Omnaris

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Omnaris

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Omnaris

Quick Facts

Property Description
Active ingredient Ciclesonide
Form Nasal Spray (Aqueous suspension, metered-dose)
Pharmacological class Corticosteroid (Glucocorticoid)
Common use Localized anti-inflammatory activity
Origin Synthetic (Pro-drug)
Status Prescription Only (Rx)

Omnaris is a prescription-only pharmaceutical product, manufactured by Covis Pharma GmbH, and classified as a Topical Nasal Corticosteroid. The core of the medication is the synthetic active substance, Ciclesonide, which belongs to the class of non-halogenated glucocorticoids. It is a single-ingredient product designed specifically to provide localized anti-inflammatory activity to help manage discomfort and symptoms within the nasal passages, such as those associated with seasonal allergies in specific patient groups.

The Fundamental Identity: What Type of Medicine is Ciclesonide?

Ciclesonide is chemically notable for functioning as a specialized pro-drug. This designation means the compound is delivered in an inactive state and is rapidly transformed by enzymes in the nasal lining into its highly potent active metabolite, des-ciclesonide (RM1). This pro-drug mechanism is designed for minimizing the systemic exposure of the active compound. This specialized conversion process provides a targeted approach to achieving inflammation control.

Formulation and Delivery: Intranasal Aqueous Suspension

Omnaris is supplied as a metered-dose, manual-pump Nasal Spray, formulated as a hypotonic aqueous suspension. This delivery system utilizes the Intranasal route of administration to ensure the Ciclesonide pro-drug is deposited directly onto the nasal mucosa. The formulation, which includes a water-based vehicle and necessary inactive components, is designed for efficient delivery. This focus on localized administration is characterized by very low systemic absorption of the active metabolite, maximizing the anti-inflammatory effect where it is needed most.

Regulatory References

  1. DailyMed Label for OMNARIS (Ciclesonide) Nasal Spray
  2. DailyMed Label for OMNARIS (Ciclesonide) Nasal Spray - Clinical Pharmacology

What side effects are possible with Omnaris?

Adverse Reaction Scope

Category Description
Key Adverse Reaction Categories Includes local nasal effects (e.g., irritation, nosebleeds), central effects (headache), ophthalmic issues, and potential systemic corticosteroid effects.
Frequency Classification Most frequently reported reactions are classified as Common (occurring in ge1% of adult and adolescent patients) [1.7, 2.1]. Serious events are typically categorized as Post-Marketing/Not Known (Rare).
System-Organ Classes Involved Respiratory, Infections, Nervous System, Eye Disorders, and Endocrine Disorders are represented in the official safety documentation [2.1, 2.3].

Documented Safety Considerations

Common Adverse Reactions (Frequency ge1% in Trials) The most frequently reported side effects in clinical trials include Headache, Epistaxis (nosebleeds), and Nasopharyngitis (inflammation/infection in the nose or throat) [1.7, 2.1]. Other common reactions noted are pharyngolaryngeal pain and ear pain.

Serious Adverse Reactions Regulatory documents highlight the potential for clinically significant, though rare, adverse reactions that have been associated with the product or the corticosteroid class:

  • Ophthalmic Effects: Risk of developing or worsening Glaucoma (increased intraocular pressure) and Cataracts [1.1, 2.1].
  • Local Nasal Effects: Possibility of Nasal Septal Perforation and localized infections with Candida albicans (thrush) [1.1, 2.1].
  • Systemic Effects: Potential for Adrenal Suppression or Hypercorticism with prolonged use or excessive doses [1.1, 2.3].
  • Hypersensitivity: Documented risk of severe Hypersensitivity Reactions, including angioedema [2.1].

Population-Specific and Use-Related Safety Notes

Category Regulatory Statement
Pediatric Patients Intranasal corticosteroids may cause a reduction in growth velocity; monitoring of growth is advised for children [1.1, 2.3].
Safety Restrictions Use is contraindicated in patients with a known hypersensitivity to any ingredient. It is also restricted or cautioned against in patients with recent nasal ulcers, nasal surgery, nasal trauma, or pre-existing infections (e.g., untreated fungal, bacterial, or viral) [1.1, 3.2].
Duration Patterns Monitoring for local adverse effects and Candida infection is recommended for use over several months or longer [2.1].

