Name: Belbuca

Side Effects of Belbuca

Belbuca can cause serious side effects. See “Belbuca Precautions.”

The most common side effects of Belbuca include:

  • nausea
  • constipation 
  • headache
  • vomiting
  • fatigue
  • dizziness
  • somnolence
  • diarrhea
  • dry mouth
  • upper respiratory tract infection

Constipation (incomplete or hard bowel movements) is a very common side effect of all opioid medicines. Talk to your doctor about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using Belbuca.

Talk to your doctor about any side effect that bother you or do not go away.

These are not all the possible side effects of Belbuca. For a complete list, ask your doctor or pharmacist.

Inform MD

Before applying Belbuca, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • heart rhythm problems (long QT syndrome)
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of Belbuca during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with Belbuca. It may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Belbuca with certain other medicines can cause serious side effects and could lead to death.

Belbuca and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in Belbuca, buprenorphine, has been detected in breast milk. Because of the potential for serious adverse effects in the nursing infant, breastfeeding is not recommended during treatment with Belbuca.

Belbuca Dosage

Take Belbuca exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Belbuca dose your doctor recommends will be based on the following: 

  • the condition being treated and the severity of your pain
  • other medical conditions you have
  • other medications you are taking or have taken for pain
  • how you respond to this medication

The recommended starting dose for a patient that has not been taking opioid medications is one 75 mcg film once daily or, if tolerated, every 12 hours for at least 4 days, then increase dose to 150 mcg every 12 hours. The dose may be gradually increased to a dose that provides adequate pain relief and minimizes adverse reactions should proceed in increments of 150 mcg every 12 hours, no more frequently than every 4 days.

The maximum Belbuca dose is 900 mcg every 12 hours. 

Belbuca Side Effects

Along with its needed effects, a medicine 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:

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
  • sleepiness
  • unusual tiredness or weakness

Some side effects 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
  • 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
  • sneezing
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

How is this medicine (Belbuca) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Take Belbuca at the same time of day.
  • Do not use if the pouch that holds this medicine is torn, open, or not sealed all the way.
  • Do not use for fast pain relief or on an as needed basis.
  • Do not use for pain relief after surgery if you have not been taking drugs like Belbuca (buprenorphine buccal film).
  • Do not use this medicine if it is cut, damaged, or changed in any way.
  • Do not put Belbuca on any areas with sores.
  • Use right after opening.
  • Wash your hands before use.
  • Be sure your hands are dry before you touch this medicine.
  • Wet the inside of your cheek with your tongue or water.
  • Place the film inside the mouth on a wet cheek. Place the yellow side of the film against the inside of the cheek. Hold for 5 seconds so it sticks to the cheek. Let it melt.
  • Do not touch or move Belbuca with your tongue or finger after it has been placed.
  • Do not eat or drink until this medicine has melted all the way.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Indications and Usage for Belbuca

Belbuca is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of  Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve Belbuca for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Belbuca is not indicated as an as-needed (prn) analgesic.