Important Safety Information

Approved Uses for SYMBICORT

Prescription SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol is a controller medicine for the long-term maintenance treatment of asthma. SYMBICORT is for people 12 years and older whose doctor has decided are not well controlled on another asthma-controller medicine or who need two asthma-controller medicines. SYMBICORT is not for the treatment of sudden asthma symptoms.

Important Safety Information about SYMBICORT for Asthma

What is the most important safety information I should know about SYMBICORT?

  • SYMBICORT contains formoterol, a long-acting beta2-agonist (LABA). Medicines containing LABAs may increase the chance of asthma-related death. So, SYMBICORT should be used only if your health care professional decides another asthma-controller medicine alone does not control your asthma or you need two controller medicines.

  • While taking SYMBICORT, never use another medicine containing a LABA.

What other important safety information should I know about SYMBICORT?

  • SYMBICORT won't replace rescue inhalers for sudden symptoms. Do not use SYMBICORT more than twice a day.
  • If you are taking SYMBICORT, see your health care professional if your asthma does not improve or gets worse.
  • Some people may experience increased blood pressure, heart rate, or change in heart rhythm. Tell your doctor if you have a heart condition or high blood pressure.
  • If you are switching to SYMBICORT from an oral corticosteroid, follow your doctor's instructions to avoid health risks when you stop using oral corticosteroids.
  • Avoid exposure to infections such as chicken pox or measles. Tell your health care professional immediately if you think you have been exposed.
  • Side Effects: In clinical studies, common side effects included nose and throat irritation, headache, upper respiratory tract infection, sore throat, sinusitis, and stomach discomfort.

Talk to your doctor about prescription SYMBICORT.

Please read full Prescribing InformationPDF (PDF - 437 KB)

Read Important Product Information for PatientsPDF(PDF - 101 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.

This product information is intended for US customers only.

SYMBICORT is a registered trademark of the AstraZeneca group of companies.