CICLESONIDE

N/A

Manufactured by Covis Pharma US, Inc

74,022 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CICLESONIDE

CICLESONIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Covis Pharma US, Inc. The most commonly reported adverse reactions for CICLESONIDE include ASTHMA, DYSPNOEA, WHEEZING, THERAPEUTIC PRODUCT EFFECT INCOMPLETE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CICLESONIDE.

Top Adverse Reactions

ASTHMA5,711 reports
DYSPNOEA4,479 reports
WHEEZING3,589 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE2,550 reports
COUGH2,483 reports
OBSTRUCTIVE AIRWAYS DISORDER1,752 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES1,734 reports
PNEUMONIA1,686 reports
DRUG INEFFECTIVE1,506 reports
PRODUCTIVE COUGH1,464 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION1,439 reports
FATIGUE1,251 reports
CHEST DISCOMFORT1,169 reports
MALAISE1,112 reports
CONDITION AGGRAVATED1,056 reports
FULL BLOOD COUNT ABNORMAL1,007 reports
NASOPHARYNGITIS995 reports
HEADACHE980 reports
WEIGHT DECREASED815 reports
PAIN814 reports
OFF LABEL USE783 reports
NAUSEA768 reports
GASTROOESOPHAGEAL REFLUX DISEASE748 reports
BLOOD PRESSURE INCREASED738 reports
SINUSITIS730 reports
DYSPNOEA EXERTIONAL724 reports
HYPERTENSION708 reports
PYREXIA691 reports
INFLUENZA660 reports
SPUTUM DISCOLOURED660 reports
HYPERSENSITIVITY657 reports
BLOOD COUNT ABNORMAL655 reports
NASAL CONGESTION652 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE649 reports
ANXIETY637 reports
ARTHRALGIA623 reports
WEIGHT INCREASED619 reports
DIZZINESS608 reports
PAIN IN EXTREMITY602 reports
BRONCHITIS585 reports
BRONCHIECTASIS569 reports
FALL553 reports
VOMITING533 reports
DIARRHOEA526 reports
INFECTION522 reports
HEART RATE INCREASED510 reports
ASTHENIA506 reports
OROPHARYNGEAL PAIN492 reports
DRUG HYPERSENSITIVITY487 reports
PRURITUS482 reports
LOWER RESPIRATORY TRACT INFECTION468 reports
FORCED EXPIRATORY VOLUME DECREASED459 reports
PRODUCT DOSE OMISSION ISSUE445 reports
ARTHRITIS439 reports
HYPOXIA438 reports
BACK PAIN433 reports
INSOMNIA433 reports
ILLNESS429 reports
PERIPHERAL SWELLING422 reports
OEDEMA PERIPHERAL421 reports
LUNG DISORDER414 reports
PULMONARY EMBOLISM411 reports
HOSPITALISATION406 reports
DYSPHONIA390 reports
RESPIRATORY DISORDER383 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION382 reports
DEPRESSION381 reports
MIDDLE INSOMNIA380 reports
NASAL POLYPS375 reports
MYALGIA373 reports
RASH369 reports
DRUG INTOLERANCE368 reports
BREATH SOUNDS ABNORMAL367 reports
EOSINOPHIL COUNT INCREASED360 reports
CHEST PAIN359 reports
URTICARIA357 reports
RHINORRHOEA346 reports
ABDOMINAL PAIN344 reports
THROMBOSIS336 reports
DEATH334 reports
NODULE332 reports
HERPES ZOSTER330 reports
OXYGEN SATURATION DECREASED325 reports
GAIT DISTURBANCE314 reports
CONJUNCTIVITIS ALLERGIC310 reports
EOSINOPHILIA310 reports
SPIROMETRY ABNORMAL307 reports
DUST ALLERGY306 reports
JOINT SWELLING304 reports
MITE ALLERGY297 reports
RHINITIS297 reports
MYCOTIC ALLERGY290 reports
SLEEP APNOEA SYNDROME288 reports
HYPOTHYROIDISM284 reports
NORMOCHROMIC NORMOCYTIC ANAEMIA279 reports
ASTHMA CHRONIC OBSTRUCTIVE PULMONARY DISEASE OVERLAP SYNDROME278 reports
HAEMOPTYSIS275 reports
ANAEMIA273 reports
VIRAL INFECTION267 reports
ECZEMA265 reports

Report Outcomes

Out of 13,073 classified reports for CICLESONIDE:

Serious 90.3%Non-Serious 9.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female7,762 (65.3%)
Male4,120 (34.7%)
Unknown3 (0.0%)

Reports by Age

Age 72357 reports
Age 65300 reports
Age 60286 reports
Age 59265 reports
Age 52254 reports
Age 62252 reports
Age 73251 reports
Age 68249 reports
Age 70240 reports
Age 63239 reports
Age 76229 reports
Age 54223 reports
Age 80221 reports
Age 56216 reports
Age 67199 reports
Age 69196 reports
Age 71190 reports
Age 64188 reports
Age 66188 reports
Age 74177 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with CICLESONIDE?

This profile reflects 74,022 FDA FAERS reports that mention CICLESONIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CICLESONIDE?

Frequently reported terms in FAERS include ASTHMA, DYSPNOEA, WHEEZING, THERAPEUTIC PRODUCT EFFECT INCOMPLETE, COUGH, OBSTRUCTIVE AIRWAYS DISORDER. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CICLESONIDE?

Labeling and FAERS entries often list Covis Pharma US, Inc in connection with CICLESONIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.