Drug · FAERS side-effect profile with label screen
Oxymorphone side effects: what 11,596 FDA adverse event reports show
Drug class
Opioid agonist
FDA label, Indications wording of the closest related product
Label matched
Oxymorphone Hydrochloride (Oxymorphone Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
11,596 reports · 98% serious · 5,716 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Oxymorphone hydrochloride tablets is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, o.
FDA label, Indications and Usage
What it is
Oxymorphone Hydrochloride Tablets (oxymorphone hydrochloride) is an opioid agonist available in 5 mg and 10 mg tablet strengths for oral administration.
FDA label, Description section
Boxed warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS Addiction, Abuse, and Misuse Because the use .
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 13Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 18
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.
- 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. 343 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 | 4,904 | 175.2 171.2–179.3ROR 302.9 · χ² 775,316 / p <1e-300 | 159.5 EB05 155.8 · IC025 +7.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 94.0 · 100% consumer | no trial data cached |
| Neonatal hypoacusis | 14 | 114.5 66.7–196.6ROR 114.7 · χ² 1,376 / p <1e-300 | 94.2 EB05 59.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Vision abnormal neonatal | 22 | 99.1 64.5–152.2ROR 99.3 · χ² 1,932 / p <1e-300 | 87.0 EB05 60.6 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 100% consumer | no trial data cached |
| Learning disorder | 90 | 69.3 56.2–85.4ROR 69.8 · χ² 5,765 / p <1e-300 | 65.8 EB05 55.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=90 · 100% consumer | no trial data cached |
| Multiple drug overdose accidental | 16 | 64.6 39.2–106.3ROR 64.6 · χ² 906 / p 3e-199 | 58.2 EB05 38.0 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Speech disorder developmental | 94 | 60.9 49.6–74.7ROR 61.4 · χ² 5,298 / p <1e-300 | 58.3 EB05 49.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=94 · 100% consumer | no trial data cached |
| Drug diversion | 150 | 48.6 41.4–57.1ROR 49.3 · χ² 6,768 / p <1e-300 | 47.1 EB05 41.1 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=149 · 98% consumer | no trial data cached |
| Drug withdrawal syndrome neonatal | 350 | 43.3 39.0–48.1ROR 44.6 · χ² 14,093 / p <1e-300 | 42.2 EB05 38.6 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.8 · 100% consumer | no trial data cached |
| Back injury | 243 | 41.5 36.6–47.1ROR 42.4 · χ² 9,351 / p <1e-300 | 40.5 EB05 36.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 · 100% consumer | no trial data cached |
| Developmental delay | 174 | 35.2 30.4–40.9ROR 35.8 · χ² 5,645 / p <1e-300 | 34.5 EB05 30.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · 100% consumer | no trial data cached |
| Spinal cord injury | 33 | 34.8 24.7–49.1ROR 34.9 · χ² 1,029 / p 4e-226 | 33.5 EB05 25.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 15% (drug 44%) · 100% consumer | no trial data cached |
| Toxicity to various agents | 2,759 | 30.2 29.2–31.2ROR 39.3 · χ² 77,223 / p <1e-300 | 29.7 EB05 28.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 | no trial data cached |
| Polysubstance abuse | 10 | 28.5 15.3–53.2ROR 28.5 · χ² 235 / p 3e-53 | 26.7 EB05 15.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Learning disability | 74 | 25.1 20.0–31.6ROR 25.3 · χ² 1,668 / p <1e-300 | 24.7 EB05 20.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=74 · 100% consumer | no trial data cached |
| Attention deficit hyperactivity disorder | 52 | 22.9 –ROR 23.0 · χ² – | – | Not in label — unassessed | serious n=52 · 100% consumer | no trial data cached |
