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Prescription medicine

Ciclesonide Brand names: Alvesco, Omnaris

Ciclesonide (Alvesco) is a prescription medicine with an FDA approval on record since 2006. No generic is listed; pharmacies paid $42.97 per gram (Alvesco 160 mcg inhaler) in the October 7, 2026 NADAC survey.

  • No generic listed

Check it at the source: the ciclesonide FDA label on DailyMed (effective February 28, 2025, Covis Pharma US, Inc); the NDA 22004 record on Drugs@FDA; every ciclesonide label on DailyMed.

Highlights of the record

FDA label of February 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older.

Forms and strengths

Aerosol (metered); spray.

On the market

Earliest approval on file
October 20, 2006 Omnaris, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent
February 1, 2028 Alvesco aerosol; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$42.97 per gram Alvesco 160 mcg inhaler
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
13,541 through July 30, 2026

What is ciclesonide used for?

From the label: indications and usage

ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use: ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age. ALVESCO is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use: ALVESCO is not indicated for the relief of acute bronchospasm or in pediatric patients less than 12 years of age.

Conditions named in the indications of ciclesonide's FDA labels, with every medicine labeled for each:

From other ciclesonide labels

Allergies: 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 …

Source: FDA drug label (Alvesco), NDA021658 (Azurity), as published by Covis Pharma US, Inc, effective February 28, 2025 (SPL set 9f6112fb-78ef-43cf-8ae3-36370eb45468), via openFDA; the full label on DailyMed

Is there a generic for ciclesonide (Alvesco)?

No generic ciclesonide is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Alvesco aerosol, the last expiring on February 1, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2006 earliest approval on file
  • 2028 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for ciclesonide (Alvesco)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $42.97 per gram (Alvesco 160 mcg inhaler), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Omnaris 50 mcg nasal spray (brand)
$22.64
$22.51
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Alvesco 160 mcg inhalerBrand$42.97 per gramn/a-0.1%
Alvesco 80 mcg inhalerBrand$42.96 per gramn/ano change
Omnaris 50 mcg nasal sprayBrand$22.55 per gramn/ano change

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the ciclesonide label say about other medicines?

The ciclesonide label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name ciclesonide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Albuteroldrug interactionsDRUG INTERACTIONS In clinical studies, concurrent administration of ciclesonide and other drugs commonly used in the treatment of asthma (albuterol, formoterol) had no effect on pharmacokinetics of des-ciclesonide [see Clinical Pharmacology ( 12.3 )].
Erythromycindrug interactionsErythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of ciclesonide [see Clinical Pharmacology ( 12.3 )].
Formoteroldrug interactionsDRUG INTERACTIONS In clinical studies, concurrent administration of ciclesonide and other drugs commonly used in the treatment of asthma (albuterol, formoterol) had no effect on pharmacokinetics of des-ciclesonide [see Clinical Pharmacology ( 12.3 )].
Ketoconazoledrug interactionsIn 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.
Prednisonewarnings and precautionsPatients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.

Other labels that name ciclesonide

Check ciclesonide against other medicines

Source: FDA drug label (Alvesco), NDA021658 (Azurity), as published by Covis Pharma US, Inc, effective February 28, 2025 (SPL set 9f6112fb-78ef-43cf-8ae3-36370eb45468), via openFDA; the full label on DailyMed

What do FAERS reports show for ciclesonide?

The FDA Adverse Event Reporting System holds 13,541 reports that list ciclesonide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 622 are coded as a death and 6,094 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Asthma (a use or a product term, not a reaction)5,858
  • Dyspnoea4,621
  • Wheezing (named in the label)3,710
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)2,598
  • Cough (named in the label)2,578
  • Obstructive Airways Disorder1,818
  • Loss Of Personal Independence In Daily Activities1,783
  • Pneumonia (named in the label)1,772

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as ciclesonide?

8 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as ciclesonide or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (respiratory (inhalation))Pharmacy costShortage
AlbuterolAsthma33 labelers$0.0612 per mL 2.5 mg/3 mL solutionResolved
Fluticasone and salmeterolAsthma8 labelers$1.07 per unit 100-50A presentation being discontinued
BudesonideAsthma13 labelers$0.676 per mL 0.5 mg/2 mL suspensionNo current entry
Budesonide and formoterolAsthma2 labelers$17.26 per gram 160-4.5No current entry
BeclomethasoneAsthma2 labelers$20.57 per gram 40 mcgNo current entry
Formoterol and mometasoneAsthmanone listed$25.22 per gram 100 mcg-5 mcg inhalerNo current entry
EpinephrineAsthmanone listedn/aA presentation being discontinued
Albuterol and budesonideAsthmanone listed$45.03 per gram 90-80 mcg inhalerNo current entry

Every medicine labeled for the same conditions as ciclesonide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to ciclesonide
8 medicines for the same use
Ciclesonide side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other