Drug · FAERS side-effect profile with label screen
Buprenorphine side effects: what 91,989 FDA adverse event reports show
Who reports
91,989 reports · 59% serious · 26,296 with death outcome · 56% 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 adverse reaction 5Labeled (related wording) 11Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 18
What the badges mean
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,185 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 |
|---|---|---|---|---|---|---|
| Drug delivery system removal | 99 | 1,583.6 904.9–2,771.2ROR 1,585.3 · calibrated p 2e-17 ✓ | 189.9 EB05 160.5 · IC025 +6.3 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=74 · ♀ 31% (drug 56%) | not reported in cached trials |
| Placental hypertrophy | 23 | 303.0 161.9–567.1ROR 303.0 · calibrated p 4e-10 ✓ | 117.0 EB05 82.1 · IC025 +4.4 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Hepatic enzyme | 67 | 211.3 151.4–295.1ROR 211.5 · calibrated p 7e-10 ✓ | 106.0 EB05 86.3 · IC025 +5.5 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=67 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Oral administration complication | 420 | 185.5 163.0–211.1ROR 186.4 · calibrated p 8e-10 ✓ | 101.5 EB05 93.6 · IC025 +6.3 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Reporting / coding artifact | serious n=19 · 95% consumer | not reported in cached trials |
| Inadequate analgesia | 3,050 | 126.1 120.7–131.8ROR 130.4 · calibrated p 1e-8 ✓ | 81.0 EB05 78.6 · IC025 +6.3 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Reporting / coding artifact | serious n=147 · 91% consumer | not reported in cached trials |
| Rhesus incompatibility | 33 | 84.0 56.3–125.3ROR 84.0 · calibrated p 1e-6 ✓ | 59.3 EB05 44.2 · IC025 +4.4 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Application site odour | 38 | 80.3 55.4–116.3ROR 80.3 · calibrated p 1e-6 ✓ | 57.7 EB05 43.9 · IC025 +4.5 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | 100% consumer | not reported in cached trials |
| Application site perspiration | 45 | 78.7 56.1–110.6ROR 78.8 · calibrated p 1e-6 ✓ | 57.2 EB05 44.5 · IC025 +4.7 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=18 · ♀ 84% (drug 56%) · 100% consumer | not reported in cached trials |
| Application site rash | 3,066 | 65.1 62.5–67.7ROR 67.3 · calibrated p 2e-6 ✓ | 50.6 EB05 49.1 · IC025 +5.6 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled adverse reaction exact term | serious n=85 · 90% consumer | not reported in cached trials |
| Facet joint syndrome | 689 | 63.7 58.5–69.3ROR 64.2 · calibrated p 3e-6 ✓ | 49.7 EB05 46.7 · IC025 +5.5 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=689 · ♀ 100% (drug 56%) · 95% clinician | not reported in cached trials |
| Amaurosis fugax | 191 | 49.4 42.3–57.8ROR 49.5 · calibrated p 2e-5 ✓ | 40.5 EB05 35.9 · IC025 +5.0 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=191 · 95% clinician | not reported in cached trials |
| Injection site erosion | 57 | 44.2 33.2–58.7ROR 44.2 · calibrated p 4e-5 ✓ | 36.6 EB05 29.3 · IC025 +4.4 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | ♀ 25% (drug 56%) | not reported in cached trials |
| Application site discharge | 188 | 44.0 37.7–51.5ROR 44.1 · calibrated p 3e-5 ✓ | 36.8 EB05 32.6 · IC025 +4.8 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=20 · 73% consumer | not reported in cached trials |
| Application site scar | 200 | 43.1 37.1–50.2ROR 43.2 · calibrated p 4e-5 ✓ | 36.2 EB05 32.2 · IC025 +4.8 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=43 · 73% consumer | not reported in cached trials |
| Application site vesicles | 1,024 | 42.4 39.7–45.3ROR 42.9 · calibrated p 3e-5 ✓ | 35.8 EB05 34.0 · IC025 +5.0 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=67 · 80% consumer | not reported in cached trials |
| Drug detoxification | 131 | 39.2 32.5–47.1ROR 39.2 · calibrated p 7e-5 ✓ | 33.3 EB05 28.8 · IC025 +4.6 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=124 · ♀ 35% (drug 56%) | NCT00723697: 2/1,305 (0.2%) on Buprenorphine (serious AE) |
