Hydromorphone hydrochloride: adverse event reports filed with FDA

11,824

reports as suspect product

0.1% of all reports · about 528 a year

769

reports, 12 months to June 2026

967 in the 12 months before

94.2%

marked serious by the reporter

91.7% across the class

23.4%

record death among outcomes, as reported

2,766 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 Hydromorphone hydrochloride reports recording the termmedian drug in opioid agonist

1. Drug dependencedependence on a medicine37.7%4,454
2. Overdosea dose above the recommended amount23.1%2,729
3. Painpain, site not specified19.6%2,317
4. Drug ineffectivethe medicine did not work as expected13.6%1,606
5. Drug hypersensitivityan allergic-type reaction to a medicine12%1,423
6. Off label useused for a purpose or in a way not on the label11.8%1,390
7. Vomitingbeing sick10.6%1,254
8. Nauseafeeling sick10.2%1,208
9. Headachehead pain9.2%1,091
10. Asthmaasthma8.5%1,007
11. Dyspnoeashortness of breath8.5%1,004
12. Emotional distressemotional distress8.3%976
13. Deaththe patient died; cause not stated by this term7.2%855
14. Fatiguetiredness7.2%852
15. Constipationconstipation7.1%841
16. Pneumonialung infection6.8%807
17. Malaisegeneral feeling of being unwell6.8%799
18. Pyrexiafever6.7%794
19. Drug intolerancethe medicine was not tolerated6.1%722
20. Hyperhidrosisexcessive sweating6%712
21. Drug abusemisuse of a medicine6%705
22. Infusion related reactiona reaction during or soon after an infusion5.9%695
23. Drug withdrawal syndromesymptoms on stopping a medicine5.7%670
24. Wheezingwheezing5.4%641
25. Hypertensionhigh blood pressure5.4%636
26. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease5.1%599
27. Abdominal painstomach or belly pain5%597
28. Depressionlow mood5%586
29. Hypersensitivityan allergic-type reaction4.8%566
30. Anxietyanxiety4.8%565

Top 30 of 1,401 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. 47.3% 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 11,824 reports.

Drugs most often listed in the same reports

Other products listed in reports where Hydromorphone 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 Hydromorphone hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (2,665) 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.