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Arnuity Ellipta Side Effects

Generic Name: fluticasone

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

For the Consumer

Applies to fluticasone: inhalation aerosol powder, inhalation disk, inhalation powder

In addition to its needed effects, some unwanted effects may be caused by fluticasone (the active ingredient contained in Arnuity Ellipta). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking fluticasone:

More common:
  • White patches in the mouth and throat
Less common:
  • 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
  • shortness of breath
  • sore throat
  • trouble swallowing
  • vaginal discharge (creamy white) and itching
  • vomiting
Rare
  • Blindness, blurred vision, eye pain
  • bone fractures
  • excess facial hair in women
  • fullness or roundness of the face, neck, and trunk
  • growth reduction in children or adolescents
  • heart problems
  • high blood pressure
  • hives and skin rash
  • impotence in males
  • increased hunger, thirst, or urination
  • lack of menstrual periods
  • muscle wasting
  • numbness and weakness of hands and feet
  • weakness
  • swelling of the face, lips, or eyelids
  • tightness in the chest, troubled breathing, or wheezing
Incidence not known:
  • Dizziness
  • fast heartbeat

If any of the following symptoms of overdose occur while taking fluticasone, get emergency help immediately:

Symptoms of overdose:
  • Darkening of skin
  • fainting
  • loss of appetite
  • mental depression
  • unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with fluticasone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
  • fainting
  • 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:
  • Blurred vision
  • 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
Very rare (less than 0.01%):
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]

References

1. "Product Information. Flovent HFA (fluticasone)." GlaxoSmithKline, Research Triangle Park, NC.

2. "Product Information. Arnuity Ellipta (fluticasone)." GlaxoSmithKline, Research Triangle Park, NC.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. "Product Information. Flovent Diskus (fluticasone)." GlaxoSmithKline, Research Triangle Park, NC.

Not all side effects for Arnuity Ellipta may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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