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Subutex

Last reviewed on RxList: 3/16/2020
Subutex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Subutex?

Subutex (buprenorphine) is an opioid (narcotic) medication used to treat narcotic addiction. The brand name Subutex is discontinued, but generic versions may be available.

What Are Side Effects of Subutex?

Common side effects of Subutex include:

Dosage for Subutex

Subutex sublingual tablet is administered sublingually as a single daily dose.

What Drugs, Substances, or Supplements Interact with Subutex?

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.

    Subutex During Pregnancy and Breastfeeding

    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.

    Additional Information

    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.

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Subutex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;
  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • slow heartbeat or weak pulse;
  • a light-headed feeling, like you might pass out;
  • chest pain, trouble breathing;
  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may be more likely to occur, such as:

  • constipation, nausea, vomiting;
  • headache;
  • increased sweating;
  • sleep problems (insomnia); or
  • pain anywhere in your body.

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)

Subutex Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Respiratory and CNS Depression [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Opioid Withdrawal [see WARNINGS AND PRECAUTIONS]
  • Hepatitis, Hepatic Events [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
  • Elevation of Cerebrospinal Fluid Pressure [see WARNINGS AND PRECAUTIONS]
  • Elevation of Intracholedochal Pressure [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

The safety of SUBUTEX was supported by clinical trials using SUBUTEX, 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 (%)N (%)
SUBUTEX 16 mg/day
N=103
Placebo
N=107
Body as a Whole
Asthenia5 (4.9%)7 (6.5%)
Chills8 (7.8%)8 (7.5%)
Headache30 (29.1%)24 (22.4%)
Infection12 (11.7%)7 (6.5%)
Pain19 (18.4%)20 (18.7%)
Pain Abdomen12 (11.7%)7 (6.5%)
Pain Back8 (7.8%)12 (11.2%)
Withdrawal Syndrome19 (18.4%)40 (37.4%)
Cardiovascular System
Vasodilation4 (3.9%)7 (6.5%)
Digestive System
Constipation8 (7.8%)3 (2.8%)
Diarrhea5 (4.9%)16 (15.0%)
Nausea14 (13.6%)12 (11.2%)
Vomiting8 (7.8%)5 (4.7%)
Nervous System
Insomnia22 (21.4%)17 (15.9%)
Respiratory System
Rhinitis10 (9.7%)14 (13.1%)
Skin and Appendages
Sweating13 (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)
Low*
(N=180)
Moderate*
(N=186)
High*
(N=181)
Total*
(N=731)
N (%)N (%)N (%)N (%)N (%)
Body as a Whole
Abscess9 (5%)2 (1%)3 (2%)2 (1%)16 (2%)
Asthenia26 (14%)28 (16%)26 (14%)24 (13%)104 (14%)
Chills11 (6%)12 (7%)9 (5%)10 (6%)42 (6%)
Fever7 (4%)2 (1%)2 (1%)10 (6%)21 (3%)
Flu Syndrome4 (2%)13 (7%)19 (10%)8 (4%)44 (6%)
Headache51 (28%)62 (34%)54 (29%)53 (29%)220 (30%)
Infection32 (17%)39 (22%)38 (20%)40 (22%)149 (20%)
Injury Accidental5 (3%)10 (6%)5 (3%)5 (3%)25 (3%)
Pain47 (26%)37 (21%)49 (26%)44 (24%)177 (24%)
Pain Back18 (10%)29 (16%)28 (15%)27 (15%)102 (14%)
Withdrawal Syndrome45 (24%)40 (22%)41 (22%)36 (20%)162 (22%)
Digestive System
Constipation10 (5%)23 (13%)23 (12%)26 (14%)82 (11%)
Diarrhea19 (10%)8 (4%)9 (5%)4 (2%)40 (5%)
Dyspepsia6 (3%)10 (6%)4 (2%)4 (2%)24 (3%)
Nausea12 (7%)22 (12%)23 (12%)18 (10%)75 (10%)
Vomiting8 (4%)6 (3%)10 (5%)14 (8%)38 (5%)
Nervous System
Anxiety22 (12%)24 (13%)20 (11%)25 (14%)91 (12%)
Depression24 (13%)16 (9%)25 (13%)18 (10%)83 (11%)
Dizziness4 (2%)9 (5%)7 (4%)11 (6%)31 (4%)
Insomnia42 (23%)50 (28%)43 (23%)51 (28%)186 (25%)
Nervousness12 (7%)11 (6%)10 (5%)13 (7%)46 (6%)
Somnolence5 (3%)13 (7%)9 (5%)11 (6%)38 (5%)
Respiratory System
Cough Increase5 (3%)11 (6%)6 (3%)4 (2%)26 (4%)
Pharyngitis6 (3%)7 (4%)6 (3%)9 (5%)28 (4%)
Rhinitis27 (15%)16 (9%)15 (8%)21 (12%)79 (11%)
Skin and Appendages
Sweat23 (13%)21 (12%)20 (11%)23 (13%)87 (12%)
Special Senses
Runny Eyes13 (7%)9 (5%)6 (3%)6 (3%)34 (5%)
*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 (4 mg solution) approximates a 6 mg tablet dose
”Moderate” dose (8 mg solution) approximates a 12 mg tablet dose
”High” dose (16 mg solution) approximates a 24 mg tablet dose

Postmarketing Experience

The following adverse reactions have been identified during post approval use of buprenorphine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in SUBUTEX.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Local reactions: Glossodynia, glossitis, oral mucosal erythema, oral hypoesthesia, and stomatitis.

Read the entire FDA prescribing information for Subutex (Buprenorphine)

Related Resources for Subutex

Related Drugs

© Subutex Patient Information is supplied by Cerner Multum, Inc. and Subutex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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