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Meds A-Z

Terbinafine

Detailed information about Terbinafine

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
  • wobbly/unsteady walking (1 reports)
  • Hypokalaemia (1 reports)
  • Hyperthermia (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
  • wobbly/unsteady walking
  • Hypokalaemia
  • Hyperthermia

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Hypokalaemia (1 reports)
  • Hyperthermia (1 reports)

When to call your vet:

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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 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 15, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Image coming soon
Terbinafine

Terbinafine

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: Gel, Otic Suspension, Solution
Identifiers:
ANADA: 200719 ANADA: 200829 NADA: 141437 NADA: 141440 NADA: 141598 NDC Package: 17030-001-10 NDC Package: 17033-277-02 NDC Package: 17033-277-20 NDC Package: 17033-283-02 NDC Package: 17033-283-20 NDC Package: 51072-122-00 NDC Package: 51072-122-01 NDC Package: 51072-122-02 NDC Package: 58198-0027-1 NDC Package: 58198-0027-2 NDC Package: 58198-0027-3 NDC Package: 58198-0027-4 NDC Package: 86032-057-01 NDC Package: 86136-125-67 NDC Product: 17030
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
30
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Diarrhea, Appetite loss Skin & allergy (4) · Hives, Hair loss, Ear pruritus Neurologic (1) · Unsteady walking (ataxia) Other (24) · Increased band neutrophilia, Hypokalaemia, Hyperthermia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Skin & allergy 1 Dog 1
Other 1 Cat 1

Species coverage: Cat (17) Dog (15)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Non-serious - 1
Neurologic Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Skin & allergy Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Skin & allergy Cat Serious - 1
Other Cat Serious - 1
Digestive Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Skin & allergy Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog 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 (5)
  • Klentz™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18162/Klentz%E2%84%A2
  • Otiserene® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17106/Otiserene%C2%AE
  • 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
  • Osurnia™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2330/Osurnia%E2%84%A2
FOI (5)
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 15, 2026, 10:04 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™ Osurnia™ Otiserene® SIMPLERA™
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Gel, Otic Suspension, Solution Otic
Applications: ANADA 200-829 • NADA 141-598 • ANADA 200-719 • NADA 141-440 • NADA 141-437
Documents: 5 (FOI: 5) • SPL: 5 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 23 Cat 8 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
Unsteady walking (ataxia) (1) Hypokalaemia (1) Hyperthermia (1) Hyperglycaemia (1) Horner's syndrome (1) Horizontal nystagmus (1) Hives (1) Head tilt - ear disorder (1)

Identifiers & Packages

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

Identifiers
ANADA: 200719 ANADA: 200829 NADA: 141437 NADA: 141440 NADA: 141598 NDC Package: 17030-001-10 NDC Package: 17033-277-02 NDC Package: 17033-277-20 NDC Package: 17033-283-02 NDC Package: 17033-283-20 NDC Package: 51072-122-00 NDC Package: 51072-122-01 NDC Package: 51072-122-02 NDC Package: 58198-0027-1 NDC Package: 58198-0027-2 NDC Package: 58198-0027-3 NDC Package: 58198-0027-4 NDC Package: 86032-057-01 NDC Package: 86136-125-67 NDC Product: 17030 NDC Product: 17033 NDC Product: 51072 NDC Product: 58198 NDC Product: 86032
Package NDC Product NDC Form / Route Status
17030-001-10 17030 -
17033-277-02 17033 -
17033-277-20 17033 -
17033-283-02 17033 -
17033-283-20 17033 -
51072-122-00 51072 -
51072-122-01 51072 -
51072-122-02 51072 -
58198-0027-1 58198 -
58198-0027-2 58198 -
58198-0027-3 58198 -
58198-0027-4 58198 -
86032-057-01 86032 -
86136-125-67 86136 -

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 8 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, Ear discharge, Vomiting, Loss of hearing, Deafness, Head shake - ear disorder. (Official, 2026-02-12)
  • usage: For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius ) and yeast ( Malassezia pachyder… (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
Aurora Pharmaceutical, Inc. ANADA 200-829 Approved Jan 5, 2026
Otiserene®
RX
Dexamethasone Marbofloxacin Terbinafine
Otic Suspension Otic
Dechra, Ltd. NADA 141-598 Approved Jun 3, 2025
SIMPLERA™
RX
Florfenicol Mometasone furoate Terbinafine
Solution Otic
Vetoquinol USA, Inc. ANADA 200-719 Approved Oct 3, 2022
CLARO™
RX
Florfenicol Mometasone furoate Terbinafine
Solution Otic
Elanco US Inc. NADA 141-440 Approved Aug 3, 2021
Osurnia™
RX
Betamethasone Acetate Florfenicol Terbinafine
Gel Otic
Dechra, Ltd. NADA 141-437 Approved Aug 11, 2020

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

Composition / specifications
15.1 mg marbofloxacin, 22.7 mg terbinafine, 2.01 mg dexamethasone per tube
Dogs
Indication

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

Dosage

Administer one dose (1 tube) per affected ear once.