| Application site erosion | 184 | 37.8 32.3–44.1ROR 37.8 · calibrated p 8e-5 ✓ | 32.4 EB05 28.6 · IC025 +4.7 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | 77% consumer | not reported in cached trials |
| Drug effect increased | 453 | 37.4 33.8–41.3ROR 37.6 · calibrated p 8e-5 ✓ | 32.1 EB05 29.7 · IC025 +4.8 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Reporting / coding artifact | serious n=19 · 92% consumer | not reported in cached trials |
| Application site burn | 697 | 37.2 34.4–40.3ROR 37.5 · calibrated p 8e-5 ✓ | 32.0 EB05 30.1 · IC025 +4.8 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=88 · 77% consumer | not reported in cached trials |
| Peripheral venous disease | 560 | 37.1 33.9–40.5ROR 37.3 · calibrated p 8e-5 ✓ | 31.9 EB05 29.8 · IC025 +4.8 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=560 · ♀ 100% (drug 56%) · 93% clinician | not reported in cached trials |
| Hypocholesterolaemia | 43 | 36.9 26.7–50.9ROR 36.9 · calibrated p 1e-4 ✓ | 31.4 EB05 24.3 · IC025 +4.0 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=43 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Application site irritation | 1,710 | 36.2 34.4–38.1ROR 36.9 · calibrated p 8e-5 ✓ | 31.3 EB05 30.1 · IC025 +4.9 3/3 methods agree vs other Partial Opioid Agonists: PRR 2,409.3 (1,001.6–5,795.5) | Labeled adverse reaction exact term | serious n=39 · 93% consumer | not reported in cached trials |
| Onychomadesis | 547 | 34.5 31.5–37.7ROR 34.7 · calibrated p 1e-4 ✓ | 30.0 EB05 27.9 · IC025 +4.7 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=546 · ♀ 100% (drug 56%) · 95% clinician | not reported in cached trials |
| Drug screen negative | 227 | 33.6 29.2–38.6ROR 33.6 · calibrated p 1e-4 ✓ | 29.2 EB05 26.2 · IC025 +4.6 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Reporting / coding artifact | serious n=19 | not reported in cached trials |
| Blepharospasm | 797 | 33.5 31.1–36.1ROR 33.8 · calibrated p 1e-4 ✓ | 29.3 EB05 27.6 · IC025 +4.7 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=796 · ♀ 100% (drug 56%) · 92% clinician | not reported in cached trials |
| Application site reaction | 882 | 32.3 30.1–34.6ROR 32.6 · calibrated p 2e-4 ✓ | 28.3 EB05 26.8 · IC025 +4.7 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled adverse reaction exact term | serious n=19 · 94% consumer | not reported in cached trials |
| Breakthrough pain | 289 | 32.2 28.5–36.4ROR 32.3 · calibrated p 2e-4 ✓ | 28.2 EB05 25.6 · IC025 +4.6 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=33 · 89% consumer | not reported in cached trials |
| Rheumatic fever | 523 | 30.9 28.2–33.9ROR 31.1 · calibrated p 2e-4 ✓ | 27.3 EB05 25.4 · IC025 +4.6 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=523 · ♀ 100% (drug 56%) · 94% clinician | not reported in cached trials |
| Drug withdrawal syndrome neonatal | 1,772 | 30.5 29.1–32.1ROR 31.1 · calibrated p 2e-4 ✓ | 27.0 EB05 26.0 · IC025 +4.7 3/3 methods agree vs other Partial Opioid Agonists: PRR 45.6 (40.1–51.7) | Labeled (related wording) related wording | serious PRR 26.1 · 81% consumer | not reported in cached trials |
| Breast cancer stage iii | 732 | 29.2 27.0–31.5ROR 29.4 · calibrated p 3e-4 ✓ | 25.9 EB05 24.4 · IC025 +4.5 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=732 · ♀ 100% (drug 56%) · 96% clinician | not reported in cached trials |
| Application site pruritus | 2,379 | 26.6 25.5–27.8ROR 27.3 · calibrated p 4e-4 ✓ | 23.9 EB05 23.1 · IC025 +4.5 3/3 methods agree vs other Partial Opioid Agonists: PRR 2,793.3 (1,253.8–6,223.2) | Labeled adverse reaction exact term | age-adj. PRR 39.2 · serious n=145 · 80% consumer | not reported in cached trials |
| Duodenal ulcer perforation | 737 | 25.4 23.5–27.4ROR 25.6 · calibrated p 6e-4 ✓ | 22.9 EB05 21.5 · IC025 +4.4 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious PRR 22.2 · ♀ 100% (drug 56%) · 95% clinician | not reported in cached trials |
| Application site discolouration | 402 | 24.9 22.5–27.6ROR 25.0 · calibrated p 7e-4 ✓ | 22.5 EB05 20.7 · IC025 +4.3 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled (related wording) related wording | serious n=28 · 86% consumer | not reported in cached trials |
