Butrans: adverse event reports filed with FDA

60,029

reports as suspect product

0.3% of all reports · about 3,217 a year

590

reports, 12 months to June 2026

727 in the 12 months before

57.3%

marked serious by the reporter

60.2% across the class

35.5%

record death among outcomes, as reported

21,317 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 Butrans reports recording the termmedian drug in partial opioid agonist

1. Deaththe patient died; cause not stated by this term19.4%11,668
2. Drug dependencedependence on a medicine15.4%9,230
3. Overdosea dose above the recommended amount15.3%9,196
4. Toxicity to various agentspoisoning or toxic effect of one or more substances15.3%9,177
5. Painpain, site not specified10.4%6,244
6. Drug withdrawal syndromesymptoms on stopping a medicine7.6%4,569
7. Drug ineffectivethe medicine did not work as expected7.5%4,507
8. Emotional distressemotional distress7.4%4,448
9. Inadequate analgesia4.9%2,956
10. Application site rash4.9%2,927
11. Nauseafeeling sick4.8%2,869
12. Application site pruritusitching where the product was applied3.6%2,133
13. Rashskin rash3.5%2,121
14. Product adhesion issue3.4%2,052
15. Dizzinesslight-headedness or unsteadiness2.9%1,742
16. Drug effect decreasedthe medicine had less effect2.8%1,659
17. Application site irritation2.7%1,625
18. Application site erythemaredness where the product was applied2.6%1,579
19. Drug abusemisuse of a medicine2.6%1,545
20. Headachehead pain2.2%1,334
21. Drug withdrawal syndrome neonatal2.2%1,306
22. Vomitingbeing sick2%1,230
23. Depressionlow mood1.9%1,125
24. Off label useused for a purpose or in a way not on the label1.6%969
25. Application site vesicles1.6%962
26. Dyspnoeashortness of breath1.5%905
27. Confusional stateconfusion1.5%896
28. Fatiguetiredness1.5%892
29. Application site reactiona reaction where the product was applied1.4%853
30. Drug intolerancethe medicine was not tolerated1.4%850

Top 30 of 1,025 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. 95.6% 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 60,029 reports.

Drugs most often listed in the same reports

Other products listed in reports where Butrans 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 Butrans as a suspect or interacting product; reports listing it only as a concomitant medication (2,366) 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.