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Prescription medication · Inhaled Corticosteroid

ciclesonide

Also sold as Alvesco. Omnaris Nasal Spray treats nasal symptoms from seasonal allergies in adults and kids 6 years and older.

Data updated 2026-05-15

13,075
FDA reportsModerately reported
6
InteractionsFew interactions
$43.10
Brand price (NADAC)

What the data shows

ciclesonide (Alvesco) is a prescription Inhaled Corticosteroid, reported less often than most tracked drugs (13,075 FDA reports), with 6 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

ciclesonide (Alvesco) is a prescription Inhaled Corticosteroid. Omnaris Nasal Spray treats nasal symptoms from seasonal allergies in adults and kids 6 years and older.

Omnaris Nasal Spray is a medicine that helps treat nasal allergy symptoms. It contains a corticosteroid to reduce inflammation in your nose.

Drug Pricing (NADAC)

Brand Price

$43.10/unit

Generic Available

No

COVIS

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Omnaris Nasal Spray treats nasal symptoms from seasonal allergies in adults and kids 6 years and older.

Common side effects

Headache, Nosebleeds, Common cold

Key warnings

Omnaris may cause nosebleeds or Candida (fungal) infections in the nose.

The sections below are summarized in plain English from ciclesonide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Omnaris contains ciclesonide, a corticosteroid. It works by reducing inflammation in your nasal passages. This helps to relieve allergy symptoms like congestion and runny nose.

How to Take It

Use Omnaris Nasal Spray only in your nose. Shake the bottle gently before each use. Prime the pump by spraying 8 times before the first use. If you haven't used it for 4 days, re-prime with 1 spray. Spray 2 times in each nostril once a day.

This is a plain-language summary of ciclesonide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

There is not enough information about Omnaris use in pregnant women. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Omnaris passes into breast milk.

This is a plain-language summary of ciclesonide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

This is a plain-language summary of ciclesonide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store Omnaris at room temperature (77°F). Do not freeze. Keep out of reach of children.

Side Effects (from patient reports)

Based on 13,075 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for ciclesonide, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for ciclesonide each year to the FDA Adverse Event Reporting System (FAERS).

-1,00001,0002,0003,000 20062009201220152018202120242025 902

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where ciclesonide sits

ciclesonide has more FDA adverse-event reports than 45% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is ciclesonide; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 13,075 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2006–2025.

Total Reports

13,075

Reports Mentioning Death

576

4.4% of reports — not proof of cause

Hospitalization Reports

5,864

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 7,762 (65%)
Male 4,120 (35%)

Age Distribution

0–17 406
18–44 1,592
45–64 3,431
65–74 2,346
75+ 1,564

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 ASTHMA 5,711
2 DYSPNOEA 4,479
3 WHEEZING 3,589
4 THERAPEUTIC PRODUCT EFFECT INCOMPLETE 2,550
5 COUGH 2,483
6 OBSTRUCTIVE AIRWAYS DISORDER 1,752
7 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 1,734
8 PNEUMONIA 1,686
10 PRODUCTIVE COUGH 1,464
11 SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 1,439
12 FATIGUE 1,251
13 CHEST DISCOMFORT 1,169
14 MALAISE 1,112
15 CONDITION AGGRAVATED 1,056
16 FULL BLOOD COUNT ABNORMAL 1,007

Reactions in Death Reports

DEATH 334
ASTHMA 144
DYSPNOEA 140
WHEEZING 97
PNEUMONIA 86
PRODUCTIVE COUGH 73
FORCED EXPIRATORY VOLUME DECREASED 72
OBSTRUCTIVE AIRWAYS DISORDER 72
ANXIETY 71
CONDITION AGGRAVATED 66

Reactions in Hospitalization Reports

ASTHMA 3,280
DYSPNOEA 2,636
WHEEZING 2,226
THERAPEUTIC PRODUCT EFFECT INCOMPLETE 1,446
COUGH 1,189
PNEUMONIA 1,156
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 1,103
OBSTRUCTIVE AIRWAYS DISORDER 1,033
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 974
PRODUCTIVE COUGH 966

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Omnaris may cause nosebleeds or Candida (fungal) infections in the nose. It could cause a hole in the nasal septum, or slow wound healing. It may also increase the risk of glaucoma or cataracts. Tell your doctor if you have vision changes or a history of eye problems. Omnaris may worsen existing infections like tuberculosis, herpes, or chickenpox. High doses can cause hormone and adrenal problems. It may slow down growth in children, so growth should be monitored.

