Ciclesonide Oral Inhalation
Ciclesonide oral inhalation is an inhaled corticosteroid (steroid) used for the long-term, preventive treatment of asthma in people 12 and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Alvesco (ciclesonide) is a preventive steroid inhaler for asthma in people 12 and older. It is a prodrug (it becomes active once inside the body) that calms airway inflammation, and it has been on the U.S. market since about 2009 as a less commonly prescribed member of the inhaled steroids, the usual first choice for daily asthma control. Most people tolerate it well, noticing at most a headache, a stuffy nose or a sore throat. It is not a rescue inhaler, and the real danger is coming off an oral steroid like prednisone too fast when switching, since adrenal problems, including deaths, have happened during that change. Full benefit can take four weeks or longer, so keep using it and talk with your prescriber before stopping.
Clinical pearls
- Rinse your mouth with water and spit after every dose to help prevent thrush, white patches from a mouth yeast infection.
- Prime the inhaler before first use and again whenever it has gone unused for more than 10 days.
- Carry a fast-acting inhaler such as albuterol, and get help if wheezing suddenly worsens right after an Alvesco dose.
- Tell any prescriber about Alvesco before starting ketoconazole, an antifungal that raises levels of ciclesonide's active form.
Patient information guide A plain-language walkthrough of Ciclesonide Oral Inhalation, written from its FDA label.
What Ciclesonide Oral Inhalation is used for
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Ciclesonide oral inhalation is used for one purpose in the supplied evidence:
- Alvesco is used for maintenance (preventive) treatment of asthma in adults and teens 12 years and older.
- Alvesco is not for relief of sudden breathing trouble (acute bronchospasm).
- Alvesco is not indicated for children under 12.
How Ciclesonide Oral Inhalation works
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Ciclesonide is a prodrug. After you inhale it, the body converts it into its active form, des-ciclesonide, which has strong anti-inflammatory activity and binds to glucocorticoid receptors.
Corticosteroids calm many cells and chemical signals involved in asthma inflammation. They do not work immediately, and full benefit may take four weeks or longer. Asthma control can last for several days after stopping.
Ciclesonide Oral Inhalation dosage
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Alvesco is inhaled by mouth, usually twice a day. Your prescriber chooses the starting dose based on what you used before, then may adjust it. Once asthma is stable, the goal is the lowest effective dose.
- Prime the inhaler before first use and if unused for more than 10 days.
- Rinse your mouth with water and spit it out after each use.
- Do not exceed the highest recommended daily dose.
Dosing details from the FDA-approved label
From the Ciclesonide Oral Inhalation prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Patients ≥ 12 years who received bronchodilators alone
- Recommended starting dose 80 mcg twice daily
- Maximum: 160 mcg twice daily
- Maximum benefit may not be achieved for four weeks or longer after initiation; after asthma stability is achieved, titrate to the lowest effective dosage
- Patients ≥ 12 years who received inhaled corticosteroids
- Recommended starting dose 80 mcg twice daily
- Maximum: 320 mcg twice daily
- For patients who do not respond adequately to the starting dose after 4 weeks of therapy, higher doses may provide additional asthma control
- Patients ≥ 12 years who received oral corticosteroids
- Recommended starting dose 320 mcg twice daily
- Maximum: 320 mcg twice daily
- Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2 ) Prime ALVESCO before first use or when inhaler not used for more than 10 days. ( 2 ) 1 Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions ( 5.1 )] . Previous Therapy Recommended Starting Dose Highest Recommended Dose Patients ≥ 12 years who received bronchodilators alone 80 mcg twice daily 160 mcg twice daily Patients ≥ 12 years who received inhaled corticosteroids 80 mcg twice daily 320 mcg twice daily Patients ≥ 12 years who received oral corticosteroids 1 320 mcg twice daily 320 mcg twice daily 2.1 Administration Information Administer ALVESCO by the orally inhaled route. After administration, rinse the mouth with water and spit out without swallowing to help reduce the risk of oropharyngeal candidiasis [see Warnings and Precautions ( 5.1 )] . Priming Prime ALVESCO before using for the first time by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. 2.2 Recommended Dosage The recommended starting dosage and the highest recommended dosage of ALVESCO are listed in Table 1 Table 1: Recommended Dosages for Adults and Pediatric Patients 12 Years and Older 1 Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions ( 5.1 )] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ciclesonide Oral Inhalation side effects
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Common side effects seen in studies include:
Common side effects
- Headache
- Nasopharyngitis (stuffy or runny nose and sore throat)
- Sinusitis (sinus infection)
- Sore throat or throat pain
- Upper respiratory infection
- Joint pain
- Nasal congestion
- Back pain or pain in the arms and legs
When to get medical help
- Call your doctor right away if you have asthma attacks that do not respond to your usual rescue medicine.
