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Omnaris

Last reviewed on RxList: 12/15/2016
Omnaris Side Effects Center

Last reviewed on RxList 02/14/2017

Omnaris (ciclesonide nasal spray) is a corticosteroid used to treat nasal symptoms of seasonal allergies and hay fever, such as sneezing, itching, and runny or stuffy nose. Common side effects of Omnaris include:

  • nosebleeds,
  • irritation of the nose,
  • headache,
  • stuffy nose,
  • sore throat, or
  • ear pain.

Tell your doctor if you have rare but very serious side effects of Omnaris including:

  • severe nosebleeds,
  • severe pain in the nose,
  • whistling sound while breathing, or
  • eye pain.

The recommended dose of Omnaris Nasal Spray for adults and children 6 years and older is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). Omnaris may interact with ketoconazole. Tell your doctor all medications you use. During pregnancy, Omnaris should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Omnaris (ciclesonide nasal spray) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Omnaris Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nasal steroid medicine can be absorbed into your bloodstream, which may cause steroid side effects throughout the body. Although it is not likely that your body will absorb enough of this medication to cause serious side effects, tell your doctor if you have any of these steroid-related symptoms:

  • irregular menstrual periods;
  • acne or increased hair growth;
  • swelling, rapid weight gain, roundness of the face;
  • increased sweating; or
  • depression, anxiety, unusual thoughts or behavior.

Call your doctor at once if you have sores or white patches inside or around your nostrils, or if you have any vision problems, such as tunnel vision.

Less serious side effects may include:

  • headache;
  • nosebleed;
  • stuffy nose, sore throat; or
  • ear pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Omnaris (Ciclesonide Nasal Spray)

Omnaris Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below for adults and adolescents 12 years of age and older are based on 3 clinical trials of 2 to 6 weeks duration and one 52-week trial. In the 3 trials of 2 to 6 weeks duration, 1524 patients (495 males and 1029 females, ages 12 to 86 years old) with seasonal or perennial allergic rhinitis were treated with OMNARIS Nasal Spray 200, 100, 50, or 25 mcg or placebo once daily. The racial distribution in these three trials included 1374 Caucasians, 69 Blacks, 31 Asians, and 50 patients classified as Other. The 52-week trial was conducted in 663 patients (227 males and 436 females, ages 12 to 73 years old) treated with OMNARIS Nasal Spray 200 mcg or placebo once daily. The racial distribution in this trial included 538 Caucasians, 69 Blacks, 16 Asians, and 40 patients classified as Other. The data from pediatric patients are based upon 4 clinical trials in which 1541 children (871 males and 670 females, ages 2 to 11 years old) with seasonal or perennial allergic rhinitis were treated with OMNARIS Nasal Spray 200, 100, or 25 mcg or placebo once daily for 2 to 12 weeks. The racial distribution in these four trials included 1136 Caucasians, 273 Blacks, 20 Asians, and 112 patients classified as Other.

Adults and Adolescents 12 Years of Age and Older in Short-Term (2-6 weeks) Trials

In three short-term trials conducted in the US and Canada, 546 patients were treated with OMNARIS Nasal Spray 200 mcg daily. Adverse reactions did not differ appreciably based on age, gender, or race. Approximately 2% of patients treated with OMNARIS Nasal Spray 200 mcg in clinical trials discontinued because of adverse reactions; this rate was similar for patients treated with placebo. The table below displays reactions that occurred with an incidence of 2% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo in clinical trials of 2 to 6 weeks in duration.

Table 1 : Adverse Events from Controlled Clinical Trials 2 to 6 Weeks in Duration in Patients 12 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis

Adverse Event OMNARIS Nasal Spray 200 mcg Once Daily
(N = 546)
%
Placebo
(N = 544)
%
Headache 6.0 4.6
Epistaxis 4.9 2.9
Nasopharyngitis 3.7 3.3
Ear Pain 2.2 0.6

Pediatric Patients Aged 6 to 11 Years in Short-Term (2-12 weeks) Trials

In two short-term trials, conducted in the US and Canada, 913 patients were treated with OMNARIS Nasal Spray 200 mcg, 100 mcg or 25 mcg daily. Adverse events did not differ appreciably based on age, gender, or race. In clinical trials, 1.6% and 2.7% of patients treated with OMNARIS Nasal Spray 200 mcg or 100 mcg, respectively, discontinued because of adverse reactions; these rates were lower than the rate in patients treated with placebo (2.8%). Table 2 displays adverse events that occurred with an incidence of 3% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo.

Table 2 : Adverse Events from Controlled Clinical Trials 2 to 12 Weeks in Duration in Patients 6 to 11 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis

Adverse Event OMNARIS Nasal Spray 200 mcg Once Daily
(N = 380)
%
Placebo
(N = 369)
%
Headache 6.6 5.7
Nasopharyngitis 6.6 5.4
Pharyngolaryngeal pain 3.4 3.3

Pediatric Patients Aged 2 to 5 Years in Short-Term (6-12 weeks) Trials

In two short-term trials conducted in the US, 183 patients were treated with OMNARIS Nasal Spray 200 mcg, 100 mcg or 25 mcg daily. The distribution of adverse events was similar to that seen in the 6 to 11 year old children.

Long-Term (52-Week) Safety Trial

In a 52-week double-blind, placebo-controlled safety trial that included 663 adults and adolescent patients (441 treated with ciclesonide: 227 males and 436 females) with perennial allergic rhinitis, the adverse reaction profile over the treatment period was similar to the adverse event profile in trials of shorter duration. ´┐ŻAdverse reactions, irrespective of drug relationship, that occurred with an incidence of 3% or greater and more frequently with OMNARIS Nasal Spray 200 mcg than with placebo were epistaxis, pharyngolaryngeal pain, sinusitis, headache, nasal discomfort, cough, bronchitis, influenza, back pain, and urinary tract infection. No patient experienced a nasal septal perforation or nasal ulcer during this long-term trial of OMNARIS Nasal Spray.

Post-Marketing Experience

The following adverse reactions have been reported in association with postmarketing use of OMNARIS Nasal Spray and are not listed above: nasal congestion, nasal ulcer and dizziness. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Omnaris (Ciclesonide Nasal Spray)

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