Bupropion Hydrobromide side effects: what 573 FDA adverse event reports show
Drug class
Not stated in label
Who reports
573 reports · 66% serious · 53 with death outcome · 74% female
Used for
Bupropion Hydrobromide Extended-Release Tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient.
What it is
Bupropion Hydrobromide Extended-Release Tablets, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines.
Boxed warning
SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
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. 15 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Full blood count abnormal | 51 | 177.9 136.8–231.3ROR 195.1 · χ² 8,754 / p <1e-300 | 166.1 EB05 131.2 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 204.1 · ♀ 100% (drug 74%) | no trial data cached |
| Blood test abnormal | 56 | 146.5 114.2–188.0ROR 162.3 · χ² 7,923 / p <1e-300 | 139.1 EB05 111.1 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 194.0 · ♀ 100% (drug 74%) | no trial data cached |
| Carpal tunnel syndrome | 56 | 146.5 114.2–188.0ROR 162.3 · χ² 7,922 / p <1e-300 | 139.1 EB05 111.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 156.5 · ♀ 100% (drug 74%) | no trial data cached |
| Sleep disorder due to a general medical condition | 56 | 127.2 99.1–163.2ROR 140.8 · χ² 6,865 / p <1e-300 | 121.5 EB05 97.1 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 213.9 · ♀ 98% (drug 74%) | no trial data cached |
| Nephropathy | 31 | 121.3 86.1–170.9ROR 128.2 · χ² 3,568 / p <1e-300 | 112.6 EB05 83.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 111.8 · ♀ 97% (drug 74%) | no trial data cached |
| Sleep apnoea syndrome | 55 | 105.5 82.0–135.7ROR 116.6 · χ² 5,579 / p <1e-300 | 101.6 EB05 81.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 108.6 · ♀ 100% (drug 74%) | no trial data cached |
| Obstructive airways disorder | 28 | 92.0 64.1–132.1ROR 96.7 · χ² 2,426 / p <1e-300 | 86.5 EB05 62.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 82.9 · ♀ 100% (drug 74%) | no trial data cached |
| Fibromyalgia | 58 | 87.6 68.6–111.8ROR 97.3 · χ² 4,873 / p <1e-300 | 85.0 EB05 68.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 99.8 · ♀ 100% (drug 74%) | no trial data cached |
| Hypothyroidism | 57 | 65.6 51.3–84.0ROR 72.8 · χ² 3,562 / p <1e-300 | 64.2 EB05 51.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 62.6 · ♀ 100% (drug 74%) | no trial data cached |
| Incorrect route of product administration | 29 | 63.3 44.4–90.2ROR 66.6 · χ² 1,714 / p <1e-300 | 60.7 EB05 44.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 109.5 | no trial data cached |
| Wheezing | 85 | 52.7 43.3–64.1ROR 61.6 · χ² 4,261 / p <1e-300 | 52.0 EB05 43.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 62.2 · ♀ 100% (drug 74%) | no trial data cached |
| Coeliac disease | 13 | 48.5 28.3–83.1ROR 49.6 · χ² 558 / p 1e-123 | 45.5 EB05 28.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 52.4 | no trial data cached |
| Loss of personal independence in daily activities | 62 | 47.8 37.8–60.4ROR 53.4 · χ² 2,795 / p <1e-300 | 47.1 EB05 38.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 53.7 | no trial data cached |
| Therapeutic product effect incomplete | 89 | 46.1 38.1–55.8ROR 54.4 · χ² 3,891 / p <1e-300 | 45.6 EB05 38.2 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 72.7 · ♀ 100% (drug 74%) | no trial data cached |
| Renal disorder | 56 | 43.9 34.3–56.4ROR 48.6 · χ² 2,310 / p <1e-300 | 43.3 EB05 34.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 46.7 · ♀ 100% (drug 74%) | no trial data cached |
| Middle insomnia | 22 | 43.3 28.8–65.3ROR 45.0 · χ² 868 / p 5e-191 | 41.8 EB05 29.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 81.9 · ♀ 100% (drug 74%) | no trial data cached |
| Rib fracture | 24 | 42.8 28.9–63.4ROR 44.7 · χ² 939 / p 2e-206 | 41.5 EB05 29.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 40.6 · ♀ 100% (drug 74%) | no trial data cached |
| Prescribed overdose | 22 | 41.6 27.6–62.8ROR 43.3 · χ² 832 / p 2e-183 | 40.3 EB05 28.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 58.8 | no trial data cached |
