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Butrans

Last reviewed on RxList: 8/25/2017
Butrans Side Effects Center

Last reviewed on RxList 8/25/2017

Butrans (buprenorphine) is a narcotic (opiate) analgesic used to help relieve moderate to severe ongoing pain (such as due to arthritis, chronic back pain). Common side effects of Butrans include:

  • nausea,
  • vomiting,
  • constipation,
  • dry mouth,
  • upset stomach,
  • lightheadedness,
  • dizziness,
  • drowsiness,
  • headache, or
  • irritation, itching, redness, or skin rash where the patch was worn.

Tell your doctor if you have serious side effects of Butrans including:

The dose of Butrans is individualized and based on the patient's medical condition, the severity of the pain, and other factors. It is for transdermal use (on intact skin) only. Butrans is worn for 7 days. Butrans may interact with pain medications, narcotic antagonists, cimetidine, nefazodone, St. John's wort, azole antifungals, calcium channel blockers, HIV drugs, macrolide antibiotics, rifamycins, anti-seizure medications, or other products that may also affect breathing or cause drowsiness including alcohol, allergy or cough-and-cold products, medicine for sleep or anxiety, muscle relaxants, other narcotics, and psychiatric medicines. Tell your doctor all medications and supplements you use. During pregnancy, Butrans should be used only when prescribed. It may slightly increase risk of birth defects if used during the first two months of pregnancy. Using it near the expected delivery date may harm the fetus. Tell the doctor if you notice symptoms in your newborn such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Butrans (buprenorphine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Butrans Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using buprenorphine and call your doctor at once if you have a serious side effect such as:

  • slow heart rate, weak or shallow breathing, deep sighs, snoring that is new or unusual;
  • confusion, severe dizziness, feeling like you might pass out;
  • blisters, swelling, or severe irritation where the patch was worn;
  • seizure (convulsions); or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • vomiting, dry mouth, upset stomach, constipation;
  • mild dizziness or drowsiness; or
  • redness, itching, or mild skin rash where the patch was worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Butrans (Buprenorphine Transdermal System)

Butrans Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 5,415 patients were treated with BUTRANS in controlled and open-label chronic pain clinical trials. Nine hundred twenty-four subjects were treated for approximately six months and 183 subjects were treated for approximately one year. The clinical trial population consisted of patients with persistent moderate to severe pain.

The most common serious adverse drug reactions (all <0.1%) occurring during clinical trials with BUTRANS were: chest pain, abdominal pain, vomiting, dehydration, and hypertension/blood pressure increased.

The most common adverse events (≥ 2%) leading to discontinuation were: nausea, dizziness, vomiting, headache, and somnolence.

The most common adverse reactions (≥ 5%) reported by patients in clinical trials comparing BUTRANS 10 or 20 mcg/hour to placebo are shown in Table 2, and comparing BUTRANS 20 mcg/hour to BUTRANS 5 mcg/hour are shown in Table 3 below:

Table 2: Adverse Reactions Reported in ≥ 5% of Patients during the Open- Label Titration Period and Double-Blind Treatment Period: Opioid-Na´ve Patients

MedDRA Preferred Term Open-Label Titration Period BUTRANS
(N = 1024)
Double-Blind BUTRANS
(N = 256)
Treatment Period Placebo
(N = 283)
Nausea 23% 13% 10%
Dizziness 10% 4% 1%
Headache 9% 5% 5%
Application site pruritus 8% 4% 7%
Somnolence 8% 2% 2%
Vomiting 7% 4% 1%
Constipation 6% 4% 1%

Table 3: Adverse Reactions Reported in ≥ 5% of Patients during the Open- Label Titration Period and Double-Blind Treatment Period: Opioid- Experienced Patients

MedDRA Preferred Term Open-Label Titration Period BUTRANS
(N = 1160)
Double-Blind BUTRANS 20
(N = 219)
Treatment Period BUTRANS 5
(N = 221)
Nausea 14% 11% 6%
Application site pruritus 9% 13% 5%
Headache 9% 8% 3%
Somnolence 6% 4% 2%
Dizziness 5% 4% 2%
Constipation 4% 6% 3%
Application site erythema 3% 10% 5%
Application site rash 3% 8% 6%
Application site irritation 2% 6% 2%

The following table lists adverse reactions that were reported in at least 2.0% of patients in four placebo/active-controlled titration-to-effect trials.

