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Glycopyrrolate / indacaterol Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 16, 2022.

For the Consumer

Applies to glycopyrrolate/indacaterol: inhalation capsule

Side effects requiring immediate medical attention

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

Rare

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • decreased urination
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • pain in the lower abdomen, groin, upper back, or sides
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss

Incidence not known

  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

Side effects not requiring immediate medical attention

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

Rare

Less common

  • Hoarseness
  • voice changes

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]

Frequently asked questions

References

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

2. Canadian Pharmacists Association "e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink." (2006):

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

4. "Product Information. Utibron Neohaler (glycopyrrolate-indacaterol (glycopyrronium-indacaterol))." Novartis Pharmaceuticals, East Hanover, NJ.

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.