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Glycopyrrolate / indacaterol Side Effects

For the Consumer

Applies to glycopyrrolate / indacaterol: inhalation capsule

Along with its needed effects, glycopyrrolate/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 glycopyrrolate / indacaterol:

Less common Incidence not known
  • Abdominal or stomach pain
  • blindness
  • convulsions
  • decrease in the frequency of urination
  • decrease in urine volume
  • decreased vision
  • difficulty in passing urine (dribbling)
  • dry mouth
  • eye pain
  • fainting
  • flushed, dry skin
  • fruit-like breath odor
  • hives or welts, itching, or skin rash
  • increased hunger
  • increased thirst
  • increased urination
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • painful urination
  • redness of the skin
  • sweating
  • tearing
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vision problems

Some side effects of glycopyrrolate / 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

For Healthcare Professionals

Applies to glycopyrrolate / indacaterol: inhalation capsule

General

The most common adverse reaction was nasopharyngitis and hypertension. Cough was also common, but usually of mild intensity.[Ref]

Respiratory

Very common (10% or more): Upper and lower respiratory tract infection
Common (1% to 10%): Nasopharyngitis (4.1%), oropharyngeal pain (1.6%), pneumonia, rhinitis, sinusitis, cough, throat irritation
Uncommon (0.1% to 1%): Paradoxical bronchospasm, epistaxis
Very rare (less than 0.01%): Chest pain[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroesophageal reflux disease, dyspepsia, dental caries, gastroenteritis
Uncommon (0.1% to 1%): Dry mouth[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia
Uncommon (0.1% to 1%): Diabetes mellitus[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, musculoskeletal pain
Uncommon (0.1% to 1%): Muscle spasm, myalgia, pain in extremity[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Paraesthesia[Ref]

Other

Common (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Fatigue, peripheral edema[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypertension (2%), ischemic heart disease, atrial fibrillation, tachycardia, palpitations
Very rare (less than 0.01%): Atrial fibrillation, palpitations, tachycardia[Ref]

Dermatologic

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

Genitourinary

Uncommon (0.1% to 1%): Bladder obstruction, urinary retention[Ref]

Ocular

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

Psychiatric

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

References

1. "Product Information. Utibron Neohaler (glycopyrrolate-indacaterol (glycopyrronium-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

4. Canadian Pharmacists Association "e-CPS. Available from: URL: http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink."

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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