Drug · FAERS side-effect profile with label screen

Bupropion Er side effects: what 469 FDA adverse event reports show

Bupropion Hcl Er · 8 reaction terms · 57 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Bupropion Hcl Er (Bupropion Hcl Er (Xl))

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

469 reports · 58% serious · 64 with death outcome · 71% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD.

FDA label, Indications and Usage

What it is

Bupropion hydrochloride extended-release tablets (XL), 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 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 .

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 3 strongest signals

Outcome field, not a reaction 1Not in label — unassessed 2

What the badges mean

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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hospice care	7	31.8 15.2–66.3ROR 32.3 · χ² 179 / p 4e-41	29.1 EB05 14.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Completed suicide (death by suicide)	27	14.4 9.9–20.7ROR 15.2 · χ² 323 / p 1e-72	13.9 EB05 9.8 · IC025 +2.9 3/3 methods agree	Outcome field, not a reaction	serious PRR 14.2 · 100% clinician	no trial data cached
Multiple sclerosis relapse	8	5.2 2.6–10.3ROR 5.2 · χ² 23 / p 8e-7	4.1 EB05 2.3 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Completed suicide (death by suicide)	27	14.4 9.9–20.7ROR 15.2 · χ² 323 / p 1e-72	13.9 EB05 9.8 · IC025 +2.9 3/3 methods agree	Outcome field, not a reaction	serious PRR 14.2 · 100% clinician	no trial data cached
Multiple sclerosis relapse	8	5.2 2.6–10.3ROR 5.2 · χ² 23 / p 8e-7	4.1 EB05 2.3 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Hospice care	7	31.8 15.2–66.3ROR 32.3 · χ² 179 / p 4e-41	29.1 EB05 14.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dependence	3	2.4 0.8–7.5ROR 2.4 · χ² 1 / p 0.129	2.0 EB05 0.8 · IC025 -1.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 2.4	no trial data cached
Incorrect drug administration duration	3	4.7 1.5–14.5ROR 4.7 · χ² 5 / p 0.010	3.1 EB05 1.2 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 13.2	no trial data cached
Drug dispensing error	3	8.7 2.8–26.7ROR 8.7 · χ² 13 / p 1e-4	4.5 EB05 1.7 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Libido decreased (lower sex drive)	3	10.8 3.5–33.4ROR 10.9 · χ² 18 / p 1e-5	5.5 EB05 1.9 · IC025 +0.1	Labeled (related wording) related wording	serious PRR 12.7	no trial data cached
Affect lability	3	13.9 4.5–42.9ROR 14.0 · χ² 24 / p 5e-7	7.1 EB05 2.1 · IC025 +0.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ 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 Er?

In FDA FAERS, the most frequently co-reported reaction terms for Bupropion Er are multiple sclerosis relapse, hospice care, dependence, libido decreased, affect lability. 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 Er 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 Er 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 df959e1b-3f6d-42cf-8521-fe03b5a4ceb8, effective 20260204; matched on openfda.generic_name.exact:"BUPROPION HCL ER")
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, field patient.drug.openfda.generic_name.exact, 8 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.