Budesonide/Formoterol Side Effects

Please note - some side effects for 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.

Side Effects of Budesonide/Formoterol - for the Consumer

Budesonide/Formoterol Aerosol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Budesonide/Formoterol Aerosol:

Back pain; dizziness; dry mouth; headache; nausea; nervousness; stomach pain or upset; stuffy nose; throat irritation; tiredness; tremor; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); bone pain; chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased mucus production or change in color of mucus; new or worsening asthma or COPD symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); seizures; severe or persistent dizziness, headache, nervousness, or tremor; severe or persistent muscle pain or cramps; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); tingling or numbness of the arms or legs; trouble speaking; vision changes; white patches in your mouth or throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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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