| Paranoia | 19 | 40.2 25.8–62.5ROR 41.5 · χ² 687 / p 1e-151 | 38.7 EB05 26.2 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 43.8 | no trial data cached |
| Muscle twitching | 25 | 39.6 27.0–58.1ROR 41.4 · χ² 903 / p 1e-198 | 38.5 EB05 27.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 47.1 · ♀ 96% (drug 74%) | no trial data cached |
| Bursitis | 13 | 39.5 23.1–67.6ROR 40.4 · χ² 449 / p 5e-100 | 37.4 EB05 23.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 40.3 | no trial data cached |
| Poor quality sleep | 23 | 39.4 26.4–58.8ROR 41.0 · χ² 822 / p 4e-181 | 38.2 EB05 26.8 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 60.2 · ♀ 100% (drug 74%) | no trial data cached |
| Body temperature increased | 22 | 39.4 26.1–59.3ROR 40.9 · χ² 785 / p 6e-173 | 38.1 EB05 26.5 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 42.1 · ♀ 100% (drug 74%) | no trial data cached |
| Asthma | 119 | 38.9 33.1–45.6ROR 48.8 · χ² 4,374 / p <1e-300 | 38.6 EB05 33.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 46.6 · ♀ 97% (drug 74%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 84 | 38.4 31.5–46.8ROR 44.8 · χ² 3,029 / p <1e-300 | 38.0 EB05 31.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 51.8 · ♀ 96% (drug 74%) | no trial data cached |
| Respiratory disorder | 30 | 36.6 25.9–51.9ROR 38.6 · χ² 1,005 / p 8e-221 | 35.8 EB05 26.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 39.4 · ♀ 100% (drug 74%) | no trial data cached |
| Sinus tachycardia | 14 | 36.2 21.6–60.7ROR 37.1 · χ² 444 / p 6e-99 | 34.6 EB05 21.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 32.0 | no trial data cached |
| Sedation | 23 | 32.3 21.6–48.2ROR 33.6 · χ² 667 / p 2e-147 | 31.5 EB05 22.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 38.6 · ♀ 96% (drug 74%) | no trial data cached |
| Ankle fracture | 13 | 30.7 17.9–52.6ROR 31.4 · χ² 345 / p 3e-77 | 29.5 EB05 18.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 30.1 | no trial data cached |
| Burning sensation | 58 | 30.3 23.7–38.7ROR 33.6 · χ² 1,618 / p <1e-300 | 30.0 EB05 24.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 56.7 · ♀ 100% (drug 74%) | no trial data cached |
| Immunodeficiency | 12 | 29.8 17.0–52.2ROR 30.5 · χ² 306 / p 7e-69 | 28.6 EB05 17.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.1 | no trial data cached |
| Nightmare | 25 | 26.3 17.9–38.6ROR 27.5 · χ² 585 / p 2e-129 | 25.9 EB05 18.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 35.7 | no trial data cached |
| Psychotic disorder | 19 | 23.6 15.1–36.7ROR 24.3 · χ² 388 / p 9e-87 | 23.0 EB05 15.5 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.2 | no trial data cached |
| Cardiac disorder | 56 | 21.8 17.0–28.0ROR 24.1 · χ² 1,097 / p 8e-241 | 21.7 EB05 17.3 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.9 · ♀ 100% (drug 74%) | no trial data cached |
| Adverse event | 43 | 17.1 12.8–22.8ROR 18.4 · χ² 638 / p 6e-141 | 16.9 EB05 13.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 31.9 · ♀ 98% (drug 74%) | no trial data cached |
| Contraindicated product administered | 14 | 17.0 10.1–28.5ROR 17.4 · χ² 195 / p 1e-44 | 16.2 EB05 9.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 18.4 | no trial data cached |
| Intentional product use issue | 40 | 16.7 12.3–22.5ROR 17.8 · χ² 575 / p 2e-127 | 16.5 EB05 12.5 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 20.2 | no trial data cached |
| Irritability | 27 | 16.4 11.4–23.7ROR 17.2 · χ² 376 / p 4e-84 | 16.1 EB05 11.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.5 | no trial data cached |
| Vertigo (spinning dizziness) | 25 | 15.0 10.2–22.0ROR 15.6 · χ² 314 / p 2e-70 | 14.6 EB05 10.1 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 · ♀ 100% (drug 74%) | no trial data cached |
| Feeling hot | 24 | 14.3 9.7–21.2ROR 14.9 · χ² 285 / p 3e-64 | 13.8 EB05 9.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.3 · ♀ 96% (drug 74%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Asthma | 119 | 38.9 33.1–45.6ROR 48.8 · χ² 4,374 / p <1e-300 | 38.6 EB05 33.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 46.6 · ♀ 97% (drug 74%) | no trial data cached |
