Side Effects of Nasonex (mometasone furoate)

Nasonex (mometasone furoate) is a synthetic (man-made) steroid hormone in the glucocorticoid family of steroid hormones used to treat nasal allergies. 

The naturally occurring glucocorticoid hormone is cortisol or hydrocortisone which is produced in the adrenal glands. Glucocorticoid hormones are potent reducers of inflammation (anti-inflammatory). When used as a nasal inhaler or spray, medications travel directly to the inner lining of the nose, and very little is absorbed into the body to cause side effects. 

Common side effects of Nasonex include

• headache,
• nasal irritation,
• sneezing, and,
• occasionally, nosebleeds.

Serious side effects of Nasonex include

• nasal septal perforation,
• fungal infection of the nose, and disturbances of taste and smell,
• suppression of the body's ability to make its own natural glucocorticoid in the adrenal gland,
• growth suppression,
• weakened immune system, and
• increased risk of glaucoma and cataracts. 

Allergic reactions, including swelling of face, throat and tongue, as well as rash, hives, and breathing problems may occur.

Drug interactions of Nasonex include drugs (for example, ketoconazole) that reduce the activity of enzymes that break down Nasonex, which may increase the blood levels of Nasonex since Nasonex is excreted primarily by the liver. 

Use of Nasonex during pregnancy has not been adequately evaluated. It is unknown if Nasonex is secreted in breast milk. Other medications in this class are secreted into breast milk. 

It is unknown if the small amounts of Nasonex that may appear in breast milk have an effect on the infant. Consult your doctor before breastfeeding.

The most common side effects associated with nasal mometasone furoate are:

• headache,
• nasal irritation,
• sneezing, and, occasionally,
• bleeding from the nose.

Nasal septal perforation, fungal infection of the nose, and disturbances of taste and smell have been reported. Higher doses of mometasone may cause suppression of the body's ability to make its own natural glucocorticoid in the adrenal gland.

People with suppression of their adrenal glands (which can be diagnosed by a doctor) would need increased amounts of glucocorticoids, probably by the oral or intravenous route, during periods of high physical stress or acute illness when glucocorticoids are particularly important.

Intranasal steroids may

• cause growth suppression,
• weaken the immune system, and
• may increase the risk of glaucoma, and cataracts.

Allergic reactions, including swelling of face, throat and tongue, as well as rash, hives, and breathing problems may occur.

Systemic and local corticosteroid use may result in the following:

• Epistaxis, ulcerations, Candida albicans infection, impaired wound healing
• Cataracts and glaucoma
• Immunosuppression
• Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction

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 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 Nasal Spray 50 mcg, 200 mcg/day vs. placebo and that were more common with Nasonex 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)

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 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 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 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 ≥5% of pediatric patients (ages 3 to 11 years) treated with Nasonex 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 Nasal Spray 50 mcg group vs. 4% in placebo) and vomiting (5% in Nasonex 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 with Nasonex 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 Nasal Spray, 50 mcg, 100 mcg/day in a clinical trial vs. placebo including 56 subjects (28 each Nasonex Nasal Spray, 50 mcg and placebo) and that was more common with Nasonex 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 furoate 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 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 Nasal Spray 50 mcg was comparable to patients with the placebo except for epistaxis, which was

• 9% for 200 mcg once daily,
• 13% for 200 mcg twice daily, and
• 5% for the placebo.

Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with Nasonex 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 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 Nasal Spray 50 mcg than in patients with the placebo included

• sinus headache (1.2% in Nasonex Nasal Spray 50 mcg group vs. 0.2% in placebo) and
• epistaxis (1% in Nasonex 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 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.

No formal drug-drug interaction studies have been conducted with Nasonex 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.