Dulera Side Effects

Generic name: formoterol / mometasone

Medically reviewed by Drugs.com. Last updated on Feb 20, 2024.

Note: This document provides detailed information about Dulera Side Effects associated with formoterol / mometasone. Some dosage forms listed on this page may not apply specifically to the brand name Dulera.

Applies to formoterol / mometasone: inhalation aerosol powder.

Serious side effects of Dulera

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
• sore throat
• stuffy or runny nose
• tightness of the chest
• troubled breathing
• 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

Other side effects of Dulera

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

For healthcare professionals

Applies to formoterol / mometasone: inhalation aerosol.

General

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

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, vision blurred^[Ref]

Gastrointestinal

Formoterol-Mometasone:

• Frequency not reported: Nausea^[Ref]

Cardiovascular

Formoterol-Mometasone:

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

Metabolic

Formoterol-Mometasone:

• Postmarketing reports: Hypokalemia, hyperglycemia

Further information

Dulera side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer