OpenPV Signal Explorer
FAERS disproportionality dashboard
← All drug classes
Drug class · FAERS comparison

Partial Opioid Agonist side effects compared: 3 drugs, 100,199 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

DrugFAERS reportsSeriousDeath outcomeBoxed warningTop labeled signalsUnlabeled (unassessed)
Buprenorphine91,98959%26,296boxedApplication site rash; Application site pruritus; Drug withdrawal syndrome neonatalBlepharospasm; Duodenal ulcer perforation
Buprenorphine7,33775%1,012boxedDependence; Drug withdrawal syndrome neonatal; Withdrawal syndromeIll-defined disorder; Dental caries
Buprenorphine87392%152boxedDrug withdrawal syndrome; Respiratory depression; Withdrawal syndrome–

Class-wide signals (flagged in at least 2 of 3 members)

ReactionMembers flaggedMedian PRRReports (sum)In label
Drug withdrawal syndrome neonatal2/341.02,0372/2 members' labels
Withdrawal syndrome2/312.62612/2 members' labels

Member-specific signals (flagged in exactly one drug)

No strong single-member signals (n ≥ 50) in this class.

Common questions

Which partial opioid agonist has the most FDA adverse event reports?

Buprenorphine has the most FAERS co-reports in this class (91,989), followed by Buprenorphine (7,337). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across partial opioid agonist drugs?

Reaction terms flagged in at least half of the 3 members include drug withdrawal syndrome neonatal, withdrawal syndrome. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.