Meds A-Z
Hydrocortisone Aceponate
Detailed information about Hydrocortisone Aceponate
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).
What it does:
For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).
When it's needed:
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.
Call your vet sooner if you notice:
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
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?
Hydrocortisone Aceponate
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141330 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 |
Species coverage: Cat (23) Dog (9)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2022-US-059489
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 2 • Secondary summaries: 0
- UCM287927.pdf · FOI
- Easotic® · SPL
No source yet.
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:05 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 51311-360-10 | 51311 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
UCM287927.pdf
• FOI summary • Official
• May 14, 2024
FDA FOI summary for application 141330
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membran… (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Lack of efficacy (bacteria) - NOS, Vomiting, Pinnal erythema. (Official, 2026-02-12)
- usage: For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius … (Official, 2026-02-12)
- 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 |
|---|---|---|---|---|
|
Easotic®
RX
Gentamicin Sulfate Hydrocortisone aceponate Miconazole Nitrate
Otic Suspension
• Otic
|
Virbac AH, Inc. | NADA 141-330 | Approved | May 14, 2024 |
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
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
FOI UCM287927.pdf
Summary
Easotic® suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius).
- Easotic® (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
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. Do not use in dogs with known tympanic membrane perforation.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 8 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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, ['Pit Bull', 'Dog (unknown)'], Male, 7 year, 20.865 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per dose, Frequency: 1 per day • Reactions: Loss of hearing • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055761
- Serious AE: Yes
- Treated For AE: No
- Sex: Male
- Age: 7.00 Year
- Weight: 20.865 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 dose per dose
- Frequency: 1 per day
Dog, Terrier (unspecified), Female, 14 year, 6.985 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Loss of hearing • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055553
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 14.00 Year
- Weight: 6.985 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 Other per dose
- Frequency: 1 per day
Dog, Chihuahua, Female, 1.5 year, 5.443 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Chewing - pruritus, Application site scratching, Lack of efficacy - NOS • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055857
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 1.50 Year
- Weight: 5.443 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 dose per animal
- Frequency: 1 per day
Dog, Shepherd Dog - Australian, Male, 1.7 year, 18.688 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Hives, Localised rash • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-054269
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 1.70 Year
- Weight: 18.688 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 dose per animal
- Frequency: 1 per day
Dog, Shih Tzu, Female, 8 year, 4.627 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Pinnal ulcer • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-052998
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 8.00 Year
- Weight: 4.627 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 Other per dose
- Frequency: 1 per day
Cat, Domestic Shorthair, Female, 6.1 year, 8.21 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 mL per dose, Frequency: 1 per day • Reactions: Vestibular disorder NOS, Unable to stand, Wobbliness • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2024-US-035205
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 6.10 Year
- Weight: 8.210 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 mL per dose
- Frequency: 1 per day
Cat, Maine Coon, Female, 15 year, 2.722 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Ear pain, Ear infection NOS, Lack of efficacy (bacteria) - NOS, Administration error NOS • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2023-US-031866
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 15.00 Year
- Weight: 2.722 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 Other per dose
- Frequency: 1 per day
Cat, Cat (unknown), Male, 10 year, 8.165 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 mL per animal, Frequency: 24 per hour • Reactions: Blood in vomit, Diarrhea, Decreased appetite, Decreased drinking, Bloody diarrhoea… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2022-US-059489
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 8.165 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 1 mL per animal
- Frequency: 24 per hour
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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