Buprenorphine side effects: what 873 FDA adverse event reports show
Who reports
873 reports · 92% serious · 152 with death outcome · 41% female
Used for
Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate release opioids. Limitations of Use Bec.
What it is
Buprenorphine transdermal system is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days.
Boxed warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUPRENORPHINE TRANSDERMAL SYSTEM Addiction, Abuse, and Misuse Because the use of buprenorphine transdermal system exposes patients and other users to the risks of opioid.
Causality screen of the 26 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.
- 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. 7 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 |
|---|---|---|---|---|---|---|
| Intentional drug misuse | 56 | 63.5 49.3–81.9ROR 67.8 · χ² 3,378 / p <1e-300 | 62.1 EB05 49.6 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 71.2 · 92% clinician | no trial data cached |
| Drug exposure during pregnancy | 46 | 32.0 24.2–42.4ROR 33.8 · χ² 1,352 / p 2e-296 | 31.6 EB05 24.7 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 20.9 · ♀ 83% (drug 41%) · 97% clinician | no trial data cached |
| Respiratory depression | 16 | 31.3 19.3–50.9ROR 31.9 · χ² 440 / p 6e-98 | 30.3 EB05 19.7 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.3 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 12 | 18.3 10.4–32.1ROR 18.5 · χ² 179 / p 4e-41 | 17.3 EB05 9.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Drug toxicity | 9 | 15.6 8.2–30.0ROR 15.8 · χ² 109 / p 8e-26 | 13.7 EB05 6.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Anorexia | 8 | 14.7 7.4–29.3ROR 14.8 · χ² 89 / p 2e-21 | 12.3 EB05 5.4 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.1 | no trial data cached |
| Drug withdrawal syndrome neonatal | 9 | 14.4 7.5–27.7ROR 14.6 · χ² 100 / p 9e-24 | 12.4 EB05 5.8 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Hepatitis c | 7 | 13.8 6.6–28.8ROR 13.9 · χ² 71 / p 2e-17 | 10.7 EB05 4.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 | no trial data cached |
| Abortion induced | 5 | 12.7 5.3–30.5ROR 12.8 · χ² 43 / p 3e-11 | 8.4 EB05 3.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Myoclonus | 6 | 12.1 5.4–26.8ROR 12.2 · χ² 50 / p 6e-13 | 8.5 EB05 3.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Abscess | 8 | 12.0 6.0–24.0ROR 12.1 · χ² 70 / p 2e-17 | 9.4 EB05 4.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Incorrect route of drug administration | 17 | 11.3 7.0–18.0ROR 11.5 · χ² 149 / p 1e-34 | 10.1 EB05 6.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 35.3 | no trial data cached |
| Pregnancy | 9 | 10.7 5.6–20.5ROR 10.8 · χ² 70 / p 4e-17 | 8.3 EB05 4.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Accident | 5 | 10.1 4.2–24.2ROR 10.1 · χ² 32 / p 7e-9 | 6.4 EB05 2.7 · IC025 +0.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.5 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 6 | 9.5 4.3–21.2ROR 9.6 · χ² 38 / p 4e-10 | 6.5 EB05 3.0 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Hallucination, visual | 8 | 9.1 4.6–18.2ROR 9.2 · χ² 50 / p 7e-13 | 6.8 EB05 3.5 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Medication error | 20 | 8.6 5.6–13.3ROR 8.8 · χ² 128 / p 6e-30 | 7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Withdrawal syndrome | 15 | 8.5 5.2–14.1ROR 8.7 · χ² 92 / p 4e-22 | 7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.7 | no trial data cached |
| Drug withdrawal syndrome | 25 | 6.8 4.6–10.0ROR 6.9 · χ² 118 / p 1e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Abortion spontaneous | 11 | 6.6 3.6–11.8ROR 6.6 · χ² 47 / p 5e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.2 | no trial data cached |
| Wrong technique in drug usage process | 9 | 5.9 3.1–11.2ROR 5.9 · χ² 32 / p 9e-9 | 4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 | no trial data cached |
