Dulera Side Effects
Generic name: formoterol / mometasone
Medically reviewed by Drugs.com. Last updated on Jan 23, 2023.
Note: This document contains side effect information about formoterol / mometasone. Some dosage forms listed on this page may not apply 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:
- 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
- Sore mouth or tongue
- white patches in the mouth or on the tongue
Incidence not known
- blurred vision
- cough or hoarseness
- creamy white, curd-like patches in the mouth or throat
- darkening of the skin
- decreased vision
- eye pain
- 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
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:
- Voice changes
For Healthcare Professionals
Applies to formoterol / mometasone: inhalation aerosol.
Postmarketing reports: Angina pectoris, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia, electrocardiogram QT prolongation, blood pressure increase (including hypertension)[Ref]
Common (1% to 10%): Headache
Common (1% to 10%): Headache
Common (1% to 10%): Headache[Ref]
Uncommon (0.1% to 1%): Oral candidiasis[Ref]
Common (1% to 10%): Sinusitis, nasopharyngitis, dysphonia
Postmarketing reports: Cough, dyspnea, wheezing, bronchospasm
Common (1% to 10%): Sinusitis, nasopharyngitis
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]
Postmarketing reports: Anaphylactic reaction, angioedema, severe hypotension, rash, pruritus[Ref]
Frequency not reported: Decrease in bone mineral density[Ref]
Frequency not reported: Glaucoma, increased intraocular pressure, cataracts, vision blurred[Ref]
Frequency not reported: Nausea[Ref]
The most common side effects reported include sinusitis, nasopharyngitis, and headache.
Postmarketing reports: Hypokalemia, hyperglycemia
More about Dulera (formoterol / mometasone)
- Check interactions
- Pricing & coupons
- Reviews (61)
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: bronchodilator combinations
- En español
Related treatment guides
1. "Product Information. Dulera (formoterol-mometasone)." Schering-Plough Corporation (2010):
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.