Connection to the overall safety profile The official safety information formally defines the most frequently expected side effects, which are primarily localized, alongside a defined risk for rare but serious systemic and local adverse reactions, such as those affecting the eyes or the integrity of the nasal structure. This framework establishes the necessary constraints and monitoring requirements, particularly concerning chronic use and specific patient groups like children.

Overdose and Emergency Response

Omnaris (ciclesonide) nasal spray is a glucocorticoid intended for local action, which minimizes the systemic absorption of the medication. Consequently, an acute overdose from a single, excessive use is generally not expected to cause immediate, severe symptoms. The maximum recommended dosage for adults and adolescents is 2 sprays in each nostril once daily (200 mcg/day).

However, exceeding the recommended dosage for a prolonged period (months to years) may increase the risk of systemic corticosteroid effects. These effects relate to the suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which manages the body’s natural production of cortisol. Chronic overuse may lead to symptoms such as:

Potential Signs of Chronic Overuse (Systemic Effects)
Easy bruising or thinning skin
Weight gain (especially in the face and torso)
Increased or worsening acne
Extreme fatigue or weakness
Irregular menstrual periods

If a person mistakenly uses an excessive amount of Omnaris on one occasion, contacting a poison control center or healthcare professional for guidance is the appropriate first step, even if symptoms are absent. Immediate medical attention should be sought if an individual experiences symptoms of a serious allergic reaction (e.g., hives, swelling of the face, tongue, or throat, or difficulty breathing) or signs of acute adrenal insufficiency (severe nausea, vomiting, dizziness, or fainting), which are rare but serious complications. Continued, long-term use at higher than recommended doses requires medical supervision.

Therapeutic Uses of Omnaris

What Omnaris Treats: Main Uses and Benefits

Omnaris is a prescription nasal spray used to manage nasal symptoms associated with both seasonal allergic rhinitis (such as hay fever) and perennial allergic rhinitis (year-round allergies). It is used for adults and adolescents, as well as children aged 6 years and older for seasonal symptoms.

The medication helps address symptom clusters that may become intense or disruptive, including nasal congestion, frequent sneezing, rhinorrhea (runny nose), and nasal itching. It is generally applied in scenarios where allergy symptoms are classified as moderate to severe, particularly when the discomfort involves symptoms that interfere with daily functioning. The objective of treatment is to provide symptomatic relief that helps improve day-to-day comfort during periods when triggers are present.

Quick Fact: Symptomatic Relief Domains

Symptom Targeted Typical Scenario Benefit Provided
Nasal congestion (stuffy nose) Seasonal or year-round allergy flare-ups Helps reduce nasal passage swelling to improve airflow
Sneezing & Itching Exposure to environmental allergens Provides relief from persistent irritation and sneezing fits
Rhinorrhea (Runny nose) Acute symptomatic periods Aids in managing excessive nasal discharge and drainage

Eligibility and Restrictions for Use

Who can and cannot use Omnaris?

Eligibility for Omnaris (ciclesonide) Nasal Spray is determined by official regulatory documents based on age, specific conditions, and history of allergies.


Age-Group Eligibility

Age Group Approved Use Status
Adults and Adolescents ( ge 12 years) Approved for Seasonal and Perennial Allergic Rhinitis.
Children ( ge 6 to 11 years) Approved for Seasonal Allergic Rhinitis only.
Children ( < 6 years) Safety and effectiveness not established.

Absolute Contraindications and Restrictions

Omnaris must not be used if a patient has a known hypersensitivity or allergy to the active ingredient, ciclesonide, or any of the inactive ingredients in the nasal spray formulation. This is an absolute population restriction.

Use is also restricted in certain clinical scenarios and should be avoided until healing is complete in individuals with:

  • Recent nasal trauma, surgery, or unhealed ulcers.
  • Untreated localized infections of the nasal mucosa (bacterial, viral, or fungal).
  • Active or quiescent tuberculosis of the respiratory tract.

Use During Pregnancy and Lactation

Use during pregnancy is advised only if the potential benefit justifies the potential risk. It is not known if the medication is present in breast milk, and caution is advised when administered to a nursing woman.

