Mometasone furoate (2)

What Mometasone furoate (2) is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Mometasone furoate ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and pediatric patients 2 years of age or older. …

— FDA label: Mometasone Furoate, Padagis Israel Pharmaceuticals Ltd, effective August 27, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (ointment, topical), Mometasone Furoate, Padagis Israel Pharmaceuticals Ltd; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 33 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 33 FDA labels for this medicine have a boxed warning.

Mometasone furoate (2) side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

• Endocrine System Adverse Reactions [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]
• Ophthalmic Adverse Reactions [see Warnings and Precautions (5.2)]
• Allergic Contact Dermatitis [see Warnings and Precautions (5.3)]
• Concomitant Skin infections [see Warnings and Precautions (5.4)] Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 clinical practice. In controlled clinical trials the incidence of adverse reactions associated with the use of mometasone furoate ointment was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Cases of rosacea associated with the use of mometasone furoate ointment have been reported. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of topical corticosteroids. Because adverse 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.

• Endocrine Disorders: Cushing’s syndrome, linear growth retardation, and delayed weight gain.
• Local Adverse Reactions: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, striae, and miliaria.
• Nervous System Disorders: intracranial hypertension.
• Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure

— FDA label: Mometasone Furoate, Padagis Israel Pharmaceuticals Ltd, effective August 27, 2026. Read the full label on DailyMed →

Mometasone furoate (2) dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

• Mometasone furoate ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
• Apply a thin film of mometasone furoate ointment to the affected skin areas once daily. Avoid use on the face, groin, or axillae. Wash hands after each application.
• Avoid contact with eyes [see Warnings and Precautions (5.2)].
• Do not use mometasone furoate ointment with occlusion. Do not use mometasone furoate ointment in the treatment of diaper dermatitis.

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• Discontinue therapy when control is achieved.
• If no improvement is seen within 2 weeks, consider reassessment of diagnosis [see Warnings and Precautions (5.1)].
• For topical use only. Not for oral, ophthalmic, or intravaginal use. (2)
• Apply a thin film to the affected skin areas once daily. (2)
• Discontinue therapy when control is achieved. (2)
• If no improvement is seen within 2 weeks, reassess diagnosis. (2)
• Do not use with occlusion. (2)

— FDA label: Mometasone Furoate, Padagis Israel Pharmaceuticals Ltd, effective August 27, 2026. Read the full label on DailyMed →

Mometasone furoate (2) in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary There are no adequate and well-controlled studies in pregnant women. Available data from postmarketing reports and published observational studies over decades of use with mometasone furoate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. Maternal use of potent or very potent topical corticosteroids may be associated with an increased risk of low birth weight infants (see Data).

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Advise pregnant women to use mometasone furoate ointment on the smallest area of skin and for the shortest duration possible. When administered subcutaneously, orally, or topically to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Mometasone furoate also caused dystocia and related complications when administered to rats during the end of pregnancy (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of mometasone furoate observed in animal studies to the systemic exposure that would be expected in humans after topical use of mometasone furoate ointment. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Published data from one observational study that included 60,497 pregnancies exposed to topical corticosteroids, including 10,056 pregnancies exposed to topical mometasone, did not identify an increased risk of low birth weight infants. However, data from other observational studies demonstrate that maternal use of potent to very potent topical corticosteroids was associated with an increased risk of low birth weight infants, especially when the cumulative dosage throughout pregnancy was greater than 300 grams. Available studies have limitations including confounding by disease severity, imprecision in birth weight outcomes, and data reliance on filled prescriptions rather than actual use. Animal Data In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. In rats, mometasone furoate produced umbilical hernias at topical doses of 600 mcg/kg and above. Mometasone furoate produced delays in ossification, but no malformations at 300 mcg/kg. In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above. In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg.

— FDA label: Mometasone Furoate, Padagis Israel Pharmaceuticals Ltd, effective August 27, 2026. This is part of the section. Read the full label on DailyMed →

When Mometasone furoate (2) should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Mometasone furoate ointment is contraindicated in patients with a history of hypersensitivity to mometasone furoate or any of the excipients in mometasone furoate ointment.

• Mometasone furoate ointment is contraindicated in patients with a history of hypersensitivity to mometasone furoate or any of the excipients in mometasone furoate ointment. (4)

— FDA label: Mometasone Furoate, Padagis Israel Pharmaceuticals Ltd, effective August 27, 2026. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines that contain Mometasone furoate (2)

• Mometasone furoate and formoterol fumarate dihydrateDulera · 3 products

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Bryant Ranch Prepack12 products
• Organon LLC5 products
• Padagis Israel Pharmaceuticals Ltd3 products
• Preferred Pharmaceuticals Inc.3 products
• Proficient Rx LP3 products
• Cosette Pharmaceuticals, Inc.2 products
• Encube Ethicals, Inc.2 products
• A-S Medication Solutions2 products
• Intersect ENT, Inc.1 product
• Sun Pharmaceutical Industries, Inc.1 product
• Amneal Pharmaceuticals LLC1 product
• Sportpharm LLC1 product
• Torrent Pharmaceuticals Limited1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (10)

• ANDA076067Padagis Us · March 18, 2002
• ANDA076481Encube · November 14, 2003
• ANDA076679Sun Pharma Canada · December 21, 2004
• ANDA077180Padagis Israel · April 6, 2005
• ANDA077447Cosette Pharms Nc · May 22, 2006
• ANDA077401Cosette Pharms Nc · June 20, 2006
• ANDA076499Encube · November 21, 2007
• ANDA078541Glenmark Pharms · May 28, 2008
• ANDA207989Amneal Pharms · April 3, 2017
• ANDA207899Torrent · July 13, 2018

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. May 28, 2024 · Class III · Ongoing · D-0550-2024

   Defective Container

   Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02 — Organon Llc

2. May 28, 2024 · Class III · Ongoing · D-0551-2024

   Defective Container

   Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03 — Organon Llc

3. January 4, 2023 · Class III · Terminated · D-0167-2023

   Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

   SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01. — Intersect ENT, Inc.

4. January 26, 2022 · Class II · Terminated · D-0169-2024

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD Inte — CARDINAL HEALTHCARE

Official identifiers

Next steps

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• Asmanex HFABrand page: products, maker and price
• AsmanexBrand page: products, maker and price
• SinuvaBrand page: products, maker and price
• Bryant Ranch PrepackMaker or distributor
• Organon LLCMaker or distributor
• Padagis Israel Pharmaceuticals LtdMaker or distributor
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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Mometasone Furoate, Padagis Israel Pharmaceuticals Ltd, effective August 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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