Skip to main content

Buprenorphine / naloxone Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 26, 2024.

Applies to buprenorphine / naloxone: film, tablet.

Serious side effects

Along with its needed effects, buprenorphine/naloxone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking buprenorphine / naloxone:

More common

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine / naloxone:

Symptoms of overdose

Other side effects

Some side effects of buprenorphine / naloxone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to buprenorphine / naloxone: buccal film, sublingual film, sublingual tablet.


The most commonly observed adverse events included headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema. Additionally, oral hypoesthesia was reported with the sublingual film.[Ref]


Very common (10% or more): Pain (22.4%)

Common (1% to 10%): Asthenia, chills, pyrexia, malaise, injury, ear pain

Uncommon (0.1% to 1%): Hypothermia, heat stroke

Postmarketing reports: Vertigo[Ref]

Nervous system

Very common (10% or more): Headache (36.4%)

Common (1% to 10%): Migraine, dizziness, hypertonia, paraesthesia, somnolence

Uncommon (0.1% to 1%): Amnesia, convulsion, hyperkinesia, speech disorder, tremor


Postmarketing reports: Neonatal withdrawal syndrome including symptoms of hypertonia, neonatal tremor, neonatal agitation, and myoclonus; reports of neonatal convulsions, apnea, respiratory depression, and bradycardia[Ref]



Common (1% to 10%): Pharyngitis, rhinitis, cough, sinusitis, upper respiratory infection, asthma, bronchitis, dyspnea, pneumonia, increased sputum

Uncommon (0.1% to 1%): Yawning

Frequency not reported: Rhinorrhea


Frequency not reported: Significant respiratory depression, coma, death[Ref]

There have been postmarketing reports coma and death associated with concomitant use of buprenorphine and benzodiazepines; many of these reports have involved misuse by self-injection.[Ref]


Very common (10% or more): Constipation (12.1%), nausea (15%), abdominal pain (11.2%)

Common (1% to 10%): Vomiting, diarrhea, dyspepsia, flatulence, oral hypoesthesia

Uncommon (0.1% to 1%): Mouth ulceration, tongue discoloration, tooth abscess, glossodynia, mucosal erythema (oral), toothache

Frequency not reported: Stomach discomfort,

Postmarketing reports: Stomatitis, glossitis, tongue disorder, pancreatitis[Ref]


Common (1% to 10%): Erectile dysfunction, decreased libido

Uncommon (0.1% to 1%): Amenorrhea, ejaculation disorder, menorrhagia, metrorrhagia

Postmarketing reports: Disorders of pregnancy


Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]



Frequency not reported: Hypersensitivity reactions including bronchospasm, angioneurotic edema, and anaphylactic shock; more commonly reported as rash hives, and pruritus


Frequency not reported: Hypersensitivity reactions including bronchospasm, angioneurotic edema, and anaphylactic shock; more commonly reported as rash hives, and pruritus[Ref]


Postmarketing reports: Glossodynia, oral mucosal erythema, oral hypoesthesia, stomatitis[Ref]


Common (1% to 10%): Vasodilation, hypertension

Uncommon (0.1% to 1%): Angina pectoris, bradycardia, myocardial infarction, palpitations, tachycardia, hypotension, chest pain

Postmarketing reports: Peripheral edema, syncope, orthostatic hypotension, heart rate and rhythm disorders[Ref]


Common (1% to 10%): Amblyopia, lacrimal disorder

Uncommon (0.1% to 1%): Conjunctivitis, miosis[Ref]



Common (1% to 10%): Abnormal liver function tests


Frequency not reported: Cytolytic hepatitis, hepatitis with jaundice, transient asymptomatic elevations of hepatic transaminases, hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy.[Ref]

In clinical trials and in postmarketing reports, cases of cytolytic hepatitis and hepatitis with jaundice have been reported in association with buprenorphine use. The spectrum of abnormalities has ranged from transient asymptomatic elevations of hepatic transaminases to hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy. The presence of preexisting liver enzyme abnormalities, viral hepatitis, concomitant hepatotoxic drug use, and ongoing IV drug abuse may have played a causative or contributory role.[Ref]


Common (1% to 10%): Anxiety, depression, nervousness, abnormal thinking

Uncommon (0.1% to 1%): Abnormal dreams, agitation, apathy, depersonalization, drug dependence, euphoric mood, hostility

Frequency not reported: Restlessness, irritability

Postmarketing reports: Hallucination, attempted suicide, insomnia[Ref]


Very common (10% or more): Sweating (14%)

Common (1% to 10%): Pruritus, rash, urticaria, ecchymosis

Uncommon (0.1% to 1%): Acne, alopecia, dermatitis exfoliative, dry skin, skin mass, herpes simplex, skin nodule

Frequency not reported: Piloerection, cold sweat[Ref]


Common (1% to 10%): Urine abnormality

Uncommon (0.1% to 1%): Urinary tract infection, vaginal infection, albuminuria, dysuria, hematuria, urinary retention[Ref]


Uncommon (0.1% to 1%): Anemia, leucocytosis, leukopenia, lymphadenopathy, thrombocytopenia[Ref]


Common (1% to 10%): Influenza, infection[Ref]


Uncommon (0.1% to 1%): Decreased appetite, hyperglycemia, hyperlipidemia, hypoglycemia, decreased weight[Ref]


Common (1% to 10%): Back pain, arthralgia, muscle spasms, myalgia, rigid neck, leg cramps, joint disorder

Uncommon (0.1% to 1%): Arthritis

Frequency not reported: Arthralgia[Ref]


Uncommon (0.1% to 1%): Nephrolithiasis, blood creatinine increased[Ref]

Frequently asked questions


1. (2002) "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

4. (2015) "Product Information. Bunavail (buprenorphine-naloxone)." BioDelivery Sciences International, Inc.

5. (2015) "Product Information. Zubsolv (buprenorphine-naloxone)." Orexo US, Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.