Recommended Topic Related To:

Butrans

"Nov. 26, 2014 -- Gift-buying season is here, and on top of the wish list for most people is the latest tech gadget or gizmo. But some experts are concerned that more tech may equal more pain for frequent users.

For starters, we take"...

Butrans

Butrans Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Butrans (buprenorphine) is used to help relieve moderate to severe ongoing pain (such as due to arthritis, chronic back pain). It is a narcotic (opiate) analgesic. Common side effects include nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache. Mild irritation, itching, or redness at the application site may also occur.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Butrans in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Butrans Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, dry mouth, or headache may occur. Irritation, itching, or redness at the application site may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), difficulty urinating, swelling/blistering at the patch application site.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up, fast/irregular heartbeat, severe dizziness.

This drug may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, yellowing eyes/skin, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Butrans (Buprenorphine Transdermal System)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Butrans FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 Double-Blind Treatment Period
BUTRANS
(N = 1024)
BUTRANS
(N = 256)
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 Double-Blind Treatment Period
BUTRANS
(N = 1160)
BUTRANS 20
(N = 219)
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.

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

A A A

Butrans - User Reviews

Butrans User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Butrans sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Chronic Pain/Back Pain

Find tips and advances in treatment.