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Buprenorphine Side Effects

The most commonly reported side effects of buprenorphine include drug dependence, overdose, and death, based on 136,008 FDA adverse event reports from 2004 to 2025. 5.7% of reports found the drug to be ineffective.

Buprenorphine side effects

Percentages show how often each reaction appears relative to total reports for buprenorphine.

1
Drug Dependence14.9%20,219
2
Overdose11.5%15,685
3
Death10.6%14,352
4
Toxicity To Various Agents8.6%11,738
5
Pain8.5%11,537
6
Drug Withdrawal Syndrome7.7%10,492
7
Drug Ineffective5.7%7,739
8
Emotional Distress5.5%7,467
9
Nausea5.1%6,923
10
Drug Abuse4.3%5,816
11
Off Label Use3.4%4,563
12
Vomiting3.0%4,114
13
Product Adhesion Issue2.8%3,820
14
Headache2.8%3,819
15
Foetal Exposure During Pregnancy2.7%3,712

These are voluntary reports and do not establish that buprenorphine caused these reactions.

Report severity

63.2%Serious85,967 reports
14.8%Hospitalizations20,137 reports
21.6%Fatal29,338 reports

Seriousness is determined by the reporter, not by OpenClaim.

Buprenorphine drug interactions

Other drugs that appear in adverse event reports alongside buprenorphine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Oxycodone32.3%43,955
2
Acetaminophen28.1%38,176
3
Hydromorphone-hydrochloride24.9%33,815
4
Morphine-sulfate24.7%33,639
5
Hydrocodone23.2%31,557
6
Naloxone-hydrochloride19.1%26,003
7
Fentanyl18.9%25,655
8
Oxymorphone-hydrochloride17.5%23,835
9
Aspirin16.5%22,426
10
Tapentadol16.2%22,042
11
Tramadol-hydrochloride8.0%10,914
12
Ibuprofen5.3%7,269
13
Methadone-hydrochloride2.7%3,715
14
Pregabalin1.7%2,267
15
Diazepam1.6%2,185

Taken alongside

1
Acetaminophen3.8%5,151
2
Naloxone-hydrochloride3.6%4,942
3
Gabapentin2.5%3,368
4
Omeprazole1.9%2,553
5
Oxycodone1.7%2,361
6
Ibuprofen1.7%2,266
7
Albuterol1.5%2,073
8
Levothyroxine-sodium1.5%2,037
9
Pregabalin1.5%1,991
10
Ergocalciferol1.4%1,930
11
Aspirin1.4%1,862
12
Duloxetine-hydrochloride1.3%1,750
13
Furosemide1.3%1,711
14
Clonazepam1.2%1,636
15
Atorvastatin-calcium1.2%1,636

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports buprenorphine side effects

40.0% of buprenorphine adverse event reports involve female patients and 34.6% involve male patients. The largest age group is adult at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female40.0%
Male34.6%
Unknown25.4%

Age group

< 25.4%
2–110.8%
12–170.8%
18–6477.4%
65+15.6%

What is buprenorphine used for

Conditions and purposes for which patients were taking buprenorphine when the adverse event was reported.

Abdominal AdhesionsAbdominal DiscomfortAbdominal PainAbdominal Pain UpperAbnormal BehaviourAbortion SpontaneousAccidentAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental OverdoseAccidental PoisoningAcneAcromegaly

Showing 15 of 912 indications

Buprenorphine brand names and reporting trend

Buprenorphine is sold under brand names including Butrans, Subutex.

Brand names

Butrans42,819
Subutex101

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking buprenorphine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.