Subutex Side Effects

Generic Name: buprenorphine hydrochloride

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

Side Effects of Subutex - for the Consumer

Subutex

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Subutex:

Chills; constipation; diarrhea; dizziness; drowsiness; flushing; headache; nausea; sleeplessness; stomach pain; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety or nervousness; dark urine; mental or mood changes (eg, depression); pale stools; slow or shallow breathing; severe or persistent stomach pain; yellowing of eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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 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 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. 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 may increase intracholedochal pressure.

Hypersensitivity

Hypersensitivity reactions associated with buprenorphine have included rash, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock.

Other

Neonatal withdrawal has been reported in infants of women who took buprenorphine 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 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 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).

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