FDA-filed SPL labeling · retrieved through openFDA

Ciclesonide Nasal Spray

Ciclesonide nasal spray is a corticosteroid used to treat nasal symptoms of seasonal and perennial allergic rhinitis (hay fever and year-round nasal allergies).

Brand names OmnarisZetonnaAlvesco
Rx Form 1 Route Nasal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 →

At a glance
Linked label effectiveNov 8, 2022
AvailabilityRx
Earliest approval/marketing year 2006
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Ciclesonide Nasal Spray at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ciclesonide nasal spray (Omnaris) is a once-daily nasal steroid that effectively reduces allergy-related nasal inflammation in seasonal and perennial allergic rhinitis. Nosebleeds and headaches are the most common side effects, and the spray is generally well-tolerated at recommended doses. Use it consistently as directed, prime the pump before first use, and check in with your doctor if you notice vision changes, signs of infection, or unusual fatigue.

📖 Ciclesonide Nasal Spray: Patient Information Guide

A plain-language walkthrough of Ciclesonide Nasal Spray — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Ciclesonide nasal spray is a corticosteroid prescribed to relieve nasal symptoms caused by allergic rhinitis.

  • Omnaris Nasal Spray treats nasal symptoms of seasonal allergic rhinitis (hay fever from pollen and similar triggers) in adults and children 6 years and older
  • Omnaris Nasal Spray treats nasal symptoms of perennial allergic rhinitis (year-round nasal allergies) in adults and adolescents 12 years and older
⚙️How it works

Ciclesonide is a prodrug, which means it starts out inactive and needs to be converted by enzymes in your nasal tissue into its working form, called des-ciclesonide. Des-ciclesonide binds strongly to glucocorticoid receptors — the body's own steroid receptors — and dials down the immune cells (like mast cells, eosinophils, and lymphocytes) and inflammatory chemicals (like histamine and leukotrienes) that cause nasal swelling, congestion, and runny nose during allergic reactions. The precise way it relieves allergy symptoms is not fully understood, but this broad anti-inflammatory action is central to how it works.

💊How it's taken

Omnaris Nasal Spray is used intranasally — sprayed into each nostril — once daily. No food restrictions apply since it works locally in the nose. Before the very first use, shake the bottle gently and prime the pump (spray into the air) until a fine mist appears. If you skip four or more days, shake and re-prime before your next dose.

  • Use at roughly the same time each day to keep it consistent
  • If you miss a dose, take it as soon as you remember — then return to your regular schedule; do not double up
  • Your prescriber will set the right dose for your age and condition; always follow their instructions and the package label
🤒Side effects — in detail

Most people tolerate ciclesonide nasal spray well, but some side effects can occur:

  • Nosebleeds (epistaxis) — the most commonly reported side effect
  • Headache
  • Nasopharyngitis (irritation or infection of the nose and throat)
  • Ear pain
  • Pharyngolaryngeal pain (sore or irritated throat or voice box)
  • Nasal discomfort
  • Nasal congestion or nasal ulcers (reported after the product was on the market)
  • Dizziness (reported after the product was on the market)

More serious reactions — including yeast infections in the nose or throat, vision changes, signs of adrenal suppression, or slowed growth in children — should be reported to your doctor promptly.

⚠️Warnings & precautions
  • Nosebleeds and nasal tissue effects: Nosebleeds are more common with this spray than with placebo. Yeast (Candida) infections of the nose and throat can develop, especially with long-term use. Rarely, a nasal septal perforation (a hole in the wall between your nostrils) has been reported with nasal corticosteroids. Do not use if you've recently had nasal surgery or injury until healed.
  • Eye problems: Nasal corticosteroids may increase the risk of glaucoma (high eye pressure) or cataracts (clouding of the eye lens). Tell your doctor about any history of these conditions or any change in vision.
  • Immune suppression: Corticosteroids can weaken immune defenses. Chickenpox and measles can be more severe in people using steroid medicines — contact your doctor right away if you've been exposed.
  • Adrenal suppression: At high doses or in sensitive individuals, this spray can reduce the body's natural cortisol production. Stopping abruptly after long-term use can cause withdrawal symptoms. Your doctor should guide any changes in dosing.
  • Growth in children: Nasal corticosteroids can slow growth rate in children. Doctors should monitor height regularly in any child using this medication long-term.
🔀What it interacts with

Ciclesonide nasal spray has a low risk of drug interactions because very little reaches the bloodstream, but some interactions are worth knowing:

