Formoterol is a long-acting bronchodilator. Mometasone is a steroid.

Formoterol and mometasone is a combination medicine used to control and prevent the symptoms of asthma in adults and children at least 5 years old.

Formoterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when formoterol and mometasone are used together as a combination product.

Formoterol and mometasone may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to formoterol or mometasone.

Mometasone can weaken your immune system. Tell your doctor about any illness or infection you've had within the past several weeks.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• a weak immune system;
• liver disease;
• osteoporosis;
• glaucoma, cataracts, or other vision problems;
• diabetes;
• a drug allergy;
• pheochromocytoma (tumor of the adrenal gland);
• a thyroid disorder; or
• an aneurysm (a weakened or damaged blood vessel that could tear and cause severe bleeding).

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Formoterol and mometasone is not approved for use by anyone younger than 5 years old.

Use Dulera (Formoterol And Mometasone) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening asthma symptoms;
• tremors, nervousness, chest pain, fast or pounding heartbeats;
• fever, chills, cough with mucus, feeling short of breath;
• wheezing, choking, or other breathing problems after using this medication;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Mometasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• runny or stuffy nose, sinus pain;
• headache; or
• cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not use a second inhaled bronchodilator that contains formoterol or a similar medicine (such as arformoterol, indacaterol, olodaterol, salmeterol, or vilanterol).

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a medicine that contains mometasone (a steroid).