Anoro Ellipta

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.

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

• Chest discomfort
• dizziness
• fainting
• fast or irregular heartbeat
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• sweating
• vomiting

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

Applies to umeclidinium / vilanterol: inhalation powder

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

Common (1% to 10%): Diabetes Mellitus

Common (1% to 10%): Constipation, dry mouth, diarrhea, nausea, abdominal pain, toothache

Uncommon (0.1% to 1%): Dyspepsia, gastroesophageal reflux disease, vomiting

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

Frequency not reported: Signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination)

Common (1% to 10%): Pain in extremity, muscle spasms, neck pain, back pain, arthralgia

Uncommon (0.1% to 1%): Musculoskeletal chest pain

Common (1% to 10%): Headache

Postmarketing reports: Dysgeusia, tremor

Common (1% to 10%): Vertigo

Uncommon (0.1% to 1%): Asthenia

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

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

Uncommon (0.1% to 1%): Pruritus, rash

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)

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

Postmarketing reports: Anxiety