Subutex Side Effects

Generic Name: buprenorphine

Note: This document contains side effect information about buprenorphine. Some of the dosage forms listed on this page may not apply to the brand name Subutex.

Some side effects of Subutex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to buprenorphine: sublingual tablet

Along with its needed effects, buprenorphine (the active ingredient contained in Subutex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking buprenorphine:

Incidence not known
  • Blurred vision
  • confusion
  • difficult or troubled breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • irregular, fast, slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • pinpoint pupils
  • relaxed and calm feeling
  • shortness of breath
  • sleepiness
  • unusual tiredness or weakness

Some side effects of buprenorphine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • cough or hoarseness
  • difficulty having a bowel movement (stool)
  • fever or chills
  • headache
  • lower back or side pain
  • nausea
  • painful or difficult urination
  • runny nose
  • sleeplessness
  • sneezing
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • unable to sleep
  • vomiting
Less common
  • Diarrhea
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • lack or loss of strength
  • sweating

For Healthcare Professionals

Applies to buprenorphine: compounding powder, injectable solution, sublingual tablet, transdermal film extended release

General

Side effects affecting the body as a whole in opioid dependent patients have included asthenia (6.5% vs 6.5% with placebo), chills (7.5% vs 7.5% with placebo), headache (36.4% vs 22.4% with placebo), infection (5.6% vs 6.5% with placebo), pain (22.4% vs 18.7% with placebo), abdominal pain (11.2% vs 6.5% with placebo), back pain (3.7% vs 11.2% with placebo), and withdrawal syndrome (25.2% vs 37.4% with placebo). Sublingual buprenorphine (the active ingredient contained in Subutex) may cause withdrawal symptoms in opioid dependent patients.

Chronic administration of buprenorphine may result in dependence and withdrawal symptoms may occur upon abrupt withdrawal. Buprenorphine may also cause withdrawal symptoms if administered to opioid-dependent patients.

Nervous system

Nervous system side effects associated with parenteral buprenorphine (the active ingredient contained in Subutex) have most commonly included sedation (60%). Dizziness, vertigo, headache have been reported in 5% to 10% of patients. Confusion, weakness, fatigue, nervousness, slurred speech, and paresthesia have been reported in less than 1% of patients. Buprenorphine may elevate cerebrospinal fluid pressure and produce changes in the level of consciousness. Somnolence, tinnitus, agitation, tremor, coma, and convulsions have also been reported.

Nervous system side effects in opioid dependent patients have included insomnia (14% vs 15.9% with placebo). Increased CNS depression may occur in patients receiving concurrent CNS depressants (e.g., narcotic analgesics, general anesthetics, benzodiazepines, phenothiazines, tranquilizers, sedative/hypnotics, or alcohol). Side effects associated with buprenorphine alone have included anxiety, depression, dizziness, insomnia, nervousness, somnolence, and elevated cerebrospinal fluid pressure.

Respiratory

Respiratory system side effects have included respiratory depression with therapeutic doses of injectable and sublingual buprenorphine (the active ingredient contained in Subutex) Death has occurred with intravenous misuse of buprenorphine, usually with concurrent benzodiazepines, alcohol, and/or other CNS depressants. Hypoventilation (1% to 5%), dyspnea (less than 1%), cyanosis (less than 1%), and apnea (less than 1%) have also been reported.

Respiratory system side effects in opioid dependent patients have included rhinitis (4.7% vs 13.1% with placebo) and respiratory depression, particularly after intravenous administration. Sublingual buprenorphine has been implicated in a case of noncardiogenic pulmonary edema. Death has occurred with intravenous misuse of buprenorphine, usually with concurrent benzodiazepines, alcohol, and/or other CNS depressants.

Gastrointestinal

Gastrointestinal side effects in opioid dependent patients have included constipation (12.1% vs 2.8% with placebo), diarrhea (3.7% vs 15% with placebo), nausea (15% vs 11.2% with placebo), and vomiting (7.5% vs 4.7% with placebo). Buprenorphine (the active ingredient contained in Subutex) may increase intracholedochal pressure.

Hypersensitivity

Hypersensitivity reactions associated with buprenorphine (the active ingredient contained in Subutex) have included rash, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock.

Other

Neonatal withdrawal has been reported in infants of women who took buprenorphine (the active ingredient contained in Subutex) during pregnancy.

Cardiovascular

Cardiovascular side effects in opioid dependent patients have included vasodilation (9.3% vs 6.5% with placebo). Buprenorphine may cause orthostatic hypotension. Misuse of crushed buprenorphine (the active ingredient contained in Subutex) tablets by inhalation has been associated with chest pain and acute anterior myocardial infarction in a 22-year-old male.

Endocrine

Endocrine effects have included sweating (sublingual in opioid dependent patients, 14% vs. 10.3% with placebo; parenteral for analgesia, 1% to 5%).

Ocular

Ocular side effects have included blurred vision, conjunctivitis, amblyopia, and miosis.

Psychiatric

Psychiatric side effects associated with parenteral buprenorphine (the active ingredient contained in Subutex) have included euphoria, depersonalization, depression, dreaming, and psychosis in less than 1% of patients. Dysphoria has been reported rarely. Auditory and visual hallucinations have been associated with parenteral and sublingual buprenorphine.

Genitourinary

Genitourinary side effects have included urinary retention (less than 1%).

Dermatologic

Dermatologic side effects have included pruritus (less than %) and urticaria. Dermatologic side effects associated with the transdermal patch have included application site pruritus (15%), application site erythema (7%), application site rash (6%), and pruritus (4%).

Musculoskeletal

Musculoskeletal side effects have included lack of muscle coordination (rare).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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