  • Ketoconazole and other strong CYP3A4 inhibitors (some antifungals) — can increase blood levels of the active form of ciclesonide significantly; tell your doctor if you take these
  • Erythromycin (a moderate CYP3A4 inhibitor antibiotic) — did not meaningfully affect ciclesonide levels in studies, but disclose all medicines to your prescriber
  • Other corticosteroids (oral, injectable, or inhaled steroids) — combining steroid medications can increase the risk of adrenal suppression and other steroid-related side effects

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use ciclesonide nasal spray if you have a known allergy to ciclesonide or any ingredient in the product
  • Tell your doctor if you have had recent nasal ulcers, nasal surgery, or nasal trauma — wait until fully healed before starting
  • Mention any history of glaucoma, cataracts, or high intraocular (eye) pressure
  • Disclose any active or past tuberculosis, fungal infections, viral infections (including ocular herpes simplex), or bacterial infections
  • If pregnant: no human studies exist; animal studies showed fetal harm at high doses by non-nasal routes. Discuss risks and benefits carefully with your doctor
  • If breastfeeding: it is not known whether enough of the drug passes into breast milk to affect a nursing infant; discuss with your doctor
  • Children under 6 years of age: safety and effectiveness for seasonal allergic rhinitis have not been established for children under 6; for perennial allergic rhinitis, not established for those under 12
  • Children using this spray should have their growth monitored regularly (such as by height measurement)
  • If you are switching from long-term oral steroid therapy to this nasal spray, your doctor should monitor you closely for signs of adrenal insufficiency
🚑If you take too much

Using more than the recommended amount over time may lead to signs of too much cortisol (hypercorticism) — such as weight gain, easy bruising, or changes in body fat distribution. There is no specific data on what happens with acute (sudden) overdose of this nasal spray. If you suspect an overdose, contact a poison control center or seek medical attention promptly.

📡Pharmacodynamics — effects in the body

At recommended doses, Omnaris Nasal Spray results in very little measurable effect on the body's cortisol (stress hormone) levels in most adults and adolescents. In clinical studies, normal adrenal function — the body's ability to make its own cortisol — was generally preserved. In children, there was a small numerical decrease in urinary cortisol with higher doses, but the differences were not statistically significant compared to placebo. This suggests the spray works mainly in the nose with minimal whole-body steroid effects at approved doses.

🔬Pharmacokinetics — how your body processes it

When sprayed into the nose, ciclesonide is converted locally into its active form (des-ciclesonide) and very little enters the bloodstream — serum levels are extremely low at recommended doses. Both ciclesonide and its active form are more than 99% bound to plasma proteins, and any that is swallowed has less than 1% oral bioavailability (meaning the gut barely absorbs it). The active metabolite is further broken down in the liver, mainly by an enzyme called CYP3A4, and is eliminated primarily through bile and feces, with a smaller amount cleared through urine.

📦How to store it

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) . Do not freeze. Keep out of reach of children.

📄 Written from Ciclesonide Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Ciclesonide Nasal Spray — the kind of thing our pharmacy team would talk through with you at the counter.

What is ciclesonide nasal spray actually used for?
It's a nasal steroid spray used to relieve the stuffy, runny, itchy nose and sneezing that come with allergies. Omnaris Nasal Spray is approved for seasonal allergic rhinitis — like pollen allergies — in people 6 and older, and for year-round (perennial) allergic rhinitis in people 12 and older. It works by calming the inflammation in your nasal passages that's driving those symptoms.
How do I use it correctly — and do I need to prime it first?
Yes, you do need to prime it before the first use. Gently shake the bottle, then spray it into the air 8 times until you see a fine mist. After that, use 2 sprays in each nostril once a day. If you haven't used it for 4 days in a row, give it a quick shake and 1 re-prime spray before your next dose. One important tip: aim the spray away from the center wall inside your nose — spraying directly onto the septum can irritate it over time.
What side effects should I expect, and which ones mean I should call my doctor?
The most common side effect is nosebleeds — they happen more often with this spray than with placebo, but they're usually mild. Headaches and a sore or irritated nose and throat are also possible. Those are generally not a cause for alarm. You should call your doctor if you notice white patches in your nose or throat (a sign of a yeast infection), any changes in your vision, or if you feel unusually tired or weak — especially if you've been using it for a long time. For kids, let your pediatrician know right away if growth seems slower than expected.
Is it safe to use long-term? Will it affect my whole body like an oral steroid would?
At recommended doses, ciclesonide nasal spray stays mostly in the nose and very little enters your bloodstream — so the whole-body steroid effects are much lower than with oral or injected steroids. Studies showed that it didn't significantly suppress the body's natural cortisol production in most adults and adolescents. That said, using it at higher than recommended doses or for a very long time — especially in children — can still have some systemic effects, which is why doctors monitor kids' growth and periodically reassess whether you still need it.
Can I use this spray if I'm pregnant or breastfeeding?
There aren't human studies specifically looking at this nasal spray in pregnancy, so we don't have definitive safety data. Animal studies at doses much higher than what's recommended for humans did show some harm, but the spray reaches the bloodstream in very small amounts, which is reassuring. The same uncertainty applies to breastfeeding. The honest answer is: talk to your doctor before using it while pregnant or nursing so you can weigh the benefits of treating your allergy symptoms against any potential risk.
Are there any medications I need to watch out for interactions with?
Because so little of the drug gets into your bloodstream, drug interactions are not a big concern with this nasal spray. The main one to know: strong antifungal medicines like ketoconazole can raise blood levels of the active ingredient. It's always a good idea to let your doctor or pharmacist know about everything you take — including other steroid medicines — since combining steroids can increase the risk of side effects over time.
Is Ciclesonide Nasal Spray available over the counter?
Ciclesonide Nasal Spray is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Ciclesonide Nasal Spray first available?
Ciclesonide Nasal Spray has been available in the United States since at least 2006, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Ciclesonide Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Ciclesonide Nasal Spray comes

