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Roxee Medication Guide

Hydrocortisone Aceponate

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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Veterinary professional?

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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.
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Hydrocortisone Aceponate

Hydrocortisone Aceponate

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.

Hydrocortisone Aceponate

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
Hydrocortisone Aceponate
Species
Both
Completeness
76%
Validation
Incomplete

Indications / Uses

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. Do not use in dogs with known tympanic membrane perforation.

  • 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

Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Lack of efficacy (bacteria) - NOS, Vomiting, Pinnal erythema.

FAQ

Both

Related Conditions

Otitis Externa (Ear Infection)

Source Transparency

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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 in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).

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
  • Do not use in dogs with known tympanic membrane perforation
  • Weight loss (1 reports)
  • Vomiting (1 reports)
  • Vestibular disorder 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 Hydrocortisone Aceponate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2022-US-059489
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 29 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2022-US-059489
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-2022-US-059489
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

Weight loss (1 reports), Vomiting (1 reports), Vestibular disorder NOS (1 reports), Unsteady walking (ataxia) (1 reports), Unable to stand (1 reports)

Body systems represented Signal grouping

Digestive (5), Skin & allergy (4), Neurologic (2), Effectiveness (2)

Species and breed lens

Species represented in reports Species lens

Cat (20 reports), Dog (12 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Hydrocortisone Aceponate 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, Do not use in dogs with known tympanic membrane perforation, Weight loss, Vomiting, Vestibular disorder NOS

Call sooner if Escalation

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

Bottom line: Use this Hydrocortisone Aceponate 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-2022-US-059489 · adverse_reaction · adverse reactions
  2. Medication contraindications · safety_warning · warnings contraindications
  3. 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
  • Do not use in dogs with known tympanic membrane perforation
  • Weight loss
  • Vomiting
  • Vestibular disorder NOS

Most reported reactions:

  • Weight loss (1 reports)
  • Vomiting (1 reports)
  • Vestibular disorder 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 in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).
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. Do not…
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:
NADA: 141330 NDC Package: 51311-360-10 NDC Product: 51311

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.
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
29
Species represented
2
Grouped by Body System
Digestive (5) · Vomiting, Diarrhea, Decreased appetite Skin & allergy (4) · Localised rash, Hives, Facial swelling (possible allergy) Neurologic (2) · Unsteady walking (ataxia), Tiredness (lethargy) Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (bacteria) - NOS Other (19) · Weight loss, Vestibular disorder NOS, Unable to stand
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Digestive 1 Cat 1
Other 1 Cat 1
Neurologic 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Neurologic 1 Cat 1

Species coverage: Cat (20) Dog (12)

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

UCM287927.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

1

UCM287927.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. Do not use in dogs with known tympanic membrane perforation. (Contraindication, High)
Top reaction signals
Weight loss (1) Vomiting (1) Vestibular disorder NOS (1) Unsteady walking (ataxia) (1) Unable to stand (1) Tympanic rupture (1) Tympanic alteration (1) Tiredness (lethargy) (1)

Identifiers & Packages

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

Identifiers
NADA: 141330 NDC Package: 51311-360-10 NDC Product: 51311
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 & Change Log

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

Official 7 Clinical 9 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. Do not use in dogs with known tympanic membran… (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. Do not use in dogs with known tympanic membran… (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. Do not use in dogs with known tympanic membran… (Clinical, 2026-04-11)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Lack of efficacy (bacteria) - NOS, Vomiting, Pinnal erythema. (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Lack of efficacy (bacteria) - NOS, Vomiting, Pinnal erythema. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Lack of efficacy (bacteria) - NOS, Vomiting, Pinnal erythema. (Clinical, 2026-04-11)
  • usage: For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius … (Clinical, 2026-05-02)
  • usage: For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius … (Clinical, 2026-04-15)
  • usage: For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius … (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. Do not use in dogs with known tympanic membran… (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. 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, 2026-04-30)
  • 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, 2026-04-30)
  • 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)
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 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. Do not use in dogs with known tympanic membrane perforation.

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 Decreased appetite (1) • Cat Bloody diarrhoea (1) • Cat Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Localised rash (1) • Dog Hives (1) • Dog Facial swelling (possible allergy) (1) • Dog Chewing - pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat Tiredness (1) • Cat

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (bacteria) - NOS (1) • Cat

Showing top 5 for Effectiveness.

Other
Weight loss (1) • Cat Vestibular disorder NOS (1) • Cat Unable to stand (1) • Cat Tympanic rupture (1) • Dog Tympanic alteration (1) • Dog
Show more (14)
Pinnal ulcer (1) • Dog Pain NOS (1) • Dog Not drinking (1) • Cat Mydriasis (1) • Cat Loss of hearing (1) • Dog Hypoglycaemia (1) • Cat Ear pain (1) • Cat Ear infection NOS (1) • Cat Ear canal inflammation (1) • Dog Decreased drinking (1) • Cat Bradycardia (1) • Cat Application site scratching (1) • Dog Administration error NOS (1) • Cat Abnormal radiograph finding (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.

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.