| Therapeutic product effect incomplete | 89 | 46.1 38.1–55.8ROR 54.4 · χ² 3,891 / p <1e-300 | 45.6 EB05 38.2 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 72.7 · ♀ 100% (drug 74%) | no trial data cached |
| Wheezing | 85 | 52.7 43.3–64.1ROR 61.6 · χ² 4,261 / p <1e-300 | 52.0 EB05 43.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 62.2 · ♀ 100% (drug 74%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 84 | 38.4 31.5–46.8ROR 44.8 · χ² 3,029 / p <1e-300 | 38.0 EB05 31.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 51.8 · ♀ 96% (drug 74%) | no trial data cached |
| Loss of personal independence in daily activities | 62 | 47.8 37.8–60.4ROR 53.4 · χ² 2,795 / p <1e-300 | 47.1 EB05 38.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 53.7 | no trial data cached |
| Burning sensation | 58 | 30.3 23.7–38.7ROR 33.6 · χ² 1,618 / p <1e-300 | 30.0 EB05 24.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 56.7 · ♀ 100% (drug 74%) | no trial data cached |
| Fibromyalgia | 58 | 87.6 68.6–111.8ROR 97.3 · χ² 4,873 / p <1e-300 | 85.0 EB05 68.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 99.8 · ♀ 100% (drug 74%) | no trial data cached |
| Hypothyroidism | 57 | 65.6 51.3–84.0ROR 72.8 · χ² 3,562 / p <1e-300 | 64.2 EB05 51.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 62.6 · ♀ 100% (drug 74%) | no trial data cached |
| Cardiac disorder | 56 | 21.8 17.0–28.0ROR 24.1 · χ² 1,097 / p 8e-241 | 21.7 EB05 17.3 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.9 · ♀ 100% (drug 74%) | no trial data cached |
| Renal disorder | 56 | 43.9 34.3–56.4ROR 48.6 · χ² 2,310 / p <1e-300 | 43.3 EB05 34.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 46.7 · ♀ 100% (drug 74%) | no trial data cached |
| Sleep disorder due to a general medical condition | 56 | 127.2 99.1–163.2ROR 140.8 · χ² 6,865 / p <1e-300 | 121.5 EB05 97.1 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 213.9 · ♀ 98% (drug 74%) | no trial data cached |
| Carpal tunnel syndrome | 56 | 146.5 114.2–188.0ROR 162.3 · χ² 7,922 / p <1e-300 | 139.1 EB05 111.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 156.5 · ♀ 100% (drug 74%) | no trial data cached |
| Blood test abnormal | 56 | 146.5 114.2–188.0ROR 162.3 · χ² 7,923 / p <1e-300 | 139.1 EB05 111.1 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 194.0 · ♀ 100% (drug 74%) | no trial data cached |
| Sleep apnoea syndrome | 55 | 105.5 82.0–135.7ROR 116.6 · χ² 5,579 / p <1e-300 | 101.6 EB05 81.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 108.6 · ♀ 100% (drug 74%) | no trial data cached |
| Full blood count abnormal | 51 | 177.9 136.8–231.3ROR 195.1 · χ² 8,754 / p <1e-300 | 166.1 EB05 131.2 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 204.1 · ♀ 100% (drug 74%) | no trial data cached |
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.
- Carpal tunnel syndrome — n=56, PRR 146.5
- Nephropathy — n=31, PRR 121.3
- Sleep apnoea syndrome — n=55, PRR 105.5
- Obstructive airways disorder — n=28, PRR 92.0
- Fibromyalgia — n=58, PRR 87.6
- Hypothyroidism — n=57, PRR 65.6
- Wheezing — n=85, PRR 52.7
- Loss of personal independence in daily activities — n=62, PRR 47.8
- Renal disorder — n=56, PRR 43.9
- Middle insomnia — n=22, PRR 43.3
✓ 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 Hydrobromide?
In FDA FAERS, the most frequently co-reported reaction terms for Bupropion Hydrobromide are asthma, wheezing, gastrooesophageal reflux disease, loss of personal independence in daily activities, burning sensation, fibromyalgia. 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 Hydrobromide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials .
Do FAERS signals prove that Bupropion Hydrobromide 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
- FDA label via openFDA (set ID 3ec04240-baef-44d7-8d73-a181171eec43, effective 20260601; matched on
openfda.generic_name.exact:"BUPROPION HYDROBROMIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 55 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
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.