Applies to ciclesonide: inhalation aerosol liquid.
Serious side effects of Ciclesonide
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
Other side effects of Ciclesonide
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
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]
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]
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
Rare (0.01% to 0.1%): Palpitations, hypertension
Frequency not reported: Chest discomfort[Ref]
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]
Psychiatric
Very rare (less than 0.01%): Agitation, insomnia, depression, anxiety, behavioral changes[Ref]
