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Flovent Diskus Side Effects

Generic Name: fluticasone

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

For the Consumer

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

Along with its needed effects, fluticasone (the active ingredient contained in Flovent Diskus) 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

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 the hands and feet
  • swelling of the face, lips, or eyelids
  • tightness in the chest
  • troubled breathing
  • weakness

Incidence not known

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

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

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

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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