Budesonide / formoterol Side Effects

Some side effects of budesonide / formoterol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to budesonide / formoterol: inhalation aerosol

Get emergency medical help if you have any of these signs of an allergic reaction while taking budesonide / formoterol: 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 of budesonide / formoterol 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.

For Healthcare Professionals

Applies to budesonide / formoterol: inhalation aerosol

Respiratory

Respiratory side effects have included nasopharyngitis, upper and lower respiratory tract infection, sinusitis, nasal and sinus congestion, pharyngitis, allergic rhinitis,acute bronchitis, asthma,and pharyngolaryngeal pain.

Gastrointestinal

Gastrointestinal side effects have included stomach discomfort, vomiting, nausea, viral gastroenteritis, dyspepsia, upper abdominal pain, and diarrhea.

Musculoskeletal

Musculoskeletal side effects have included back pain, muscle spasms, arthralgia, myalgia, and pain in the extremities.

Genitourinary

Genitourinary side effects have included urinary tract infections.

Nervous system

Nervous system side effects have included tension headache, dizziness, sinus headache and migraine.

General

General side effects have included oral candidiasis, dysphonia, and pyrexia.

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