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Roxee Medication Guide

Mometasone

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Source review pending Regulatory linkage incomplete Owner quick guide first
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Data freshness

Reference facts
Source review pending
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Roxee is still reviewing source support for this medication profile.

FDA applications
Regulatory match pending
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Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.

Safety reports
No safety reports linked
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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed May 2, 2026, 10:05 AM UTC
    The reference fact projection used for browse cards and quick facts.
Image coming soon
Mometasone

Mometasone

Drug type: Generic ingredient • Generic profile • Regulatory linkage incomplete

Both 76% reference complete

Species: Both

Approval status: Official document linked, regulatory match incomplete. An official source document is available, but Roxee has not linked this row to a confirmed FDA animal-drug application or product record yet.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Mometasone

For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci). POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis ). CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). Species commonly shown: Both.

Generic name
Mometasone
Species
Both
Completeness
76%
Validation
Incomplete

Indications / Uses

For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecalis , Proteus mirabilis , and beta-hemolytic streptococci). POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ). CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in 'Neurological'), Vomiting.

FAQ

Both

Related Conditions

Otitis Externa (Ear Infection)

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecal...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • For otic use in dogs only
  • Tympanic rupture (1 reports)
  • Twitching (1 reports)
  • Neurological signs NOS (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Mometasone; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2024-US-077320
Safety signal coverage Reported signals

22 tracked reaction signals; 16 reported cases; 4 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2024-US-077320
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2024-US-077320
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Tympanic rupture (1 reports), Twitching (1 reports), Neurological signs NOS (1 reports), Medication error NOS (1 reports), Vomiting (1 reports)

Body systems represented Signal grouping

Digestive (2), Skin & allergy (1), Neurologic (2), Effectiveness (1)

Species and breed lens

Species represented in reports Species lens

Dog (13 reports), Cat (9 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Mometasone fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

For otic use in dogs only, Tympanic rupture, Twitching, Neurological signs NOS

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Mometasone brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2024-US-077320 · adverse_reaction · adverse reactions
  2. Medication contraindications · safety_warning · warnings contraindications
  3. FOI summary · document · documents
  4. FOI summary · document · documents
  5. FOI summary · document · documents
  6. FOI summary · document · documents
  7. FOI summary · document · documents
  8. FOI summary · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: May 2, 2026, 10:05 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • For otic use in dogs only
  • Tympanic rupture
  • Twitching
  • Neurological signs NOS

Most reported reactions:

  • Tympanic rupture (1 reports)
  • Twitching (1 reports)
  • Neurological signs NOS (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Not linked yet
Indication / use
For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-po…
Form / route / dose
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federa…
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Manufacturer not confirmed
Identifiers:
ANADA: 200536 ANADA: 200719 ANADA: 200829 ANADA: 200848 NADA: 141177 NADA: 141266 NADA: 141440 NADA: 141600 NDC Package: 0061-0089-01 NDC Package: 0061-0089-02 NDC Package: 0061-0089-03 NDC Package: 0061-1246-01 NDC Package: 0061-1246-02 NDC Package: 0061-1246-04 NDC Package: 0061-1246-05 NDC Package: 0061-5432-01 NDC Package: 13985-701-07 NDC Package: 13985-701-15 NDC Package: 13985-701-21 NDC Package: 13985-701-30

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
22
Reported cases
16
Serious reports
4
Species represented
2
Grouped by Body System
Digestive (2) · Vomiting, Diarrhea Skin & allergy (1) · Twitching Neurologic (2) · Neurological signs NOS, Lethargy (see also Central nervous system depression in 'Neurological') Effectiveness (1) · Lack of efficacy - NOS Other (16) · Upper respiratory sounds, Uncomfortable, Unclassifiable adverse event
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Skin & allergy 1 Dog 1
Neurologic 1 Dog 1
Other 1 Dog 1
Digestive 1 Cat 0
Other 1 Cat 0
Other 1 Dog 0
Other 1 Cat 0

Species coverage: Dog (13) Cat (9)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Skin & allergy Dog Serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Neurologic Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Effectiveness Cat Non-serious - 1
Other Dog Non-serious - 1
Digestive Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
Neurologic Dog Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Only technical FDA review documents are linked right now. Owner handouts, official label / PI, and SPL documents are not linked yet.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

