Applies to fluticasone / umeclidinium / vilanterol: inhalation powder.

Serious side effects

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

Less common

• Bladder pain
• bloody or cloudy urine
• chest pain or tightness
• chills
• cough
• diarrhea
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• headache
• loss of appetite
• lower back or side pain
• nausea
• pain in the nose and mouth
• pain or tenderness around the eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• stomach pain
• trouble breathing
• weakness

Incidence not known

• Difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• redness of the skin
• unusual tiredness or weakness

Other side effects

Some side effects of fluticasone / 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

• Back pain
• change in taste
• headache
• loss of taste

For Healthcare Professionals

Applies to fluticasone / umeclidinium / vilanterol: inhalation powder.

Gastrointestinal

Common (1% to 10%): Oropharyngeal pain, diarrhea, gastroenteritis^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Respiratory

Common (1% to 10%): Cough^[Ref]

Nervous system

Common (1% to 10%): Headache, dysgeusia^[Ref]