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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 ConsumerApplies to umeclidinium / vilanterol: inhalation powder
Inhalation route (Powder)
Asthma-related death: Long-acting beta(2)-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to the usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABA, including vilanterol, one of the active ingredients in the umeclidinium/vilanterol combination. The safety and efficacy of umeclidinium / vilanterol in patients with asthma have not been established. Umeclidinium / vilanterol is not indicated for the treatment of asthma.
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
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
Rare
For Healthcare Professionals
Applies to umeclidinium / vilanterol: inhalation powder
GeneralThe most common adverse reaction was nasopharyngitis (9%).
EndocrineCommon (1% to 10%): Diabetes Mellitus
GastrointestinalCommon (1% to 10%): Constipation, dry mouth, diarrhea, nausea, abdominal pain, toothache
Uncommon (0.1% to 1%): Dyspepsia, gastroesophageal reflux disease, vomiting
GenitourinaryCommon (1% to 10%): Urinary tract infection
Frequency not reported: Signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination)
MusculoskeletalCommon (1% to 10%): Pain in extremity, muscle spasms, neck pain, back pain, arthralgia
Uncommon (0.1% to 1%): Musculoskeletal chest pain
Nervous systemCommon (1% to 10%): Headache
Postmarketing reports: Dysgeusia, tremor
OtherCommon (1% to 10%): Vertigo
Uncommon (0.1% to 1%): Asthenia
RespiratoryCommon (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
CardiovascularUncommon (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
DermatologicUncommon (0.1% to 1%): Pruritus, rash
OcularUncommon (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)
HypersensitivityPostmarketing reports: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria
PsychiatricPostmarketing reports: Anxiety
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Anoro Ellipta (www.drugs.com/anoro-ellipta.html).
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