FOI Summary oA 200-848 Approved April 8, 2026.pdf FOI · FOI summary FOI Summary oA 200-829 Approved December 22, 2025.pdf FOI · FOI summary ucm117265.pdf FOI · FOI summary

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

0
No SPL links yet.

FOI

10

FOI Summary oA 200-848 Approved April 8, 2026.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-829 Approved December 22, 2025.pdf

FOI · FOI summary

Open original

ucm117265.pdf

FOI · FOI summary

Open original

ucm117268.pdf

FOI · FOI summary

Open original

ucm117269.pdf

FOI · FOI summary

Open original

FOI Summary oN 141-600 Approved April 29 2025_ef.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-719 Approved September 28, 2022.pdf

FOI · FOI summary

Open original

UCM465253.pdf

FOI · FOI summary

Open original

UCM256757.pdf

FOI · FOI summary

Open original

UCM504539.pdf

FOI · FOI summary

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed May 2, 2026, 10:05 AM UTC
    The reference fact projection used for browse cards and quick facts.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Otitis Externa (Ear Infection)
Linked using: Usage_Inferred (0.78)
Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Tympanic rupture (1) Twitching (1) Neurological signs NOS (1) Medication error NOS (1) Vomiting (1) Upper respiratory sounds (1) Uncomfortable (1) Unclassifiable adverse event (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200536 ANADA: 200719 ANADA: 200829 ANADA: 200848 NADA: 141177 NADA: 141266 NADA: 141440 NADA: 141600 NDC Package: 0061-0089-01 NDC Package: 0061-0089-02 NDC Package: 0061-0089-03 NDC Package: 0061-1246-01 NDC Package: 0061-1246-02 NDC Package: 0061-1246-04 NDC Package: 0061-1246-05 NDC Package: 0061-5432-01 NDC Package: 13985-701-07 NDC Package: 13985-701-15 NDC Package: 13985-701-21 NDC Package: 13985-701-30 NDC Package: 17030-001-10 NDC Package: 17033-273-15 NDC Package: 17033-273-21 NDC Package: 17033-273-30
Package NDC Product NDC Form / Route Status
0061-0089-01 0061 -
0061-0089-02 0061 -
0061-0089-03 0061 -
0061-1246-01 0061 -
0061-1246-02 0061 -
0061-1246-04 0061 -
0061-1246-05 0061 -
0061-5432-01 0061 -
13985-701-07 13985 -
13985-701-15 13985 -
13985-701-21 13985 -
13985-701-30 13985 -
17030-001-10 17030 -
17033-273-15 17033 -
17033-273-21 17033 -
17033-273-30 17033 -
17033-273-75 17033 -
51072-122-00 51072 -
51072-122-01 51072 -
51072-122-02 51072 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 15 Clinical 10 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-05-02)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Clinical, 2026-04-11)
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-04-30)
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Clinical, 2026-04-11)
  • usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Clinical, 2026-05-02)
  • usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Clinical, 2026-04-15)
  • usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Official, 2026-04-30)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or o… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Official, 2026-02-12)
  • usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Official, 2026-04-30)
  • usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

Usage

For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecalis , Proteus mirabilis , and beta-hemolytic streptococci). POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ). CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Cat Diarrhea (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Twitching (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Neurological signs NOS (1) • Dog Tiredness (lethargy) • Dog

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Cat

Showing top 5 for Effectiveness.

Other
Upper respiratory sounds (1) • Cat Uncomfortable (1) • Dog Unclassifiable adverse event (1) • Cat Tympanic rupture (1) • Dog Product compounding error (1) • Cat
Show more (11)
No sign (1) • Cat Nasal discharge (1) • Cat Medication error NOS (1) • Dog Loss of hearing (1) • Dog Drug administration duration too long (1) • Dog Cough (1) • Cat Temporary deafness • Dog PR-EAR(S), LESION • Dog Partial deafness • Dog Deafness • Dog Allergic skin reaction • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

No case-level openFDA reports are linked for this medication yet.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.