term
serious PRR 5.8 · 92% cliniciannot reported in cached trials
Diarrhoea (diarrhea)1,6301.2
1.1–1.3ROR 1.2 · χ² 56 / p 4e-14
1.2 EB05 1.2 · IC025 +0.2Labeled adverse reaction
exact term
serious PRR 1.2NCT01601704: 35/4,455 (0.8%) on Bupropion; 21/4,450 (0.5%) control

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 toxicity to various agents, fatigue, nausea, headache, depression, 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.