- Get help if wheezing suddenly gets worse right after a dose (paradoxical bronchospasm). Use a fast-acting inhaler.
- Tell your doctor about white patches or soreness in your mouth or throat (possible thrush, a yeast infection).
- Seek emergency care for swelling of the lips, tongue or throat, which can be a serious allergic reaction (angioedema).
- Report fatigue, weakness, nausea, vomiting or low blood pressure, especially if you recently stopped oral steroids. These can be signs of adrenal insufficiency.
- Tell your doctor about any change in vision.
- Avoid exposure to chickenpox or measles if you have not had them or been immunized, and call your doctor if exposed.
Seek help for allergic swelling, mouth yeast infection, sudden worsening wheeze after a dose, or signs of adrenal insufficiency.
Ciclesonide Oral Inhalation warnings and precautions
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- Switching from oral steroids: adrenal insufficiency, including deaths, has occurred. Taper slowly under medical supervision.
- Not a rescue inhaler: sudden asthma attacks need a fast-acting bronchodilator.
- Mouth yeast infection: rinse after each use.
- Infections: chickenpox and measles can be more serious. Use caution with tuberculosis, untreated infections or ocular herpes simplex.
- Long-term effects: lower bone density, slowed growth in children, glaucoma and cataracts.
- Paradoxical bronchospasm: wheezing may get worse right after a dose.
Ciclesonide Oral Inhalation interactions
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Few interactions were found in the label.
- Ketoconazole, a strong CYP3A4 blocker, raised the active form of ciclesonide about 3.6-fold.
- Albuterol and formoterol did not change how the active form is handled.
- Oral steroids need a slow taper when switching to Alvesco.
Interactions listed in the FDA-approved label
From the Ciclesonide Oral Inhalation prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Albuterol, formoterol (other drugs commonly used in the treatment of asthma): Concurrent administration had no effect on pharmacokinetics of des-ciclesonide in clinical studies.
- Ketoconazole (potent cytochrome P450 3A4 inhibitor): Co-administration of orally inhaled ciclesonide and oral ketoconazole increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged.
- Metabolic or protein binding-based interactions (des-ciclesonide): In vitro and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions.
Read the label’s full interactions text
7 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 )] . In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see Clinical Pharmacology ( 12.3 )] . 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.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ciclesonide Oral Inhalation
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- Do not use for status asthmaticus or other acute asthma episodes needing intensive care.
- Do not use if allergic to ciclesonide or any ingredient.
- Not for children under 12; effectiveness was not shown in younger children.
- Pregnancy: no human data. Poorly controlled asthma itself carries risks in pregnancy.
- Breastfeeding: it is unknown whether it passes into milk. Discuss benefits and risks with your doctor.
- Liver problems raised exposure to the active form, but no dose adjustment is needed.
- Tell your doctor about eye problems, bone risk factors, or infections.
Ciclesonide Oral Inhalation overdose
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Long-term overuse may cause hypercorticism, meaning too much steroid effect in the body. Do not exceed the highest recommended dose. Contact your doctor or poison control if you think you have used too much.
How your body processes Ciclesonide Oral Inhalation
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Swallowed ciclesonide and its active form are barely absorbed (under 1%). Inhaled, about 22% of ciclesonide reaches the bloodstream, and the active form peaks about one hour after inhaling. Both are highly bound to plasma proteins. The liver breaks down the active form mainly through CYP3A4, and most of the drug leaves through bile and feces. The active form's half-life is about 6 to 7 hours.
How to store Ciclesonide Oral Inhalation
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Store at 25°C (77°F). store near heat or open flame.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Ciclesonide Oral Inhalation
166 supplements and herbal products have documented interactions with Ciclesonide Oral Inhalation in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 134
- Minor · 30
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Ciclesonide Oral Inhalation: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ciclesonide Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
What is Alvesco for?
