Drug · FAERS side-effect profile with label screen

Buprenorphine and Naloxone side effects: what 1,211 FDA adverse event reports show

Buprenorphine And Naloxone · 49 reaction terms · 1,059 drug–reaction co-reports · data 2026-09-14

Drug class

Partial Opioid Agonist

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Buprenorphine (Buprenorphine)

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

Who reports

1,211 reports · 55% serious · 129 with death outcome · 50% 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 25 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 5Labeled (related wording) 1Reporting / coding artifact 10Outcome field, not a reaction 1Not in label — unassessed 7

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. 24 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
Dental caries	36	56.6 41.0–78.1ROR 58.3 · χ² 1,904 / p <1e-300	54.8 EB05 41.4 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 75.6 · ♀ 71% (drug 50%) · 92% consumer	no trial data cached
Withdrawal syndrome	76	31.2 25.1–38.8ROR 33.2 · χ² 2,192 / p <1e-300	30.9 EB05 25.5 · IC025 +4.3 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 24.6 · 73% consumer	no trial data cached
Tooth fracture	15	23.6 14.3–39.0ROR 23.9 · χ² 302 / p 7e-68	22.9 EB05 14.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 34.7	no trial data cached
Product substitution issue	78	23.5 18.9–29.1ROR 25.0 · χ² 1,658 / p <1e-300	23.3 EB05 19.3 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 18.0 · 75% consumer	no trial data cached
Injection site reaction	91	23.0 18.9–28.0ROR 24.8 · χ² 1,894 / p <1e-300	22.8 EB05 19.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	99% consumer	no trial data cached
Tooth loss	25	20.7 14.1–30.6ROR 21.2 · χ² 450 / p 4e-100	20.4 EB05 14.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 24.8 · 100% consumer	no trial data cached
Product packaging quantity issue	12	19.0 10.8–33.4ROR 19.2 · χ² 187 / p 6e-43	18.1 EB05 10.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Cardio-respiratory arrest	42	17.3 12.8–23.3ROR 17.9 · χ² 629 / p 5e-139	17.1 EB05 13.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.0 · 100% clinician	no trial data cached
Drug abuse	71	14.7 11.7–18.4ROR 15.5 · χ² 895 / p 5e-197	14.6 EB05 11.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 15.3 · ♀ 26% (drug 50%) · 91% clinician	no trial data cached
Drug withdrawal syndrome	73	14.2 11.4–17.8ROR 15.1 · χ² 889 / p 1e-195	14.1 EB05 11.6 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached
Drug withdrawal syndrome neonatal	12	13.9 7.9–24.4ROR 14.0 · χ² 131 / p 1e-30	12.5 EB05 6.7 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.5	no trial data cached
Serotonin syndrome	13	11.8 6.8–20.2ROR 11.9 · χ² 118 / p 1e-27	10.2 EB05 5.8 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.3	no trial data cached
Restless legs syndrome	12	11.4 6.5–20.0ROR 11.5 · χ² 104 / p 1e-24	9.7 EB05 5.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 17.8	no trial data cached
Respiratory arrest	18	11.2 7.1–17.7ROR 11.4 · χ² 157 / p 2e-36	10.1 EB05 6.3 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.7	no trial data cached
Incorrect route of product administration	10	10.3 5.6–19.1ROR 10.4 · χ² 75 / p 2e-18	8.2 EB05 4.4 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 17.1	no trial data cached
Product dispensing error	11	8.8 4.9–15.8ROR 8.8 · χ² 68 / p 8e-17	7.0 EB05 4.0 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Restlessness	18	8.5 5.4–13.4ROR 8.6 · χ² 112 / p 2e-26	7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.2	no trial data cached
Hyperhidrosis (excessive sweating)	55	7.4 5.7–9.6ROR 7.7 · χ² 299 / p 3e-67	7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.9	no trial data cached
Toxicity to various agents	67	6.9 5.5–8.7ROR 7.3 · χ² 335 / p 3e-75	6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.2 · 99% clinician	no trial data cached
Completed suicide (death by suicide)	31	6.4 4.5–9.0ROR 6.5 · χ² 136 / p 1e-31	5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 6.6 · ♀ 76% (drug 50%) · 100% clinician	no trial data cached
