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Mometasone Furoate

Detailed information about Mometasone Furoate

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

What to watch for:

  • For otic use in dogs only
  • Not drinking (1 reports)
  • Neutrophilia (1 reports)
  • Neutropenia (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 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?
Safety & side effects

What to watch:

  • For otic use in dogs only
  • Not drinking
  • Neutrophilia
  • Neutropenia

Most reported reactions:

  • Not drinking (1 reports)
  • Neutrophilia (1 reports)
  • Neutropenia (1 reports)

When to call your vet:

  • 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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:02 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Image coming soon
Mometasone Furoate

Mometasone Furoate

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
Form: Liquid (Suspension), Otic Suspension, Solution, Suspension, Topical Suspension
Identifiers:
ANADA: 200536 ANADA: 200719 ANADA: 200829 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
Source metadata:

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
32
Reported cases
32
Serious reports
24
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Bloody diarrhoea Skin & allergy (2) · Hair loss at application site, Application site swelling Neurologic (2) · Unsteady walking (ataxia), Head tilt - neurological disorder Other (26) · Not eating, Not drinking, Neutrophilia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Cat (21) Dog (11)

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

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (0)
  • No official label or package insert links yet.
SPL (7)
  • Klentz™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18162/Klentz%E2%84%A2
  • Mometamax™ Otic Suspension · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/489/Mometamax%E2%84%A2%20Otic%20Suspension
  • Mometamax Single™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17190/Mometamax%20Single%E2%84%A2
  • SIMPLERA™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13011/SIMPLERA%E2%84%A2
  • CLARO™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2303/CLARO%E2%84%A2
  • Posatex® Otic Suspension · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2213/Posatex%C2%AE%20Otic%20Suspension
  • Mometavet® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2573/Mometavet%C2%AE
FOI (9)
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
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: CLARO™ Klentz™ Mometamax Single™ Mometamax™ Otic Suspension Mometavet® Posatex® Otic Suspension SIMPLERA™
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Liquid (Suspension), Otic Suspension, Solution, Suspension, Topical Suspension • Otic, Topical
Applications: ANADA 200-829 • NADA 141-177 • NADA 141-600 • ANADA 200-719 • NADA 141-440 • NADA 141-266 • ANADA 200-536
Documents: 9 (FOI: 9) • SPL: 7 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 28 • Cat 10 • View
Case summaries: 10 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Otitis Externa (Ear Infection)
Linked using: Fda_Label (0.95)
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
Not drinking (1) Neutrophilia (1) Neutropenia (1) Mucous stool (1) Lymphocytosis (1) Loss of smell (1) Loss of hearing (1) Leucocytosis NOS (1)

Identifiers & Packages

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

Identifiers
ANADA: 200536 ANADA: 200719 ANADA: 200829 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 NDC Package: 17033-273-75
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 12 Clinical 0 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… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (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, 2026-02-12)
Recent Revisions
  • 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

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Klentz™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Aurora Pharmaceutical, Inc. ANADA 200-829 Approved Jan 5, 2026
Mometamax™ Otic Suspension
RX
Clotrimazole Gentamicin Sulfate Mometasone Furoate Monohydrate
Liquid (Suspension) • Topical
Label highlights
Official documents
Intervet, Inc. NADA 141-177 Approved Dec 3, 2025
Mometamax Single™
RX
Gentamicin Mometasone furoate posaconazole
Otic Suspension • Otic
Label highlights
Official documents
Intervet, Inc. NADA 141-600 Approved Jun 3, 2025
SIMPLERA™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Vetoquinol USA, Inc. ANADA 200-719 Approved Oct 3, 2022
CLARO™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Elanco US Inc. NADA 141-440 Approved Aug 3, 2021
Posatex® Otic Suspension
RX
Mometasone Furoate Monohydrate Orbifloxacin posaconazole
Topical Suspension • Otic
Label highlights
Official documents
Intervet, Inc. NADA 141-266 Approved Mar 23, 2020
Mometavet®
RX
Clotrimazole Gentamicin Sulfate Mometasone furoate
Suspension • Otic
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-536 Approved Aug 16, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate
Dogs
Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each gram contains 3 mg gentamicin base; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 10 mg clotrimazole, in a mineral oil-based system containing a plasticized hydrocarbon gel.
Dogs
Indication
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).
Dosage
For dogs weighing less than 30 lbs, instill 4 drops from the 7.5g, 15g, or 30g bottle into the ear canal (2 drops from the 215g bottle) or, for dogs weighing 30 lbs or more, instill 8 drops from the 7.5g, 15g or 30g bottle into the ear canal (4 drops from the 215g bottle), once daily for 7 days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
A 0.8 mL dose delivers 6.88 mg gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.
Dogs
Indication

For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.

