Specifically, the Food and Drug Administration (FDA) has approved Belbuca for severe and persistent pain that needs long-term treatment. It’s used when other treatments aren’t managing your pain.
This article describes possible side effects of Belbuca. You can learn more about Belbuca by talking with your doctor.
Belbuca is a brand-name medication that comes as a film that dissolves inside your cheek. It isn’t available in a generic version.
Belbuca has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Side effects of Belbuca in detail” section and the “Warnings for Belbuca” section below.
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More common side effects of Belbuca
Belbuca may cause mild or serious side effects. Below are some of the more common side effects of this medication.
Commonly reported side effects of Belbuca include:
- nausea
- constipation
- headache
- drowsiness
- dizziness
Mild side effects of Belbuca
Belbuca may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.
Mild side effects of Belbuca that occurred in studies include:
Belbuca may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.
Serious side effects of Belbuca
Belbuca may cause certain serious side effects. If you have any serious side effects from Belbuca, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.
After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Belbuca.
Serious side effects of Belbuca that occurred in studies include:
- opioid-induced hyperalgesia (increased sensitivity to pain after taking an opioid)
- adrenal insufficiency (inability of the adrenal glands to make enough cortisol hormone)
- severely low blood pressure
- liver damage
- long QT syndrome (a certain type of heart rhythm problem)
- misuse and addiction*
- respiratory depression*
- overdose with accidental ingestion*
- serious harm if used with certain drugs*
- teeth problems†
- withdrawal symptoms†
- neonatal opioid withdrawal syndrome (NOWS)*
* Belbuca has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of Belbuca in detail” section and the “Warnings for Belbuca” section below.
† To learn more about this side effect, see the “Side effects of Belbuca in detail” section below.
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Get free cardAllergic reaction
For some people, Belbuca can cause an allergic reaction.
In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Belbuca, your doctor may recommend taking a different medication instead.
Common questions about side effects of Belbuca
Here are answers to some common questions about side effects of Belbuca. If you have other questions, talk with your doctor or pharmacist.
How do the side effects of Belbuca vs. Suboxone compare?
Belbuca and Suboxone are used for different medical purposes. Belbuca is approved to treat severe and persistent pain that isn’t managed by other treatments. Suboxone is used to treat opioid use disorder. With opioid use disorder, it’s difficult to stop taking opioids.
The active ingredient of each medication is also different. An active ingredient is what makes a drug work. Suboxone contains buprenorphine and naloxone while Belbuca only contains buprenorphine. So the side effects of these drugs may be different.
To learn about how the side effects of Belbuca and Suboxone compare, talk with your doctor or pharmacist. You can also view this article for more details about Suboxone’s side effects.
If I take Belbuca with gabapentin, will my risk of side effects increase?
Yes. Gabapentin is a central nervous system (CNS) depressant (drug that slows your brain function). Taking Belbuca with a CNS depressant can increase your risk of serious side effects. These include low blood pressure, respiratory depression, excessive sleepiness, and coma. It can even cause death in certain cases. Belbuca has a boxed warning for respiratory depression. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of Belbuca in detail” section below.
Due to this risk, your doctor likely won’t prescribe gabapentin and Belbuca together unless this combination is the best or only treatment option. If you and your doctor decide that you’ll take these medications, you and your loved ones should look out for signs or symptoms of respiratory depression. These include:
- shallow breaths
- extreme sleepiness
- change in skin color
- confusion
- long periods between breaths
If you develop any of these symptoms, call 911 or a local emergency number to get medical help right away.
Talk with your doctor or pharmacist if you have questions about taking gabapentin with Belbuca.
Does Belbuca cause long-term side effects?
Yes, in some cases Belbuca may cause long-term side effects. These can last for a while after you’ve stopped taking the drug.
Examples of long-term side effects reported with Belbuca include:
- liver damage
- drug dependence
- teeth problems*
Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of Belbuca may last.
* To learn more about this side effect, see the “Side effects of Belbuca in detail” section below.
Side effects of Belbuca in detail
Below you’ll find details on some of the side effects of Belbuca.
Boxed warnings
Below are details about boxed warnings for Belbuca. Boxed warnings are the most serious warnings from the FDA.
Risk of misuse and addiction
Taking Belbuca can lead to misuse and addiction. With misuse, a drug is taken in a way other than how a doctor prescribes it. With addiction, a drug is used even if it’s causing harmful outcomes.
Addiction can occur even if Belbuca is taken at the recommended dosage. And the risk is higher if you misuse Belbuca. Other factors can increase the risk of misuse and addiction with Belbuca. These include a personal or family history of substance use disorder or mental health conditions.
Ways to manage
To lower the risk of misuse and addiction, take Belbuca exactly as prescribed by your doctor. And don’t share your medication with anyone.
If you experience misuse or addiction, tell your doctor. They’ll likely recommend ways to get help.
Respiratory depression
Belbuca can cause respiratory depression, even if it’s taken as recommended. Respiratory depression can be life threatening if it’s not recognized right away and treated. It can happen at any time during treatment. But the risk is highest when you first start Belbuca or when the dosage is increased.
