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Anoro Ellipta Side Effects

Generic Name: umeclidinium / vilanterol

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

For the Consumer

Applies to umeclidinium / vilanterol: inhalation powder

Along with its needed effects, umeclidinium/vilanterol 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 / vilanterol:

Less common

  • Body aches or pain
  • chest pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • headache
  • hoarseness
  • pain or tenderness around the eyes and cheekbones
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • tightness of the chest
  • trouble breathing
  • trouble swallowing
  • voice changes

Rare

Some side effects of umeclidinium / vilanterol 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

  • Diarrhea
  • difficulty having a bowel movement (stool)
  • muscle spasms

Rare

  • Acid or sour stomach
  • belching
  • burning, dry, or itching eyes
  • discharge or excessive tearing
  • dry mouth
  • heartburn
  • indigestion
  • lack or loss of strength
  • rash or itching skin
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to umeclidinium / vilanterol: inhalation powder

General

The most common adverse reaction was nasopharyngitis (9%).[Ref]

Endocrine

Common (1% to 10%): Diabetes Mellitus[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, dry mouth, diarrhea, nausea, abdominal pain, toothache
Uncommon (0.1% to 1%): Dyspepsia, gastroesophageal reflux disease, vomiting[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Frequency not reported: Signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination)[Ref]

Musculoskeletal

Common (1% to 10%): Pain in extremity, muscle spasms, neck pain, back pain, arthralgia
Uncommon (0.1% to 1%): Musculoskeletal chest pain[Ref]

Nervous system

Common (1% to 10%): Headache
Postmarketing reports: Dysgeusia, tremor[Ref]

Other

Common (1% to 10%): Vertigo
Uncommon (0.1% to 1%): Asthenia[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, sinusitis, nasopharyngitis, lower respiratory tract infection, upper respiratory tract infections, cough, chest pain, pleuritic pain, viral respiratory tract infection, oropharyngeal pain
Uncommon (0.1% to 1%): Productive cough, chest discomfort
Frequency not reported: Paradoxical bronchospasm[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Atrial fibrillation, ventricular extrasystoles, supraventricular extrasystoles, myocardial infarction, rhythm idioventricular, tachycardia, supraventricular tachycardia
Frequency not reported: Symptoms of increases in pulse rate, systolic or diastolic blood pressure
Postmarketing reports: Palpitations[Ref]

Dermatologic

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

Ocular

Uncommon (0.1% to 1%): Conjunctivitis
Frequency not reported: Worsening of narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema)[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria

Psychiatric

Postmarketing reports: Anxiety

References

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

2. "Product Information. Anoro Ellipta (umeclidinium-vilanterol)." GlaxoSmithKline, Research Triangle Park, NC.

3. Kelleher DL, Mehta RS, Jean-Francois BM, et al. "Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial." PLoS One 7 (2012): e50716

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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