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Indacaterol Side Effects

In Summary

More frequently reported side effects include: headache and nasopharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to indacaterol: inhalation capsule

Along with its needed effects, indacaterol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking indacaterol:

More Common

  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • cough
  • dizziness
  • fainting
  • fast or irregular heartbeat
  • fever or chills
  • nausea
  • shortness of breath
  • sneezing
  • sore throat
  • sweating
  • tightness in the chest
  • troubled breathing
  • wheezing

Less Common

  • Abdominal or stomach pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • dry mouth
  • ear congestion
  • fainting
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • loss of consciousness
  • loss of voice
  • rapid weight gain
  • runny or stuffy nose
  • stomachache
  • sweating
  • tingling of the hands or feet
  • unexplained weight loss
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting

Incidence Not Known

  • Fast, irregular, pounding, or racing heartbeat or pulse

Some side effects of indacaterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

  • Muscle or bone pain
  • muscle spasm
  • pain or tenderness around the eyes and cheekbones

Incidence Not Known

  • Itching skin
  • rash

For Healthcare Professionals

Applies to indacaterol: inhalation capsule

General

The most commonly reported adverse reactions at the recommended doses were nasopharyngitis, cough, upper respiratory tract infection, headache, sinusitis, peripheral edema, and noncardiac chest pain (less than 1%). The majority of these side effects was mild to moderate and became less frequent if treatment was discontinued.

The most common serious adverse reactions reported were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation.[Ref]

Respiratory

Very common (10% or more): Cough following inhalation (up to 24%), nasopharyngitis (up to 14.3%), upper respiratory tract infection (up to 14.2%)

Common (1% to 10%): Cough, sinusitis, rhinorrhea, chest pain

Uncommon (0.1% to 1%): Paradoxical bronchospasm, chest discomfort[Ref]

Gastrointestinal

Common (1% to 10%): Oropharyngeal pain, throat irritation, nausea, dry mouth[Ref]

Metabolic

Common (1% to 10%): Diabetes mellitus, hyperglycemia[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasm musculoskeletal pain

Uncommon (0.1% to 1%): Myalgia[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Paresthesia, vertigo

Postmarketing reports: Dizziness[Ref]

Other

Common (1% to 10%): Peripheral edema[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Ischemic heart disease, atrial fibrillation, palpitations, tachycardia

Postmarketing reports: Tachycardia, heart rate increase, palpitations[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritus, rash[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Arcapta Neohaler (indacaterol)." Novartis Pharmaceuticals, East Hanover, NJ.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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