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Commonly reported side effects of buprenorphine/naloxone include: constipation, diarrhea, headache, and nausea. See below for a comprehensive list of adverse effects.
For the ConsumerApplies 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
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine / naloxone:
Symptoms of overdose
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
GeneralThe 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.
OtherVery 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
Nervous systemVery 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
RespiratoryBuprenorphine-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.
GastrointestinalVery 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
EndocrineCommon (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
HypersensitivityBuprenorphine:
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
LocalPostmarketing reports: Glossodynia, oral mucosal erythema, oral hypoesthesia, stomatitis
CardiovascularCommon (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
OcularCommon (1% to 10%): Amblyopia, lacrimal disorder
Uncommon (0.1% to 1%): Conjunctivitis, miosis
HepaticBuprenorphine-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.
PsychiatricCommon (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
DermatologicVery 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
GenitourinaryCommon (1% to 10%): Urine abnormality
Uncommon (0.1% to 1%): Urinary tract infection, vaginal infection, albuminuria, dysuria, hematuria, urinary retention
HematologicUncommon (0.1% to 1%): Anemia, leucocytosis, leukopenia, lymphadenopathy, thrombocytopenia
ImmunologicCommon (1% to 10%): Influenza, infection
MetabolicUncommon (0.1% to 1%): Decreased appetite, hyperglycemia, hyperlipidemia, hypoglycemia, decreased weight
MusculoskeletalCommon (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
RenalUncommon (0.1% to 1%): Nephrolithiasis, blood creatinine increased
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Buprenorphine Hcl/naloxon (www.drugs.com/mtm/buprenorphine-and-naloxone-oral-sublingual.html).
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