Table 4: Adverse Reactions Reported in Titration-to-Effect Placebo/Active- Controlled Clinical Trials with Incidence ≥ 2%

MedDRA Preferred Term BUTRANS
(N = 392)
Placebo
(N = 261)
Nausea 21% 6%
Application site pruritus 15% 12%
Dizziness 15% 7%
Headache 14% 9%
Somnolence 13% 4%
Constipation 13% 5%
Vomiting 9% 1%
Application site erythema 7% 2%
Application site rash 6% 6%
Dry mouth 6% 2%
Fatigue 5% 1%
Hyperhidrosis 4% 1%
Peripheral edema 3% 1%
Pruritus 3% 0%
Stomach discomfort 2% 0%

The adverse reactions seen in controlled and open-label studies are presented below in the following manner: most common (≥ 5%), common (≥ 1% to < 5%), and less common (< 1%).

The most common adverse reactions (≥ 5%) reported by patients treated with BUTRANS in the clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash.

The common(≥ 1% to < 5%) adverse reactions reported by patients treated with BUTRANS in the clinical trials organized by MedDRA (Medical Dictionary for Regulatory Activities) System Organ Class were:

Gastrointestinal disorders: diarrhea, dyspepsia, and upper abdominal pain

General disorders and administration site conditions: fatigue, peripheral edema, application site irritation, pain, pyrexia, chest pain, and asthenia

Infections and infestations: urinary tract infection, upper respiratory tract infection, nasopharyngitis, influenza, sinusitis, and bronchitis

Injury, poisoning and procedural complications: fall

Metabolism and nutrition disorders: anorexia

Musculoskeletal and connective tissue disorders: back pain, arthralgia, pain in extremity, muscle spasms, musculoskeletal pain, joint swelling, neck pain, and myalgia

Nervous system disorders: hypoesthesia, tremor, migraine, and paresthesia

Psychiatric disorders: insomnia, anxiety, and depression

Respiratory, thoracic and mediastinal disorders: dyspnea, pharyngolaryngeal pain, and cough

Skin and subcutaneous tissue disorders: pruritus, hyperhidrosis, rash, and generalized pruritus

Vascular disorders: hypertension

Other less common adverse reactions, including those known to occur with opioid treatment, that were seen in < 1% of the patients in the BUTRANS trials include the following in alphabetical order:

Abdominal distention, abdominal pain, accidental injury, affect lability, agitation, alanine aminotransferase increased, angina pectoris, angioedema, apathy, application site dermatitis, asthma aggravated, bradycardia, chills, confusional state, contact dermatitis, coordination abnormal, dehydration, depersonalization, depressed level of consciousness, depressed mood, disorientation, disturbance in attention, diverticulitis, drug hypersensitivity, drug withdrawal syndrome, dry eye, dry skin, dysarthria, dysgeusia, dysphagia, euphoric mood, face edema, flatulence, flushing, gait disturbance, hallucination, hiccups, hot flush, hyperventilation, hypotension, hypoventilation, ileus, insomnia, libido decreased, loss of consciousness, malaise, memory impairment, mental impairment, mental status changes, miosis, muscle weakness, nervousness, nightmare, orthostatic hypotension, palpitations, psychotic disorder, respiration abnormal, respiratory depression, respiratory distress, respiratory failure, restlessness, rhinitis, sedation, sexual dysfunction, syncope, tachycardia, tinnitus, urinary hesitation, urinary incontinence, urinary retention, urticaria, vasodilatation, vertigo, vision blurred, visual disturbance, weight decreased, and wheezing.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of buprenorphine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in BUTRANS.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Butrans (Buprenorphine Transdermal System)

Related Resources for Butrans

Read the Butrans User Reviews »

© Butrans Patient Information is supplied by Cerner Multum, Inc. and Butrans Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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