What should I know about interactions with other medicines?

The potential for clinically relevant drug-drug interactions with Omnaris (ciclesonide nasal spray) is considered very low. This assessment is based on the negligible systemic serum concentrations of ciclesonide and its active metabolite, des-ciclesonide, achieved after intranasal administration at the recommended dosage.

Pharmacokinetic Interaction Potential

The active metabolite, des-ciclesonide, is primarily metabolized by the Cytochrome P450 CYP3A4 isozyme and, to a lesser extent, by CYP2D6.

  • Interacting Medicinal Product Class: Potent CYP3A4 inhibitors (e.g., ketoconazole, protease inhibitors used for HIV infection) are the primary class of concern documented in regulatory information.

  • Observed Effect: Co-administration with a potent CYP3A4 inhibitor (specifically oral ketoconazole, used in a drug interaction study) has been shown to increase the systemic exposure (area under the curve, AUC) of des-ciclesonide by approximately 3.5-fold for inhaled ciclesonide.

Interaction-Related Restriction

  • Use with Caution: Although the clinical relevance is low due to the nasal spray’s minimal systemic absorption, co-administration with potent CYP3A4 inhibitors (such as protease inhibitors) should still be considered with caution due to the potential for increased systemic des-ciclesonide drug levels.

Mechanism of Action

A mechanism characterized by localized action and gene modulation suppresses the inflammatory cascade within the nasal mucosa. Its action is defined by three key biological domains: bioactivation, genomic reprogramming, and cascade suppression.

Localized Bioactivation by Esterase Enzymes

The administered pro-drug Ciclesonide is inert until it undergoes enzymatic hydrolysis by esterase enzymes directly within the nasal mucosal cells. This conversion forms the active metabolite, des-ciclesonide (RM1). This localized activation step provides a high concentration of the glucocorticoid agonist at the site of inflammation, initiating the anti-inflammatory cascade at the tissue level.

Glucocorticoid Receptor Agonism and Genomic Reprogramming

Des-ciclesonide acts as a strong agonist at the Glucocorticoid Receptor (GR), triggering the translocation of the complex into the cell nucleus. The complex then modulates gene expression by transrepression (suppressing pro-inflammatory genes like cytokines) and transactivation (enhancing anti-inflammatory genes). This gene modulation results in a broad and persistent alteration of the cell’s inflammatory mediator production.

Suppression of Inflammatory Cascades and Cellular Infiltration

The genetic changes result in the widespread suppression of crucial pathways, including Eicosanoid Synthesis (by inhibiting Phospholipase A2), leading to a reduction in mediators like leukotrienes and prostaglandins. This suppression reduces the concentration of inflammatory cells (e.g., eosinophils and mast cells) in the nasal lining, which physiologically limits plasma exudation and fluid accumulation in the tissue. The need for this molecular turnover dictates a delayed onset for the maximal physiological effect.

Dosage and Administration Information

Instructions for Using Omnaris (Ciclesonide) Nasal Spray

Omnaris is a prescription medication administered via the intranasal route only. The dosing for adults and children 6 years of age and older is two sprays (100 mcg total) per nostril once daily, for a maximum daily dosage of 200 mcg. Continuous and regular use, as prescribed, is necessary to achieve effectiveness.


Administration and Preparation

Procedural Step Requirement
Preparation Gently shake the container before initial use or before priming.
Initial Priming Before the first use, the pump must be primed by 8 actuations until a fine mist appears.
Repriming If unused for four or more consecutive days, reprime with 1 actuation or until a fine mist appears.
Before Use Gently blow the nose to clear the nostrils.
Administration Avoid spraying directly onto the nasal septum. While inhaling gently through the nose, press the pump quickly and firmly.

Usage Rules

Usage Context Rule
Age Groups Approved for seasonal allergic rhinitis in patients 6 years and older and perennial allergic rhinitis in those 12 years and older.
Missed Dose Skip the missed dose and continue with the regular daily schedule. Do not use a double dose.
Discard Discard the device after 120 actuations following initial priming, or after 4 months following removal from the foil pouch, whichever comes first.

