Dulera

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.

Applies to formoterol / mometasone: inhalation aerosol powder

Along with its needed effects, formoterol/mometasone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking formoterol/mometasone:

Less common

• Cough
• fever
• headache
• muscle aches
• pain or tenderness around the eyes and cheekbones
• shortness of breath or troubled breathing
• sore throat
• stuffy or runny nose
• tightness of the chest or wheezing
• unusual tiredness or weakness

Rare

• Sore mouth or tongue
• white patches in the mouth or on the tongue

Incidence not known

• Blindness
• blurred vision
• cough or hoarseness
• creamy white, curd-like patches in the mouth or throat
• darkening of the skin
• decreased vision
• diarrhea
• dizziness
• eye pain
• fainting
• fever or chills
• loss of appetite
• lower back or side pain
• mental depression
• nausea or vomiting
• pain when eating or swallowing
• painful or difficult urination
• skin rash
• tearing

Some side effects of formoterol/mometasone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Voice changes

Applies to formoterol / mometasone: inhalation aerosol

Formoterol-Mometasone:

Postmarketing reports: Angina pectoris, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia, electrocardiogram QT prolongation, blood pressure increase (including hypertension)

Formoterol-Mometasone:

Common (1% to 10%): Headache

Mometasone Furoate:

Common (1% to 10%): Headache

Formoterol:

Common (1% to 10%): Headache

Formoterol-Mometasone:

Uncommon (0.1% to 1%): Oral candidiasis

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

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.

Formoterol-Mometasone:

Postmarketing reports: Anaphylactic reaction, angioedema, severe hypotension, rash, pruritus

Mometasone:

Frequency not reported: Decrease in bone mineral density

Mometasone:

Frequency not reported: Glaucoma, increased intraocular pressure, cataracts, vision blurred

Formoterol-Mometasone:

Frequency not reported: Nausea

The most common side effects reported include sinusitis, nasopharyngitis, and headache.

Formoterol-Mometasone:

Postmarketing reports: Hypokalemia, hyperglycemia