Buprenorphine/Naloxone Side Effects

Please note - some side effects for Buprenorphine/Naloxone 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/Naloxone - 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.

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).

Chronic administration of buprenorphine may result in dependence and withdrawal symptoms may occur upon abrupt withdrawal. The naloxone component may produce severe withdrawal symptoms if buprenorphine-naloxone is injected by opioid-dependent individuals. Sublingual buprenorphine-naloxone may also cause withdrawal symptoms if taken before the opioid agonist effects have subsided.

Other

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

Nervous system

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). Buprenorphine may elevate cerebrospinal fluid pressure. Side effects associated with buprenorphine alone have included anxiety, depression, dizziness, insomnia, nervousness, and somnolence.

Respiratory

Respiratory system side effects in opioid dependent patients have included rhinitis (4.7% vs 13.1% with placebo).

Respiratory depression has been associated with buprenorphine, particularly after intravenous administration. 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.

Endocrine

Endocrine effects in opioid dependent patients have included sweating (14% vs 10.3% with placebo).

Hypersensitivity

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

Cardiovascular

Misuse of crushed buprenorphine tablets by inhalation has been associated with chest pain and acute anterior myocardial infarction in a 22-year-old male.

Cardiovascular side effects in opioid dependent patients have included vasodilation (9.3% vs 6.5% with placebo). Buprenorphine may cause orthostatic hypotension.

Ocular

Ocular side effects associated with buprenorphine may include miosis.

Hepatic

Hepatic side effects associated with sublingual buprenorphine have included cytolytic hepatitis and hepatitis with jaundice in opioid addicts. Preexisting liver dysfunction, hepatitis B or C virus infection, injectable drug use, or concomitant hepatotoxic drugs may have had contributory roles. Baseline and periodic monitoring of liver function tests is recommended during therapy. Close monitoring or careful discontinuation is recommended if a hepatic adverse reaction is suspected.

Psychiatric

Auditory and visual hallucinations have been associated with parenteral and sublingual buprenorphine.

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