Opioid agonist: adverse event reports filed with FDA

965,051

reports across the class

4.7% of all reports

20,413

reports, 12 months to June 2026

25,028 in the 12 months before

91.7%

marked serious by the reporter

57.4% across all reports

42

drugs with a page

brand and generic names counted separately

Drugs in the 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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

1. Drug dependencedependence on a medicine36.3%350,674
2. Overdosea dose above the recommended amount24%232,032
3. Painpain, site not specified17.4%168,212
4. Deaththe patient died; cause not stated by this term16.2%155,890
5. Emotional distressemotional distress14.4%138,963
6. Toxicity to various agentspoisoning or toxic effect of one or more substances12.8%123,379
7. Drug withdrawal syndromesymptoms on stopping a medicine11.2%108,533
8. Dependence6.8%65,951
9. Drug abusemisuse of a medicine6.6%63,854
10. Drug ineffectivethe medicine did not work as expected3.9%38,061
11. Anxietyanxiety3.5%33,988
12. Drug withdrawal syndrome neonatal3.5%33,358
13. Depressionlow mood3.2%31,095
14. Drug hypersensitivityan allergic-type reaction to a medicine3.1%30,007
15. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3%28,831
16. Nauseafeeling sick2.8%27,115
17. Vomitingbeing sick2.4%23,456
18. Developmental delayslower development in a child2%19,621
19. Learning disability2%19,568
20. Fatiguetiredness2%18,996
21. Off label useused for a purpose or in a way not on the label2%18,942
22. Ill-defined disordera condition that was not clearly described1.9%18,442
23. Headachehead pain1.9%18,051
24. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.8%16,992
25. Dyspnoeashortness of breath1.8%16,939

Solid bar: share of all class reports. Hollow bar: the median share across the 42 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.