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Nasonex

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Nasonex

Nasonex

Nasonex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nasonex (mometasone furoate monohydrate) Nasal Spray is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. It is also used to treat nasal polyps in adults. Nasonex is a steroid. Common side effects include nose/throat dryness or irritation, blood-tinged mucus/phlegm, and nosebleeds.

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. Other drugs may interact with Nasonex. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Nasonex should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

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.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nasonex in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • severe or ongoing nose bleed;
  • sores in the nose that won't heal;
  • wheezing, trouble breathing;
  • vision problems; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • headache;
  • stuffy nose, sore throat, cough;
  • muscle or joint pain;
  • nausea; or
  • sores or white patches inside or around your nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nasonex (Mometasone Furoate (nasal spray)) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nasonex Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Precautions.

Nose/throat dryness or irritation, blood-tinged mucus/phlegm, and nosebleeds may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: pain/sores in your nose, white patches in your nose/mouth, painful swallowing/trouble swallowing.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nasonex (Mometasone Furoate (nasal spray))»

What is Prescribing information?

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

Nasonex FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Nasonex (Mometasone Furoate (nasal spray)) »

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Nasonex - User Reviews

Nasonex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Nasonex sorted by most helpful. Patient Discussions FAQs

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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