Oxymorphone Hydrochloride
According to the FDA label: Oxymorphone hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
11,594 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Oxymorphone Hydrochloride in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Dependence 4,903 reports
A state in which the body or mind has come to rely on a substance, so that stopping it causes difficulty. Closely related to drug dependence.
Full definition in the glossary →Death 3,324 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Toxicity to Various Agents 2,759 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Overdose 2,310 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Drug Dependence 583 reports
A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Full definition in the glossary →Drug Abuse 551 reports
A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Full definition in the glossary →Back Pain 432 reports
Drug Withdrawal Syndrome Neonatal 350 reports
Withdrawal symptoms in a newborn whose mother took certain medications during pregnancy.
Full definition in the glossary →Foetal Exposure During Pregnancy 331 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →Pain 307 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Back Injury 243 reports
Intentional Product Misuse 220 reports
A report that a medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Full definition in the glossary →Ill-Defined Disorder 203 reports
A reported condition that could not be clearly identified or categorized. This is a record-keeping category.
Full definition in the glossary →Depression 201 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →- Developmental Delay 174 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 2,415 |
| Female | 1,878 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 16 |
| 18-34 | 83 |
| 35-49 | 97 |
| 50-64 | 77 |
| 65-74 | 20 |
| 75+ | 27 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Oxymorphone Hydrochloride. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 6,426 |
| Death | 5,716 |
| Hospitalization | 738 |
| Non-Serious | 186 |
| Disability | 48 |
| Life-Threatening | 25 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Oxymorphone Hydrochloride. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 18 |
| 2005 | 30 |
| 2006 | 3 |
| 2007 | 5 |
| 2008 | 2 |
| 2009 | 8 |
| 2010 | 14 |
| 2011 | 19 |
| 2012 | 35 |
| 2013 | 25 |
| 2014 | 24 |
| 2015 | 34 |
| 2016 | 25 |
| 2017 | 121 |
| 2018 | 5,823 |
| 2019 | 33 |
| 2020 | 51 |
| 2021 | 150 |
| 2022 | 70 |
| 2023 | 4,875 |
| 2024 | 210 |
| 2025 | 16 |
| 2026 (partial) | 3 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Oxymorphone Hydrochloride
In FDA adverse event reports that mention Oxymorphone Hydrochloride, these medications appeared most often in the same report.
- Hydromorphone (5,360 reports)
- Tapentadol (5,265 reports)
- Hydrocodone (5,245 reports)
- Buprenorphine (5,047 reports)
- Tramadol (3,908 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026