Oxymorphone hydrochloride: adverse event reports filed with FDA

11,544

reports as suspect product

0.1% of all reports · about 515 a year

12

reports, 12 months to June 2026

56 in the 12 months before

98.6%

marked serious by the reporter

91.7% across the class

49.7%

record death among outcomes, as reported

5,732 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Oxymorphone hydrochloride reports recording the termmedian drug in opioid agonist

1. Dependence42.4%4,898
2. Deaththe patient died; cause not stated by this term28.7%3,317
3. Toxicity to various agentspoisoning or toxic effect of one or more substances24.1%2,779
4. Overdosea dose above the recommended amount19.9%2,295
5. Drug dependencedependence on a medicine5%581
6. Drug abusemisuse of a medicine4.9%571
7. Back painback pain3.7%430
8. Drug withdrawal syndrome neonatal3%349
9. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.8%329
10. Painpain, site not specified2.5%292
11. Back injury2.1%242
12. Intentional product misusedeliberate use not as intended1.9%222
13. Ill-defined disordera condition that was not clearly described1.7%202
14. Depressionlow mood1.7%192
15. Developmental delayslower development in a child1.5%174
16. Withdrawal syndrome1.4%163
17. Anxietyanxiety1.4%162
18. Drug diversion1.3%148
19. Dysphagiadifficulty swallowing1.1%127
20. Arthralgiajoint pain1.1%126
21. Gastrointestinal disorder0.9%107
22. Accidental overdosean accidental overdose0.9%101
23. Asthmaasthma0.8%94
24. Road traffic accidenta road accident0.8%94
25. Speech disorder developmental0.8%93
26. Gastrooesophageal reflux diseaseacid reflux0.8%92
27. Learning disorder0.8%90
28. Emotional distressemotional distress0.8%87
29. Spinal operation0.7%78
30. Maternal exposure during pregnancythe mother took the medicine during pregnancy0.6%74

Top 30 of 402 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 42 drugs in the opioid agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 965,051 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 11,544 reports.

Drugs most often listed in the same reports

Other products listed in reports where Oxymorphone hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the opioid agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Oxymorphone hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (149) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.