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Molecule

Ciclesonide

Available on requestRespiratory
Presentations
3
Brands
2
Manufacturers
1
Available from stock
0

Ciclesonide is a prescription medicine indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults, among other approved uses. MedsAcross supplies Ciclesonide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
R01AD13 Ciclesonide · Topical decongestant, subgroup R01ADR03BA08 Ciclesonide · Inhaled corticosteroid
US FDA first approval
20 October 2006
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Inhalation, Nasal
Dosage forms
Inhaler, Nasal spray
Identifiers
UNII S59502J185RxCUI 274964CAS 126544-47-6DrugBank DB01410Q5119448

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Source: US FDA prescribing information

How it works

Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application. Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120-times higher than the parent compound. The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic inflammation.

Source: US FDA prescribing information

Dosing overview

Administer OMNARIS Nasal Spray by the intranasal route only. Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. If the product is not used for four consecutive days, it should be gently shaken and reprimed with one spray or until a fine mist appears. Illustrated patient’s instructions for proper use accompany each package of OMNARIS Nasal Spray. For Intranasal Use Only • 2 sprays per nostril once daily. (200 mcg). • Priming Information: Gently shake and prime OMNARIS Nasal Spray before using for the first time or when not used for four consecutive days.

Source: US FDA prescribing information

Contraindications

OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray. Patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray.

Source: US FDA prescribing information

Warnings and precautions

• Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid spraying OMNARIS directly onto the nasal septum. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. • Development of glaucoma or cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. • Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals.

Source: US FDA prescribing information

Side effects

Systemic and local corticosteroid use may result in the following: • Epistaxis, nasal septal perforations, Candida albicans infection, impaired wound healing • Cataracts and glaucoma • Immunosuppression • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction The most common adverse reactions (>2% incidence) included headache, epistaxis, nasopharyngitis, ear pain, and pharyngolaryngeal pain.

Source: US FDA prescribing information

Interactions

In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions. In a drug interaction study, co-administration of orally inhaled ciclesonide and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged. Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of ciclesonide.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Ciclesonide, sorted by availability.

MedicineManufacturerRegisterAvailability
Alvesco 160 mcg inhalerInhalationCovis PharmaUS FDAAvailable on request
Alvesco 80 mcg inhalerInhalationCovis PharmaUS FDAAvailable on request
Omnaris 50 mcg nasal sprayNasalCovis PharmaUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 20 October 2006Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Ciclesonide available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Ciclesonide and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Ciclesonide have?

The catalogue lists 2 brand names for Ciclesonide, including Alvesco, Omnaris.

Is Ciclesonide approved by the US FDA?

Yes. The US FDA first approved Ciclesonide on 20 October 2006, according to Drugs@FDA.

Does Ciclesonide need cold chain shipping?

No listed presentation of Ciclesonide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Ciclesonide in?

Ciclesonide is classified under ATC code R01AD13 (Ciclesonide).

References

  1. Omnaris prescribing information (Covis Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 8 November 2022

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