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Systemic and local corticosteroid use may result in the following:
- Epistaxis, ulcerations, nasal septal perforations, Candida albicans infection, impaired wound healing [see WARNINGS AND PRECAUTIONS]
- Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]
- Immunosuppression [see WARNINGS AND PRECAUTIONS]
- Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see WARNINGS AND PRECAUTIONS, Use in Specific Populations]
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 (%)
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.
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.
Read the Zetonna (ciclesonide) Side Effects Center for a complete guide to possible side effects
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]. 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 pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of ciclesonide [see CLINICAL PHARMACOLOGY].
Read the Zetonna Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Zetonna Information
- Zetonna Drug Interactions Center: ciclesonide nasl
- Zetonna Side Effects Center
- Zetonna FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
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