From the Guidelines
Buprenorphine buccal film can cause several side effects, including nausea, constipation, headache, vomiting, dizziness, and drowsiness, as well as more serious side effects like respiratory depression and physical dependence, as noted in the 2017 HIVMA of IDSA clinical practice guideline for the management of chronic pain in patients living with HIV 1.
Common Side Effects
- Nausea
- Constipation
- Headache
- Vomiting
- Dizziness
- Drowsiness Many patients also experience application site reactions such as irritation, redness, or pain where the film is placed in the mouth.
Serious Side Effects
- Respiratory depression (slowed or difficult breathing), which is more likely when starting treatment or increasing doses, especially if combined with other central nervous system depressants like alcohol or benzodiazepines
- Physical dependence can develop with long-term use, leading to withdrawal symptoms if the medication is stopped abruptly Some patients may experience allergic reactions, liver problems, adrenal insufficiency, or decreased sex hormone levels with prolonged use.
Additional Considerations
Dental problems can also occur due to dry mouth caused by the medication. It's essential to take buprenorphine exactly as prescribed, never use more than directed, and inform your healthcare provider about all other medications you're taking to minimize side effect risks. Patients should seek immediate medical attention if experiencing severe side effects like extreme drowsiness, difficulty breathing, or signs of allergic reaction, as recommended in the 2021 Society for Perioperative Assessment and Quality Improvement (SPAQI) consensus statement on preoperative management of opioid and nonopioid analgesics 1.
From the FDA Drug Label
The most frequent side effect in clinical studies involving 1,133 patients was sedation which occurred in approximately two-thirds of the patients. Although sedated, these patients could easily be aroused to an alert state Other less frequent adverse reactions occurring in 5-10% of the patients were: Nausea Dizziness/Vertigo Occurring in 1-5% of the patients: Sweating Headache Hypotension Nausea/Vomiting Vomiting Hypoventilation Miosis The following adverse reactions were reported to have occurred in less than 1% of the patients: CNS Effect: confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia.
The following reactions have been reported to occur rarely: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination
Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the postmarketing experience of buprenorphine hydrochloride injection and other buprenorphine- containing products. The most common signs and symptoms include rashes, hives, and pruritus Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported.
The side effects of buprenorphine buccal film include:
- Common side effects: sedation, nausea, dizziness/vertigo, sweating, headache, hypotension, nausea/vomiting, vomiting, hypoventilation, and miosis
- Less common side effects: confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia
- Rare side effects: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination
- Allergic reactions: rashes, hives, pruritus, bronchospasm, angioneurotic edema, and anaphylactic shock 2
From the Research
Side Effects of Buprenorphine Buccal Film
- Constipation is one of the most common side effects of buprenorphine, but the rate of constipation is lower when patients are switched from sublingual buprenorphine-naloxone tablets or films to a bilayered bioerodible mucoadhesive buccal film formulation 3
- Respiratory depression is a potential side effect of buprenorphine, with a frequency of 11.8% in pediatric single-substance exposures, 11.2% in pediatric multiple-substance exposures, 11.3% in adult single-substance exposures, and 11.9% in adult multiple-substance exposures 4
- Other common symptoms reported by patients taking buprenorphine include dry mouth, decreased appetite, sweating, fatigue, nausea, itchy skin, trouble urinating, menstrual problems, lightheadedness, blurred vision, and heart racing 5
- Opioid-induced nausea and vomiting (OINV) are also potential side effects of buprenorphine, with research suggesting that approximately 40% of patients may experience nausea and 15%-25% of patients may experience vomiting after opioid administration 6
- Nausea and vomiting can lead to complications such as electrolyte imbalances, malnutrition, and volume depletion, and can also negatively affect quality of life and postoperative recovery 6, 7
Management of Side Effects
- The clinical profiles of different formulations of buprenorphine and buprenorphine-naloxone can help facilitate the understanding and management of opioid-dependent patients at risk of developing opioid-induced constipation 3
- Medications such as serotonin receptor antagonists, dopamine receptor antagonists, and neurokinin-1 receptor antagonists can be used to treat OINV 6
- Opioid-sparing analgesic agents may provide a further alternative to avoid nausea and vomiting due to their reduced reliance on mu-opioid signalling pathways to induce analgesia 7