Subutex
Subutex Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Subutex in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.
Call your doctor at once if you have a serious side effect such as:
- slow or shallow breathing;
- feeling light-headed, fainting;
- confusion, unusual thoughts or behavior; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may be more likely to occur, such as:
- headache;
- stomach pain, nausea, vomiting, constipation;
- warmth or tingly feeling;
- chills, increased sweating;
- weakness;
- back pain;
- anxiety, depression;
- sleep problems (insomnia); or
- runny nose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Subutex (Buprenorphine) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Subutex FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Events in Clinical Trials
The safety of SUBUTEX sublingual tablet was supported by clinical trials using SUBUTEX sublingual tablet, SUBOXONE (buprenorphine/naloxone sublingual tablet) and other trials using buprenorphine sublingual solutions. In total, safety data were available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction.
Few differences in adverse event profile were noted between SUBUTEX or buprenorphine administered as a sublingual solution.
The following adverse events were reported to occur by at least 5% of patients in a 4-week study (Table 1).
Table 1: Adverse Events > 5% by Body System and Treatment
Group in a 4-week study
| Body System / Adverse Event (COSTART Terminology) | N (%) SUBUTEX 16 mg/day N=103 |
N (%) Placebo N=107 |
| Body as a Whole | ||
| Asthenia | 5 (4.9%) | 7 (6.5%) |
| Chills | 8 (7.8%) | 8 (7.5%) |
| Headache | 30 (29.1%) | 24 (22.4%) |
| Infection | 12 (11.7%) | 7 (6.5%) |
| Pain | 19 (18.4%) | 20 (18.7%) |
| Pain Abdomen | 12 (11.7%) | 7 (6.5%) |
| Pain Back | 8 (7.8%) | 12 (11.2%) |
| Withdrawal Syndrome | 19 (18.4%) | 40 (37.4%) |
| Cardiovascular System | ||
| Vasodilation | 4 (3.9%) | 7 (6.5%) |
| Digestive System | ||
| Constipation | 8 (7.8%) | 3 (2.8%) |
| Diarrhea | 5 (4.9%) | 16 (15.0%) |
| Nausea | 14 (13.6%) | 12 (11.2%) |
| Vomiting | 8 (7.8%) | 5 (4.7%) |
| Nervous System | ||
| Insomnia | 22 (21.4%) | 17 (15.9%) |
| Respiratory System | ||
| Rhinitis | 10 (9.7%) | 14 (13.1%) |
| Skin And Appendages | ||
| Sweating | 13 (12.6%) | 11 (10.3%) |
The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. Table 2 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.
Table 2: Adverse Events ( ≥ 5%) by Body System and
Treatment Group in a 16-week Study
| Body System /Adverse Event (COSTART Terminology) | Buprenorphine Dose* | ||||
| Very Low* (N=184) N (%) |
Low* (N=180) N (%) |
Moderate* (N=186) N (%) |
High* (N=181) N (%) |
Total* (N=731) N (%) |
|
| *Sublingual solution. Doses in this table cannot necessarily
be delivered in tablet form, but for comparison purposes: “Very low” dose (1 mg solution) would be less than a tablet dose of 2 mg “Low” dose (4mg solution) approximates a 6 mg tablet dose “Moderate” dose (8mg solution) approximates a 12 mg tablet dose “High” dose (16mg solution) approximates a 24 mg tablet dose |
|||||
| Body as a Whole | |||||
| 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%) |
| Digestive System | |||||
| 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%) |
| Nervous System | |||||
| 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%) |
| Respiratory System | |||||
| 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%) |
| Skin And Appendages | |||||
| Sweat | 23 (13%) | 21 (12%) | 20 (11%) | 23 (13%) | 87 (12%) |
| Special Senses | |||||
| Runny Eyes | 13 (7%) | 9 (5%) | 6 (3%) | 6 (3%) | 34 (5%) |
Adverse Events - Post-marketing Experience with SUBUTEX Sublingual Tablets
The most frequently reported post-marketing adverse events with SUBUTEX not observed in clinical trials, excluding drug exposure during pregnancy, was drug misuse or abuse.
Read the entire FDA prescribing information for Subutex (Buprenorphine) »
Additional Subutex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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