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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
  • headache
  • lower back or side pain
  • painful or difficult urination
  • sweating
Incidence not known
  • 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
  • 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 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
  • nausea
  • pain
  • trouble sleeping
  • vomiting
Less common
  • Back pain
  • diarrhea
  • runny nose
  • sneezing
  • stuffy nose

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[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]

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

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]

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]

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Subutex (buprenorphine)." Reckitt and Colman Pharmaceuticals Inc, Richmond, VA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

5. "Product Information. Zubsolv (buprenorphine-naloxone)." Orexo US, Inc, New York City, NY.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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