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Bunavail

Last reviewed on RxList: 4/1/2021
Bunavail Side Effects Center

What Is Bunavail?

Bunavail (buprenorphine and naloxone) Buccal Film is a combination of an opioid partial agonist-antagonist and an opioid receptor antagonist used for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

What Are Side Effects of Bunavail?

Common side effects of Bunavail include:

  • headache,
  • drug withdrawal syndrome,
  • lethargy (lack of energy),
  • weakness,
  • increased sweating,
  • constipation,
  • sleep problems (insomnia),
  • fatigue and sleepiness,
  • tongue pain or redness,
  • numbness inside your mouth,
  • runny or stuffy nose,
  • watery eyes,
  • nausea,
  • vomiting,
  • depression,
  • anxiety,
  • swelling in your arms or legs,
  • abscess,
  • chills,
  • fever,
  • flu symptoms,
  • infection,
  • back pain,
  • diarrhea,
  • indigestion,
  • dizziness,
  • insomnia,
  • nervousness,
  • cough, and
  • sore throat.

Dosage for Bunavail

Bunavail buccal film is applied to the buccal mucosa as a single daily dose.

What Drugs, Substances, or Supplements Interact with Bunavail?

Bunavail may interact with azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, HIV protease inhibitors, efavirenz, phenobarbital, carbamazepine, phenytoin, rifampicin, NNRTIs such as efavirenz and delavirdine, and benzodiazepines. Tell your doctor all medications and supplements you use.

Bunavail During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before taking Bunavail. If you become pregnant while taking this drug, tell your doctor as there may be significant risks to you and your baby; your baby may have withdrawal symptoms at birth. This drug can pass into your breast milk and may harm a nursing baby. Monitor your baby for increased sleepiness and breathing problems. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Additional Information

Our Bunavail (buprenorphine and naloxone) Buccal Film 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.

SLIDESHOW

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Bunavail Consumer Information

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

Like other narcotic medicines, buprenorphine and naloxone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

  • weak or shallow breathing, breathing that stops during sleep;
  • a light-headed feeling, like you might pass out;
  • confusion, loss of coordination, extreme weakness;
  • blurred vision, slurred speech;
  • liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
  • withdrawal symptoms;
  • tongue pain, redness or numbness inside your mouth;
  • nausea, vomiting, constipation;
  • headache, back pain;
  • fast or pounding heartbeats, increased sweating; or
  • sleep problems (insomnia).

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 Bunavail (Buprenorphine and Naloxone Buccal Film)

Bunavail Professional Information

SIDE EFFECTS

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

Clinical Trials 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.

The safety of BUNAVAIL is supported by clinical trials using buprenorphine and naloxone sublingual tablets, and other trials using buprenorphine tablets and buprenorphine sublingual solutions, as well as an open-label study in 249 patients treated with BUNAVAIL. In total, safety data from clinical studies are available from over 3000 opioid-dependent subjects exposed to buprenorphine at doses in the range used in the treatment of opioid addiction. Few differences in the adverse event profile were noted among buprenorphine and naloxone sublingual tablets, buprenorphine sublingual tablets and a buprenorphine ethanolic sublingual solution.

The safety and tolerability of BUNAVAIL was evaluated in a 12-week clinical study of BUNAVAIL in 249 opioid-dependent subjects stabilized on buprenorphine and naloxone sublingual tablet or film dosages of buprenorphine 8 to 32 mg/day.

The following adverse reactions were reported to occur by at least 5% of patients in a 12-week study with BUNAVAIL: drug withdrawal syndrome, lethargy and headache.

The adverse reactions listed below represent those that were reported by >1% but less than 5% of patients from the 12-week clinical trial while receiving BUNAVAIL. Events are classified by system organ class.

  • General disorders and administration site conditions: fatigue and chills
  • Nervous system disorders: somnolence
  • Psychiatric disorders: drug dependence and insomnia
  • Gastrointestinal disorders: constipation and oral mucosal erythema
  • Respiratory, thoracic and mediastinal disorders: rhinorrhea
  • Skin and subcutaneous tissue disorders: hyperhidrosis

The following adverse events were reported to occur by at least 5% of patients in a 4-week study with buprenorphine and naloxone sublingual tablets (Table 1)

Table 1: Adverse Events (> 5%) by Body System and Treatment Group in a 4-week Study

