Drugs › Partial opioid agonist
Generic name
Buprenorphine hcl: adverse event reports filed with FDA
569 reports list it as a suspect or interacting product, 2004–2021. Class: Partial opioid agonist.
- 569
- reports as suspect product
- 0% of all reports · about 26 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 92.1%
- marked serious by the reporter
- 60.2% across the class
- 17.2%
- record death among outcomes, as reported
- 98 reports · not verified by FDA
569 adverse event reports received by FDA list buprenorphine hcl, a generic name as a suspect or interacting product, from May 2004 to August 2021. A further 297 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, 0 reports listed it, and none 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 26 reports a year and 0% of the 20,646,523 reports in the database, and 0.6% 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.
Reporters most often recorded intentional drug misuse (9.3%), drug exposure during pregnancy (7.7%) and intentional misuse (6.3%). A report can list several reactions, so shares add to more than 100%; 274 different terms appear across these reports. Intentional drug misuse is recorded in 9.3% of these reports, with no counterpart in the median partial opioid agonist drug (0%).
92.1% of the reports are marked serious by the reporter (60.2% across the class); 17.2% record death among the outcomes and 42.2% record hospitalisation, as reported. 41.3% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (47.5%). 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
Reactions recorded in the reports
share of Buprenorphine hcl reports recording the termmedian drug in partial opioid agonist
- Intentional drug misuse9.3%53
- Drug exposure during pregnancythe medicine was taken during pregnancy7.7%44
- Intentional misuse6.3%36
- Drug interactionan interaction between medicines4%23
- Somnolencedrowsiness3.7%21
- Drug withdrawal syndromesymptoms on stopping a medicine3.3%19
- Medication errora mistake in prescribing, dispensing or taking a medicine3%17
- Overdosea dose above the recommended amount3%17
- Vomitingbeing sick3%17
- Confusional stateconfusion2.8%16
- Incorrect route of drug administrationthe medicine was given by the wrong route2.8%16
- Nauseafeeling sick2.5%14
- Respiratory depressionslow or shallow breathing2.5%14
- Oedema peripheralswelling of the legs, ankles or hands2.3%13
- Drug abusemisuse of a medicine2.1%12
- Drug ineffectivethe medicine did not work as expected2.1%12
- Cyanosis1.9%11
- Dyspnoeashortness of breath1.9%11
- Endocarditis staphylococcal1.9%11
- Inflammationinflammation1.9%11
- Pyrexiafever1.9%11
- Coma1.8%10
- Completed suicidedeath by suicide1.8%10
- Deaththe patient died; cause not stated by this term1.8%10
- Endocarditis1.6%9
- Loss of consciousnesspassing out1.6%9
- Necrosisdeath of tissue1.6%9
- Suicidal ideationthoughts of suicide1.6%9
- Drug abuser1.4%8
- Drug dependencedependence on a medicine1.4%8
Top 30 of 274 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. 18.5% 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 | 116 | 20.4% |
| Pain | 40 | 7% |
| Drug withdrawal maintenance therapy | 6 | 1.1% |
| Back pain | 4 | 0.7% |
| Detoxification | 4 | 0.7% |
| Drug abuser | 4 | 0.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 569 reports.
In context
| Measure | Buprenorphine hcl | Partial opioid agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 569 | 94,902 | 20,646,523 |
| Share of that pool | — | 0.6% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 92.1% | 60.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 172 | 286 | 91 |
| Hospitalisation recorded, per 1,000 reports | 422 | 99 | 213 |
| Consumer-filed share | 10.4% | 46.8% | 45.8% |
| Top term, share of reports | Intentional drug misuse 9.3% | median 0% | 0.1% |
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% |
| Brixadi | brand | 1,973 | 680 | 7.3% |
| Buprenorphine Transdermal System | brand | 955 | 169 | 11.7% |
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 Buprenorphine hcl reports
How many adverse event reports has FDA received for Buprenorphine hcl?
569 reports list Buprenorphine hcl as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 297 list it only as a concomitant medication.
What reactions are recorded in Buprenorphine hcl reports?
intentional drug misuse (9.3%), drug exposure during pregnancy (7.7%), intentional misuse (6.3%), drug interaction (4%) and somnolence (3.7%). 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 Buprenorphine hcl was responsible.
How serious are the reports?
92.1% are marked serious by the reporter. Among the outcomes recorded, 17.2% of reports include death and 42.2% 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 (41.3%), physician (29.5%) and not given (12.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Buprenorphine hcl rising?
0 reports in the 12 months to June 2026, and none 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 Buprenorphine hcl 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 Buprenorphine hcl?
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 Buprenorphine hcl as a suspect or interacting product; reports listing it only as a concomitant medication (297) 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.