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Subutex

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Subutex

Subutex

Subutex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Subutex (buprenorphine) is an opioid (narcotic) medication used to treat narcotic addiction. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include headache, stomach pain, nausea, vomiting, constipation, warmth or tingly feeling, chills, sweating, weakness, back pain, anxiety, depression, insomnia, or runny nose.

Subutex sublingual tablet is administered sublingually as a single daily dose. Subutex may interact with other narcotics, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing, conivaptan, imatinib, isoniazid, nefazodone, antibiotics, antifungals, heart or blood pressure medications, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use. It is unknown if Subutex will harm a fetus. This drug may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant before using Subutex. This drug can pass into breast milk and may harm a nursing baby. Do not breastfeed while using Subutex. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Subutex (buprenorphine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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) »

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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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