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 usageALVESCO 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- October 20, 2006 Omnaris, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 usageALVESCO 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 labelsAllergies: 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)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alvesco 160 mcg inhaler | Brand | $42.97 per gram | n/a | -0.1% |
| Alvesco 80 mcg inhaler | Brand | $42.96 per gram | n/a | no change |
| Omnaris 50 mcg nasal spray | Brand | $22.55 per gram | n/a | no 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 named | Section | What the label says |
|---|---|---|
| Albuterol | drug interactions | DRUG 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 )]. |
| Erythromycin | drug interactions | 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 [see Clinical Pharmacology ( 12.3 )]. |
| Formoterol | drug interactions | DRUG 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 )]. |
| Ketoconazole | 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. |
| Prednisone | warnings and precautions | Patients 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
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
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.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Albuterol | Asthma | 33 labelers | $0.0612 per mL 2.5 mg/3 mL solution | Resolved |
| Fluticasone and salmeterol | Asthma | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Budesonide | Asthma | 13 labelers | $0.676 per mL 0.5 mg/2 mL suspension | No current entry |
| Budesonide and formoterol | Asthma | 2 labelers | $17.26 per gram 160-4.5 | No current entry |
| Beclomethasone | Asthma | 2 labelers | $20.57 per gram 40 mcg | No current entry |
| Formoterol and mometasone | Asthma | none listed | $25.22 per gram 100 mcg-5 mcg inhaler | No current entry |
| Epinephrine | Asthma | none listed | n/a | A presentation being discontinued |
| Albuterol and budesonide | Asthma | none listed | $45.03 per gram 90-80 mcg inhaler | No 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