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Brand Names: Symbicort

Generic Name: budesonide and formoterol inhalation (Pronunciation: bue DES oh nide and for MOE te rol)

• What is budesonide and formoterol inhalation (Symbicort)?
• What are the possible side effects of budesonide and formoterol inhalation (Symbicort)?
• What is the most important information I should know about budesonide and formoterol inhalation (Symbicort)?
• What should I discuss with my healthcare provider before using budesonide and formoterol inhalation (Symbicort)?
• How should I use budesonide and formoterol inhalation (Symbicort)?
• What happens if I miss a dose (Symbicort)?
• What happens if I overdose (Symbicort)?
• What should I avoid while using budesonide and formoterol inhalation (Symbicort)?
• What other drugs will affect budesonide and formoterol (Symbicort)?
• Where can I get more information?

What is budesonide and formoterol inhalation (Symbicort)?

Budesonide is a steroid that reduces inflammation in the body.

Formoterol is a bronchodilator that relaxes muscles in the airways to improve breathing.

The combination of budesonide and formoterol is used to prevent bronchospasm in people with asthma or chronic obstructive pulmonary disease (COPD).

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

What are the possible side effects of budesonide and formoterol inhalation (Symbicort)?

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

Call your doctor at once if you have any of these serious side effects:

• worsening asthma symptoms;
• chest pain, fast or pounding heartbeats, tremors, nervousness;
• wheezing, throat irritation, choking, or other breathing problems after using this medication;
• signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding, unusual weakness;
• blurred vision, eye pain, or seeing halos around lights;
• white patches or sores in your mouth or throat; or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• headache;
• nausea, vomiting, diarrhea, upset stomach;
• back pain;
• stuffy nose;
• muscle or joint pain; or
• changes in your voice.

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.

What is the most important information I should know about budesonide and formoterol inhalation (Symbicort)?

Budesonide and formoterol inhalation may increase the risk of asthma-related death. Use only the prescribed dose of budesonide and formoterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using this medication.

Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

Before using budesonide and formoterol, tell your doctor if you have heart disease, high blood pressure, a seizure disorder, an infection (including herpes infection of the eyes), diabetes, tuberculosis, a thyroid disorder, or an electrolyte imbalance (such as low potassium levels in your blood).

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