These instructions reflect the requirements for device preparation and daily application of the medication. Adherence to the specified priming, administration technique, and dosage schedule is necessary for appropriate use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Omnaris

Evidence for Use in Seasonal Allergic Rhinitis

The primary evidence base for the use of the medicine in conditions characterized by fluctuating or episodic manifestations like seasonal allergic rhinitis (SAR) is based on numerous short-term, randomized controlled trials (RCTs). These studies were designed to be double-blind and placebo-controlled. Researchers monitored changes in patient-reported outcomes describing perceived discomfort. These trials were typically conducted over defined time intervals, such as two to four weeks, during periods of increased symptom activity. Research explored the medicine in adults, adolescents, and and children over the age of six.

Research monitored changes in the Reflective Total Nasal Symptom Score (rTNSS), which is a measurement of core symptoms like nasal congestion, runny nose, sneezing, and itching. Studies monitored changes in rTNSS measurements when compared to a placebo. Research also explored outcomes related to daily functioning or activity level, using patient questionnaires. This evidence contributes to the broader research landscape exploring symptom patterns related to these conditions.

Evidence for Use in Perennial Allergic Rhinitis

For conditions where symptoms may vary in intensity year-round, known as perennial allergic rhinitis (PAR), research also relies on randomized controlled trials. These trials monitored physiological strain or stress and outcomes related to physical discomfort over longer periods, typically six weeks to three months. The study populations included adults, adolescents, and children, as research explored the medicine in studies of these long-term conditions.

In these studies, researchers monitored patient-reported outcomes describing perceived discomfort using the rTNSS. Findings related to systemic or functional imbalance were also monitored, specifically by assessing the body’s cortisol levels, as an outcome related to systemic or functional imbalance. The data describe patterns related to symptom changes measured during the study period. For the pediatric populations (age 6 to 11), however, findings were mixed in some of the initial trials for PAR, with some studies reporting inconsistent distinction from placebo on the primary symptom outcomes.

Key Research Limitations and Uncertainties

Research highlights what is known—and what is still uncertain—about the medicine. The certainty remains low for several aspects due to structural limitations in the research landscape.

  • Follow-up durations were limited in the main efficacy trials, and long-term effects are not fully established.
  • Comparative evidence is lacking, as the majority of trials compared the medicine to a placebo rather than to other active, commonly used nasal sprays.
  • Data for certain groups remain insufficient, particularly for long-term outcomes and for children under the age of six for symptom assessment.

Key Studies & References

  1. Comparative efficacy and acceptability of licensed dose intranasal corticosteroids for moderate-to-severe allergic rhinitis: a systematic review and network meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Omnaris (FAQ)


Q: Is Omnaris the same kind of medicine as Flonase or Nasonex?

A: Omnaris is classified by regulatory authorities as a nasal corticosteroid, which is the same type of anti-inflammatory medicine as Flonase (fluticasone) and Nasonex (mometasone). A key feature of Omnaris, according to official information, is that its active ingredient is a pro-drug. This means it becomes an active substance only after it is absorbed by cells in the nasal lining.


Q: How quickly should I feel relief after starting Omnaris?

A: Clinical information indicates that symptom improvement may begin within 24 to 48 hours after the first dose. However, because this medicine works by reducing long-term inflammation, the maximum benefit may take several weeks or longer to be achieved, as noted in the drug labeling.


Q: What happens if I miss a dose of Omnaris?

A: Official use instructions state that the prescribed procedure is to skip the missed dose and continue with the regular once-daily schedule. The instructions direct users to not use a double dose or extra sprays to compensate for the missed dose.


Q: Does Omnaris cause drowsiness or fatigue?

A: Drowsiness or common fatigue is generally not listed as a frequent side effect. However, official safety information does note that symptoms like extreme tiredness or muscle weakness are potential signs of a rare, serious systemic effect called adrenal gland suppression, which may occur with prolonged use.


Q: Can Omnaris be used along with antihistamine pills?

A: Regulatory documents primarily focus on the potential for interaction with a specific type of medication called potent CYP3A4 inhibitors. There is no specific warning in the official labeling about drug-drug interactions with common, non-CYP3A4 inhibiting antihistamine pills.


Q: Does Omnaris help with post-nasal drip?

