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Belbuca Side Effects

Generic name: buprenorphine

Medically reviewed by Drugs.com. Last updated on Apr 19, 2023.

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

Applies to buprenorphine: injection solution. Other dosage forms:

Warning

Injection route (Solution)

Use of buprenorphine hydrochloride increases the risk of opioid addiction, abuse, or misuse, which may cause overdose or death. Assess the risk prior to therapy and monitor for signs of addiction, abuse, or misuse during therapy. Serious, life-threatening, or fatal respiratory depression may occur, particularly at treatment initiation and with dose increases. Monitor for signs of respiratory depression during treatment. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome, which may be life-threatening if unnoticed and untreated. If prolonged use is required in a pregnant woman, advise the patient of the risk to the fetus. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation.

Serious side effects of Belbuca

Along with its needed effects, buprenorphine (the active ingredient contained in Belbuca) 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 or nurse immediately if any of the following side effects occur while taking buprenorphine:

More common

Rare

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking buprenorphine:

Symptoms of overdose

Other side effects of Belbuca

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:

Less common

Rare

Incidence not known

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.[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

Immunologic

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

Common (1% to 10%): Abscess[Ref]

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[Ref]

Cardiovascular

QT prolongation has been observed. In clinical trials of buprenorphine (the active ingredient contained in Belbuca) 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.[Ref]

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[Ref]

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[Ref]

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[Ref]

Metabolic

Common (1% to 10%): Anorexia

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

Postmarketing reports: Neonatal feeding disorder[Ref]

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[Ref]

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

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[Ref]

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[Ref]

Endocrine

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.[Ref]

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Frequently asked questions

References

1. Product Information. Subutex (buprenorphine). Reckitt and Colman Pharmaceuticals Inc. 2002.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. Product Information. Butrans (buprenorphine). Purdue Pharma LP. 2010.

5. Product Information. Sublocade (buprenorphine). Reckitt Benckiser Pharmaceuticals Inc. 2018.

6. Product Information. Buprenex (buprenorphine). Reckitt and Colman Pharmaceuticals Inc. 2001;PROD.

7. Product Information. Probuphine (buprenorphine). Braeburn Pharmaceuticals. 2016.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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