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Zetonna

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Zetonna

Zetonna Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Zetonna nasal aerosol is a corticosteroid indicated for treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. Zetonna may cause side effects such as nosebleeds, headache, nasal ulcers, thrush, increased risk of infection, nasal septal perforation, slow wound healing and eye problems such as cataracts and glaucoma.

Zetonna is supplied in a 6.1g canister containing 60 doses. Each dose contains 37 mcg of ciclesonide.

It is not known if Zetonna is harmful to unborn babies. Zetonna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Zetonna is excreted in human milk. Caution should be used when Zetonna is administered to nursing women.

Our Zetonna 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zetonna FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

The safety data described below for adults and adolescents 12 years of age and older are based on 4 clinical trials evaluating doses of ciclesonide nasal aerosol from 74 to 282 mcg. Three of the clinical trials were 2 to 6 weeks in duration and one trial was 26 weeks in duration with an additional 26-week open-label extension. Data from the first 6 weeks of the 26-week trial were pooled with data from the three 2-week trials. Short-term data (2 to 6 weeks) included 3001 patients with seasonal and perennial allergic rhinitis, of these, 884 received

ZETONNA Nasal Aerosol 74 mcg once daily and 892 received placebo. The short-term data included 1098 (36.6%) males, 1903 (63.4%) females, 2587 (86.2%) Caucasians, 320 (10.7%) Blacks, 49 (1.6%) Asians, and 45 (1.5%) patients classified as Other. The 26-week trial was conducted in 1110 patients with perennial allergic rhinitis [394 (35.5%) males and 716 (64.5%) females, ages 12 to 78 years old] treated with ZETONNA Nasal Aerosol 74 mcg, 148 mcg or placebo once daily. Of these patients, 298 were treated with 74 mcg ZETONNA Nasal Aerosol, 505 with 148 mcg, and 307 with placebo. The racial distribution in this trial included 922 (83.1%) Caucasians, 146 (13.2%) Blacks, 18 (1.6%) Asians, and 24 (2.2%) patients classified as Other. The 26-week open-label extension included 824 patients [295 (35.8%) males and 529 (64.2%) females, ages 12 to 79 years old] given ZETONNA Nasal Aerosol 148 mcg once daily. The racial distribution in the open-label extension included 690 (83.7%) Caucasians, 104 (12.6%) Blacks, 15 (1.8%) Asians, and 15 (1.8%) patients classified as Other.

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.

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

In three short-term trials and the first 6 weeks of one long-term trial, conducted in the US, 884 patients with a history of seasonal or perennial allergic rhinitis were treated with ZETONNA Nasal Aerosol 74 mcg daily. Adverse reactions did not differ appreciably based on age, gender, or race. The table below displays reactions that occurred with an incidence of at least 2.0% and more frequently with ZETONNA Nasal Aerosol 74 mcg than with placebo in seasonal or perennial allergic rhinitis clinical trials of 2 to 6 weeks duration.

Table 1: Adverse Reactions Occurring with a Frequency of at least 2.0% and Greater than Placebo 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 Reaction ZETONNA Nasal Aerosol 74 mcg Once Daily
N = 884 (%)
Placebo
N = 892 (%)
Nasal discomforta 28 (3.2) 16 (1.8)
Headache 27 (3.1) 11 (1.2)
Epistaxis 26 (2.9) 24 (2.7)
a Nasal discomfort includes both nasal discomfort and instillation site discomfort

When considering the data from higher doses evaluated in the short-term trials, epistaxis demonstrated a dose response. In addition, two patients treated with ZETONNA Nasal Aerosol 74 mcg experienced nasal septal perforations in the short-term trials compared to no patients treated with placebo.

Approximately 1.2% of patients treated with ZETONNA Nasal Aerosol 74 mcg in clinical trials discontinued because of adverse reactions; this rate was similar for patients treated with placebo.

Discontinuations due to local adverse reactions were similar in ZETONNA Nasal Aerosol 74 mcg treated patients (0.8%) compared to placebo treated patients (0.8%). Local adverse reactions leading to discontinuation that occurred only in ZETONNA Nasal Aerosol treated patients included ear infection, nasal discomfort, nasal dryness, nasal mucosal/septum disorders, pharyngitis, streptococcal pharyngitis, sinus headache, and tonsillitis.

Pediatric Patients Aged 2 to 11 Years

Trials of ZETONNA Nasal Aerosol have not been conducted in pediatric patients aged 2 to 11 years.

Long-Term (26-Week Double-Blind and 26-Week Open-Label) Safety Trial

In one 26-week double-blind, placebo-controlled safety trial that included 1110 adult and adolescent patients with perennial allergic rhinitis, additional adverse reactions, with an incidence of at least 2%, that occurred more frequently with ZETONNA Nasal Aerosol than with placebo were upper respiratory tract infection, urinary tract infection, oropharyngeal pain, nasal mucosal/septum disorders, viral upper respiratory tract infection, cough, influenza, bronchitis, streptococcal pharyngitis, muscle strain, and nausea. Nasal discomfort (5.7%) and epistaxis (11.4%) were also more frequent in the 26-week safety trial compared to clinical trials 2 to 6 weeks in duration. Nasal mucosal/septum disorders and cough demonstrated a dose response.

Discontinuations due to adverse reactions were higher in ZETONNA Nasal Aerosol treated patients compared to placebo treated patients and demonstrated a dose response. Local adverse reactions leading to discontinuation were also higher in ZETONNA Nasal Aerosol 74 mcg treated patients (1.7%) compared to placebo treated patients (0.7%). The only local adverse reaction leading to discontinuation that occurred in ZETONNA Nasal Aerosol treated patients and was not observed in the 2- to 6-week trials was upper respiratory tract infection.

A total of 824 patients with perennial allergic rhinitis who completed the 26-week double-blind trial enrolled into an open-label extension and received ZETONNA Nasal Aerosol 148 mcg for 26 weeks. Additional adverse reactions, observed with an incidence of at least 2% were sinusitis, nasopharyngitis, and back pain.

A total of 4 nasal septal ulcerations were also reported in the 26-week open-label extension. There were no reports of nasal septal perforations in the long-term safety trial.

Post-marketing Experience

Additional adverse reactions have been identified during worldwide post-marketing use with other formulations of ciclesonide, ALVESCO® Inhalation Aerosol and OMNARIS® Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

ALVESCO® Inhalation Aerosol: immediate or delayed hypersensitivity reactions such as angioedema with swelling of the lips, tongue, and pharynx.

OMNARIS® Nasal Spray: nasal congestion, nasal ulcer, and dizziness. Localized infections of the nose or mouth with Candida albicans have also occurred with OMNARIS® Nasal Spray.

Read the entire FDA prescribing information for Zetonna (Ciclesonide) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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