Indacaterol Side Effects

Some side effects of indacaterol 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 indacaterol: inhalation capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking indacaterol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using indacaterol and call your doctor at once if you have any of these serious side effects:

• chest pain, tremors, fast heart rate, pounding heartbeats or fluttering in your chest;

• new or worsening cough, fever, trouble breathing;

• swelling of your ankles or feet;

• bronchospasm (wheezing, chest tightness, trouble breathing);

• feeling suddenly short of breath;

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or

• worsening of your condition.

Less serious side effects of indacaterol may include:

• throat pain;

• nausea;

• headache;

• muscle pain or spasm; or

• cold symptoms such as stuffy nose, sinus pain, sneezing, cough.

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 indacaterol: inhalation capsule

Cardiovascular

Frequency not reported: Peripheral edema
Postmarketing reports: Tachycardia/heart rate increase/palpitations

Respiratory

Common (1% to 10%): Cough (6.5%), nasopharyngitis (5.3%), oropharyngeal pain (2.2%)
Frequency not reported: Sinusitis, upper respiratory tract infection
Postmarketing reports: Paradoxical bronchospasm

Metabolic

Frequency not reported: Diabetes mellitus, hyperglycemia

Nervous system

Common (1% to 10%): Headache (5.1%)
Postmarketing reports: Dizziness

Gastrointestinal

Common (1% to 10%): Nausea (2.4%)

Dermatologic

Postmarketing reports: Pruritus/rash

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions

Musculoskeletal

Frequency not reported: Muscle spasm, musculoskeletal pain

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