What the label lists and what reports show
Oxymorphone side effects
Oxymorphone's FDA label lists its adverse reactions in its own words. FAERS holds 11,596 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dependence (4,904 reports).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the oxymorphone FDA label on DailyMed (effective June 29, 2026, Aurolife Pharma, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions (5.3)] Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions [see Warnings and Precautions (5.8)] Adrenal Insufficiency [see Warnings and Precautions (5.9)] Severe Hypotension [see Warnings and Precautions (5.10)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Withdrawal [see Warnings and Precautions (5.14 )] Opioid-Induced Hyperalgesia and Allodynia [See Warnings and Precautions (5.6)] Adverse reactions …
Table 1: Adverse Reactions Reported in Placebo-Controlled Trials
| MedDRA Preferred Term | Oxymorphone Hydrochloride Tablets (N=557) | Placebo (N=270) |
|---|---|---|
| Nausea | 19% | 12% |
| Pyrexia | 14% | 8% |
| Somnolence | 9% | 2% |
| Vomiting | 9% | 7% |
| Pruritus | 8% | 4% |
| Headache | 7% | 4% |
| Dizziness (Excluding Vertigo) | 7% | 2% |
| Constipation | 4% | 1% |
| Confusion | 3% | <1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Aurolife Pharma, LLC, effective June 29, 2026 (SPL set 22c7652a-aa16-4fa8-89d9-517e69059068), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,596 reports list oxymorphone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,716 are coded as a death and 738 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (5,823, against a median of 70 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Oxymorphone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions