Drugs › Partial opioid agonist
Brand name · Buprenorphine
Brixadi: adverse event reports filed with FDA
1,973 reports list it as a suspect or interacting product, 2022–2026. Class: Partial opioid agonist.
- 1,973
- reports as suspect product
- 0% of all reports · about 439 a year
- 680
- reports, 12 months to June 2026
- 909 in the 12 months before
- 7.3%
- marked serious by the reporter
- 60.2% across the class
- 0.6%
- record death among outcomes, as reported
- 11 reports · not verified by FDA
1,973 adverse event reports received by FDA list the brand name Brixadi (buprenorphine) as a suspect or interacting product, from January 2022 to June 2026. A further 11 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 680 reports listed it, down 25% from 909 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 439 reports a year and 0% of the 20,646,523 reports in the database, and 2.1% of the reports for the partial opioid agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are withdrawal syndrome (13.1%), drug withdrawal syndrome (11.5%) and therapeutic response shortened (7.5%). A report can list several reactions, so shares add to more than 100%; 241 different terms appear across these reports. Withdrawal syndrome is recorded in 13.1% of these reports, a larger share than in the median partial opioid agonist drug (2%).
7.3% of the reports are marked serious by the reporter (60.2% across the class); 0.6% record death among the outcomes and 3.4% record hospitalisation, as reported. 52.2% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (13.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Brixadi reports recording the termmedian drug in partial opioid agonist
- Withdrawal syndrome13.1%259
- Drug withdrawal syndromesymptoms on stopping a medicine11.5%226
- Injection site painpain where the injection was given6%118
- Drug ineffectivethe medicine did not work as expected5.9%116
- Nauseafeeling sick5%99
- Off label useused for a purpose or in a way not on the label4.7%93
- Product dose omission issuea dose was missed4.5%89
- Injection site mass3.9%76
- Drug dependencedependence on a medicine3.6%71
- Injection site erythemaredness where the injection was given3.3%65
- Fatiguetiredness3%60
- Vomitingbeing sick2.6%51
- Hyperhidrosisexcessive sweating2.4%48
- Injection site pruritusitching where the injection was given2.4%48
- Headachehead pain2.2%44
- Injection site reactiona reaction where the injection was given2.1%41
- Injection site swellingswelling where the injection was given2%40
- Somnolencedrowsiness1.9%38
- Anxietyanxiety1.9%37
- Painpain, site not specified1.9%37
- Rashskin rash1.8%35
- Feeling abnormalfeeling odd or not right1.7%34
- Illness1.7%33
- Insomniadifficulty sleeping1.7%33
- Constipationconstipation1.6%31
- Maternal exposure during pregnancythe mother took the medicine during pregnancy1.6%31
- Inappropriate schedule of product administrationthe product was taken at the wrong times1.5%30
- Malaisegeneral feeling of being unwell1.5%30
- Injection site bruisingbruising where the injection was given1.4%27
Top 30 of 241 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Drug dependence | 564 | 28.6% |
| Drug use disorder | 321 | 16.3% |
| Drug abuse | 24 | 1.2% |
| Illness | 19 | 1% |
| Dependence | 13 | 0.7% |
| Substance use disorder | 6 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,973 reports.
In context
| Measure | Brixadi | Partial opioid agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 1,973 | 94,902 | 20,646,523 |
| Share of that pool | — | 2.1% | 0% |
| Reports, latest 12 months | 680 | — | 1,332,454 |
| Marked serious | 7.3% | 60.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 6 | 286 | 91 |
| Hospitalisation recorded, per 1,000 reports | 34 | 99 | 213 |
| Consumer-filed share | 29.4% | 46.8% | 45.8% |
| Top term, share of reports | Withdrawal syndrome 13.1% | median 2% | 0.2% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Butrans | brand | 60,029 | 590 | 57.3% |
| Buprenorphine | generic | 19,240 | 1,749 | 79.3% |
| Sublocade | brand | 5,028 | 434 | 20.3% |
| Buprenorphine hydrochloride | generic | 4,069 | 210 | 94.1% |
| Belbuca | brand | 3,039 | 284 | 60.4% |
| Buprenorphine Transdermal System | brand | 955 | 169 | 11.7% |
| Buprenorphine hcl | generic | 569 | 0 | 92.1% |
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.
Questions about Brixadi reports
How many adverse event reports has FDA received for Brixadi?
1,973 reports list Brixadi as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 680 of them arrived in the latest 12 months. Another 11 list it only as a concomitant medication.
What reactions are recorded in Brixadi reports?
withdrawal syndrome (13.1%), drug withdrawal syndrome (11.5%), therapeutic response shortened (7.5%), injection site pain (6%) and drug ineffective (5.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Brixadi was responsible.
How serious are the reports?
7.3% are marked serious by the reporter. Among the outcomes recorded, 0.6% of reports include death and 3.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (52.2%), consumer or non-health professional (29.4%) and physician (9.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Brixadi rising?
680 reports in the 12 months to June 2026, down 25% from 909 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Brixadi was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Brixadi?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Brixadi as a suspect or interacting product; reports listing it only as a concomitant medication (11) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.