Buprenorphine Hcl/naloxon

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

Applies to buprenorphine / naloxone: film, tablet

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
• 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 tightness in the chest
• tingling of the hands or feet
• 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 troubled 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

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 nose
• sneezing
• stuffy nose

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

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.

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

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

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

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.

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

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

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

Postmarketing reports: Glossodynia, oral mucosal erythema, oral hypoesthesia, stomatitis

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

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

Uncommon (0.1% to 1%): Conjunctivitis, miosis

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.

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.

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

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

Common (1% to 10%): Urine abnormality

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

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

Common (1% to 10%): Influenza, infection

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

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

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