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ciclesonide Side Effects

Also known as: Alvesco

Analysis of 13,075 adverse event reports submitted to the FDA from 2006 to 2025.

Total Reports

13,075

Death-Related

576

4.4% of reports

Hospitalizations

5,864

44.8% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

ASTHMA
5,711
DYSPNOEA
4,479
WHEEZING
3,589
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
2,550
COUGH
2,483
OBSTRUCTIVE AIRWAYS DISORDER
1,752
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES
1,734
PNEUMONIA
1,686
DRUG INEFFECTIVE
1,506
PRODUCTIVE COUGH
1,464
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION
1,439
FATIGUE
1,251
CHEST DISCOMFORT
1,169
MALAISE
1,112
CONDITION AGGRAVATED
1,056
FULL BLOOD COUNT ABNORMAL
1,007
NASOPHARYNGITIS
995
HEADACHE
980
WEIGHT DECREASED
815
PAIN
813

Who Reports Side Effects

Gender Distribution

Female 7,762 (65%)
Male 4,120 (35%)
Unknown 3

Age Distribution

0-17 406 (4%)
18-44 1,592 (17%)
45-64 3,431 (37%)
65-74 2,346 (25%)
75+ 1,564 (17%)

Reporting Trend by Year

2006 2025

Reactions in Death Reports

Top reactions reported in 576 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 334
ASTHMA 144
DYSPNOEA 140
WHEEZING 97
PNEUMONIA 86
PRODUCTIVE COUGH 73
FORCED EXPIRATORY VOLUME DECREASED 72
OBSTRUCTIVE AIRWAYS DISORDER 72
ANXIETY 71
CONDITION AGGRAVATED 66
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 64
LUNG DISORDER 64
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 64
THROMBOSIS 64
THERAPEUTIC PRODUCT EFFECT INCOMPLETE 62
ARTERIOSCLEROSIS 61
HAEMOPTYSIS 61
PAIN IN EXTREMITY 61
HYPOXIA 60
HYPOTHYROIDISM 59

Reactions in Hospitalization Reports

Top reactions in 5,864 reports where hospitalization was an outcome.

Reaction Reports
ASTHMA 3,280
DYSPNOEA 2,636
WHEEZING 2,226
THERAPEUTIC PRODUCT EFFECT INCOMPLETE 1,446
COUGH 1,189
PNEUMONIA 1,156
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 1,103
OBSTRUCTIVE AIRWAYS DISORDER 1,033
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 974
PRODUCTIVE COUGH 966
CONDITION AGGRAVATED 693
CHEST DISCOMFORT 649
MALAISE 646
FULL BLOOD COUNT ABNORMAL 642
FATIGUE 636
DRUG INEFFECTIVE 624
NASOPHARYNGITIS 498
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 455
BLOOD PRESSURE INCREASED 446
HEADACHE 445

Nearby — Related Medications

Compare ciclesonide vs aclidinium →

What the FAERS Data Reveals About ciclesonide Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 13,075 voluntary reports linked to ciclesonide and its brand equivalents (Alvesco), spanning 2006 through 2025. Of those, 576 (4.4%) listed death as an outcome and 5,864 (44.8%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 65% were female and 35% male; age distribution skews toward 45-64, with 3,431 reports in that bracket. The single most reported reaction is asthma with 5,711 submissions, followed by dyspnoea and wheezing.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.