Belbuca: adverse event reports filed with FDA

3,039

reports as suspect product

0% of all reports · about 281 a year

284

reports, 12 months to June 2026

294 in the 12 months before

60.4%

marked serious by the reporter

60.2% across the class

7%

record death among outcomes, as reported

214 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 Belbuca reports recording the termmedian drug in partial opioid agonist

1. Dependence48.5%1,474
2. Overdosea dose above the recommended amount22.9%695
3. Ill-defined disordera condition that was not clearly described8.9%270
4. Product adhesion issue8.5%259
5. Drug ineffectivethe medicine did not work as expected6.9%209
6. Deaththe patient died; cause not stated by this term6.7%203
7. Product solubility abnormal5%153
8. Wrong technique in product usage processthe product was used in the wrong way4.1%125
9. Withdrawal syndrome3.8%116
10. Nauseafeeling sick3.4%104
11. Therapeutic response decreasedthe medicine worked less well3.3%100
12. Dental caries2.9%89
13. Painpain, site not specified2.9%87
14. Depressionlow mood2.8%85
15. Headachehead pain2.6%78
16. Anxietyanxiety2.3%71
17. Oral administration complication2.2%66
18. Product packaging quantity issue2%60
19. Product physical consistency issue1.9%59
20. Product dose omission issuea dose was missed1.9%57
21. Dizzinesslight-headedness or unsteadiness1.6%49
22. Drug withdrawal syndromesymptoms on stopping a medicine1.6%49
23. Vomitingbeing sick1.5%47
24. Drug withdrawal syndrome neonatal1.5%45
25. Foetal exposure during pregnancythe unborn baby was exposed to the medicine1.4%44
26. Off label useused for a purpose or in a way not on the label1.4%44
27. Tooth loss1.3%39
28. Incorrect route of product administrationthe product was given by the wrong route1.3%38
29. Product physical issuea physical defect in the product1.2%37
30. Product quality issuea problem with the product itself1.2%37

Top 30 of 302 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. 99.6% 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 3,039 reports.

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 Belbuca as a suspect or interacting product; reports listing it only as a concomitant medication (626) 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.