Dulera Side Effects

Generic name: formoterol / mometasone

Note: This document contains side effect information about formoterol / mometasone. Some of the dosage forms listed on this page may not apply to the brand name Dulera.

Some side effects of Dulera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to formoterol / mometasone: inhalation aerosol

Get emergency medical help if you have any of these signs of an allergic reaction while taking formoterol / mometasone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have:

• sores or white patches in your mouth or throat;

• wheezing, choking, or other breathing problems after using this medication;

• blurred vision, eye pain, or seeing halos around lights;

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;

• chest pain, fast or pounding heartbeats, tremors, restless feeling, seizure;

• increased thirst or hunger, urinating more than usual; or

• worsening asthma symptoms.

Common side effects may include:

• headache;

• runny or stuffy nose, sinus pain

• dry mouth, sore throat; or

• hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to formoterol / mometasone: inhalation aerosol

Cardiovascular

Cardiovascular side effects have included clinically significant cardiovascular effects and fatalities in association with excessive use of inhaled sympathomimetic drugs, including formoterol. Excessive beta-adrenergic stimulation has been associated with angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, and palpitations.

Nervous system

Nervous system side effects have included excessive beta-adrenergic stimulation which has been associated with seizures, nervousness, headache, tremor, dizziness, fatigue, malaise, and insomnia.

Immunologic

Immunologic side effects have included increased susceptibility to infections, for example, chicken pox and measles.

Endocrine

Endocrine side effects have included hypercorticism and adrenal suppression (including adrenal crisis).

Respiratory

Respiratory side effects have included inhalation induced bronchospasm with an immediate increase in wheezing after dosing that may be life-threatening. Nasopharyngitis and sinusitis are commonly reported. Dysphonia was observed in longer term treatment.

Hypersensitivity

Hypersensitivity side effects have included urticaria, flushing, allergic dermatitis, and bronchospasm. Postmarketing reports have included anaphylactic reaction and angioedema.

Musculoskeletal

Musculoskeletal side effects have included decreases in bone mineral density. Orally inhaled corticosteroids, including mometasone, may cause a reduction in growth velocity when administered to pediatric patients

Ocular

Ocular side effects have included glaucoma, increased intraocular pressure, and cataracts.

Local

Local side effects have included localized infections of the mouth and pharynx with Candida albicans.

Gastrointestinal

Gastrointestinal side effects have included nausea.

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