Subutex Side Effects
Generic Name: buprenorphine
Note: This page contains side effects data for the generic drug buprenorphine. It is possible that some of the dosage forms included below may not apply to the brand name Subutex.
It is possible that some side effects of Subutex may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to buprenorphine: sublingual tablet
As well as its needed effects, buprenorphine (the active ingredient contained in Subutex) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking buprenorphine, check with your doctor immediately:Incidence not known
- Blurred vision
- difficult or troubled breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular, fast, slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint pupils
- relaxed and calm feeling
- shortness of breath
- unusual tiredness or weakness
Some buprenorphine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common
- Back pain
- cough or hoarseness
- difficulty having a bowel movement (stool)
- fever or chills
- lower back or side pain
- painful or difficult urination
- runny nose
- stomach pain
- stuffy nose
- trouble sleeping
- unable to sleep
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- lack or loss of strength
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 (the active ingredient contained in Subutex) 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 (the active ingredient contained in Subutex) 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 (the active ingredient contained in Subutex) 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 (the active ingredient contained in Subutex) may increase intracholedochal pressure.
Hypersensitivity reactions associated with buprenorphine (the active ingredient contained in Subutex) have included rash, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock.
Neonatal withdrawal has been reported in infants of women who took buprenorphine (the active ingredient contained in Subutex) 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 (the active ingredient contained in Subutex) 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 (the active ingredient contained in Subutex) 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 (3%) 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 about Subutex (buprenorphine)
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