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SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol
SYMBICORT for Asthma

For patients 12 years and older whose asthma is not well controlled on a long-term asthma medicine or whose disease severity warrants.

ABOUT ASTHMA

Control Asthma Symptoms

Asthma control is about more than just treating sudden asthma symptoms. Asthma control is about managing your asthma daily so you may have few or no asthma symptoms in the first place.

When you have asthma, you always have inflammation or swelling in the airways of your lungs. You may not feel this inflammation, but your lungs do. Uncontrolled inflammation (swelling) makes your airways more sensitive to asthma triggers like pollen, dust, and smoke. Exposure to these asthma triggers can cause constriction (tightening) of the muscles around your airways, leading to asthma symptoms like shortness of breath, wheezing, tightness of the chest, and coughing. Medicines that help to control asthma can help control the inflammation in your airways and help reduce your sensitivity to asthma triggers.

Is your asthma under control?

  • Do you experience asthma symptoms more than twice a week?
  • Do you use asthma rescue medicine more than twice a week?
  • Do your asthma symptoms limit your activities?

If you answer “yes” to any of these questions, you may not be in control of your asthma and it is important that you talk to your doctor to determine if a medicine that helps control asthma, like SYMBICORT, may be right for you. To help with that conversation, take this simple, private, and free Asthma Assessment and print the results for your doctor to review.

When your asthma is under control, you can do more of the things you like to do with fewer interruptions due to your asthma. You should have fewer asthma symptoms throughout the day and night. And you shouldn't need to rely on your rescue medicine as much. Remember: medicines that help control asthma are not rescue medicines, and should not be used to treat sudden asthma symptoms. Once your asthma is well controlled, your doctor will decide if you can stop taking SYMBICORT without loss of control and may prescribe a long-term asthma control medicine, such as an inhaled corticosteroid.

Important Safety Information About SYMBICORT including Boxed WARNING

SYMBICORT contains formoterol, a long-acting beta2-adrenergic agonist (LABA). LABA medicines such as formoterol increase the risk of death from asthma problems. It is not known whether budesonide, the other medicine in SYMBICORT, reduces the risk of death from asthma problems seen with formoterol.

  • Call your health care provider if breathing problems worsen over time while using SYMBICORT. You may need different treatment
  • Get emergency medical care if:
    • Breathing problems worsen quickly, and
    • You use your rescue inhaler medicine, but it does not relieve your breathing problems

SYMBICORT should be used only if your health care provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid, or that your asthma is severe enough to begin treatment with SYMBICORT.

If you are taking SYMBICORT, see your health care provider if your asthma does not improve or gets worse. It is important that your health care provider assess your asthma control on a regular basis. Your doctor will decide if it is possible for you to stop taking SYMBICORT and start taking a long-term asthma control medicine without loss of asthma control.

Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

SYMBICORT does not replace rescue inhalers for sudden symptoms.

Be sure to tell your health care provider about all your health conditions, including heart conditions or high blood pressure, and all medicines you may be taking. Some patients taking SYMBICORT may experience increased blood pressure, heart rate, or change in heart rhythm.

Do not use SYMBICORT more often than prescribed. While taking SYMBICORT, never use another medicine containing a LABA for any reason. Ask your health care provider or pharmacist if any of your other medicines are LABA medicines.

SYMBICORT can cause serious side effects, including:

  • Pneumonia and other lower respiratory tract infections. People with COPD may have a higher chance of pneumonia. Call your doctor if you notice any of the following symptoms: change in amount or color of mucus, fever, chills, increased cough, or increased breathing problems
  • Serious allergic reactions including rash, hives, swelling of the face, mouth and tongue, and breathing problems
  • Immune system effect and a higher chance of infection. Tell your health care provider if you think you are exposed to infections such as chicken pox or measles, or if you have any signs of infection such as fever, pain, body aches, chills, feeling tired, nausea, or vomiting
  • Adrenal insufficiency. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
  • Using too much of a LABA medicine may cause chest pain, increase in blood pressure, fast and irregular heartbeat, headache, tremor, or nervousness
  • Increased wheezing right after taking SYMBICORT. Always have a rescue inhaler with you to treat sudden wheezing
  • Eye problems including glaucoma and cataracts. You should have regular eye exams while using SYMBICORT
  • Lower bone mineral density can happen in people who have a high chance for low bone mineral density (osteoporosis)
  • Slowed growth in children. A child's growth should be checked regularly while using SYMBICORT
  • Swelling of blood vessels (signs include a feeling of pins and needles or numbness of arms or legs, flu like symptoms, rash, pain or swelling of the sinuses), decrease in blood potassium and increase in blood sugar levels

Common side effects in patients with asthma include nose and throat irritation, headache, upper respiratory tract infection, sore throat, sinusitis, stomach discomfort, flu, back pain, nasal congestion, vomiting, and thrush in the mouth and throat.

Approved Uses for SYMBICORT

SYMBICORT 80/4.5 and 160/4.5 are medicines for the treatment of asthma for people 12 years and older whose doctor has determined that their asthma is not well controlled with a long-term asthma control medicine such as an inhaled corticosteroid or whose asthma is severe enough to begin treatment with SYMBICORT. SYMBICORT is not a treatment for sudden asthma symptoms.

Please see full Prescribing Information and Medication Guide and discuss with your doctor.

Talk to your doctor about prescription SYMBICORT.

Read Prescribing Information, including Boxed WARNING, with Medication GuideAdobe PDF (PDF — 551 KB)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

FlagThis site is intended for US consumers only.

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about SYMBICORT, asthma, or COPD, talk to your doctor or pharmacist. Only you and your doctor can decide if SYMBICORT is right for you.