Budesonide is a steroid. Formoterol is a long-acting bronchodilator. Glycopyrrolate is an anticholinergic.

Budesonide, formoterol, and glycopyrrolate is a combination medicine used in adults to help control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

This medicine is not for use in treating asthma or a bronchospasm attack.

Budesonide, formoterol, and glycopyrrolate may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to budesonide, formoterol, or glycopyrrolate (this includes Pulmicort, Rhinocort, Perforomist, Bevespi, Dulera, and others).

Budesonide 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 or kidney disease;
• osteoporosis;
• glaucoma, cataracts, or other vision problems;
• enlarged prostate, urination problems;
• diabetes;
• tuberculosis;
• a weak immune system;
• a thyroid disorder; or
• any type of bacterial, fungal, or viral infection.

Tell your doctor if you are pregnant or breastfeeding.

This medicine is not approved for use by anyone younger than 18 years old.

Use Breztri Aerosphere (Budesonide Formoterol and Glycopyrrolate) 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:

• worsened breathing problems;
• wheezing, choking, or other breathing problems after using this medication;
• tremors, nervousness, chest pain, fast or pounding heartbeats;
• sores or white patches in your mouth and throat, pain when swallowing;
• flu symptoms, body aches, unusual tiredness;
• painful or burning when you urinate, little or no urination;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• signs of a lung infection--fever, chills, cough with mucus, chest pain, feeling short of breath; or
• signs of a hormonal disorder--tiredness or weakness, feeling light-headed, nausea, vomiting.

Common side effects may include:

• throat pain or irritation;
• white patches in your mouth or throat;
• headache, joint pain, muscle spasms;
• pounding heartbeats, feeling anxious;
• high blood sugar levels;
• painful or difficult urination;
• nausea, diarrhea;
• cough, hoarse voice;
• flu symptoms; or
• cold symptoms such as stuffy or runny nose, sneezing, sinus pain, 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.

If this medication gets in your eyes, rinse with water and call your doctor if you have severe eye redness.

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 steroid such as budesonide.

Ask your doctor before using a second inhaled bronchodilator that contains formoterol or a similar medicine (such as arformoterol, formoterol, indacaterol, olodaterol, salmeterol, or vilanterol).