Suboxone: adverse event reports filed with FDA

20,919

reports as suspect product

0.1% of all reports · about 937 a year

552

reports, 12 months to June 2026

383 in the 12 months before

66.8%

marked serious by the reporter

62.4% across the class

5.5%

record death among outcomes, as reported

1,161 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 Suboxone reports recording the termmedian drug in opioid antagonist

1. Drug dependencedependence on a medicine20%4,187
2. Drug withdrawal syndromesymptoms on stopping a medicine16%3,351
3. Painpain, site not specified11.1%2,326
4. Off label useused for a purpose or in a way not on the label9.3%1,944
5. Overdosea dose above the recommended amount8.5%1,782
6. Emotional distressemotional distress6.8%1,423
7. Nauseafeeling sick6.3%1,318
8. Vomitingbeing sick5.6%1,181
9. Anxietyanxiety5.6%1,178
10. Foetal exposure during pregnancythe unborn baby was exposed to the medicine5.5%1,155
11. Substance abuse5.2%1,096
12. Drug abusemisuse of a medicine5.1%1,070
13. Intentional underdose5%1,037
14. Insomniadifficulty sleeping4.7%982
15. Drug withdrawal syndrome neonatal4.6%952
16. Product use issuea problem in how the product was used4.4%925
17. Headachehead pain4.3%893
18. Depressionlow mood4.2%889
19. Feeling abnormalfeeling odd or not right4.2%875
20. Wrong technique in drug usage processthe medicine was used in the wrong way3.8%785
21. Product preparation error3.7%771
22. Wrong technique in product usage processthe product was used in the wrong way3.6%758
23. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.6%751
24. Inappropriate schedule of product administrationthe product was taken at the wrong times3.5%738
25. Hyperhidrosisexcessive sweating3.1%641
26. Dental caries3.1%639
27. Suicidal ideationthoughts of suicide3%618
28. Malaisegeneral feeling of being unwell2.8%589
29. Diarrhoealoose or frequent stools2.4%502
30. Intentional product misusedeliberate use not as intended2.3%481

Top 30 of 1,401 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. 94.2% 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 20,919 reports.

Drugs most often listed in the same reports

Other products listed in reports where Suboxone 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 Suboxone as a suspect or interacting product; reports listing it only as a concomitant medication (3,974) 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.