Medication Guide App

Subutex Side Effects

Generic Name: buprenorphine

Note: This page contains side effects data for the generic drug buprenorphine. It is possible that some of the dosage forms included below may not apply to the brand name Subutex.

It is possible that some side effects of Subutex may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to buprenorphine: sublingual tablet

As well as its needed effects, buprenorphine (the active ingredient contained in Subutex) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking buprenorphine, check with your doctor immediately:

Incidence not known
  • 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
  • shortness of breath
  • sleepiness
  • unusual tiredness or weakness

Some buprenorphine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Back pain
  • cough or hoarseness
  • difficulty having a bowel movement (stool)
  • fever or chills
  • headache
  • lower back or side pain
  • nausea
  • painful or difficult urination
  • runny nose
  • sleeplessness
  • sneezing
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • unable to sleep
  • vomiting
Less common
  • Diarrhea
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • lack or loss of strength
  • sweating

For Healthcare Professionals

Applies to buprenorphine: compounding powder, injectable solution, sublingual tablet, transdermal film extended release

General

The most common adverse reactions were headache, insomnia, pain, signs and symptoms of withdrawal, nausea, constipation, application site pruritus, application site erythema, vomiting, hyperhidrosis, dizziness, somnolence, dry mouth, and application site rash.[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 28%), withdrawal syndrome (up to 24%), anxiety (up to 14%), depression (up to 13%)
Common (1% to 10%): Hostility, agitation, paranoid reaction, thinking abnormal, confusion
Uncommon (0.1% to 1%): Affect lability, depersonalization, libido decreased, nightmare, euphoric mood, psychosis, hallucination, euphoria
Very rare (less than 0.01%): Dependence, mood swings
Frequency not reported: Dreaming
Postmarketing reports: Neonatal withdrawal syndrome[Ref]

Respiratory

Very common (10% or more): Rhinitis (up to 15%)
Common (1% to 10%): Cough increased, pharyngitis, upper respiratory tract infection, influenza, sinusitis, bronchitis, dyspnea, pharyngolaryngeal pain, hypoventilation, yawning
Uncommon (0.1% to 1%): Asthma aggravated, hiccups, hyperventilation, hypoxia, wheezing, apnea
Rare (less than 0.1%): Respiratory depression, respiratory failure
Postmarketing reports: Asphyxia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 23%), constipation (up to 14%), abdominal pain (11.7%), diarrhea (up to 10%)
Common (1% to 10%): Vomiting, dyspepsia, dry mouth, stomach discomfort, upper abdominal pain, flatulence
Rare (0.01% to 0.1%): Diverticulitis, dysphagia, ileus, heartburn
Very rare (less than 0.01%): Retching[Ref]

Dermatologic

Very common (10% or more): Application site pruritus (up to 15%), sweating (up to 13%), application site erythema (up to 10%)
Common (1% to 10%): Application site rash, application site irritation, hyperhidrosis, pruritus, rash, generalized pruritus
Uncommon (0.1% to 1%): Contact dermatitis, application site dermatitis, dry skin, facial edema, urticaria, pallor
Very rare (less than 0.01%): Pustules, vesicles
Frequency not reported: Injection site reaction, angioedema, application site edema[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 16%)
Common (1% to 10%): Arthralgia, pain in extremity, muscle spasm, musculoskeletal pain, joint swelling, neck pain, myalgia, chest pain, leg cramps, bone pain, general spasm, muscle weakness
Uncommon (0.1% to 1%): Muscle cramps, rigors, muscle spasm
Very rare (less than 0.01%): Muscle fasciculation, ear pain[Ref]

Other

Very common (10% or more): Pain (up to 26%), asthenia (up to 16%)
Common (1% to 10%): Chills, fever, accidental injury, fatigue, pyrexia, fall, malaise, tiredness, lethargy
Uncommon (0.1% to 1%): Edema
Frequency not reported: Death[Ref]

Immunologic

Very common (10% or more): Infection (up to 22%), flu syndrome (up to 10%)
Common (1% to 10%): Abscess[Ref]

Nervous system

Very common (10% or more): Headache (up to 34%)
Common (1% to 10%): Dizziness/vertigo, nervousness, somnolence, hypoesthesia, tremor, migraine, paresthesia, syncope, hypertonia, dysgeusia, exanthema
Uncommon (0.1% to 1%): Tinnitus, concentration impairment, coordination abnormal, dysarthria, memory impairment, restlessness, sedation, sleep disorder, slurred speech, coma
Rare (less than 0.1%): Disequilibrium, numbness
Frequency not reported: Convulsions
Postmarketing reports: Neonatal tremor[Ref]

Cardiovascular

Common (1% to 10%): Vasodilation, hypotension, peripheral edema, hypertension, palpitations
Uncommon (0.1% to 1%): Orthostatic hypotension, tachycardia, angina pectoris, flushing, bradycardia, cyanosis
Frequency not reported: Wenckebach block[Ref]

Ocular

Common (1% to 10%): Runny eyes, miosis, mydriasis, lacrimation disorder
Uncommon (0.1% to 1%): Dry eye, vision blurred, conjunctivitis
Rare (less than 0.1%): Eyelid edema, visual disturbance
Frequency not reported: Diplopia, visual abnormalities, amblyopia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, dysmenorrhea
Uncommon (0.1% to 1%): Urinary incontinence, urinary retention
Rare (less than 0.1%): Urinary hesitation, decreased erection, sexual dysfunction[Ref]

Metabolic

Common (1% to 10%): Anorexia
Uncommon (0.1% to 1%): Dehydration, loss of appetite, weight decreased
Postmarketing reports: Neonatal feeding disorder[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction
Rare (0.01% to 0.1%): Anaphylactic responses
Very rare (less than 0.01%): Serious allergic reactions[Ref]

Hepatic

Rare (less than 0.1%): Biliary colic
Frequency not reported: Hepatitis, jaundice, hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy, transaminases increased[Ref]

References

1. "Product Information. Butrans (buprenorphine)." Purdue Pharma LP, Stamford, CT.

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

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

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

5. "Product Information. Buprenex (buprenorphine)." Reckitt and Colman Pharmaceutical, Richmond, VA.

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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