Formoterol Side Effects

Some side effects of 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 formoterol: inhalation capsule, inhalation solution

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

• chest pain, fast or pounding heartbeats, tremors, headache, or restless feeling;

• seizure (convulsions);

• wheezing, choking, or other breathing problems after using this medication;

• increased thirst or hunger, urinating more than usual; or

• worsening asthma symptoms.

Less serious side effects of formoterol may include:

• dizziness, anxiety, headache;

• sleep problems (insomnia);

• back pain, muscle cramps;

• sore throat, dry mouth, cough, stuffy nose;

• skin rash, itching; 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 formoterol: inhalation capsule, inhalation solution

Cardiovascular

Cardiovascular side effects have included angina, hypertension or hypotension, tachycardia, palpitations and arrhythmias. Post marketing reports have included atrial fibrillation, ventricular extrasystoles, tachyarrhythmia and prolonged QT interval on electrocardiogram.

Dermatologic

Dermatologic side effects have included rash (1.1%).

Endocrine

Endocrine side effects have included hyperglycemia.

Gastrointestinal

Gastrointestinal side effects have included dry mouth and nausea.

Metabolic

Metabolic side effects have included hypokalemia and metabolic acidosis.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps.

Nervous system

Nervous system side effects have included nervousness, headache, tremor, dizziness, and insomnia.

Respiratory

Respiratory side effects have included bronchitis (4.6%), chest infection (2.7%), dyspnea (2.1%), dysphonia (1%) and tonsillitis (1.2%). Post marketing reports have included cough.

General

General side effects have included fatigue and malaise.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm. Postmarketing reports have included angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema) and severe hypotension.

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