| Neck injury | 35 | 21.7 15.6–30.3ROR 21.8 · χ² 663 / p 1e-146 | 21.3 EB05 16.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=35 · 100% consumer | no trial data cached |
| Overdose | 2,310 | 19.5 18.8–20.2ROR 24.1 · χ² 40,466 / p <1e-300 | 19.3 EB05 18.6 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.2 · 98% consumer | no trial data cached |
| Drug abuse | 551 | 12.0 11.0–13.0ROR 12.5 · χ² 5,521 / p <1e-300 | 11.9 EB05 11.1 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Spinal operation | 79 | 11.9 9.5–14.8ROR 11.9 · χ² 771 / p 5e-170 | 11.6 EB05 9.6 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 100% consumer | no trial data cached |
| Accidental death | 11 | 10.8 6.0–19.5ROR 10.8 · χ² 88 / p 4e-21 | 8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Accident at work | 13 | 10.7 6.2–18.4ROR 10.7 · χ² 104 / p 1e-24 | 9.0 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Neck surgery | 13 | 10.3 6.0–17.7ROR 10.3 · χ² 99 / p 1e-23 | 8.6 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Sedation complication | 12 | 8.7 4.9–15.4ROR 8.7 · χ² 74 / p 4e-18 | 7.0 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Spina bifida | 10 | 8.6 4.6–16.1ROR 8.6 · χ² 60 / p 5e-15 | 6.7 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Post-traumatic stress disorder | 31 | 8.4 5.9–11.9ROR 8.4 · χ² 193 / p 3e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% consumer | no trial data cached |
| Autism spectrum disorder | 24 | 8.0 5.3–11.9ROR 8.0 · χ² 139 / p 3e-32 | 7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% consumer | no trial data cached |
| Foetal exposure during pregnancy | 331 | 7.4 6.6–8.2ROR 7.6 · χ² 1,823 / p <1e-300 | 7.3 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 100% consumer | no trial data cached |
| Withdrawal syndrome | 167 | 7.2 6.2–8.3ROR 7.3 · χ² 880 / p 1e-193 | 7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.9 · 99% consumer | no trial data cached |
| Death | 3,324 | 7.0 6.8–7.2ROR 9.4 · χ² 17,761 / p <1e-300 | 7.0 EB05 6.8 · IC025 +2.7 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 4.1 · 97% consumer | no trial data cached |
| Exposure via breast milk | 15 | 7.0 4.2–11.5ROR 7.0 · χ² 70 / p 2e-17 | 5.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial data cached |
| Knee operation | 35 | 6.5 4.7–9.1ROR 6.6 · χ² 158 / p 1e-36 | 6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 100% consumer | no trial data cached |
| Drug dependence | 583 | 6.5 6.0–7.0ROR 6.8 · χ² 2,719 / p <1e-300 | 6.5 EB05 6.0 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 95% consumer | no trial data cached |
| Ill-defined disorder | 203 | 6.1 5.3–6.9ROR 6.1 · χ² 851 / p 2e-187 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 100% consumer | no trial data cached |
| Accidental overdose | 116 | 5.8 4.8–6.9ROR 5.8 · χ² 450 / p 3e-100 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Shoulder operation | 13 | 5.6 3.2–9.6ROR 5.6 · χ² 44 / p 1e-11 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious n=13 | no trial data cached |
| Intervertebral disc degeneration | 28 | 5.5 3.8–7.9ROR 5.5 · χ² 97 / p 3e-23 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 100% consumer | no trial data cached |
| Multiple drug overdose | 15 | 5.4 3.3–9.0ROR 5.4 · χ² 49 / p 1e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Creatinine renal clearance decreased | 12 | 5.4 3.1–9.5ROR 5.4 · χ² 39 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Disability | 55 | 5.0 3.9–6.6ROR 5.1 · χ² 174 / p 6e-40 | 4.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 100% consumer | no trial data cached |
| Renal function test abnormal | 12 | 4.7 2.7–8.3ROR 4.7 · χ² 32 / p 9e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious n=12 | 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 | 4,904 | 175.2 171.2–179.3ROR 302.9 · χ² 775,316 / p <1e-300 | 159.5 EB05 155.8 · IC025 +7.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 94.0 · 100% consumer | no trial data cached |
