Summary

Commonly reported side effects of buprenorphine/naloxone include: constipation, diarrhea, headache, and nausea. Continue reading for a comprehensive list of adverse effects.

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

• Chills
• cough
• feeling faint, dizzy, or lightheaded
• feeling of warmth or heat
• fever
• flushing or redness of the skin, especially on the face and neck
• headache
• hoarseness
• lower back or side pain
• painful or difficult urination
• sweating

Incidence not known

• Agitation
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest tightness
• darkening of the skin
• diarrhea
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, skin rash
• loss of appetite
• mental depression
• nausea
• overactive reflexes
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• restlessness shivering talking or acting with excitement you cannot control
• tingling of the hands or feet
• toothache
• trembling or shaking twitching
• unusual weight gain or loss
• vomiting

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

Symptoms of overdose

• Blurred vision
• confusion
• difficult or trouble breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• irregular, fast, slow, or shallow breathing
• pale or blue lips, fingernails, or skin
• pinpoint pupils
• relaxed and calm feeling
• sleepiness
• unusual tiredness or weakness

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

• Difficulty having a bowel movement
• lack or loss of strength
• stomach pain
• trouble sleeping

Less common

• Back pain
• diarrhea
• runny or stuffy nose
• sneezing

Incidence not known

• Burning or sore mouth
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings inside the mouth
• decline or loss of libido or sexual desire
• irritability
• mood swings
• poor concentration
• redness, swelling, or soreness of the tongue
• reduced muscle strength
• swelling, inflammation, or redness of the mouth

For Healthcare Professionals

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

General

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]

Other

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

Buprenorphine:

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]

Respiratory

Buprenorphine-naloxone:

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

Buprenorphine:

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]

Gastrointestinal

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]

Endocrine

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

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

Postmarketing reports: Disorders of pregnancy

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency^[Ref]

Hypersensitivity

Buprenorphine:

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

Naloxone:

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

Local

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

Cardiovascular

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]

Ocular

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

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

Hepatic

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]

Buprenorphine-naloxone:

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

Buprenorphine:

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

Psychiatric

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]

Dermatologic

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]

Genitourinary

Common (1% to 10%): Urine abnormality

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

Hematologic

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

Immunologic

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

Metabolic

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

Musculoskeletal

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]

Renal

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