Dilaudid: adverse event reports filed with FDA

64,191

reports as suspect product

0.3% of all reports · about 2,854 a year

173

reports, 12 months to June 2026

276 in the 12 months before

95.7%

marked serious by the reporter

91.7% across the class

36.1%

record death among outcomes, as reported

23,204 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 Dilaudid reports recording the termmedian drug in opioid agonist

1. Drug dependencedependence on a medicine52.5%33,707
2. Overdosea dose above the recommended amount34.2%21,956
3. Painpain, site not specified28.5%18,278
4. Emotional distressemotional distress26.6%17,089
5. Drug withdrawal syndromesymptoms on stopping a medicine21.7%13,913
6. Deaththe patient died; cause not stated by this term21%13,454
7. Toxicity to various agentspoisoning or toxic effect of one or more substances15%9,610
8. Drug abusemisuse of a medicine4.4%2,824
9. Drug withdrawal syndrome neonatal4.2%2,728
10. Anxietyanxiety3.5%2,237
11. Depressionlow mood3%1,935
12. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3%1,898
13. Learning disability2.3%1,488
14. Developmental delayslower development in a child2.1%1,343
15. Drug ineffectivethe medicine did not work as expected1.8%1,180
16. Mental disorder1.8%1,126
17. Nauseafeeling sick1.7%1,080
18. Drug hypersensitivityan allergic-type reaction to a medicine1.6%1,019
19. Unevaluable eventthe event could not be assessed1.4%910
20. Disability1.3%811
21. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.2%793
22. Accidental overdosean accidental overdose1.2%780
23. Withdrawal syndrome1.2%780
24. Constipationconstipation1.2%746
25. Vomitingbeing sick1.2%745
26. Injurya physical injury1.2%742
27. Cardiac disorder1.2%739
28. Fatiguetiredness1%667
29. Headachehead pain0.9%599
30. Dependence0.9%573

Top 30 of 1,818 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. 95.7% 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 64,191 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dilaudid 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 Dilaudid as a suspect or interacting product; reports listing it only as a concomitant medication (18,075) 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.