Formoterol and mometasone
Name: Formoterol and mometasone
For Healthcare Professionals
Applies to formoterol / mometasone: inhalation aerosol
Cardiovascular
Formoterol-Mometasone:
Postmarketing reports: Angina pectoris, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia, electrocardiogram QT prolongation, blood pressure increase (including hypertension)[Ref]
Nervous system
Formoterol-Mometasone:
Common (1% to 10%): Headache
Mometasone Furoate:
Common (1% to 10%): Headache
Formoterol:
Common (1% to 10%): Headache[Ref]
Immunologic
Formoterol-Mometasone:
Uncommon (0.1% to 1%): Oral candidiasis[Ref]
Respiratory
Formoterol-Mometasone:
Common (1% to 10%): Sinusitis, nasopharyngitis, dysphonia
Postmarketing reports: Cough, dyspnea, wheezing, bronchospasm
Mometasone Furoate:
Common (1% to 10%): Sinusitis, nasopharyngitis
Formoterol:
Common (1% to 10%): Sinusitis, nasopharyngitis[Ref]
A long-term clinical trial was conducted to determine the safety over the course of a one year time period. The safety outcomes were similar to clinical trials conducted over a 12 to 26 week period with one exception. Dysphonia occurred with greater frequency in the long-term clinical trial. Dysphonia occurred at an incidence of 5% in patients randomized to the 100 mcg/5 mcg strength and 3.8% in patients randomized to 200 mcg/5 mcg strength.[Ref]
Hypersensitivity
Formoterol-Mometasone:
Postmarketing reports: Anaphylactic reaction, angioedema, severe hypotension, rash, pruritus[Ref]
Musculoskeletal
Mometasone:
Frequency not reported: Decrease in bone mineral density[Ref]
Ocular
Mometasone:
Frequency not reported: Glaucoma, increased intraocular pressure, cataracts[Ref]
Gastrointestinal
Formoterol-Mometasone:
Frequency not reported: Nausea[Ref]
General
The most common side effects reported include sinusitis, nasopharyngitis, and headache.
Metabolic
Formoterol-Mometasone:
Postmarketing reports: Hypokalemia, hyperglycemia
Some side effects of formoterol / mometasone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.