Mometasone (Nasonex) Adverse Reactions
- acneiform rash
- adrenocortical insufficiency
- anaphylactoid reactions
- angioedema
- arthralgia
- bronchospasm
- candidiasis
- cataracts
- chest pain (unspecified)
- conjunctivitis
- contact dermatitis
- cough
- Cushing’s syndrome
- diarrhea
- dysgeusia
- dysmenorrhea
- dyspepsia
- epistaxis
- erythema
- folliculitis
- furunculosis
- growth inhibition
- headache
- hyperesthesia
- hypertrichosis
- hypothalamic-pituitary-adrenal (HPA) suppression
- impaired wound healing
- increased intracranial pressure
- infection
- miliaria
- musculoskeletal pain
- myalgia
- nasal irritation
- nasal septum perforation
- nausea/vomiting
- ocular hypertension
- otalgia
- papilledema
- paresthesias
- pharyngitis
- pruritus
- purpura
- rhinitis
- sinusitis
- skin atrophy
- skin irritation
- skin ulcer
- telangiectasia
- tolerance
- withdrawal
- xerosis
Mometasone (Nasonex) Adverse Reactions
The most commonly reported (>= 5% of patients) adverse reactions to intranasal mometasone were cough, dysmenorrhea, epistaxis/blood tinged mucus, headache, and musculoskeletal pain Other adverse reactions occurring in < 5% of patients but greater than or equal to 2% of patients included arthralgia, bronchitis, bronchospasm, chest pain (unspecified), conjunctivitis, diarrhea, dyspepsia, flu-like symptoms, myalgia, nausea/vomiting, otalgia, and rhinitis. In post marketing surveillance, cases of nasal irritation/burning, anaphylactoid reactions and angioedema, and rare cases of nasal septum perforation were reported; disturbances of taste (dysgeusia) and smell were also reported very rarely.
Adverse reactions to topical mometasone formulations (cream, lotion, ointment) have included acneiform rash, bacterial infection, candidiasis (moniliasis), burning, contact dermatitis, decreased glucocorticoid levels, folliculitis, furunculosis, hypertrichosis, maceration of the skin, miliaria, paresthesias, perioral dermatitis, pruritus, skin atrophy (e.g., bruising, loss of elasticity or normal skin markings, shininess, telangiectasia, thinness), skin irritation (burning, stinging, pruritus, tingling), skin hypopigmentation, striae, and xerosis. Other dermatologic effects include erythema, hyperesthesia, purpura, and vesiculation. The incidence of the following adverse reactions, in approximate decreasing order of occurrence, may be increased if occlusive dressings are used: skin irritation, xerosis, hypertrichosis, skin hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Mometasone has a relatively low risk of hypothalamic-pituitary-adrenal (HPA) suppression when used at recommended doses. Excessive doses of intranasal corticosteroids may lead to systemic corticosteroid effects. If this does occur, intranasal mometasone should be discontinued slowly. Systemic absorption of topical mometasone is minimal but theoretically could cause systemic adverse reactions, especially if applied to a large surface area or if occlusive dressings are used. Manifestations of Cushing’s syndrome and HPA suppression with possible adrenocortical insufficiency and withdrawal symptoms after stopping treatment can occur if large doses of topical mometasone are applied over extensive areas, under occlusive dressings, or for prolonged periods of time. Patients applying mometasone to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. HPA suppression, Cushing’s syndrome, and increased intracranial pressure have been reported in children receiving topical corticosteroids. The manufacturer reports that topical mometasone products cause HPA axis suppression in 27% of children aged 6 to 23 months who had normal adrenal function by Cortrosyn test before starting treatment. The topical mometasone preparations were applied once daily for approximately 3 weeks over a mean body surface area of 41%, 40%, and 39% for the cream, lotion, and ointment, respectively. Manifestations of adrenal suppression in children include linear growth inhibition, delayed weight gain, low plasma cortisol concentrations, and absence of response to ACTH stimulation. Clinical signs of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. The severity of glucocorticoid-induced secondary adrenocortical insufficiency varies among individuals and is dependent on the dose, frequency, time and route of administration, and duration of therapy. Patients with HPA suppression will require increased doses of corticosteroid therapy during periods of excessive stress.
In general, excessive use of corticosteroids can lead to impaired wound healing. Mometasone should not be applied directly or near healing wounds, and inhaled mometasone should not be used in patients who have experienced recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma. A propensity for skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.
Secondary infection may be observed during topical or inhaled treatment with mometasone. The anti-inflammatory activity of topical corticosteroids may also mask manifestations of infection. Local immunosuppression associated with inhaled fluticasone use may be manifested as an overgrowth of fungus in the nose, mouth, and throat. Rare cases of nasal ulcers and nasal and oral candidiasis have been reported in patients treated with intranasal mometasone for longer than 4 weeks. Using an add-on spacer device, reducing the frequency of use, and rinsing the mouth following use may minimize the incidence of oropharyngeal thrush. In addition, >= 5% of patients treated with intranasal mometasone reported pharyngitis, sinusitis, upper respiratory tract infections, and viral infections.
Systemic corticosteroid therapy has been associated with the development of cataracts in adults. The risk of cataracts increases with long-term and high-dose corticosteroid use. The mechanism of corticosteroid-induced cataract formation is uncertain but may involve disruption of sodium-potassium pumps in the lens epithelium leading to accumulation of water in lens fibers and agglutination of lens proteins.[1416] Case reports describe visual impairment patients using topical corticosteroids for eczema of the face. The visual impairment was secondary to the onset of ocular hypertension. Such adverse effects, if they occur, could lead to blindness. Cataracts have also been reported, usually with large doses or therapy > 6 months. Any patient who develops changes in vision during topical corticosteroid therapy should be evaluated for ocular hypertension. Low potency corticosteroids (e.g., hydrocortisone) have been reported to be safer for short-term use around the eye area.
Tolerance may occur with the prolonged use of topical corticosteroid formulations. This may explain the dramatic responses noted initially by patients early in topical corticosteroid treatment and an apparent diminished response with time. Tolerance is reversible and may be attenuated by interrupted or cyclic schedules of application of mometasone creams or ointments for chronic dermatologic conditions.
[ Last revised: 5/13/2005 9:07:00 AM ]
References
. Cumming RG, Mitchell P, Leeder SR et al. Use of inhaled corticosteroids and the risk of cataracts. N Engl J Med 1997;337:8 - 14.
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