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Dulera Side Effects

Generic Name: formoterol / mometasone

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

For the Consumer

Applies to formoterol / mometasone: inhalation aerosol powder

In addition to its needed effects, some unwanted effects may be caused by formoterol / mometasone. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • 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

Minor Side Effects

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

Less common:
  • 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]

Nervous system

Common (1% to 10%): Headache

Mometasone Furoate:
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

Mometasone Furoate:
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[Ref]


Frequency not reported: Nausea[Ref]


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


Postmarketing reports: Hypokalemia, hyperglycemia


1. "Product Information. Dulera (formoterol-mometasone)." Schering-Plough Corporation, Kenilworth, NJ.

Not all side effects for Dulera may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.