Buprenorphine and naloxone: adverse event reports filed with FDA

1,935

reports as suspect product

0% of all reports · about 124 a year

66

reports, 12 months to June 2026

53 in the 12 months before

53.7%

marked serious by the reporter

62.4% across the class

8.5%

record death among outcomes, as reported

165 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 and naloxone reports recording the termmedian drug in opioid antagonist

1. Nauseafeeling sick12%232
2. Product substitution issuea problem after switching products9.3%180
3. Drug withdrawal syndromesymptoms on stopping a medicine8.4%162
4. Headachehead pain7.7%149
5. Vomitingbeing sick7%136
6. Drug ineffectivethe medicine did not work as expected6.8%131
7. Drug abusemisuse of a medicine6%117
8. Withdrawal syndrome5.9%115
9. Drug dependencedependence on a medicine5.2%100
10. Product solubility abnormal4.9%95
11. Injection site reactiona reaction where the injection was given4.7%90
12. Wrong technique in product usage processthe product was used in the wrong way3.2%62
13. Hyperhidrosisexcessive sweating3.1%60
14. Toxicity to various agentspoisoning or toxic effect of one or more substances3%58
15. Off label useused for a purpose or in a way not on the label2.9%57
16. Anxietyanxiety2.9%56
17. Malaisegeneral feeling of being unwell2.7%53
18. Overdosea dose above the recommended amount2.5%48
19. Painpain, site not specified2.5%48
20. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.1%40
21. Somnolencedrowsiness1.9%36
22. Completed suicidedeath by suicide1.8%35
23. Dizzinesslight-headedness or unsteadiness1.8%34
24. Intentional product use issuedeliberate use not as intended1.8%34
25. Cardio-respiratory arrestthe heart and breathing stopped1.7%33
26. Drug withdrawal syndrome neonatal1.7%32
27. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.7%32
28. Product adhesion issue1.7%32
29. Diarrhoealoose or frequent stools1.6%31
30. Product quality issuea problem with the product itself1.6%31

Top 30 of 315 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 10 drugs in the opioid antagonist 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 31,239 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. 93.4% 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 1,935 reports.

Drugs most often listed in the same reports

Other products listed in reports where Buprenorphine and naloxone 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 antagonist 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 and naloxone as a suspect or interacting product; reports listing it only as a concomitant medication (203) 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.