Prescription SYMBICORTВ® (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

asthma symptoms.

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

If you are switching to SYMBICORT from an oral corticosteroid, follow your
doctor’s instructions to avoid health risks when you stop using oral

Avoid exposure to infections such as chicken pox or measles. Tell your health
care professional immediately if you are exposed.

In clinical studies, common side effects included nose and throat irritation,
headache, upper respiratory tract infection, sore throat, sinusitis, and
stomach discomfort.

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