Known Drug Interactions

moderate darunavir

betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone ↑ corticosteroids Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing's syndrome and adrenal suppression.

Mechanism: Darunavir blocks the enzymes that break down ciclesonide, leading to an increased risk of serious hormonal side effects.

What to do: Consult your healthcare provider about adjusting your dose or watching for symptoms like unusual weight gain.

Corticosteroids primarily metabolized by CYP3A betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone ↑ corticosteroid Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression.

Mechanism: Ritonavir blocks the enzyme that breaks down ciclesonide, which causes the steroid to build up to high levels in your body. This increase can lead to serious hormonal issues like Cushing's syndrome.

What to do: Your doctor may need to monitor you closely for side effects or consider adjusting your steroid dose.

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.

Mechanism: Ketoconazole blocks the enzyme that breaks down the active part of this medicine. This causes the drug levels in your body to rise significantly.

What to do: Your doctor should monitor you closely for side effects. They may need to adjust your treatment if you experience problems.

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 )] .

Mechanism: Erythromycin does not interfere with how your body handles this medicine.

What to do: No special changes are needed when taking these two drugs at the same time.

7 DRUG 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 [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. Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the...

Mechanism: This drug does not seem to change how other medicines are broken down or carried in the blood.

What to do: You generally do not need to worry about this drug causing interactions with other medications.

Check all your medications →

This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

How long does it take for Omnaris to work?
Omnaris may take several days to start working. Use it regularly for the best results.
Can I use Omnaris if I have a cold?
Talk to your doctor before using Omnaris if you have a cold or sinus infection.
Can Omnaris cause nosebleeds?
Yes, nosebleeds are a common side effect of Omnaris.
Can I use Omnaris with other allergy medicines?
Talk to your doctor before using Omnaris with other allergy medicines.
How long can I use Omnaris?
Talk to your doctor about how long you should use Omnaris.
What should I do if Omnaris doesn't seem to be working?
Talk to your doctor if Omnaris doesn't seem to be working.
Can Omnaris affect my vision?
Yes, Omnaris may increase the risk of glaucoma or cataracts. Tell your doctor if you have vision changes.
Is it okay to share my Omnaris nasal spray with someone else?
No, do not share your Omnaris nasal spray with anyone else.
What do I do if I spray Omnaris in my eyes?
Rinse your eyes with water right away.
How often should I clean the Omnaris nasal spray nozzle?
Clean the nozzle regularly with a clean, dry tissue.
What are the common side effects of ciclesonide?
The most commonly reported side effects of ciclesonide include Headache, Nosebleeds, Common cold, Ear pain, Throat pain. Based on 13,075 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does ciclesonide interact with other medications?
Yes, ciclesonide has 6 known drug interactions. Notable interactions include darunavir, nirmatrelvir/ritonavir, ketoconazole. Always inform your doctor about all medications you are taking.
What drug class is ciclesonide?
ciclesonide belongs to the Inhaled Corticosteroid drug class. It requires a prescription (Rx). Omnaris Nasal Spray treats nasal symptoms from seasonal allergies in adults and kids 6 years and older.
Is ciclesonide safe during pregnancy?
There is not enough information about Omnaris use in pregnant women. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Inhaled Corticosteroid

Other drugs grouped near ciclesonide - same-class peers and common alternatives.

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What the FDA Data Shows for ciclesonide

The FDA label for ciclesonide (sold under brand names such as Alvesco) classifies it as a prescription-only medication in the Inhaled Corticosteroid class. Omnaris Nasal Spray treats nasal symptoms from seasonal allergies in adults and kids 6 years and older. Official labeling lists 5 commonly reported side effects, including Headache, Nosebleeds, Common cold.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 13,075 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: November 8, 2022

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page