Buprenorphine Side Effects
Some side effects of buprenorphine 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: 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:
stomach pain, nausea, vomiting, constipation;
warmth or tingly feeling;
chills, increased sweating;
sleep problems (insomnia); or
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
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 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 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 (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 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 reactions associated with buprenorphine have included rash, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock.
Neonatal withdrawal has been reported in infants of women who took buprenorphine during pregnancy.
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 effects have included sweating (sublingual in opioid dependent patients, 14% vs. 10.3% with placebo; parenteral for analgesia, 1% to 5%).
Ocular side effects have included blurred vision, conjunctivitis, amblyopia, and miosis.
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 side effects have included urinary retention (less than 1%).
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 side effects have included lack of muscle coordination (rare).
More buprenorphine resources
- buprenorphine MedFacts Consumer Leaflet (Wolters Kluwer)
- buprenorphine Concise Consumer Information (Cerner Multum)
- buprenorphine Injection Advanced Consumer (Micromedex) - Includes Dosage Information
- Buprenex Prescribing Information (FDA)
- Buprenex injection Concise Consumer Information (Cerner Multum)
- Buprenorphine Hydrochloride Monograph (AHFS DI)
- Subutex Advanced Consumer (Micromedex) - Includes Dosage Information
- Subutex MedFacts Consumer Leaflet (Wolters Kluwer)
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