Formoterol / Mometasone Side Effects

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

Applies to formoterol / mometasone: inhalation aerosol powder.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits, to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur. Talk to your doctor or pharmacist about any questions or concerns that you have.

You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with arformoterol (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), or salmeterol (Serevent®) inhalers.

Talk to your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
• You or your child have a significant decrease in your peak flow when measured as directed by your doctor.

Your doctor may want you to carry a medical identification card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

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:

Other side effects

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:

For healthcare professionals

Applies to formoterol / mometasone: inhalation aerosol.

General adverse events

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

See also:

Further information

Formoterol/mometasone 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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