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Butrans

Generic Name: buprenorphine transdermal (skin patch) (BUE pre NOR feen)
Brand Names: Butrans
Butrans (buprenorphine) transdermal patches are used to treat moderate to severe chronic pain. Includes Butrans side effects, interactions and indications.
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Drug Information:
Butrans skin patches contain Buprenorphine, an opioid pain medication. An opioid is sometimes called a narcotic. Butrans skin patches are used for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines. Butrans is not for use on an as-needed basis for pain. You should not use Butrans skin patches if you have severe asthma or breathing problems, or a blockage in your stomach or intestines. Buprenorphine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using Butrans without a prescription. Keep the medication in a place where others cannot get to it. Learn more

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Butrans Side Effects

Note: This document contains side effect information about buprenorphine. Some of the dosage forms listed on this page may not apply to the brand name Butrans.

In Summary

Common side effects of Butrans include: constipation, dizziness, drowsiness, headache, and nausea. Other side effects include: fatigue, vomiting, hyperhidrosis, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to buprenorphine: film, tablet

Other dosage forms:

  • injection solution
  • intradermal implant
  • transdermal patch extended release

Warning

Buccal mucosa route (Film)

Addiction, Abuse, and MisuseBuprenorphine exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing buprenorphine, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of buprenorphine. Monitor for respiratory depression, especially during initiation of buprenorphine or following a dose increase. Misuse or abuse of buprenorphine by chewing, swallowing, snorting or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death.Accidental ExposureAccidental exposure to even one dose of buprenorphine, especially by children, can result in a fatal overdose of buprenorphine.Neonatal Opioid Withdrawal SyndromeProlonged use of buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of buprenorphine and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Along with its needed effects, buprenorphine (the active ingredient contained in Butrans) 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:

Less common

  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty breathing
  • dizziness
  • fever
  • frequent urge to urinate
  • headache
  • loss of appetite
  • lower back or side pain
  • mouth or throat pain
  • nausea
  • nervousness
  • pale skin
  • pounding in the ears
  • rapid weight gain
  • slow or fast heartbeat
  • stomach pain
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss

Rare

  • Breakdown or tearing of the skin
  • chills
  • irregular heartbeat, recurrent
  • irritation, itching, pain, redness, swelling, tenderness, or warmth on the skin
  • unusual drowsiness, dullness, or feeling of sluggishness

Incidence not known

  • Agitation
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • blurred vision
  • confusion
  • cough
  • darkening of the skin
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • headache, severe and throbbing
  • hives, skin rash
  • irregular, fast, slow, or shallow breathing
  • mental depression
  • overactive reflexes
  • pale or blue lips, fingernails, or skin
  • pinpoint pupils
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • relaxed and calm feeling
  • restlessness
  • shivering
  • sleepiness
  • talking or acting with excitement you cannot control
  • trembling or shaking
  • twitching
  • vomiting

Some side effects of buprenorphine 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

  • Back pain
  • chills
  • cough
  • difficulty having a bowel movement
  • hoarseness
  • painful or difficult urination
  • runny nose
  • sneezing
  • stuffy nose
  • trouble sleeping

Less common

  • Anxiety
  • back pain
  • bruise
  • decreased appetite
  • fall
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • itching, skin rash
  • muscle aches or spams
  • pain or tenderness around eyes and cheekbones
  • sore throat

Rare

  • Lack or loss of strength
  • muscle or bone pain
  • neck pain
  • stomach discomfort
  • toothache

For Healthcare Professionals

Applies to buprenorphine: buccal film, compounding powder, injectable solution, subcutaneous solution extended release, subdermal implant, sublingual tablet, transdermal film extended release

General

The most common adverse reactions have included 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.

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

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

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

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

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, increased creatine phosphokinase (CPK)

Uncommon (0.1% to 1%): Muscle cramps, rigors, muscle spasm

Very rare (less than 0.01%): Muscle fasciculation, ear pain

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

Immunologic

Very common (10% or more): Infection (up to 22%), flu syndrome (up to 10%)

Common (1% to 10%): Abscess

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, sedation

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, serotonin syndrome

Cardiovascular

QT prolongation has been observed. In clinical trials of buprenorphine (the active ingredient contained in Butrans) buccal film (n=1590), post-baseline QTcF values of 450 to 480 milliseconds were observed in 2% of patients at doses up to 900 mcg every 12 hours. In a QT study in healthy subjects, therapeutic doses (10 mcg/hour transdermal patch) had no effect on the QTc interval, but higher doses (40 mcg/hour) were associated with a mean prolongation of 5.9 milliseconds.

During clinical trials, serial ECGs were collected to evaluate the effect of extended-release subcutaneous administration of buprenorphine on QT prolongation. Seven patients showed a greater than 60 msec increase QTc from baseline. One patient had a QTc greater than 500 msec. These QTc findings were reported as sporadic and transient and none led to aberrant ventricular rhythm. Review of ECG and adverse event data showed no evidence of syncope, seizure, or ventricular tachycardia or fibrillation.

Common (1% to 10%): Vasodilation, hypotension, peripheral edema, hypertension, palpitations

Uncommon (0.1% to 1%): Orthostatic hypotension, tachycardia, angina pectoris, flushing, bradycardia, cyanosis, , QT prolongation

Frequency not reported: Wenckebach block

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

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

Metabolic

Common (1% to 10%): Anorexia

Uncommon (0.1% to 1%): Dehydration, loss of appetite, weight decreased

Postmarketing reports: Neonatal feeding disorder

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

Anaphylaxis has been reported with ingredients contained in the implant. Anaphylaxis has been reported with ingredients contained in extended-release subcutaneous injection.

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased gamma-glutamyl transferase (GGT)

Rare (less than 0.1%): Biliary colic

Frequency not reported: Hepatitis, jaundice, hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy, transaminases increased

Local

Very common (10% or more): Implant site pain (13%), implant site pruritus (12%), implant site erythema (10%)

Common (1% to 10%): implant site hematoma, implant site hemorrhage, implant site edema, injection site pain, injection site pruritus, injection site erythema, injection site induration

Uncommon (0.1% to 1%): Injection site bruising, injection site swelling, injection site discomfort, injection site reaction, injection site cellulitis, injection site infection

Endocrine

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency

Cases of androgen deficiency have been reported with chronic use of opioids. Adrenal insufficiency has been reported with opioid use, especially with use of 1 month or longer.

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Butrans (www.drugs.com/butrans.html).