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How soon will it work?
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Why do I need to rinse my mouth?
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What side effects should I expect?
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Can I stop my oral steroid when I start this?
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Is it safe in pregnancy?
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Is Ciclesonide Oral Inhalation available over the counter?
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When was Ciclesonide Oral Inhalation first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ciclesonide Oral Inhalation on HelloPharmacist
Ciclesonide Oral Inhalation forms and strengths (how it comes)
Ciclesonide Oral Inhalation is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ciclesonide Oral Inhalation inactive ingredients by manufacturer.
Inhaler
How this form is used
- Alvesco is used for maintenance treatment of asthma in adults and teens 12 and older.
- Alvesco is not for relief of sudden breathing trouble or for children under 12.
- Alvesco is for oral inhalation only.
- Prime Alvesco before first use of a new canister and if unused for more than 10 days.
- After using Alvesco, rinse your mouth with water and spit it out.
- Benefit from Alvesco may take four weeks or longer.
Ciclesonide Oral Inhalation on the U.S. market: products, makers and brands
How Ciclesonide Oral Inhalation appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Ciclesonide Oral Inhalation product records with the FDA, mostly as inhaler; the earliest marketing or approval year on record is 2006. Brand names on the directory include Alvesco, Zetonna, Omnaris; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Ciclesonide Oral Inhalation is used (Medicaid data)
A general measure of how commonly Ciclesonide Oral Inhalation is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ciclesonide Oral Inhalation is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ciclesonide Oral Inhalation prescribed? Of the 1,601 medications we measure, Ciclesonide Oral Inhalation ranks #716 by Medicaid prescriptions — more than 55% of them.
Utilization by Ciclesonide Oral Inhalation product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
60 ACTUAT ciclesonide 0.08 MG/ACTUAT Metered Dose Inhaler Most dispensed
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 799038
60 ACTUAT ciclesonide 0.16 MG/ACTUAT Metered Dose Inhaler
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 799034
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ciclesonide Oral Inhalation, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 10 listed Ciclesonide Oral Inhalation NDCs with Medicaid activity.
Compare Ciclesonide Oral Inhalation products
A representative set of FDA-listed product records for Ciclesonide Oral Inhalation — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Inhaler | ||||
| 80 mcg | Respiratory (inhalation) | Covis Pharma US, Inc | NDA | View NDC → |
| 160 mcg | Respiratory (inhalation) | Covis Pharma US, Inc | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Ciclesonide Oral Inhalation NDCs →
Ciclesonide Oral Inhalation side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ciclesonide Oral Inhalation — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ciclesonide Oral Inhalation in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ciclesonide Oral Inhalation FDA approval history
How Ciclesonide Oral Inhalation went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ciclesonide Oral Inhalation recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Ciclesonide recalls since July 2021.
✅No Ciclesonide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 274964 2 dose forms · 4 strengths
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Dose form (SCDF) Metered Dose Inhaler RxCUI 799033In current FDA listingsClinical drug / strength (SCD) 60 ACTUAT ciclesonide 0.08 MG/ACTUATRxCUI 79903860 ACTUAT ciclesonide 0.16 MG/ACTUATRxCUI 799034 -
Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797837No current FDA listing
Look up RxCUI 274964 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Ciclesonide Oral Inhalation supply and shortage status
Whether Ciclesonide Oral Inhalation is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Ciclesonide Oral Inhalation costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Aerosol, Metered · Respiratory (inhalation) | 80 mcg | $42.96 per gram | NDC details & price history |
| Aerosol, Metered · Respiratory (inhalation) | 160 mcg | $42.97 per gram | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Ciclesonide Oral Inhalation brand names
Ciclesonide Oral Inhalation is sold under 3 brand names in the FDA directory — Alvesco, Zetonna, Omnaris. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ciclesonide Oral Inhalation: manufacturers and labelers
One company lists Ciclesonide Oral Inhalation products with the FDA. By number of product records, the largest are Covis Pharma US, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Ciclesonide Oral Inhalation drug class (RxNorm)
Ciclesonide Oral Inhalation belongs to the Corticosteroids class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Ciclesonide Oral Inhalation page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Covis Pharma US, Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →