Bupropion (Xl) side effects: what 2,736 FDA adverse event reports show
Drug class
Aminoketone antidepressant
Label matched
Bupropion Hydrochloride (Xl) (Bupropion Hydrochloride (Xl))
Who reports
2,736 reports · 50% serious · 218 with death outcome · 74% female
Used for
Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) Bupr.
What it is
Bupropion hydrochloride extended-release tablets (XL), 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 did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older.
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 121 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 |
|---|---|---|---|---|---|---|
| Product substitution issue | 282 | 37.7 33.8–42.1ROR 41.9 · χ² 10,022 / p <1e-300 | 37.5 EB05 33.9 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 32.4 · 72% consumer | no trial data cached |
| Cardiogenic shock | 36 | 19.4 14.0–26.8ROR 19.6 · χ² 608 / p 2e-134 | 19.1 EB05 14.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 94% clinician | no trial data cached |
| Status epilepticus | 22 | 14.9 9.8–22.6ROR 15.0 · χ² 272 / p 3e-61 | 14.4 EB05 9.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 · 100% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 30 | 14.1 9.9–20.1ROR 14.2 · χ² 351 / p 1e-78 | 13.7 EB05 9.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.3 | no trial data cached |
| Coeliac disease | 17 | 13.3 8.3–21.4ROR 13.4 · χ² 181 / p 2e-41 | 12.4 EB05 7.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Product odour abnormal | 15 | 11.1 6.7–18.4ROR 11.1 · χ² 128 / p 7e-30 | 9.7 EB05 5.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Insurance issue | 20 | 10.3 6.7–16.0ROR 10.4 · χ² 159 / p 9e-37 | 9.3 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · 90% consumer | no trial data cached |
| Completed suicide (death by suicide) | 111 | 10.1 8.4–12.1ROR 10.5 · χ² 905 / p 3e-199 | 9.9 EB05 8.4 · IC025 +3.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 11.6 · 99% clinician | no trial data cached |
| Intentional overdose | 81 | 9.7 7.9–12.1ROR 10.0 · χ² 628 / p 7e-139 | 9.5 EB05 7.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · ♀ 50% (drug 74%) · 96% clinician | no trial data cached |
| Crying | 42 | 8.8 6.5–11.9ROR 9.0 · χ² 284 / p 5e-64 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 76% consumer | no trial data cached |
| Serotonin syndrome | 21 | 8.4 5.5–12.9ROR 8.5 · χ² 130 / p 2e-30 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 | no trial data cached |
| Cardio-respiratory arrest | 45 | 8.2 6.1–11.0ROR 8.3 · χ² 278 / p 1e-62 | 7.7 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · ♀ 49% (drug 74%) · 100% clinician | no trial data cached |
| Ventricular tachycardia | 17 | 7.9 4.9–12.6ROR 7.9 · χ² 95 / p 9e-23 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Immunodeficiency | 15 | 7.8 4.7–12.9ROR 7.8 · χ² 82 / p 6e-20 | 6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 92 | 7.7 6.3–9.4ROR 7.9 · χ² 531 / p 8e-118 | 7.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.5 | no trial data cached |
| Euphoric mood | 10 | 7.4 4.0–13.8ROR 7.5 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Middle insomnia | 18 | 7.4 4.7–11.8ROR 7.5 · χ² 94 / p 2e-22 | 6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Myoclonus | 11 | 7.1 3.9–12.8ROR 7.1 · χ² 51 / p 4e-13 | 5.7 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Tinnitus (ringing in the ears) | 42 | 7.0 5.2–9.4ROR 7.1 · χ² 210 / p 6e-48 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 74% consumer | no trial data cached |
| Suicide attempt | 52 | 6.6 5.0–8.6ROR 6.7 · χ² 240 / p 2e-54 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.5 · 90% clinician | no trial data cached |
| Sinus tachycardia | 12 | 6.5 3.7–11.4ROR 6.5 · χ² 50 / p 6e-13 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Brain fog | 12 | 6.3 3.6–11.1ROR 6.3 · χ² 48 / p 2e-12 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Depression | 187 | 6.3 5.5–7.2ROR 6.7 · χ² 832 / p 3e-183 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 · 76% consumer | no trial data cached |
| Electrocardiogram qt prolonged | 29 | 6.2 4.3–8.9ROR 6.2 · χ² 121 / p 2e-28 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 93% clinician | no trial data cached |
| Intentional dose omission | 22 | 6.2 4.1–9.4ROR 6.2 · χ² 90 / p 1e-21 | 5.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · 73% consumer | no trial data cached |
| Irritability | 48 | 6.1 4.6–8.1ROR 6.2 · χ² 200 / p 8e-46 | 5.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Mental status changes | 22 | 6.1 4.0–9.2ROR 6.1 · χ² 88 / p 3e-21 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Feeling jittery | 15 | 6.0 3.6–10.0ROR 6.0 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=4 | no trial data cached |
| Infusion site pain | 10 | 6.0 3.2–11.1ROR 6.0 · χ² 37 / p 6e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Seasonal allergy | 11 | 6.0 3.3–10.8ROR 6.0 · χ² 41 / p 9e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=5 | no trial data cached |
| Withdrawal syndrome | 32 | 5.8 4.1–8.2ROR 5.9 · χ² 123 / p 8e-29 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · 78% consumer | no trial data cached |
| Panic attack | 27 | 5.7 3.9–8.3ROR 5.7 · χ² 99 / p 1e-23 | 5.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Economic problem | 11 | 5.5 3.0–9.9ROR 5.5 · χ² 36 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Impaired quality of life | 10 | 5.3 2.9–9.9ROR 5.3 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Disease recurrence | 33 | 5.3 3.8–7.4ROR 5.4 · χ² 111 / p 3e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 87% consumer | no trial data cached |
| Product quality issue | 91 | 5.2 4.2–6.3ROR 5.3 · χ² 304 / p 2e-68 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 85% consumer | no trial data cached |
| Mania | 11 | 5.1 2.8–9.3ROR 5.1 · χ² 33 / p 6e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.3 | no trial data cached |
| Disturbance in attention | 36 | 5.1 3.7–7.1ROR 5.2 · χ² 115 / p 4e-27 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Seizure | 76 | 5.1 4.1–6.3ROR 5.2 · χ² 246 / p 1e-55 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.1 | no trial data cached |
| Encephalopathy | 16 | 5.0 3.1–8.2ROR 5.0 · χ² 47 / p 3e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | 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 |
|---|---|---|---|---|---|---|
| Product substitution issue | 282 | 37.7 33.8–42.1ROR 41.9 · χ² 10,022 / p <1e-300 | 37.5 EB05 33.9 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 32.4 · 72% consumer | no trial data cached |
| Depression | 187 | 6.3 5.5–7.2ROR 6.7 · χ² 832 / p 3e-183 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 · 76% consumer | no trial data cached |
| Anxiety | 160 | 4.3 3.7–5.0ROR 4.5 · χ² 407 / p 8e-91 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.8 | no trial data cached |
| Completed suicide (death by suicide) | 111 | 10.1 8.4–12.1ROR 10.5 · χ² 905 / p 3e-199 | 9.9 EB05 8.4 · IC025 +3.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 11.6 · 99% clinician | no trial data cached |
| Feeling abnormal | 96 | 3.1 2.5–3.7ROR 3.1 · χ² 132 / p 6e-31 | 3.0 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 74% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 92 | 7.7 6.3–9.4ROR 7.9 · χ² 531 / p 8e-118 | 7.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.5 | no trial data cached |
| Product quality issue | 91 | 5.2 4.2–6.3ROR 5.3 · χ² 304 / p 2e-68 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 85% consumer | no trial data cached |
| Intentional overdose | 81 | 9.7 7.9–12.1ROR 10.0 · χ² 628 / p 7e-139 | 9.5 EB05 7.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · ♀ 50% (drug 74%) · 96% clinician | no trial data cached |
| Covid-19 | 77 | 3.3 2.7–4.2ROR 3.4 · χ² 125 / p 3e-29 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Seizure | 76 | 5.1 4.1–6.3ROR 5.2 · χ² 246 / p 1e-55 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.1 | no trial data cached |
| Overdose | 71 | 2.5 2.0–3.2ROR 2.6 · χ² 64 / p 7e-16 | 2.5 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 94% clinician | no trial data cached |
| Toxicity to various agents | 60 | 2.7 2.1–3.5ROR 2.8 · χ² 65 / p 4e-16 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 93% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 58 | 3.4 2.7–4.4ROR 3.5 · χ² 99 / p 1e-23 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Suicide attempt | 52 | 6.6 5.0–8.6ROR 6.7 · χ² 240 / p 2e-54 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.5 · 90% clinician | no trial data cached |
| Irritability | 48 | 6.1 4.6–8.1ROR 6.2 · χ² 200 / p 8e-46 | 5.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | 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.
- Cardiogenic shock — n=36, PRR 19.4
- Status epilepticus — n=22, PRR 14.9
- Insurance issue — n=20, PRR 10.3
- Crying — n=42, PRR 8.8
- Cardio-respiratory arrest — n=45, PRR 8.2
- Electrocardiogram qt prolonged — n=29, PRR 6.2
- Mental status changes — n=22, PRR 6.1
- Disturbance in attention — n=36, PRR 5.1
✓ 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 (Xl)?
In FDA FAERS, the most frequently co-reported reaction terms for Bupropion (Xl) are depression, anxiety, feeling abnormal, suicidal ideation, covid-19, seizure. 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 (Xl) 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 did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older.
Do FAERS signals prove that Bupropion (Xl) 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 8d9779e7-300e-4720-8ba5-2272b2506cd9, effective 20240405; matched on
openfda.generic_name.exact:"BUPROPION HYDROCHLORIDE (XL)") - 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, 161 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.