| Death | 3,324 | 7.0 6.8–7.2ROR 9.4 · χ² 17,761 / p <1e-300 | 7.0 EB05 6.8 · IC025 +2.7 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 4.1 · 97% consumer | no trial data cached |
| Toxicity to various agents | 2,759 | 30.2 29.2–31.2ROR 39.3 · χ² 77,223 / p <1e-300 | 29.7 EB05 28.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 | no trial data cached |
| Overdose | 2,310 | 19.5 18.8–20.2ROR 24.1 · χ² 40,466 / p <1e-300 | 19.3 EB05 18.6 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.2 · 98% consumer | no trial data cached |
| Drug dependence | 583 | 6.5 6.0–7.0ROR 6.8 · χ² 2,719 / p <1e-300 | 6.5 EB05 6.0 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 95% consumer | no trial data cached |
| Drug abuse | 551 | 12.0 11.0–13.0ROR 12.5 · χ² 5,521 / p <1e-300 | 11.9 EB05 11.1 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Back pain | 432 | 3.4 3.1–3.7ROR 3.5 · χ² 722 / p 2e-159 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 99% consumer | no trial data cached |
| Drug withdrawal syndrome neonatal | 350 | 43.3 39.0–48.1ROR 44.6 · χ² 14,093 / p <1e-300 | 42.2 EB05 38.6 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.8 · 100% consumer | no trial data cached |
| Foetal exposure during pregnancy | 331 | 7.4 6.6–8.2ROR 7.6 · χ² 1,823 / p <1e-300 | 7.3 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 100% consumer | no trial data cached |
| Pain | 307 | 0.9 0.8–1.0ROR 0.9 · χ² 3 / p 0.036 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Likely indication confounding term in indications; also in warnings | serious PRR 0.7 · ♀ 68% (drug 44%) · 90% consumer | no trial data cached |
| Back injury | 243 | 41.5 36.6–47.1ROR 42.4 · χ² 9,351 / p <1e-300 | 40.5 EB05 36.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 31.4 · 100% consumer | no trial data cached |
| Intentional product misuse | 220 | 4.6 4.0–5.2ROR 4.7 · χ² 615 / p 5e-136 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Ill-defined disorder | 203 | 6.1 5.3–6.9ROR 6.1 · χ² 851 / p 2e-187 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 100% consumer | no trial data cached |
| Depression | 201 | 1.6 1.4–1.8ROR 1.6 · χ² 44 / p 2e-11 | 1.6 EB05 1.4 · IC025 +0.4 | Labeled — boxed warning exact term | serious PRR 1.3 · 98% consumer | no trial data cached |
| Developmental delay | 174 | 35.2 30.4–40.9ROR 35.8 · χ² 5,645 / p <1e-300 | 34.5 EB05 30.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · 100% consumer | 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.
- Learning disorder — n=90, PRR 69.3
- Speech disorder developmental — n=94, PRR 60.9
- Back injury — n=243, PRR 41.5
- Developmental delay — n=174, PRR 35.2
- Spinal cord injury — n=33, PRR 34.8
- Toxicity to various agents — n=2,759, PRR 30.2
- Learning disability — n=74, PRR 25.1
- Attention deficit hyperactivity disorder — n=52, PRR 22.9
- Neck injury — n=35, PRR 21.7
- Post-traumatic stress disorder — n=31, PRR 8.4
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 Oxymorphone?
In FDA FAERS, the most frequently co-reported reaction terms for Oxymorphone are dependence, toxicity to various agents, back pain, drug withdrawal syndrome neonatal, pain, back injury. 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 Oxymorphone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS Addiction, Abuse, and Misuse Because the use .
Do FAERS signals prove that Oxymorphone 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 22c7652a-aa16-4fa8-89d9-517e69059068, effective 20260629; matched on
openfda.generic_name.exact:"OXYMORPHONE HYDROCHLORIDE") - 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, 383 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.