| Product adhesion issue | 3,429 | 24.3 23.5–25.2ROR 25.2 · calibrated p 6e-4 ✓ | 22.0 EB05 21.4 · IC025 +4.4 3/3 methods agree vs other Partial Opioid Agonists: PRR 87.5 (77.5–98.9) | Reporting / coding artifact | age-adj. PRR 48.8 · serious n=150 · 84% consumer | not reported in cached trials |
| Substance use disorder | 297 | 24.3 21.5–27.4ROR 24.4 · calibrated p 8e-4 ✓ | 22.0 EB05 20.0 · IC025 +4.2 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled adverse reaction exact term | serious n=296 · ♀ 29% (drug 56%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 677 | 23.9 22.1–25.9ROR 24.1 · calibrated p 8e-4 ✓ | 21.7 EB05 20.4 · IC025 +4.3 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Lab value / disease marker | serious PRR 21.1 · ♀ 100% (drug 56%) · 96% clinician | not reported in cached trials |
| Overlap syndrome | 65 | 23.6 18.3–30.5ROR 23.6 · calibrated p 0.001 ✓ | 21.4 EB05 17.3 · IC025 +3.8 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=65 · ♀ 100% (drug 56%) | not reported in cached trials |
| Swollen joint count | 23 | 23.4 15.2–36.0ROR 23.4 · calibrated p 0.002 ✓ | 20.9 EB05 14.6 · IC025 +3.2 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=23 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Injection site ulcer | 87 | 23.1 18.5–28.8ROR 23.1 · calibrated p 0.001 ✓ | 20.9 EB05 17.5 · IC025 +3.9 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=31 · ♀ 26% (drug 56%) · 100% clinician | not reported in cached trials |
| Onychomycosis | 400 | 22.8 20.6–25.3ROR 22.9 · calibrated p 0.001 ✓ | 20.8 EB05 19.1 · IC025 +4.2 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | serious n=400 · ♀ 100% (drug 56%) · 93% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Dependence / withdrawal | 15,963 | 13.012.8–13.2 | signal |
| Depression | 1,947 | 1.61.5–1.7 | raised |
| Liver injury | 1,414 | 1.11.0–1.1 | raised |
| Suicidality | 1,098 | 1.01.0–1.1 | no difference |
| Rhabdomyolysis / myopathy | 320 | 0.90.8–1.0 | no difference |
| Fall / fracture | 1,315 | 0.80.7–0.8 | lower than other drugs |
| Hyperglycaemia / diabetes | 921 | 0.60.6–0.6 | lower than other drugs |
| Gi bleeding | 480 | 0.60.5–0.7 | lower than other drugs |
| Seizure | 473 | 0.50.5–0.6 | lower than other drugs |
| Serious infection | 1,854 | 0.50.5–0.6 | lower than other drugs |
| Stroke | 441 | 0.40.4–0.4 | lower than other drugs |
| Extrapyramidal | 186 | 0.40.3–0.5 | lower than other drugs |
| Arrhythmia / qt | 334 | 0.40.4–0.4 | lower than other drugs |
| Interstitial lung disease | 162 | 0.40.3–0.4 | lower than other drugs |
| Hyponatraemia | 121 | 0.30.3–0.4 | lower than other drugs |
| Kidney injury | 623 | 0.30.3–0.3 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Buprenorphine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT00723697 — Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in (N=1307, phase n/a; 25 AE terms posted; arms: Patients)
- NCT00315341 — Starting Treatment With Agonist Replacement Therapies (START) (N=1269, PHASE4; 28 AE terms posted; arms: Buprenorphine/Nx; Methadone)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Death | 13,348 | 3.6 3.5–3.6ROR 4.0 · calibrated p 0.376 | 3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Partial Opioid Agonists: PRR 204.9 (186.8–224.6) | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 1.7 · serious PRR 3.4 | NCT00315341: 3/727 (0.4%) on Buprenorphine (serious AE) |
| Drug dependence | 12,509 | 18.9 18.6–19.2ROR 21.7 · calibrated p 0.001 ✓ | 17.5 EB05 17.3 · IC025 +4.1 3/3 methods agree vs other Partial Opioid Agonists: PRR 918.0 (751.3–1,121.6) | Reporting / coding artifact | age-adj. PRR 18.2 · serious PRR 16.8 · 77% consumer | NCT00723697: 1/1,305 (0.1%) on Buprenorphine (serious AE) |
| Overdose | 10,973 | 12.1 11.9–12.3ROR 13.6 · calibrated p 0.010 ✓ | 11.5 EB05 11.4 · IC025 +3.5 3/3 methods agree vs other Partial Opioid Agonists: PRR 53.4 (50.7–56.3) | Reporting / coding artifact | age-adj. PRR 5.1 · serious PRR 14.1 · 81% consumer | not reported in cached trials |