Exposure during pregnancy	16	4.5 2.7–7.2ROR 4.5 · χ² 40 / p 2e-10	4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 0.9	no trial data cached
Drug dependence	40	4.3 3.1–5.8ROR 4.4 · χ² 97 / p 3e-23	4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.6	no trial data cached
Wrong technique in product usage process	41	3.5 2.6–4.7ROR 3.6 · χ² 72 / p 1e-17	3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 71% consumer	no trial data cached
Product quality issue	27	3.5 2.4–5.0ROR 3.5 · χ² 45 / p 9e-12	3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · 85% consumer	no trial data cached
Foetal exposure during pregnancy	16	3.4 2.1–5.5ROR 3.4 · χ² 25 / p 3e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.6	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
Injection site reaction	91	23.0 18.9–28.0ROR 24.8 · χ² 1,894 / p <1e-300	22.8 EB05 19.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	99% consumer	no trial data cached
Product substitution issue	78	23.5 18.9–29.1ROR 25.0 · χ² 1,658 / p <1e-300	23.3 EB05 19.3 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 18.0 · 75% consumer	no trial data cached
Withdrawal syndrome	76	31.2 25.1–38.8ROR 33.2 · χ² 2,192 / p <1e-300	30.9 EB05 25.5 · IC025 +4.3 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 24.6 · 73% consumer	no trial data cached
Drug withdrawal syndrome	73	14.2 11.4–17.8ROR 15.1 · χ² 889 / p 1e-195	14.1 EB05 11.6 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached
Drug abuse	71	14.7 11.7–18.4ROR 15.5 · χ² 895 / p 5e-197	14.6 EB05 11.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 15.3 · ♀ 26% (drug 50%) · 91% clinician	no trial data cached
Toxicity to various agents	67	6.9 5.5–8.7ROR 7.3 · χ² 335 / p 3e-75	6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.2 · 99% clinician	no trial data cached
Hyperhidrosis (excessive sweating)	55	7.4 5.7–9.6ROR 7.7 · χ² 299 / p 3e-67	7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.9	no trial data cached
Cardio-respiratory arrest	42	17.3 12.8–23.3ROR 17.9 · χ² 629 / p 5e-139	17.1 EB05 13.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.0 · 100% clinician	no trial data cached
Wrong technique in product usage process	41	3.5 2.6–4.7ROR 3.6 · χ² 72 / p 1e-17	3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 71% consumer	no trial data cached
Drug dependence	40	4.3 3.1–5.8ROR 4.4 · χ² 97 / p 3e-23	4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.6	no trial data cached
Dental caries	36	56.6 41.0–78.1ROR 58.3 · χ² 1,904 / p <1e-300	54.8 EB05 41.4 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 75.6 · ♀ 71% (drug 50%) · 92% consumer	no trial data cached
Completed suicide (death by suicide)	31	6.4 4.5–9.0ROR 6.5 · χ² 136 / p 1e-31	5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 6.6 · ♀ 76% (drug 50%) · 100% clinician	no trial data cached
Product quality issue	27	3.5 2.4–5.0ROR 3.5 · χ² 45 / p 9e-12	3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · 85% consumer	no trial data cached
Tooth loss	25	20.7 14.1–30.6ROR 21.2 · χ² 450 / p 4e-100	20.4 EB05 14.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 24.8 · 100% consumer	no trial data cached
Restlessness	18	8.5 5.4–13.4ROR 8.6 · χ² 112 / p 2e-26	7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.2	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=36, PRR 56.6
Injection site reaction — n=91, PRR 23.0
Tooth loss — n=25, PRR 20.7
Cardio-respiratory arrest — n=42, PRR 17.3
Toxicity to various agents — n=67, PRR 6.9

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 and Naloxone?

In FDA FAERS, the most frequently co-reported reaction terms for Buprenorphine and Naloxone are injection site reaction, withdrawal syndrome, drug withdrawal syndrome, toxicity to various agents, hyperhidrosis, cardio-respiratory arrest. 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 and Naloxone 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 and Naloxone 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, field patient.drug.openfda.generic_name.exact, 49 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.