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Incruse Ellipta Side Effects

Generic Name: umeclidinium

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

For the Consumer

Applies to umeclidinium: inhalation powder

Along with its needed effects, umeclidinium (the active ingredient contained in Incruse Ellipta) 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 umeclidinium:

Less Common

  • Bladder pain
  • bloody or cloudy urine
  • cough or hoarseness
  • difficulty with breathing
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • fever or chills
  • loss of voice
  • lower back or side pain
  • painful or difficult urination
  • sore throat
  • unusual tiredness or weakness

Incidence Not Known

  • Blurred vision
  • decreased urination
  • difficulty in passing urine (dribbling)
  • eye pain or discomfort

Some side effects of umeclidinium 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

  • Acid or sour stomach
  • body aches or pain
  • depression
  • diarrhea
  • dizziness or lightheadedness
  • joint pain
  • nausea
  • rash
  • sensation of spinning
  • upper abdominal or stomach pain

For Healthcare Professionals

Applies to umeclidinium: inhalation powder

Cardiovascular

Common (1% to 10%): Tachycardia, hypertension, sinus tachycardia (greater than or equal to 1%)

Uncommon (0.1% to 1%): Atrial fibrillation, idioventricular rhythm, supraventricular tachycardia, supraventricular extrasystoles[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Gastrointestinal

Common (1% to 10%): Upper abdominal pain, toothache, dyspepsia (greater or equal to 1%), diarrhea (greater or equal to 1%), nausea (greater or equal to 1%)

Uncommon (0.1% to 1%): Constipation, dry mouth[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Frequency not reported: Worsening of urinary retention[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain, neck pain (greater or equal to 1%), pain in extremity (greater or equal to 1%)[Ref]

Nervous system

Common (1% to 10%): Headache, sinus headache (greater or equal to 1%), dizziness (greater or equal to 1%)

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

Other

Common (1% to 10%): Contusion, vertigo (greater or equal to 1%)[Ref]

Psychiatric

Common (1% to 10%): Depression (greater or equal to 1%)[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, viral respiratory tract infection, cough, sinusitis, pneumonia (greater than or equal to 1%), lower respiratory tract infection (greater than or equal to 1%), rhinitis (greater than or equal to 1%), oropharyngeal pain (greater than or equal to 1%)

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

Ocular

Frequency not reported: Worsening of narrow-angle glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema)[Ref]

References

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

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

3. "Product Information. Incruse Ellipta (umeclidinium)." GlaxoSmithKline, Research Triangle Park, NC.

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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