Buprenorphine / naloxone Side Effects
Not all side effects for buprenorphine / naloxone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to buprenorphine / naloxone: film, tablet
In addition to its needed effects, some unwanted effects may be caused by buprenorphine / naloxone. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking buprenorphine / naloxone:More common
- Cough or hoarseness
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- fever or chills
- flushing or redness of the skin, especially on the face and neck
- lower back or side pain
- painful or difficult urination
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
If any of the following symptoms of overdose occur while taking buprenorphine / naloxone, get emergency help immediately:Symptoms of overdose
- 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
- unusual tiredness or weakness
Some of the side effects that can occur with buprenorphine / naloxone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Abdominal or stomach pain
- difficulty having a bowel movement (stool)
- lack or loss of strength
- trouble sleeping
- Back pain
- runny nose
- stuffy nose
For Healthcare Professionals
Applies to buprenorphine / naloxone: buccal film, sublingual film, sublingual tablet
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.
Neonatal withdrawal has been reported in infants of women who took buprenorphine during pregnancy.
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 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 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 effects in opioid dependent patients have included sweating (14% vs 10.3% with placebo).
Hypersensitivity reactions associated with buprenorphine have included rash, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock.
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.
Ocular side effects associated with buprenorphine may include miosis.
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.
Auditory and visual hallucinations have been associated with parenteral and sublingual buprenorphine.
More about buprenorphine/naloxone
- Buprenorphine/naloxone film
- Buprenorphine and naloxone
- Buprenorphine and naloxone Sublingual (Advanced Reading)
Related treatment guides
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