Body System / Adverse Event (COSTART terminology) Buprenorphine/ naloxone sublingual tablets 16 mg/4 mg/day
N=107
n (%)
Placebo
N=107
n (%)
Body as a Whole
Asthenia 7 (6.5%) 7 (6.5%)
Chills 8 (7.5%) 8 (7.5%)
Headache 39 (36.4%) 24 (22.4%)
Infection 6 (5.6%) 7 (6.5%)
Pain 24 (22.4%) 20 (18.7%)
Pain abdomen 12 (11.2%) 7 (6.5%)
Pain back 4 (3.7%) 12 (11.2%)
Withdrawal syndrome 27 (25.2%) 40 (37.4%)
Cardiovascular System
Vasodilation 10 (9.3%) 7 (6.5%)
Digestive System
Constipation 13 (12.1%) 3 (2.8%)
Diarrhea 4 (3.7%) 16 (15.0%)
Nausea 16 (15.0%) 12 (11.2%)
Vomiting 8 (7.5%) 5 (4.7%)
Nervous System
Insomnia 15 (14.0%) 17 (15.9%)
Respiratory System
Rhinitis 5 (4.7%) 14 (13.1%)
Skin and Appendages
Sweating 15 (14.0%) 11 (10.3%)

The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solutions, over a range of doses in four months of treatment. Table 2 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.

Table 2: Adverse Events (> 5%) by Body System and Treatment Group in a 16-week Study

Body System / Adverse Event (COSTART terminology) Buprenorphine Dose*
Very Low*
(N=184) n (%)
Low*
(N=180) n (%)
Moderate*
(N=186) n (%)
High*
(N=181) n (%)
Total*
(N=731) n (%)
Body as a Whole
Abscess 9 (5%) 2 (1%) 3 (2%) 2 (1%) 16 (2%)
Asthenia 26 (14%) 28 (16%) 26 (14%) 24 (13%) 104 (14%)
Chills 11 (6%) 12 (7%) 9 (5%) 10 (6%) 42 (6%)
Fever 7 (4%) 2 (1%) 2 (1%) 10 (6%) 21 (3%)
Flu Syndrome 4 (2%) 13 (7%) 19 (10%) 8 (4%) 44 (6%)
Headache 51 (28%) 62 (34%) 54 (29%) 53 (29%) 220 (30%)
Infection 32 (17%) 39 (22%) 38 (20%) 40 (22%) 149 (20%)
Injury Accidental 5 (3%) 10 (6%) 5 (3%) 5 (3%) 25 (3%)
Pain 47 (26%) 37 (21%) 49 (26%) 44 (24%) 177 (24%)
Pain Back 18 (10%) 29 (16%) 28 (15%) 27 (15%) 102 (14%)
Withdrawal Syndrome 45 (24%) 40 (22%) 41 (22%) 36 (20%) 162 (22%)
Digestive System
Constipation 10 (5%) 23 (13%) 23 (12%) 26 (14%) 82 (11%)
Diarrhea 19 (10%) 8 (4%) 9 (5%) 4 (2%) 40 (5%)
Dyspepsia 6 (3%) 10 (6%) 4 (2%) 4 (2%) 24 (3%)
Nausea 12 (7%) 22 (12%) 23 (12%) 18 (10%) 75 (10%)
Vomiting 8 (4%) 6 (3%) 10 (5%) 14 (8%) 38 (5%)
Nervous System
Anxiety 22 (12%) 24 (13%) 20 (11%) 25 (14%) 91 (12%)
Depression 24 (13%) 16 (9%) 25 (13%) 18 (10%) 83 (11%)
Dizziness 4 (2%) 9 (5%) 7 (4%) 11 (6%) 31 (4%)
Insomnia 42 (23%) 50 (28%) 43 (23%) 51 (28%) 186 (25%)
Nervousness 12 (7%) 11 (6%) 10 (5%) 13 (7%) 46 (6%)
Somnolence 5 (3%) 13 (7%) 9 (5%) 11 (6%) 38 (5%)
Respiratory System
Cough Increase 5 (3%) 11 (6%) 6 (3%) 4 (2%) 26 (4%)
Pharyngitis 6 (3%) 7 (4%) 6 (3%) 9 (5%) 28 (4%)
Rhinitis 27 (15%) 16 (9%) 15 (8%) 21 (12%) 79 (11%)
Skin and Appendages
Sweat 23 (13%) 21 (12%) 20 (11%) 23 (13%) 87 (12%)
Special Senses
Runny Eyes 13 (7%) 9 (5%) 6 (3%) 6 (3%) 34 (5%)
*Sublingual solution. Doses in this table cannot necessarily be delivered in film form, but for comparison purposes:
“Very low” dose (1 mg solution) would be less than a tablet dose of 2 mg
“Low” dose (4 mg solution) approximates a 6 mg tablet dose
“Moderate” dose (8 mg solution) approximates a 12 mg tablet dose
“High” dose (16 mg solution) approximates a 24 mg tablet dose

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 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 BUNAVAIL.

Androgen Deficiency

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

Local Reactions

Glossodynia, glossitis, oral mucosal erythema, oral hypoesthesia, and stomatitis

Read the entire FDA prescribing information for Bunavail (Buprenorphine and Naloxone Buccal Film)

Related Resources for Bunavail

Related Health

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

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