Applies to umeclidinium / vilanterol: inhalation powder.

Serious side effects

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

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