Ciclesonide Nasal Spray 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.

Nasal spray

In the nose
Brands Omnaris Zetonna
How this form is used
What it may be used for
  • Omnaris Nasal Spray is approved to treat nasal symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older
  • Omnaris Nasal Spray is approved to treat nasal symptoms of perennial allergic rhinitis in adults and adolescents 12 years of age and older
Important instructions
  • Omnaris Nasal Spray is used by spraying into each nostril once daily — for intranasal use only
  • Before first use, gently shake Omnaris Nasal Spray and prime the pump by actuating it eight times until a fine mist appears
  • If Omnaris Nasal Spray has not been used for four consecutive days, gently shake it and re-prime with one spray before using
  • Avoid spraying Omnaris Nasal Spray directly onto the nasal septum (the wall inside your nose between the two nostrils)
Available strengths 2 strengths
4 FDA-listed product records

📊 Ciclesonide Nasal Spray across the U.S. market

How Ciclesonide Nasal Spray 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
Dose forms
1
Manufacturers
2
Brand names
4
FDA-listed product records
2006
First marketed

📈 How widely Ciclesonide Nasal Spray is used

A general measure of how commonly Ciclesonide Nasal Spray 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 Nasal Spray 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.

3,748
Medicaid prescriptions filled (Q1–Q4 2025)
$1.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ciclesonide Nasal Spray prescribed? Of the 1,596 medications we measure, Ciclesonide Nasal Spray ranks #1,091 by Medicaid prescriptions — more than 32% of them.

Where Ciclesonide Nasal Spray ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ciclesonide Nasal Spray 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.

ciclesonide 0.05 MG/ACTUAT Metered Dose Nasal Spray

3,748 Medicaid prescriptions (Q1–Q4 2025) 100% of Ciclesonide Nasal Spray prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $294 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797841

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 Nasal Spray, 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 1 of 1 listed Ciclesonide Nasal Spray NDCs with Medicaid activity.

🔍 Compare Ciclesonide Nasal Spray products

A representative set of FDA-listed product records for Ciclesonide Nasal Spray — 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
💊Nasal spray
37 mcg Nasal Covis Pharma US, Inc × 2 listings NDA View NDC →
50 mcg Nasal Covis Pharma US, Inc × 2 listings NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Ciclesonide Nasal Spray NDCs →

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.

Ingredient (IN) Ciclesonide Nasal Spray RxCUI 274964 2 dose forms · 4 strengths
  1. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797837 In current FDA listings
    Clinical drug / strength (SCD) 0.037 MG/ACTUAT RxCUI 1797838 0.05 MG/ACTUAT RxCUI 1797841

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.

🏷️ Sold under these brand names

Omnaris Zetonna Alvesco

🏭 Manufacturers & labelers

Covis Pharma US, Inc 4

RxNorm drug class

Ciclesonide Nasal Spray belongs to the Corticosteroids class.

Drug family (ATC) Corticosteroids, Glucocorticoids

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 8, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ciclesonide Nasal Spray.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ciclesonide Nasal Spray after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
1
Linked representative label
Covis Pharma US, Inc
Linked label effective
Nov 8, 2022
Composite sections available
21
Linked SPL Set ID
15fefd46-ac7e-40d0-b635-e6c3d653c666
Linked SPL Document ID
fa248cfa-08c9-43a3-8289-a28e5447cb1d
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Covis Pharma US, Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.