Buprenorphine: adverse event reports filed with FDA

19,240

reports as suspect product

0.1% of all reports · about 855 a year

1,749

reports, 12 months to June 2026

1,668 in the 12 months before

79.3%

marked serious by the reporter

60.2% across the class

23.9%

record death among outcomes, as reported

4,601 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 Buprenorphine reports recording the termmedian drug in partial opioid agonist

1. Drug dependencedependence on a medicine22.9%4,406
2. Overdosea dose above the recommended amount11.4%2,196
3. Drug abusemisuse of a medicine10.5%2,022
4. Painpain, site not specified9.4%1,817
5. Toxicity to various agentspoisoning or toxic effect of one or more substances7.9%1,522
6. Deaththe patient died; cause not stated by this term7.5%1,443
7. Drug withdrawal syndromesymptoms on stopping a medicine7%1,356
8. Emotional distressemotional distress6.9%1,320
9. Drug ineffectivethe medicine did not work as expected6.8%1,313
10. Maternal exposure during pregnancythe mother took the medicine during pregnancy4.8%933
11. Nauseafeeling sick4.6%881
12. Product adhesion issue4.4%850
13. Vomitingbeing sick4.2%805
14. Foetal exposure during pregnancythe unborn baby was exposed to the medicine4.1%783
15. Anxietyanxiety4%770
16. Off label useused for a purpose or in a way not on the label3.9%753
17. Drug interactionan interaction between medicines3.8%731
18. Somnolencedrowsiness3.8%722
19. Dizzinesslight-headedness or unsteadiness3.5%673
20. Headachehead pain3.1%598
21. Depressionlow mood3%579
22. Astheniaweakness or lack of energy2.9%561
23. Wrong technique in product usage processthe product was used in the wrong way2.9%559
24. Drug withdrawal syndrome neonatal2.9%553
25. Confusional stateconfusion2.8%535
26. Diarrhoealoose or frequent stools2.7%511
27. Fatiguetiredness2.6%492
28. Abdominal pain upperupper stomach pain2.5%473
29. Falla fall2.4%467
30. Intentional product misusedeliberate use not as intended2.4%464

Top 30 of 1,616 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 8 drugs in the partial 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 94,902 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. 54.8% 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 19,240 reports.

Drugs most often listed in the same reports

Other products listed in reports where Buprenorphine 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 partial 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 Buprenorphine as a suspect or interacting product; reports listing it only as a concomitant medication (5,122) 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.