| Toxicity to various agents | 10,773 | 15.6 15.3–15.9ROR 17.5 · calibrated p 0.004 ✓ | 14.6 EB05 14.4 · IC025 +3.8 3/3 methods agree vs other Partial Opioid Agonists: PRR 410.2 (355.0–474.1) | Not in label — unassessed | age-adj. PRR 5.3 · serious PRR 14.6 · ♀ 29% (drug 56%) | not reported in cached trials |
| Pain | 8,285 | 3.1 3.0–3.2ROR 3.3 · calibrated p 0.535 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Partial Opioid Agonists: PRR 191.4 (170.8–214.4) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 2.4 · serious PRR 3.9 | NCT00315341: 50/727 (6.9%) on Buprenorphine |
| Drug withdrawal syndrome | 7,002 | 19.5 19.0–19.9ROR 21.0 · calibrated p 0.002 ✓ | 18.0 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other Partial Opioid Agonists: PRR 360.1 (304.2–426.2) | Labeled adverse reaction exact term | age-adj. PRR 20.5 · serious PRR 16.0 | not reported in cached trials |
| Drug ineffective (drug did not work) | 6,392 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.383 | 1.1 EB05 1.1 · IC025 +0.1 vs other Partial Opioid Agonists: only this drug | Reporting / coding artifact | age-adj. PRR 1.9 · serious PRR 0.8 · 72% consumer | not reported in cached trials |
| Emotional distress | 5,452 | 10.7 10.4–11.0ROR 11.3 · calibrated p 0.021 ✓ | 10.2 EB05 10.0 · IC025 +3.3 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Not in label — unassessed | age-adj. PRR 1.9 · serious PRR 10.7 · 92% consumer | not reported in cached trials |
| Nausea | 4,544 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.529 | 1.3 EB05 1.3 · IC025 +0.3 vs other Partial Opioid Agonists: only this drug | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 0.9 | not reported in cached trials |
| Drug abuse | 3,758 | 10.7 10.3–11.0ROR 11.1 · calibrated p 0.022 ✓ | 10.2 EB05 10.0 · IC025 +3.3 3/3 methods agree vs other Partial Opioid Agonists: PRR 152.2 (130.8–177.0) | Reporting / coding artifact | age-adj. PRR 11.4 · serious PRR 9.5 · ♀ 30% (drug 56%) | not reported in cached trials |
| Product adhesion issue | 3,429 | 24.3 23.5–25.2ROR 25.2 · calibrated p 6e-4 ✓ | 22.0 EB05 21.4 · IC025 +4.4 3/3 methods agree vs other Partial Opioid Agonists: PRR 87.5 (77.5–98.9) | Reporting / coding artifact | age-adj. PRR 48.8 · serious n=150 · 84% consumer | not reported in cached trials |
| Application site rash | 3,066 | 65.1 62.5–67.7ROR 67.3 · calibrated p 2e-6 ✓ | 50.6 EB05 49.1 · IC025 +5.6 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Labeled adverse reaction exact term | serious n=85 · 90% consumer | not reported in cached trials |
| Inadequate analgesia | 3,050 | 126.1 120.7–131.8ROR 130.4 · calibrated p 1e-8 ✓ | 81.0 EB05 78.6 · IC025 +6.3 3/3 methods agree vs other Partial Opioid Agonists: only this drug | Reporting / coding artifact | serious n=147 · 91% consumer | not reported in cached trials |
| Dizziness | 2,729 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.480 | 1.2 EB05 1.2 · IC025 +0.3 vs other Partial Opioid Agonists: PRR 78.5 (68.9–89.4) | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 1.1 | not reported in cached trials |
| Rash | 2,580 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.554 | 1.4 EB05 1.3 · IC025 +0.4 vs other Partial Opioid Agonists: only this drug | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 1.0 | not reported in cached trials |
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.
- Drug delivery system removal — n=99, PRR 1,583.6
- Placental hypertrophy — n=23, PRR 303.0
- Rhesus incompatibility — n=33, PRR 84.0
- Facet joint syndrome — n=689, PRR 63.7
- Amaurosis fugax — n=191, PRR 49.4
- Injection site erosion — n=57, PRR 44.2
- Drug detoxification — n=131, PRR 39.2 (also seen in trial arm)
- Hypocholesterolaemia — n=43, PRR 36.9
- Onychomadesis — n=547, PRR 34.5
- Blepharospasm — n=797, PRR 33.5
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 toxicity to various agents, pain, drug withdrawal syndrome, emotional distress, nausea, application site rash. 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, 1,225 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 - ClinicalTrials.gov API v2 (query
BUPRENORPHINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.