Buprenorphine / naloxone Side Effects

Some side effects of 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.

For the Consumer

Applies to buprenorphine / naloxone: sublingual film, sublingual tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking buprenorphine / naloxone: 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 or seek emergency medical attention if you have:

• extreme drowsiness;

• loss of coordination, weakness or limp feeling;

• blurred vision, slurred speech, thinking problems;

• weak or shallow breathing;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• pounding heartbeats or fluttering in your chest; or

• withdrawal symptoms--diarrhea, vomiting, shaking or shivering, runny nose, watery eyes, muscle pain, and feeling very hot or cold.

Common side effects may include:

• headache, mild dizziness;

• numbness or tingling;

• drowsiness, or sleep problems (insomnia);

• stomach pain, vomiting, constipation;

• redness, pain, or numbness in your mouth;

• feeling drunk; or

• trouble concentrating.

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 / naloxone: sublingual film, sublingual tablet

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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