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.

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.

More resources:

buprenorphine

Buprenex injection

Buprenorphine

Subutex

Buprenorphine - Includes detailed dosage instructions.

Buprenorphine

Buprenex

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