Patient exposures and adverse reactions in Butrans clinical trials
Patient exposures: total of 5415 patients with chronic pain were treated with Butrans in clinical trials
- 924 patients were treated for approximately 6 months
- 183 patients were treated for approximately 1 year
- 1377 patients ≥65 years of age were administered Butrans
- Incidences of selected Butrans-related adverse events were higher in older patients
- The most common serious adverse drug reactions (all <0.1%) occurring during clinical trials with Butrans were chest pain, abdominal pain, vomiting, dehydration, and increased hypertension/blood pressure
- The most common adverse reactions (≥5%) reported by patients treated with Butrans in clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash
- The most common adverse events (≥2%) leading to discontinuation were nausea, dizziness, vomiting, headache, and somnolence
