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Ciclesonide Side Effects

For the Consumer

Applies to ciclesonide: inhalation aerosol liquid

Along with its needed effects, ciclesonide 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 ciclesonide:

More Common

  • Body aches or pain
  • chills
  • cough
  • difficulty in breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • muscle aches
  • nasal congestion
  • pain or tenderness around eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of chest or wheezing
  • unusual tiredness or weakness

Rare

  • Sore mouth or tongue
  • white patches in mouth and/or on tongue

Incidence Not Known

  • Blindness
  • blurred vision
  • creamy white, curd-like patches in mouth or throat
  • darkening of skin
  • decreased vision
  • diarrhea
  • dizziness
  • eye pain
  • fainting
  • hoarseness
  • lack or slowing of normal growth in children
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • lower back or side pain
  • mental depression
  • nausea
  • pain when eating or swallowing
  • painful or difficult urination
  • skin rash
  • tearing
  • vomiting

Some side effects of ciclesonide 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
  • difficulty in moving
  • muscle pain or stiffness
  • pain in arms or legs
  • pain in joints

Rare

  • Chest discomfort
  • dry mouth or throat
  • voice changes

For Healthcare Professionals

Applies to ciclesonide: inhalation aerosol

General

The most commonly reported adverse reactions have included headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, and back pain.[Ref]

Local

Uncommon (0.1% to 1%): Application site reaction, application site dryness[Ref]

Respiratory

Cough, dysphonia, and dry throat were reported in less than 1% of patients and at a greater incidence than with placebo. Paradoxical bronchospasm may be related to the drug, the excipient, or evaporation cooling in the case of metered dose inhalers.[Ref]

Common (1% to 10%): Nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, nasal congestion, hoarseness, pneumonia, bronchitis, tonsillitis

Uncommon (0.1% to 1%): Laryngitis

Frequency not reported: Cough, dysphonia, dry throat, paradoxical bronchospasm[Ref]

Hypersensitivity

Hypersensitivity side effects have included immediate or delayed hypersensitivity reactions such as angioedema with swelling of lips, tongue, and pharynx.[Ref]

Gastrointestinal

Common (1% to 10%): Oral candidiasis, gastroenteritis, vomiting, upper abdominal pain, diarrhea, toothache

Uncommon (0.1% to 1%): Bad taste

Frequency not reported: Dry mouth, nausea[Ref]

During clinical trials, Candida albicans infections of the mouth and pharynx occurred 32 of 3038 patients (1%); the majority of infections occurred in patients receiving 320 mcg per day. Most cases were mild to moderate. Dry mouth and nausea were reported in less than 1% of patients and at a greater incidence than with placebo.[Ref]

Nervous system

Very common (10% or more): Headache (up to 11%)

Common (1% to 10%): Dizziness[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Frequency not reported: Glaucoma, increased intraocular pressure, cataracts[Ref]

Dermatologic

Common (1% to 10%): Urticaria

Uncommon (0.1% to 1%): Eczema, rash[Ref]

Musculoskeletal

Common (1% to 10%): Extremity pain, back pain[Ref]

Cardiovascular

Chest discomfort was reported in less than 1% of patients and at a greater incidence than with placebo. Palpitations were mostly observed in patients taking concomitant medication known to have cardiac effects.[Ref]

Rare (0.01% to 0.1%): Palpitations, hypertension

Frequency not reported: Chest discomfort[Ref]

Psychiatric

Very rare (less than 0.01%): Agitation, insomnia, depression, anxiety, behavioral changes[Ref]

References

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

2. "Product Information. Alvesco (ciclesonide)." Nycomed USA, Florham Park, NJ.

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

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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