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
10 mg florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate per mL
Dogs
Indication
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
Dosage
Administer one dose (1 tube) per affected ear(s) and repeat administration in 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

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

FDA page: Open in Animal Drugs @ FDA

Usage

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

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
Vomiting (1) • Dog Diarrhea (1) • Cat Appetite loss (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hives (1) • Dog Hair loss (1) • Dog Ear pruritus (1) • Cat Application site swelling (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Other
Increased band neutrophilia (1) • Dog Hypokalaemia (1) • Cat Hyperthermia (1) • Dog Hyperglycaemia (1) • Cat Horner's syndrome (1) • Cat
Show more (19)
Horizontal nystagmus (1) • Cat Head tilt - ear disorder (1) • Cat Head shake - ear disorder (1) • Cat Flaking skin (1) • Dog Falling (1) • Cat Excoriation (1) • Dog Erythema (1) • Dog Elevated blood urea nitrogen (1) • Cat Ear canal inflammation (1) • Cat Dehydration (1) • Cat Decreased activity (1) • Dog Death by euthanasia (1) • Dog Bumps on skin (1) • Dog Bacterial skin infection NOS (1) • Dog Application site pain (1) • Cat Application site bleeding (1) • Cat Anisocoria (1) • Cat Abnormal posture (1) • Dog Abnormal cytology (1) • 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.

Dog, Terrier - Yorkshire, Female, 13 year, 6.12 kilogram • Drug: MSK, Unassigned, Unknown, Frequency: 1 per day • Reactions: Partial lack of efficacy, Hair loss, Erythema, Papule, Excoriation… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055162
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 6.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
  • Frequency: 1 per day
Reactions Reported:
Partial lack of efficacy Hair loss Erythema Papule Excoriation Skin scab Bacterial skin infection NOS Abnormal cytology
Outcomes: Ongoing

Dog, ['Hound (unspecified)', 'Crossbred Canine/dog'], Female, 7 year, 21.6 kilogram • Drug: MSK, Unknown • Reactions: Lymphopenia, Increased band neutrophilia, Monocytopenia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-051640
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 21.600 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lymphopenia Increased band neutrophilia Monocytopenia
Outcomes: Ongoing

Dog, Schnauzer - Miniature, Male, 5.33 year, 11.2 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal, Frequency: 1 per year • Reactions: Bumps on skin, Lack of efficacy (fungi) - NOS, Lack of efficacy (bacteria) - NOS, Ear canal inflammation, Flaking skin… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-051338
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.33 Year
  • Weight: 11.200 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:
Bumps on skin Lack of efficacy (fungi) - NOS Lack of efficacy (bacteria) - NOS Ear canal inflammation Flaking skin Hives Pinnal erythema
Outcomes: Outcome Unknown

Dog, Bulldog - French, Female, 6 year, 10.795 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Medication error NOS, Overdose • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-050163
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 10.795 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting Medication error NOS Overdose
Outcomes: Ongoing

Dog, Shepherd Dog - German, Male, 19 month, 42.6 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal, Frequency: 1 per year • Reactions: Malaise, Abnormal posture, Respiratory distress, Appetite loss, Death by euthanasia… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-048352
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 19.00 Month
  • Weight: 42.600 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
  • Frequency: 1 per year
Reactions Reported:
Malaise Abnormal posture Respiratory distress Appetite loss Death by euthanasia Hyperthermia Seizure NOS Decreased activity
Outcomes: Euthanized

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

Cat, Domestic Shorthair, Male, 10 year, 4.5 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal, Frequency: 1 per year • Reactions: Head shake - ear disorder, Ear canal inflammation, Application site bleeding, Tympanic rupture, Not eating… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-041669
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 4.500 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:
Head shake - ear disorder Ear canal inflammation Application site bleeding Tympanic rupture Not eating Falling Unsteady walking (ataxia) Third eyelid protrusion Ear pruritus Head tilt - ear disorder
Outcomes: Recovered/Normal

Cat, Domestic Longhair, Male, 9 week, 1.361 kilogram • Drug: MSK, Tablet, Oral, Dose: 0.25 tablet per animal, Frequency: 12 per hour • Reactions: Unsteady walking (ataxia), Shaking, Stiffness NOS, Vocalisation • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-054081
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.00 Week
  • Weight: 1.361 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 0.25 tablet per animal
  • Frequency: 12 per hour
Reactions Reported:
Unsteady walking (ataxia) Shaking Stiffness NOS Vocalisation
Outcomes: Recovered/Normal

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.

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