| Drug abuse | 16 | 4.6 2.8–7.5ROR 4.7 · χ² 42 / p 6e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Completed suicide (death by suicide) | 16 | 4.6 2.8–7.4ROR 4.6 · χ² 41 / p 7e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.9 | no trial data cached |
| Suicide attempt | 11 | 4.3 2.4–7.8ROR 4.4 · χ² 25 / p 3e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Premature baby | 5 | 4.0 1.7–9.5ROR 4.0 · χ² 8 / p 0.002 | 3.1 EB05 1.5 · IC025 +0.1 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Drug dependence | 17 | 2.5 1.6–4.0ROR 2.5 · χ² 14 / p 9e-5 | 2.4 EB05 1.6 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.5 | 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 |
|---|---|---|---|---|---|---|
| Intentional drug misuse | 56 | 63.5 49.3–81.9ROR 67.8 · χ² 3,378 / p <1e-300 | 62.1 EB05 49.6 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 71.2 · 92% clinician | no trial data cached |
| Drug exposure during pregnancy | 46 | 32.0 24.2–42.4ROR 33.8 · χ² 1,352 / p 2e-296 | 31.6 EB05 24.7 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 20.9 · ♀ 83% (drug 41%) · 97% clinician | no trial data cached |
| Drug withdrawal syndrome | 25 | 6.8 4.6–10.0ROR 6.9 · χ² 118 / p 1e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Medication error | 20 | 8.6 5.6–13.3ROR 8.8 · χ² 128 / p 6e-30 | 7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Drug dependence | 17 | 2.5 1.6–4.0ROR 2.5 · χ² 14 / p 9e-5 | 2.4 EB05 1.6 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Incorrect route of drug administration | 17 | 11.3 7.0–18.0ROR 11.5 · χ² 149 / p 1e-34 | 10.1 EB05 6.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 35.3 | no trial data cached |
| Completed suicide (death by suicide) | 16 | 4.6 2.8–7.4ROR 4.6 · χ² 41 / p 7e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.9 | no trial data cached |
| Drug abuse | 16 | 4.6 2.8–7.5ROR 4.7 · χ² 42 / p 6e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Respiratory depression | 16 | 31.3 19.3–50.9ROR 31.9 · χ² 440 / p 6e-98 | 30.3 EB05 19.7 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 20.3 | no trial data cached |
| Withdrawal syndrome | 15 | 8.5 5.2–14.1ROR 8.7 · χ² 92 / p 4e-22 | 7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.7 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 12 | 18.3 10.4–32.1ROR 18.5 · χ² 179 / p 4e-41 | 17.3 EB05 9.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Suicide attempt | 11 | 4.3 2.4–7.8ROR 4.4 · χ² 25 / p 3e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Abortion spontaneous | 11 | 6.6 3.6–11.8ROR 6.6 · χ² 47 / p 5e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.2 | no trial data cached |
| Wrong technique in drug usage process | 9 | 5.9 3.1–11.2ROR 5.9 · χ² 32 / p 9e-9 | 4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 | no trial data cached |
| Pregnancy | 9 | 10.7 5.6–20.5ROR 10.8 · χ² 70 / p 4e-17 | 8.3 EB05 4.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | 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.
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 Buprenorphine?
In FDA FAERS, the most frequently co-reported reaction terms for Buprenorphine are drug withdrawal syndrome, respiratory depression, withdrawal syndrome, cyanosis, suicide attempt, abortion spontaneous. 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 Buprenorphine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUPRENORPHINE TRANSDERMAL SYSTEM Addiction, Abuse, and Misuse Because the use of buprenorphine transdermal system exposes patients and other users to the risks of opioid.
Do FAERS signals prove that Buprenorphine 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 186e3be6-8bc0-4bb9-96f5-429d53632f45, effective 20260428; matched on
openfda.generic_name.exact:"BUPRENORPHINE") - 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, 33 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.