What the label lists and what reports show
Buprenorphine side effects
Buprenorphine's FDA label: “The most frequently reported postmarketing adverse events with buprenorphine not observed in clinical trials, excluding drug exposure during pregnancy, was drug misuse or abuse.” FAERS holds 99,861 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug dependence (12,594 reports).
- Generic listed
- DEA Schedule III
Check it at the source: the buprenorphine FDA label on DailyMed (effective June 5, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of buprenorphine sublingual tablets?Buprenorphine sublingual tablets can cause serious side effects, including: Trouble breathing. Taking buprenorphine sublingual tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants can cause breathing problems that can lead to coma and death. Sleepiness, dizziness, and problems with coordination. Physical dependence or abuse. Liver problems. Call your healthcare provider right away if you notice any of these symptoms: your skin or the white part of your eyes turns yellow (jaundice) dark or “tea-colored” urine light-colored stools (bowel movements) loss of appetite pain, aching, or tenderness on the right side of your stomach area nausea Your healthcare provider should do blood tests to check your liver before you start taking and while you take buprenorphine sublingual tablets. Allergic reaction. […]
Source: FDA drug label, SpecGx LLC, effective June 5, 2026 (SPL set b60d514d-a88a-4fa2-a5b0-30ac29e04973), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported postmarketing adverse events with buprenorphine not observed in clinical trials, excluding drug exposure during pregnancy, was drug misuse or abuse.
Table 2. Adverse Events (≥ 5%) by Body System and Treatment Group in a 16-Week Study
| Reaction | Very Low (N=184) N (%) | Low (N=180) N (%) | Moderate (N=186) N (%) | High (N=181) N (%) | Total (N=731) N (%) |
|---|---|---|---|---|---|
| Abscess | 9 (5%) | 2 (1%) | 3 (2%) | 2 (1%) | 16 (2%) |
| Asthenia | 26 (14%) | 28 (16%) | 26 (14%) | 24 (13%) | 104 (14%) |
| Chills | 11 (6%) | 12 (7%) | 9 (5%) | 10 (6%) | 42 (6%) |
| Fever | 7 (4%) | 2 (1%) | 2 (1%) | 10 (6%) | 21 (3%) |
| Flu Syndrome | 4 (2%) | 13 (7%) | 19 (10%) | 8 (4%) | 44 (6%) |
| Headache | 51 (28%) | 62 (34%) | 54 (29%) | 53 (29%) | 220 (30%) |
| Infection | 32 (17%) | 39 (22%) | 38 (20%) | 40 (22%) | 149 (20%) |
| Injury Accidental | 5 (3%) | 10 (6%) | 5 (3%) | 5 (3%) | 25 (3%) |
| Pain | 47 (26%) | 37 (21%) | 49 (26%) | 44 (24%) | 177 (24%) |
| Pain Back | 18 (10%) | 29 (16%) | 28 (15%) | 27 (15%) | 102 (14%) |
| Withdrawal Syndrome | 45 (24%) | 40 (22%) | 41 (22%) | 36 (20%) | 162 (22%) |
| Constipation | 10 (5%) | 23 (13%) | 23 (12%) | 26 (14%) | 82 (11%) |
| Diarrhea | 19 (10%) | 8 (4%) | 9 (5%) | 4 (2%) | 40 (5%) |
| Dyspepsia | 6 (3%) | 10 (6%) | 4 (2%) | 4 (2%) | 24 (3%) |
| Nausea | 12 (7%) | 22 (12%) | 23 (12%) | 18 (10%) | 75 (10%) |
| Vomiting | 8 (4%) | 6 (3%) | 10 (5%) | 14 (8%) | 38 (5%) |
| Anxiety | 22 (12%) | 24 (13%) | 20 (11%) | 25 (14%) | 91 (12%) |
| Depression | 24 (13%) | 16 (9%) | 25 (13%) | 18 (10%) | 83 (11%) |
| Dizziness | 4 (2%) | 9 (5%) | 7 (4%) | 11 (6%) | 31 (4%) |
| Insomnia | 42 (23%) | 50 (28%) | 43 (23%) | 51 (28%) | 186 (25%) |
| Nervousness | 12 (7%) | 11 (6%) | 10 (5%) | 13 (7%) | 46 (6%) |
| Somnolence | 5 (3%) | 13 (7%) | 9 (5%) | 11 (6%) | 38 (5%) |
| Cough Increase | 5 (3%) | 11 (6%) | 6 (3%) | 4 (2%) | 26 (4%) |
| Pharyngitis | 6 (3%) | 7 (4%) | 6 (3%) | 9 (5%) | 28 (4%) |
| Rhinitis | 27 (15%) | 16 (9%) | 15 (8%) | 21 (12%) | 79 (11%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [ see Warnings and Precautions ( 5.1 )] Respiratory and CNS Depression [ see Warnings and Precautions ( 5.2 , 5.3 )] Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions ( 5.5 )] Adrenal Insufficiency [ see Warnings and Precautions ( 5.6 )] Opioid Withdrawal [ see Warnings and Precautions ( 5.7 , 5.10 )] Hepatitis, Hepatic Events [ see Warnings and Precautions ( 5.8 )] Hypersensitivity Reactions [ see Warnings and Precautions ( 5.9 )] Orthostatic Hypotension [ see Warnings and Precautions ( 5.16 )] Elevation of Cerebrospinal Fluid Pressure [ see Warnings and Precautions ( 5.17 )] Elevation of Intracholedochal Pressure [ see Warnings and Precautions ( 5.18 )] Adverse events commonly observed with administration of buprenorphine are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-778-7898, or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch. …
Source: FDA drug label, SpecGx LLC, effective June 5, 2026 (SPL set b60d514d-a88a-4fa2-a5b0-30ac29e04973), via openFDA; the full label on DailyMed
What do FAERS reports show?
99,861 reports list buprenorphine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27,352 are coded as a death and 12,277 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (23,213, against a median of 5,160 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Buprenorphine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions