Nasonex

• Generic Name: mometasone furoate (nasal spray)
• Brand Name: Nasonex
• Drug Class: Corticosteroids, Intranasal

Nasonex (Mometasone Furoate (nasal spray)) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Consumer Information
• Professional Information

 

Nasonex Side Effects Center

What Is Nasonex?

Nasonex (mometasone furoate monohydrate) Nasal Spray is a steroid used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Nasonex Nasal Spray is also used to treat nasal polyps in adults.

What Are Side Effects of Nasonex?

Dosage for Nasonex?

Common side effects of Nasonex Nasal Spray include:

• headache,
• stuffy nose,
• sore throat,
• cough,
• muscle or joint pain,
• nausea,
• nose/throat dryness or irritation,
• blood-tinged mucus/phlegm,
• sores or white patches inside or around your nose, and
• nosebleeds.

Tell your doctor if you experience serious side effects of Nasonex Nasal Spray including pain or sores in your nose, white patches in your nose or mouth, or painful swallowing/trouble swallowing.

What Drugs, Substances, or Supplements Interact with Nasonex?

The recommended dose of Nasonex for adults and children 12 years and older for treatment or prevention of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, or nasal congestion associated with seasonal allergic rhinitis is 2 sprays in each nostril once daily (total daily dose of 200 mcg). The pediatric dose for children 2-11 years is one spray in each nostril once daily (100 mcg). To treat nasal polyps in adults, the dose is 2 sprays in each nostril twice daily (400 mcg). Two sprays in each nostril once daily (200 mcg) is effective in some patients.

Nasonex During Pregnancy and Breastfeeding

Other drugs may interact with Nasonex. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Additional Information

During pregnancy, Nasonex should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Nasonex (mometasone furoate monohydrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Nasonex Consumer Information

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

Call your doctor at once if you have:

• severe bleeding or increased drainage from your nose;
• nose pain or discomfort, headache;
• white patches or sores in the nose that won't heal;
• wheezing, trouble breathing;
• vision problems;
• irritation or a choking feeling in the back of your throat (may be signs that the implant has moved inside your nose); or
• ear pain or full feeling, trouble hearing, drainage from the ear.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using mometasone nasal.

Although the risk of serious side effects is low when mometasone is used in the nose, side effects can occur if the medicine is absorbed into your bloodstream. Tell your doctor if you have possible signs of long-term steroid use:

• weight gain (especially in your face or your upper back and torso);
• slow wound healing, thinning skin, increased body hair;
• irregular menstrual periods, changes in sexual function; or
• muscle weakness, tired feeling, depression, anxiety, or feeling irritable.

Common side effects may include:

• nosebleeds;
• headache;
• stuffy nose, sore throat, cough; or
• flu-like symptoms.

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 Nasonex (Mometasone Furoate (nasal spray))

 

Nasonex Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

• Epistaxis, ulcerations, 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

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)

	NASONEX 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 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, nasal septal perforation, and vision blurred. 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 entire FDA prescribing information for Nasonex (Mometasone Furoate (nasal spray))

&Copy; Nasonex Patient Information is supplied by Cerner Multum, Inc. and Nasonex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.