A: The medicine is officially indicated for the treatment of core nasal symptoms, such as sneezing, runny nose, itching, and stuffy nose, that are linked to allergic rhinitis. While post-nasal drip is often associated with a runny nose, it is not explicitly named as a monitored symptom in the official indications.


Q: Is Omnaris considered a strong steroid?

A: Official regulatory texts describe the active substance, des-ciclesonide, as having a high affinity for the glucocorticoid receptor. This characteristic is the mechanism used to provide its powerful targeted anti-inflammatory effects within the nasal tissues.


Q: Will using Omnaris affect my blood pressure?

A: Changes in blood pressure are not listed as common side effects. However, official safety information mentions that a potential rare systemic effect, such as low adrenal gland function, can be associated with symptoms like dizziness.


Q: What happens if I use Omnaris for longer than recommended?

A: Official labeling warns that the use of this medicine at higher than recommended dosages or for prolonged periods can potentially result in systemic corticosteroid effects, such as hypercorticism or adrenal suppression. Monitoring for local adverse effects is specifically recommended for use extending over several months or longer.


Q: Can I use Omnaris if I have a sinus infection?

A: Regulatory documents advise caution and recommend against use if a patient has untreated localized infections of the nasal mucosa, which includes fungal, bacterial, or viral infections. Official information indicates that consultation with a qualified professional is advised.


Q: Is Omnaris a decongestant or a different type of medicine?

A: According to regulatory information, Omnaris is a nasal corticosteroid, not a decongestant. Its purpose is to reduce inflammation and swelling in the nasal passages, which helps to ease breathing.


Q: Why is Omnaris only available as a nasal spray and not a pill?

A: Pharmacokinetic data from regulatory documents shows that the medicine has minimal oral absorption. Because the intent is to achieve a targeted, anti-inflammatory effect directly on the nasal lining, the nasal spray is the specified route of administration.


Q: How do I know if the bottle of Omnaris is empty?

A: Official instructions state that the bottle must be discarded after 120 sprays following initial priming, or after four months of being removed from the foil pouch, whichever comes first. Official information notes that the product is supplied with an indicator (like a dose counter) to track the number of sprays.


Q: What are the signs of an allergic reaction to Omnaris?

A: Official safety documents list signs of a serious allergic reaction, which include hives, rash, itching, swelling of the face, lips, tongue, or throat, or trouble breathing. Use is restricted in patients who have a known hypersensitivity to any of the ingredients.


Q: Is Omnaris a preventative medicine or a treatment for symptoms?

A: Official documents state that the medicine is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis. It works to control symptoms by decreasing inflammation, but it does not cure the underlying allergic condition.


Q: Can Omnaris affect my sense of smell?

A: Official drug information lists a change in sense of smell as a possible side effect that has been noted in clinical trials.


Q: Does Omnaris contain alcohol?

A: The official labeling for the aqueous nasal spray formulation (Omnaris) lists phenylethyl alcohol as one of its inactive ingredients.


Q: Does using Omnaris affect growth in children?

A: Official labeling states that intranasal corticosteroids, including this product, may cause a reduction in growth velocity in children. Official guidance includes that growth should be monitored routinely in pediatric patients who are prescribed this medication.


Q: Is there a generic version of Omnaris available?

A: According to regulatory drug databases, the brand-name product Omnaris (Ciclesonide aqueous nasal spray) is the formulation available. Regulatory data indicates that a generic version is currently not available.

How should Omnaris be stored and disposed of?

How to Store and Dispose of Omnaris

The storage and disposal requirements for Omnaris (Ciclesonide) Nasal Spray are officially defined to maintain product stability and ensure patient safety.

Storage Requirement Official Regulatory Statement
Temperature Range Store at room temperature, specifically 20 C to 25 C (68 F to 77 F).
Prohibited Conditions The product must not be refrigerated or frozen. Avoid excessive heat and moisture.
Container & Safety Keep the bottle stored upright and in its original container, out of the sight and reach of children.
Stability Limit The bottle must be discarded four (4) months after the initial opening of the foil pouch, or when the dose counter reads zero ('0'), whichever occurs first.

Disposal Protocol

When discarding unused or expired Omnaris, it is officially required to follow local environmental guidelines for pharmaceutical waste. Do not dispose of the medication by pouring it down a sink or flushing it down a toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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