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Arcapta Side Effects

Generic Name: indacaterol

Note: This document contains side effect information about indacaterol. Some of the dosage forms listed on this page may not apply to the brand name Arcapta.

In Summary

More frequent 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 (the active ingredient contained in Arcapta) 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. "Product Information. Arcapta Neohaler (indacaterol)." Novartis Pharmaceuticals, East Hanover, NJ.

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

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

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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