Dosage

Mometamax Single™ should be administered by veterinary personnel. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate
Dogs
Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride), 2.2 mg/mL mometasone furoate
Dogs
Indication

CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage
Administer one dose (1 dropperette) per affected ear. The duration of effect should last 30 days.
Limitations
For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each gram of POSATEX Otic Suspension contains 10 mg orbifloxacin; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 1 mg posaconazole in a mineral oil based system containing a plasticized hydrocarbon gel.
Dogs
Indication
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).
Dosage
For dogs weighing less than 30 lbs. instill 4 drops of POSATEX Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days. Four drops of POSATEX Otic Suspension delivers approximately 1.0 mg of orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each gram contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; mometasone furoate anhydrous, USP equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP.
Dogs
Indication
For the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
Dosage
For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) once daily in the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily in the ear canal. Therapy should continue for 7 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    New package size (7.5g bottle)
  • Summary
    For the treament of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis) and certain bacteria ( Pseudomonas supp. including P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci).
  • Summary
    Mometamax™ Otic Suspension is indicated for the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    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).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of otitis externa in dogs caused by susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Pseudomonas spp. [including P. aeruginosa], coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

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 ).

Source: FDA Animal Drugs @ FDA • Reference

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
Loss of appetite (1) • Cat Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Dog Application site swelling (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat Head tilt - neurological disorder (1) • Cat

Showing top 5 for Neurologic.

Other
Not eating (1) • Cat Not drinking (1) • Cat Neutrophilia (1) • Cat Neutropenia (1) • Dog Mucous stool (1) • Dog
Show more (21)
Lymphocytosis (1) • Dog Loss of smell (1) • Cat Loss of hearing (1) • Dog Leucocytosis NOS (1) • Cat Labeled drug-species interaction (1) • Cat Hypokalaemia (1) • Cat Hyperglycaemia (1) • Cat Horner's syndrome (1) • Cat Hind limb paresis (1) • Dog Head tilt - ear disorder (1) • Dog Head shake - ear disorder (1) • Cat General pain (1) • Cat Falling (1) • Cat Eosinophilia (1) • Dog Enamel disorder (1) • Dog Elevated blood urea nitrogen (1) • Cat Dehydration (1) • Cat Decreased activity (1) • Dog Death by euthanasia (1) • Cat Application site pain (1) • Cat Anisocoria (1) • Cat

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.

Dog, Bulldog - French, Male, 8 year, 10 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal • Reactions: Head tilt - ear disorder, Nystagmus • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-056126
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 10.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Head tilt - ear disorder Nystagmus
Outcomes: Ongoing

Dog, Dog (unknown), Male, 14 year, 33.566 kilogram • Drug: MSK, Solution, Unknown • Reactions: Hind limb paresis • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055509
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 33.566 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Hind limb paresis
Outcomes: Ongoing

Dog, ['Collie (unspecified)', 'Dog (unknown)'], Female, 11 year, 18.234 kilogram • Drug: MSK, Solution, Auricular (Otic) • Reactions: Decreased activity, Otitis NOS, Mucous stool, Bloody diarrhoea, Loss of hearing • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055634
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 18.234 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
Reactions Reported:
Decreased activity Otitis NOS Mucous stool Bloody diarrhoea Loss of hearing
Outcomes: Ongoing

Dog, ['Shepherd Dog - German', 'Dog (unknown)'], Female, 2.5 year • Drug: MSK, Solution, Unknown • Reactions: Neutropenia, Eosinophilia, Lymphocytosis, Enamel disorder, Tooth disorder • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055809
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 2.50 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Neutropenia Eosinophilia Lymphocytosis Enamel disorder Tooth disorder
Outcomes: Outcome Unknown

Dog, Shepherd Dog - German, Female, 6.75 year, 38.96 kilogram • Drug: MSK, Solution, Auricular (Otic) • Reactions: Itching, Hair loss at application site • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055889
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 6.75 Year
  • Weight: 38.960 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
Reactions Reported:
Itching Hair loss at application site
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Male, 14 year, 4.94 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 dose per animal • Reactions: General pain, Unsteady walking (ataxia), Nystagmus, Not eating • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-050792
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 4.940 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
General pain Unsteady walking (ataxia) Nystagmus Not eating
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 8 year, 5.36 kilogram • Drug: MSK, Solution, Auricular (Otic), Frequency: 1 per day • Reactions: Unsteady walking (ataxia), Falling • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-049831
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 5.360 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Frequency: 1 per day
Reactions Reported:
Unsteady walking (ataxia) Falling
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 10 year, 3.8 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal, Frequency: 1 per year • Reactions: Stumbling gait, Neutrophilia, Leucocytosis NOS, Hypokalaemia, Elevated blood urea nitrogen… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-048340
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 3.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 2 tube per animal
  • Frequency: 1 per year
Reactions Reported:
Stumbling gait Neutrophilia Leucocytosis NOS Hypokalaemia Elevated blood urea nitrogen Weight loss Dehydration Hyperglycaemia Unsteady walking (ataxia) Loss of smell Application site pain Tympanic alteration Horner's syndrome Third eyelid protrusion Not drinking Not eating Application site swelling Anisocoria Falling Death by euthanasia Wobbliness
Outcomes: Euthanized

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

Overdose Information

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Storage & Handling

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