Buprenex 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 Buprenex.

Some side effects of Buprenex 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

Get emergency medical help if you have any of these signs of an allergic reaction while taking buprenorphine (the active ingredient contained in Buprenex) 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.

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 Buprenex) 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 Buprenex) 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 Buprenex) 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 Buprenex) may increase intracholedochal pressure.

Hypersensitivity

Hypersensitivity reactions associated with buprenorphine (the active ingredient contained in Buprenex) 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 Buprenex) 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 Buprenex) 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 Buprenex) 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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