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Nasonex

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 the 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.

Allergic Rhinitis

Adults and adolescents 12 years of age and older

In controlled US and international clinical studies, a total of 3210 adult and adolescent patients 12 years and older with allergic rhinitis received treatment with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg at doses of 50 to 800 mcg/day. The majority of patients (n = 2103) were treated with 200 mcg/day. A total of 350 adult and adolescent patients have been treated for one year or longer. Adverse events did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators.

All adverse events (regardless of relationship to treatment) reported by 5% or more of adult and adolescent patients ages 12 years and older who received NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, 200 mcg/day vs. placebo and that were more common with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg than placebo, are displayed in TABLE 1 below.

TABLE 1: ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER - ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING)

  NASONEX (mometasone furoate (nasal spray))
200 mcg
(n = 2103)
VEHICLE PLACEBO
(n = 1671)
Headache 26 22
Viral Infection 14 11
Pharyngitis 12 10
Epistaxis/Blood-Tinged Mucus 11 6
Coughing 7 6
Upper Respiratory Tract Infection 6 2
Dysmenorrhea 5 3
Musculoskeletal Pain 5 3
Sinusitis 5 3

Other adverse events which occurred in less than 5% but greater than or equal to 2% of adult and adolescent patients (ages 12 years and older) treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, 200-mcg/day (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis.

Pediatric patients < 12 years of age

In controlled US and international studies, a total of 990 pediatric patients (ages 3 to 11 years) with allergic rhinitis received treatment with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, at doses of 25 to 200 mcg/day. The majority of pediatric patients (n = 720) were treated with 100 mcg/day. A total of 163 pediatric patients have been treated for one year or longer. Two percent or less of patients in clinical trials who received NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg discontinued treatment because of adverse events and the discontinuation rate was similar for the placebo and active comparators.

Adverse events which occurred in 55% of pediatric patients (ages 3 to 11 years) treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included upper respiratory tract infection (5% in NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg group vs. 4% in placebo) and vomiting (5% in NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg group vs. 4% in placebo).

Other adverse events which occurred in less than 5% but greater than or equal to 2% of pediatric patients (ages 3 to 11 years) treated NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: diarrhea, nasal irritation, otitis media, and wheezing.

The adverse event (regardless of relationship to treatment) reported by 5% of pediatric patients ages 2 to 5 years who received NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, 100 mcg/day in a clinical trial vs. placebo including 56 subjects (28 each NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg and placebo) and that was more common with NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg than placebo, included: upper respiratory tract infection (7% vs. 0%, respectively). The other adverse event which occurred in less than 5% but greater than or equal to 2% of mometasone furcate pediatric patients ages 2 to 5 years treated with 100 mcg doses vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: skin trauma.

Nasal Polyps

Adults 18 years of age and older

In controlled clinical studies, the types of adverse events observed in patients with nasal polyps were similar to those observed for patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg at doses of 200 mcg once or twice daily for up to 4 months for treatment of nasal polyps. The overall Incidence of adverse events for patients treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg was comparable to patients with the placebo except for eplstaxls, which was 9% for 200 mcg once dally, 13% for 200 mcg twice dally, and 5% for the placebo.

Nasal ulcers and nasal and oral candldlasls were also reported in patients treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg primarily in patients treated for longer than 4 weeks.

Nasal Congestion Associated with Seasonal Allergic Rhinitis

A total of 1008 patients aged 12 years and older received NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg 200 mcg/day (n = 506) or placebo (n = 502) for 15 days. Adverse events that occurred more frequently in patients treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg than in patients with the placebo included sinus headache (1.2% in NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg group vs. 0.2% in placebo) and epistaxis (1 % in NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg group vs. 0.2% in placebo) and the overall adverse event profile was similar to that observed in the other allergic rhinitis trials.

Post-Marketing Experience

The following adverse reactions have been identified during the post-marketing period for NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. 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 Nasonex (mometasone furoate (nasal spray)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No formal drug-drug interaction studies have been conducted with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg.

Inhibitors of Cytochrome P450 3A4: Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome CYP 3A4 in the metabolism of this compound. Coadministration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the plasma concentrations of mometasone furoate [see CLINICAL PHARMACOLOGY].

Read the Nasonex Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/7/2011
This monograph has been modified to include the generic and brand name in many instances.

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Allergies & Asthma

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