Buprenorphine hydrochloride: adverse event reports filed with FDA

4,069

reports as suspect product

0% of all reports · about 181 a year

210

reports, 12 months to June 2026

273 in the 12 months before

94.1%

marked serious by the reporter

60.2% across the class

20.5%

record death among outcomes, as reported

835 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 hydrochloride reports recording the termmedian drug in partial opioid agonist

1. Dependence55.8%2,271
2. Overdosea dose above the recommended amount29.6%1,205
3. Deaththe patient died; cause not stated by this term8.3%336
4. Foetal exposure during pregnancythe unborn baby was exposed to the medicine6.7%274
5. Drug withdrawal syndrome neonatal6%244
6. Maternal exposure during pregnancythe mother took the medicine during pregnancy5.8%235
7. Ill-defined disordera condition that was not clearly described5.2%210
8. Depressionlow mood5.1%208
9. Toxicity to various agentspoisoning or toxic effect of one or more substances4.5%184
10. Withdrawal syndrome3.9%160
11. Drug abusemisuse of a medicine3.6%148
12. Off label useused for a purpose or in a way not on the label3.5%143
13. Dizzinesslight-headedness or unsteadiness3.3%134
14. Gastrooesophageal reflux diseaseacid reflux3.2%131
15. Anxietyanxiety3.1%125
16. Nauseafeeling sick3.1%125
17. Vomitingbeing sick2.9%120
18. Drug ineffectivethe medicine did not work as expected2.9%117
19. Diarrhoealoose or frequent stools2.8%112
20. Arthralgiajoint pain2.6%107
21. Insomniadifficulty sleeping2.6%106
22. Headachehead pain2.6%104
23. Painpain, site not specified2.6%104
24. Product quality issuea problem with the product itself2.4%98
25. Abdominal pain upperupper stomach pain2.4%97
26. Premature babya baby born early2.4%97
27. Astheniaweakness or lack of energy2.1%87
28. General physical health deteriorationgeneral decline in health2.1%87
29. Memory impairmentmemory problems2.1%87
30. Blepharospasm2.1%85

Top 30 of 614 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. 70% 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 4,069 reports.

Drugs most often listed in the same reports

Other products listed in reports where Buprenorphine hydrochloride 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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (599) 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.