Drug · FAERS side-effect profile with label screen
Buprenorphine side effects: what 7,337 FDA adverse event reports show
Who reports
7,337 reports · 75% serious · 1,012 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
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.
FDA label, Description section
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.
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 — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 5Reporting / coding artifact 8Lab value / disease marker 1Not in label — unassessed 24
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. 300 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dependence | 2,855 | 154.8 150.3–159.5ROR 252.7 · χ² 414,544 / p <1e-300 | 146.7 EB05 142.2 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 113.8 · 100% consumer | no trial data cached |
| Drug withdrawal syndrome neonatal | 265 | 51.5 45.7–58.0ROR 53.4 · χ² 12,851 / p <1e-300 | 50.4 EB05 45.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 39.0 · 74% consumer | no trial data cached |
| Dental caries | 109 | 28.5 23.6–34.3ROR 28.9 · χ² 2,833 / p <1e-300 | 28.1 EB05 23.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 | no trial data cached |
| Product adhesion issue | 276 | 22.4 19.9–25.2ROR 23.2 · χ² 5,589 / p <1e-300 | 22.2 EB05 20.1 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=13 · 89% consumer | no trial data cached |
| Folliculitis | 77 | 21.4 17.2–26.8ROR 21.7 · χ² 1,470 / p <1e-300 | 21.2 EB05 17.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 · ♀ 100% (drug 52%) · 97% clinician | no trial data cached |
| Back injury | 76 | 20.2 16.1–25.3ROR 20.4 · χ² 1,358 / p 2e-297 | 20.0 EB05 16.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.4 · ♀ 91% (drug 52%) | no trial data cached |
| Ill-defined disorder | 409 | 19.3 17.6–21.3ROR 20.4 · χ² 7,069 / p <1e-300 | 19.2 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 91% consumer | no trial data cached |
| Overdose | 1,447 | 19.2 18.3–20.1ROR 23.7 · χ² 25,044 / p <1e-300 | 19.1 EB05 18.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.5 · 95% consumer | no trial data cached |
| Joint range of motion decreased | 85 | 18.3 14.8–22.6ROR 18.5 · χ² 1,363 / p 1e-298 | 18.1 EB05 15.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 69 | 17.9 14.1–22.6ROR 18.0 · χ² 1,076 / p 2e-236 | 17.7 EB05 14.4 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 15.5 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Product packaging quantity issue | 64 | 16.8 13.2–21.5ROR 17.0 · χ² 933 / p 3e-205 | 16.7 EB05 13.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Withdrawal syndrome | 246 | 16.7 14.8–18.9ROR 17.3 · χ² 3,610 / p <1e-300 | 16.6 EB05 14.9 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.7 · 91% consumer | no trial data cached |
| Bursitis | 67 | 15.9 12.6–20.3ROR 16.1 · χ² 919 / p 4e-202 | 15.8 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · ♀ 100% (drug 52%) · 99% clinician | no trial data cached |
| Premature delivery | 86 | 15.4 12.5–19.1ROR 15.6 · χ² 1,141 / p 2e-250 | 15.3 EB05 12.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 100% (drug 52%) | no trial data cached |
| Incorrect route of product administration | 79 | 13.5 10.8–16.8ROR 13.6 · χ² 897 / p 2e-197 | 13.3 EB05 11.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.9 · ♀ 81% (drug 52%) | no trial data cached |
| Hypercholesterolaemia | 42 | 12.6 9.3–17.0ROR 12.7 · χ² 435 / p 7e-97 | 12.2 EB05 9.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Taste disorder | 85 | 12.2 9.8–15.0ROR 12.3 · χ² 857 / p 1e-188 | 12.0 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · ♀ 100% (drug 52%) · 93% clinician | no trial data cached |
| Irritable bowel syndrome | 90 | 12.1 9.8–14.8ROR 12.2 · χ² 901 / p 4e-198 | 11.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 100% (drug 52%) · 97% clinician | no trial data cached |
| Synovitis | 76 | 12.1 9.7–15.1ROR 12.2 · χ² 758 / p 3e-167 | 11.9 EB05 9.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Laryngitis | 44 | 11.6 8.6–15.6ROR 11.7 · χ² 415 / p 1e-92 | 11.2 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Pericarditis | 67 | 11.5 9.1–14.6ROR 11.6 · χ² 632 / p 1e-139 | 11.3 EB05 9.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Ocular discomfort | 43 | 11.4 8.4–15.3ROR 11.4 · χ² 394 / p 5e-88 | 10.9 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=42 | no trial data cached |
| Foetal exposure during pregnancy | 300 | 10.6 9.5–11.8ROR 11.0 · χ² 2,594 / p <1e-300 | 10.5 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Wound infection | 40 | 10.5 7.7–14.4ROR 10.6 · χ² 335 / p 4e-75 | 10.0 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Helicobacter infection | 36 | 10.1 7.3–14.0ROR 10.2 · χ² 286 / p 2e-64 | 9.5 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 78 | 10.0 8.0–12.5ROR 10.1 · χ² 621 / p 2e-137 | 9.7 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 · ♀ 99% (drug 52%) · 96% clinician | no trial data cached |
| Autoimmune disorder | 32 | 9.6 6.8–13.5ROR 9.6 · χ² 237 / p 1e-53 | 8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 96% (drug 52%) · 91% clinician | no trial data cached |
