Very Common (≥10%): Upper respiratory tract infection. Common (≥1% to <10%): Nasopharyngitis, urinary tract infection (UTI), sinustitis, rhinitis, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, musculoskeletal pain, pyrexia, chest pain. Uncommon (≥0.1 to <1%) and Potentially Serious: Glaucoma, hypersensitivity, diabetes mellitus and hyperglycemia, ischemic heart disease, atrial fibrillation. Uncommon (≥0.1% to <1%): Insomnia, paresthesia, tachycardia, palpitations, epistaxis, dry mouth, pruritus/rash, muscle spasm, myalgia, bladder obstruction including urinary retention, peripheral edema, fatigue. Not Known: Angioedema.
Some serious adverse events, including hypersensitivity and ischemic heart disease, have been reported as adverse drug reactions for Ultibro Breezhaler (0.1% vs 0% for placebo and 0.4% vs 0.3% for placebo, respectively).
Elderly Patients Only:
Additional Adverse Reactions from Individual Components: Not Known and Potentially Serious:
Paradoxical bronchospasm. Not Known: Gastroenteritis, pain in extremity.