Note: This document contains side effect information about fluticasone. Some dosage forms listed on this page may not apply to the brand name Arnuity Ellipta.

Applies to fluticasone: inhalation aerosol powder, inhalation powder.

Serious side effects of Arnuity Ellipta

Along with its needed effects, fluticasone (the active ingredient contained in Arnuity Ellipta) 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:

More common

• White patches in the mouth and throat

Less common

• Bone pain
• diarrhea
• ear ache
• fever
• lower abdominal or stomach pain
• nausea
• pain on passing urine
• redness or discharge of the eye, eyelid, or lining of the eye
• sore throat
• trouble swallowing
• vaginal discharge (creamy white) and itching
• vomiting

Rare

• Blindness, blurred vision, eye pain
• bone fractures
• chest tightness
• excess facial hair in women
• fullness or roundness of the face, neck, and trunk
• growth reduction in children or teenagers
• heart problems
• high blood pressure
• hives, skin rash
• impotence in males
• increased hunger, thirst, or urination
• lack of menstrual periods
• muscle wasting
• numbness and weakness of the hands and feet
• swelling of the face, lips, or eyelids
• trouble breathing
• weakness

Incidence not known

• Dizziness
• fast heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone:

Symptoms of overdose

• Darkening of the skin
• fainting
• loss of appetite
• mental depression
• unusual tiredness or weakness

Other side effects of Arnuity Ellipta

Some side effects of fluticasone 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:

More common

• Cough
• general aches and pains or general feeling of illness
• greenish-yellow mucus in the nose
• headache
• hoarseness or other voice changes
• runny, sore, or stuffy nose

Less common

• Bloody mucus or unexplained nosebleeds
• eye irritation
• headache, severe and throbbing
• irregular or painful menstrual periods
• joint pain
• mouth irritation
• muscle soreness, sprain, or strain
• sneezing
• stomach pain

Rare

• Aggression
• agitation
• bruising
• itching
• restlessness
• weight gain

Incidence not known

• Decrease in height
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• loss of voice
• pain in the back, ribs, arms or legs
• sweating
• trouble sitting still
• unexplained weight loss

For Healthcare Professionals

Applies to fluticasone: compounding powder, inhalation aerosol, inhalation aerosol with adapter, inhalation powder, inhalation suspension.

General

The most commonly reported adverse events have included headache, upper respiratory tract infection or inflammation, throat irritation, oral candidiasis, nausea and vomiting.^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 21%), nasal congestion/blockage

Common (1% to 10%): Cough, lower respiratory infection, sinusitis/sinus infection, hoarseness/dysphonia, bronchitis, pneumonia (in COPD patients), rhinitis

Rare (0.01% to 0.1%): Paradoxical bronchospasm

Frequency not reported: Epistaxis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps

Postmarketing reports: Asthma exacerbation, wheeze^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Cutaneous hypersensitivity reactions

Rare (0.01% to 0.1%): Angioedema (mainly facial and oropharyngeal), respiratory symptoms (dyspnea and/or bronchospasm)

Very rare (less than 0.01%): Anaphylactic reactions^[Ref]

Gastrointestinal

Very common (10% or more): Oropharyngeal candidiasis (up to 13.7%), throat irritation (up to 22%)

Common (1% to 10%): Nausea, vomiting, throat irritation, gastrointestinal discomfort and pain, viral gastrointestinal infection, toothache

Very rare (less than 0.01%): Dyspepsia

Frequency not reported: Abdominal discomfort, oral ulcerations, dental discomfort, oral erythema and rashes, month and tongue disorders

Postmarketing reports: Sore throat^[Ref]

Endocrine

Rare (0.01% to 0.1%): Adrenal suppression

Frequency not reported: Cushing's syndrome, cushingoid features^[Ref]

Ocular

Rare (0.01% to 0.1%): Cataract, glaucoma

Frequency not reported: Keratitis, conjunctivitis, blepharoconjunctivitis^[Ref]

Psychiatric

Very rare (less than 0.01%): Anxiety, sleep disorders, behavioral changes including hyperactivity and irritability (predominantly in children), depression^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle injury, musculoskeletal pain, back pain

Rare (0.01% to 0.1%): Growth retardation (pediatrics), decrease in bone mineral density

Very rare (less than 0.01%): Arthralgia

Postmarketing reports: Osteoporosis^[Ref]

Nervous system

Very common (10% or more): Headache (up to 14%)

Common (1% to 10%): Malaise and fatigue

Frequency not reported: Dizziness

Postmarketing reports: Aphonia^[Ref]

Other

Common (1% to 10%): Malaise, fever

Frequency not reported: Allergic ear, nose, and throat disorders^[Ref]

Dermatologic

Common (1% to 10%): Contusions, pruritus, skin rash

Frequency not reported: Photodermatitis, acne and folliculitis

Postmarketing reports: Ecchymosis^[Ref]

Hematologic

Rare (0.01% to 0.1%): Systemic eosinophilic conditions^[Ref]

Metabolic

Very rare (less than 0.01%): Hyperglycemia

Frequency not reported: Fluid disturbances, weight gain, appetite disturbances^[Ref]

Cardiovascular

Frequency not reported: Palpitations

Postmarketing reports: Chest tightness^[Ref]