Note: This document contains side effect information about umeclidinium / vilanterol. Some dosage forms listed on this page may not apply to the brand name Anoro Ellipta.
Applies to umeclidinium / vilanterol: inhalation powder.
Serious side effects of Anoro Ellipta
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
- itching, skin rash
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- sweating
- vomiting
Incidence not known
- Blindness
- blurred vision
- burning feeling while urinating
- change in vision
- decrease in frequency of urination
- decreased vision
- difficult or painful urination
- difficulty in passing urine (dribbling)
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- hives, itching, skin rash
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- tearing
- tremor
- unusual tiredness or weakness
Other side effects of Anoro Ellipta
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
- muscle spasms
Rare
- Belching
- burning, dry, or itching eyes
- discharge or excessive tearing
- dry mouth
- heartburn
- indigestion
- lack or loss of strength
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- stomach discomfort, upset, or pain
Incidence not known
- Anxiety
- change in or lack of taste
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