With respiratory depression, your breathing becomes slowed or stopped. Symptoms may include:
- shallow breaths
- extreme sleepiness
- change in skin color
- confusion
- long periods between breaths
Certain factors can increase the risk of respiratory depression with Belbuca. These include:
- being weak or undernourished
- being age 65 years or older
- drinking alcohol
- taking other medications that cause respiratory depression
Ways to manage
If you or your loved ones recognize that you have symptoms of respiratory depression, call 911 or a local emergency number to get medical help right away. Your doctor may prescribe naloxone (Narcan) with Belbuca to help treat symptoms of respiratory depression. To learn more about this, talk with your doctor or pharmacist.
Risk of overdose with accidental ingestion
Accidentally taking even one dose of Belbuca can lead to respiratory depression, overdose, and even death. This risk is especially high for children.
Symptoms of Belbuca overdose may include:
- cold or clammy skin
- coma
- severe sleepiness
- breathing problems
- lack of muscle tone
Ways to manage
To lower the risk of accidental ingestion, keep Belbuca in a secure place that’s out of reach of children.
If you experience any symptoms of Belbuca overdose, get emergency medical help right away by calling 911 or a local emergency number.
Risk of serious harm if used with certain drugs
Taking Belbuca with certain medications can increase your risk of serious side effects, such as extreme sleepiness, slowed breathing, coma, or death. These medications include CNS depressants, such as sedatives, benzodiazepines, and muscle relaxants.
Ways to manage
To lower this risk, doctors typically won’t prescribe Belbuca if you’re taking other CNS depressants. If you and your doctor decide that you’ll take both medications, your doctor will likely prescribe the lowest effective dosage of Belbuca for the shortest amount of time needed.
Teeth problems
Belbuca can cause teeth problems. These include broken or cracked teeth, cavities, infection, tooth decay, and tooth loss. These problems can occur in people with or without a history of dental issues.
Ways to manage
Due to this risk, it’s important to take good care of your teeth while taking Belbuca. This includes:
- having regular dental checkups
- rinsing your mouth with water and swallowing the water after Belbuca is completely dissolved
- waiting at least one hour after taking Belbuca to brush your teeth
- avoiding touching or moving Belbuca with your tongue or fingers
If you develop any teeth problems, contact your doctor and dentist right away. Be sure to tell your dentist that you’re taking Belbuca.
Withdrawal symptoms
Belbuca can cause drug dependence and withdrawal symptoms. With dependence, your body needs the drug to feel like it usually does. Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on. They may include:
- restlessness
- watery eyes
- runny nose
- abdominal cramps
- loss of appetite
- diarrhea
- suicidal thoughts
Due to this risk, you shouldn’t stop taking Belbuca or lower your dosage without talking with your doctor. Doing so can cause withdrawal symptoms and return of your pain.
Ways to manage
If you’re interested in stopping Belbuca treatment, first talk with your doctor. They’ll likely lower your Belbuca dosage slowly over time until it’s safe for you to stop the drug completely. If you experience withdrawal symptoms while taking Belbuca, talk with your doctor right away.
Suicide prevention
If you or someone you know is in crisis and considering suicide or self-harm, please seek support:
- Call the 988 Suicide and Crisis Lifeline at 988.
- Text HOME to the Crisis Text Line at 741741.
- Not in the United States? Find a helpline in your country with Befrienders Worldwide.
- Call 911 or your local emergency services number if you feel safe to do so.
If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.
If you are not in the same household, stay on the phone with them until help arrives.
Warnings for Belbuca
Below are some factors you may want to discuss with your doctor before taking Belbuca.
Boxed warning
Belbuca has boxed warnings. A boxed warning is the most serious warning from the FDA.
For details, see the “Side effects of Belbuca in detail” section above and the “Belbuca and pregnancy” section below.
Other warnings
It may not be safe for you to take Belbuca if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Belbuca is a safe treatment option for you.
Before taking Belbuca, tell your doctor about your health and medications you take. Things to consider include:
- head injuries or seizures
- liver, kidney, or thyroid problems
- difficulty urinating
- tooth problems
- heart rhythm problems
- pancreas or gallbladder problems
- past allergic reaction to Belbuca
Belbuca and pregnancy
Belbuca has a boxed warning about certain risks if the drug is used during pregnancy.
Boxed warning: Risk of neonatal opioid withdrawal syndrome
Belbuca has a boxed warning about the risk of neonatal opioid withdrawal syndrome. A boxed warning is the most serious warning from the FDA.
Taking Belbuca for a long period of time during pregnancy can cause NOWS. Withdrawal symptoms are side effects that can occur when you stop taking a drug your body is used to. In this case, the withdrawal symptoms affect your newborn. These symptoms include:
- problems gaining weight
- high-pitched crying
- sleep problems
Due to this risk, doctors typically won’t prescribe Belbuca during pregnancy unless the benefits outweigh the risks. If your doctor has prescribed Belbuca during your pregnancy, they’ll monitor your newborn for symptoms of NOWS and treat them as needed. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.
Belbuca and breastfeeding
Belbuca should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with Belbuca.
Belbuca and alcohol
Belbuca is known to interact with alcohol.
Combining alcohol and Belbuca can lead to life threatening respiratory depression. Belbuca has a boxed warning for respiratory depression. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of Belbuca in detail” section above.
If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Belbuca.
Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.