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MedsAcross

Molecule

Flunisolide

Corticosteroid
Available on requestRespiratory
Presentations
1
Brands
0
Manufacturers
0
Available from stock
0

Flunisolide is a corticosteroid indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. It is available as nasal solution. MedsAcross supplies Flunisolide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Corticosteroid, Corticosteroid Hormone Receptor Agonists
ATC classification
R01AD04 Flunisolide · Topical decongestant, subgroup R01ADR03BA03 Flunisolide · Inhaled corticosteroid
US FDA first approval
24 September 1981
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Nasal
Dosage forms
Nasal solution
Identifiers
UNII 78M02AA8KFRxCUI 25120CAS 3385-03-3DrugBank DB00180Q3746835

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.

Source: US FDA prescribing information

Dosing overview

Adults: The recommended starting dose of Flunisolide Nasal Solution is 2 sprays (50 mcg) in each nostril 2 times a day (total dose 200 mcg/day). If needed, this dose may be increased to 2 sprays in each nostril 3 times a day (total dose 300 mcg/day). Pediatric Patients 6 to 14 years: The recommended starting dose of Flunisolide Nasal Solution is 1 spray (25 mcg) in each nostril 3 times a day or 2 sprays (50 mcg) in each nostril 2 times a day (total dose 150 to 200 mcg/day). Flunisolide Nasal Solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy studies, including possible adverse effects on growth, have not been conducted. Maximum total daily doses should not exceed 8 sprays in each nostril for adults (total dose 400 mcg/day) and 4 sprays in each nostril for pediatric patients under 14 years of age (total dose 200 mcg/day).

Source: US FDA prescribing information

Warnings and precautions

The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and/or depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to flunisolide should be carefully monitored to avoid acute adrenal insufficiency in response to stress. When transferred to flunisolide, careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids. This is particularly important in those patients who have associated asthma or other clinical conditions, where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

Source: US FDA prescribing information

Side effects

Adverse reactions reported in controlled clinical trials and long-term open studies in 595 patients treated with Flunisolide Nasal Solution are described below. Of these patients, 409 were treated for 3 months or longer, 323 for 6 months or longer, 259 for 1 year or longer, and 91 for 2 years or longer. In general, side effects elicited in the clinical studies have been primarily associated with the nasal mucous membranes. The most frequent complaints were those of mild transient nasal burning and stinging, which were reported in approximately 45% of the patients treated with Flunisolide Nasal Solution in placebo-controlled and long-term studies. These complaints do not usually interfere with treatment, in only 3% of patients was it necessary to decrease dosage or stop treatment because of these symptoms.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Flunisolide, sorted by availability.

MedicineManufacturerRegisterAvailability
Flunisolide 0.25 mg/mL nasal solutionNasalGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 24 September 1981Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Flunisolide in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Flunisolide available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Flunisolide and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Flunisolide approved by the US FDA?

Yes. The US FDA first approved Flunisolide on 24 September 1981, according to Drugs@FDA.

Does Flunisolide need cold chain shipping?

No listed presentation of Flunisolide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Flunisolide in?

Flunisolide is classified under ATC code R01AD04 (Flunisolide).

References

  1. Flunisolide prescribing information (Oceanside Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 2 May 2025

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