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.

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.

For the Consumer

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

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. Postmarketing reports have included cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia).

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.

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. Drugs.com 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.

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