| Premature baby | 99 | 9.4 7.7–11.4ROR 9.5 · χ² 733 / p 1e-161 | 9.2 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Tooth fracture | 34 | 8.8 6.3–12.4ROR 8.9 · χ² 228 / p 9e-52 | 8.2 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 87% consumer | no trial data cached |
| Inability to afford medication | 28 | 8.2 5.6–11.8ROR 8.2 · χ² 168 / p 9e-39 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=8 · 89% consumer | no trial data cached |
| Pemphigus | 35 | 8.1 5.8–11.2ROR 8.1 · χ² 209 / p 1e-47 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Maternal exposure during pregnancy | 245 | 8.0 7.0–9.0ROR 8.2 · χ² 1,485 / p <1e-300 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · ♀ 97% (drug 52%) | no trial data cached |
| Wound | 77 | 7.9 6.3–9.9ROR 8.0 · χ² 459 / p 4e-102 | 7.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 93% (drug 52%) · 91% clinician | no trial data cached |
| Product packaging issue | 25 | 7.7 5.2–11.4ROR 7.7 · χ² 139 / p 2e-32 | 6.9 EB05 4.9 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | 79% consumer | no trial data cached |
| Hand deformity | 34 | 7.4 5.3–10.4ROR 7.5 · χ² 183 / p 6e-42 | 6.9 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 100% (drug 52%) · 100% clinician | no trial data cached |
| Head discomfort | 44 | 7.2 5.3–9.6ROR 7.2 · χ² 226 / p 2e-51 | 6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.5 | no trial data cached |
| Impaired healing | 80 | 7.0 5.6–8.7ROR 7.0 · χ² 403 / p 6e-90 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · ♀ 100% (drug 52%) · 98% clinician | no trial data cached |
| Altered state of consciousness | 52 | 6.9 5.3–9.1ROR 6.9 · χ² 256 / p 5e-58 | 6.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 90% clinician | no trial data cached |
| Tooth loss | 48 | 6.6 5.0–8.7ROR 6.6 · χ² 221 / p 2e-50 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 81% consumer | no trial data cached |
| Night sweats | 74 | 6.6 5.2–8.3ROR 6.6 · χ² 344 / p 4e-77 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · ♀ 94% (drug 52%) · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Dependence | 2,855 | 154.8 150.3–159.5ROR 252.7 · χ² 414,544 / p <1e-300 | 146.7 EB05 142.2 · IC025 +7.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 113.8 · 100% consumer | no trial data cached |
| Overdose | 1,447 | 19.2 18.3–20.1ROR 23.7 · χ² 25,044 / p <1e-300 | 19.1 EB05 18.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.5 · 95% consumer | no trial data cached |
| Death | 459 | 1.5 1.4–1.7ROR 1.6 · χ² 85 / p 1e-20 | 1.5 EB05 1.4 · IC025 +0.5 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.2 · 75% consumer | no trial data cached |
| Ill-defined disorder | 409 | 19.3 17.6–21.3ROR 20.4 · χ² 7,069 / p <1e-300 | 19.2 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 91% consumer | no trial data cached |
| Pain | 305 | 1.4 1.3–1.6ROR 1.4 · χ² 38 / p 4e-10 | 1.4 EB05 1.3 · IC025 +0.3 | Likely indication confounding term in indications; also in warnings | serious PRR 1.1 · ♀ 75% (drug 52%) | no trial data cached |
| Foetal exposure during pregnancy | 300 | 10.6 9.5–11.8ROR 11.0 · χ² 2,594 / p <1e-300 | 10.5 EB05 9.5 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Headache | 290 | 1.3 1.2–1.5ROR 1.3 · χ² 23 / p 7e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 · ♀ 79% (drug 52%) | no trial data cached |
| Product adhesion issue | 276 | 22.4 19.9–25.2ROR 23.2 · χ² 5,589 / p <1e-300 | 22.2 EB05 20.1 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=13 · 89% consumer | no trial data cached |
| Depression | 269 | 3.4 3.0–3.8ROR 3.5 · χ² 449 / p 5e-100 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.5 | no trial data cached |
| Drug withdrawal syndrome neonatal | 265 | 51.5 45.7–58.0ROR 53.4 · χ² 12,851 / p <1e-300 | 50.4 EB05 45.5 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 39.0 · 74% consumer | no trial data cached |
| Withdrawal syndrome | 246 | 16.7 14.8–18.9ROR 17.3 · χ² 3,610 / p <1e-300 | 16.6 EB05 14.9 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 16.7 · 91% consumer | no trial data cached |
| Dizziness | 245 | 1.4 1.2–1.6ROR 1.4 · χ² 29 / p 4e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 · ♀ 77% (drug 52%) | no trial data cached |
| Maternal exposure during pregnancy | 245 | 8.0 7.0–9.0ROR 8.2 · χ² 1,485 / p <1e-300 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · ♀ 97% (drug 52%) | no trial data cached |
| Anxiety | 198 | 2.0 1.7–2.3ROR 2.0 · χ² 97 / p 4e-23 | 2.0 EB05 1.8 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 · 74% consumer | no trial data cached |
| Toxicity to various agents | 185 | 3.2 2.7–3.6ROR 3.2 · χ² 271 / p 3e-61 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · ♀ 18% (drug 52%) | 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.
- Dental caries — n=109, PRR 28.5
- Folliculitis — n=77, PRR 21.4
- Ill-defined disorder — n=409, PRR 19.3
- Joint range of motion decreased — n=85, PRR 18.3
- Bursitis — n=67, PRR 15.9
- Premature delivery — n=86, PRR 15.4
- Hypercholesterolaemia — n=42, PRR 12.6
- Taste disorder — n=85, PRR 12.2
- Irritable bowel syndrome — n=90, PRR 12.1
- Synovitis — n=76, PRR 12.1
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 dependence, ill-defined disorder, pain, headache, depression, drug withdrawal syndrome neonatal. 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, 340 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.