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The following safety information outlines important considerations and potential risks associated with using Omnaris (ciclesonide). Please review these points and consult your healthcare provider with any concerns or questions.

• Nosebleeds and Nasal Injury: Use of Omnaris (ciclesonide) may lead to nosebleeds. While nasal corticosteroids can increase the risk of damage to the nasal septum, this has not been reported with Omnaris. However, if there is an existing nasal injury, the medication might hinder healing. Users with a history of nasal surgery or ulcers should take extra precautions.

• Increased Infection Risk: Corticosteroids like Omnaris can weaken the immune system, potentially leading to infections, including fungal infections in the nose or throat, especially with prolonged use. There is also a risk of viral infections like chickenpox. Individuals taking other immune-weakening medications or those currently infected should consider this risk.

• Hormonal Effects: Exceeding the recommended dose of Omnaris or abruptly discontinuing its long-term use may disrupt hormone levels, causing either an excess or deficiency of cortisol. This risk is heightened with extended use or overuse of the medication.

• Growth Concerns in Children: Omnaris may slow growth in children. To minimize this risk, use the lowest effective dose for the shortest duration necessary. Parents should discuss any concerns about growth impacts with their child's healthcare provider to determine the suitability of this treatment.

• Allergic Reactions: Possible allergic reactions to Omnaris include severe symptoms such as facial swelling, shock, and anaphylaxis. Immediate medical attention is necessary if symptoms like hives, rash, swelling of the lips or tongue, or breathing difficulties occur.

• Eye and Vision Issues: Nasal corticosteroids can increase eye pressure and potentially cause vision problems such as glaucoma or cataracts, although this has not been observed with Omnaris. Those with a history of eye conditions should consult an eye specialist before usage and report any vision changes during treatment.

Please note that there are no specific contraindications for Omnaris at this time. Always follow your healthcare provider's guidance when using this medication.

When using this medication, some individuals may experience mild side effects such as headaches, nosebleeds, cold symptoms, and ear pain, which are generally not severe. If these persist or worsen, it is advisable to consult a healthcare provider. Additional side effects, though less common, include sinus inflammation, cough, nasal discomfort, bronchitis, flu-like symptoms, back pain, and urinary tract infections. These effects should also be discussed with a healthcare provider if they occur.

While serious side effects are rare, they require prompt medical attention. These include nasal injuries such as crusting, sores, or a hole in the cartilage, and slow wound healing. Fungal infections in the nose or throat may present as pain, redness, and white patches. A serious allergic reaction, indicated by hives, rash, swelling of the face or throat, or breathing difficulties, also warrants immediate medical care.

In rare instances, corticosteroids used in the nose may enter the bloodstream, potentially leading to symptoms like unusual tiredness, weight loss, headaches, swelling of the ankles or feet, increased thirst or urination, and vision problems. Long-term use may also result in fungal infections in the nose or throat, characterized by fever, severe sore throat, and white patches. If any of these severe symptoms occur, it is important to seek medical advice without delay.