Buprenorphine Side Effects

Brand Names: Buprenex, Subutex

Please note - some side effects for Buprenorphine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Buprenorphine - for the Consumer

Buprenorphine/Naloxone

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 Buprenorphine/Naloxone:

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; severe or persistent stomach pain; slow or shallow breathing; yellowing of eyes or skin.

Buprenorphine

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 Buprenorphine:

Constipation; dizziness; drowsiness; headache; nausea; sweating; vomiting;

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; fast or irregular heartbeat; mental or mood changes (eg, depression); pale stools; pain, redness, or swelling at the injection site; slow or shallow breathing; unusual weakness; vision changes; yellowing of eyes or skin.

Buprenorphine Tablets

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 Buprenorphine Tablets:

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.

Buprenorphine Side Effects - for the Professional

Buprenorphine

The most frequent side effect in clinical studies involving 1,133 patients was sedation which occurred in approximately two-thirds of the patients. Although sedated, these patients could easily be aroused to an alert state.

Other less frequent adverse reactions occurring in 5 to 10% of the patients were:

Nausea Dizziness/Vertigo

Occurring in 1 to 5% of the patients:

Sweating        Headache

Hypotension   Nausea/Vomiting

Vomiting        Hypoventilation

Miosis

The following adverse reactions were reported to have occurred in less than 1% of the patients:

CNS Effect: confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia.

Cardiovascular: hypertension, tachycardia, bradycardia.

Gastrointestinal: constipation.

Respiratory: dyspnea, cyanosis.

Dermatological: pruritus.

Ophthalmological: diplopia, visual abnormalities.

Miscellaneous: injection site reaction, urinary retention, dreaming, flushing/warmth, chills/cold, tinnitus, conjunctivitis, Wenckebach block, and psychosis.

Other effects observed infrequently include malaise, hallucinations, depersonalization, coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor.

The following reactions have been reported to occur rarely: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination.

Allergic Reactions: Cases of acute and chronic hypersensitivity to Buprenorphine have been reported in clinical trials and in the postmarketing experience of Buprenorphine and other Buprenorphine-containing products. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to Buprenorphine is a contraindication to Buprenorphine HCl.

In the United Kingdom, Buprenorphine HCl was made available under monitored release regulation during the first year of sale, and yielded data from 1,736 physicians on 9,123 patients (17,120 administrations). Data on 240 children under the age of 18 years were included in this monitored release program. No important new adverse effects attributable to Buprenorphine HCl were observed.

Buprenorphine Injection

The most frequent side effect in clinical studies involving 1,133 patients was sedation which occurred in approximately two-thirds of the patients. Although sedated, these patients could easily be aroused to an alert state.

Other less frequent adverse reactions occurring in 5 to 10% of the patients were:

Occurring in 1 to 5% of the patients:

The following adverse reactions were reported to have occurred in less than 1% of the patients:

CNS Effect: confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia.

Cardiovascular: hypertension, tachycardia, bradycardia.

Gastrointestinal: constipation.

Respiratory: dyspnea, cyanosis.

Dermatological: pruritus.

Ophthalmological: diplopia, visual abnormalities.

Miscellaneous: Injection site reaction, urinary retention, dreaming, flushing/warmth, chills/cold, tinnitus, conjunctivitis, Wenckebach block, and psychosis.

Other effects observed infrequently include malaise, hallucinations, depersonalization, coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor.

The following reactions have been reported to occur rarely: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination.

Allergic Reactions: Cases of acute and chronic hypersensitivity to Buprenorphine have been reported both in clinical trials and in the postmarketing experience of Buprenorphine and other Buprenorphine-containing products. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to Buprenorphine is a contraindication to Buprenorphine.

In the United Kingdom, Buprenorphine hydrochloride was made available under monitored release regulation during the first year of sale, and yielded data from 1,736 physicians on 9,123 patients (17,120 administrations). Data on 240 children under the age of 18 years were included in this monitored release program. No important new adverse effects attributable to Buprenorphine hydrochloride were observed.

Side Effects by Body System

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 (<1%), cyanosis (<1%), and apnea (<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 (<1%).

Dermatologic

Dermatologic side effects have included pruritus (<1%) and urticaria.

Musculoskeletal

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

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