Symbicort contains a combination of budesonide and formoterol. Budesonide is a corticosteroid that reduces inflammation in the body. Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Symbicort is used to control and prevent the symptoms of asthma in adults and children at least 6 years old.

Symbicort is also used to help control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Symbicort is not for use in treating an asthma or bronchospasm attack.

For people with asthma: Symbicort is for use only if asthma is severe or is not well-controlled on other long-term asthma medicines. Your doctor may tell you to stop using this medicine once your asthma is well-controlled.

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

Symbicort is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Seek medical attention you have worsening breathing problems, or if you think your medications are not working as well.

Before taking this medicine

You should not use Symbicort if you are allergic to budesonide or formoterol.

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

To make sure Symbicort is safe for you, 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;

• tuberculosis;

• a thyroid disorder; or

• an electrolyte imbalance (such as low potassium levels in your blood).

Tell your doctor if you are pregnant. It is not known whether budesonide or formoterol 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 breastfeed while using Symbicort. Ask your doctor about any risk.

Symbicort is not approved for use by anyone younger than 6 years old.

Symbicort comes with a medication guide for safe and effective use, and directions for priming and cleaning the Symbicort inhaler device. Ask your doctor or pharmacist if you have any questions.

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Symbicort is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not allow a young child to use Symbicort without help from an adult.

Rinse your mouth with water after each use of your inhaler.

It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Store at room temperature in an upright position, with the mouthpiece down. Keep away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Throw the canister away when the inhalations counter shows a 0, or if it has been longer than 3 months since you first took the canister out of its foil pouch.

You should not use Symbicort if you are allergic to budesonide or formoterol.

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

To make sure Symbicort is safe for you, 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;

• tuberculosis;

• a thyroid disorder; or

• an electrolyte imbalance (such as low potassium levels in your blood).

Tell your doctor if you are pregnant. It is not known whether budesonide or formoterol 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 breastfeed while using Symbicort. Ask your doctor about any risk.

Symbicort is not approved for use by anyone younger than 6 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, fast heartbeats, and feeling shaky or nervous.

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

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.

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

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

Call your doctor at once if you have:

• worsened breathing problems;

• sores or white patches in your mouth and throat, pain when swallowing;

• tremors, nervousness, chest pain, fast or pounding heartbeats;

• 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;

• flu symptoms - fever, chills, body aches, unusual tiredness;

• 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.

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

Common Symbicort side effects may include:

• throat pain or irritation;

• white patches in your mouth or throat;

• stomach discomfort, vomiting;

• back pain, headache;

• 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with budesonide and formoterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.