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Roxee Medication Guide

Trilostane

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

Dog Reference complete FDA data linked Rx required Capsule Multiple FDA labelers Official label facts Owner quick guide first

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Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 13, 2026, 11:29 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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 Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Trilostane

Trilostane

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

Dog Capsule Rx required 100% reference complete

Species: Dog

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Trilostane

Used to treat hyperadrenocorticism (Cushing’s disease) in dogs by inhibiting cortisol production. Requires regular monitoring via ACTH stimulation tests and electrolyte checks. Species commonly shown: Dog.

Generic name
Trilostane
Brand names
VETORYL® CAPSULES, TRILOSTANE, X, AX Pharmaceutical Corp
Manufacturer
Multiple FDA labelers
Species
Dog
Dosage forms
Capsule
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
VETORYL® CAPSULES TRILOSTANE X AX Pharmaceutical Corp Vetoryl
Dosage forms
Capsule

Indications / Uses

Used to treat hyperadrenocorticism (Cushing’s disease) in dogs by inhibiting cortisol production. Requires regular monitoring via ACTH stimulation tests and electrolyte checks.

Administration / How To Give

Oral

Storage

Store at controlled room temperature (25°C / 77°F) with excursions allowed between 15–30°C (59–86°F). Keep capsules in original container, tightly closed, and handle with care.

Warnings / Contraindications

Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors.

  • Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors.

Side Effects

Common side effects include decreased appetite, vomiting, diarrhea, and lethargy; may lead to an Addisonian crisis if cortisol is overly suppressed.

FAQ

Dog

Yes. Roxee shows this as prescription-only.

Capsule

Store at controlled room temperature (25°C / 77°F) with excursions allowed between 15–30°C (59–86°F). Keep capsules in original container, tightly closed, and handle with care.

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 pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.

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:

  • Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches
  • Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors
  • Hearing affected (1 reports)
  • Haematuria (1 reports)
  • Gastrointestinal irritation (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.

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

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 Trilostane; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-069486
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 20 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-069486
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-2025-US-069486
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

Hearing affected (1 reports), Haematuria (1 reports), Gastrointestinal irritation (1 reports), Enlarged kidney (1 reports), Elevated serum alkaline phosphatase (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (1), Behavior (1), Other (26)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (21 reports), Cat (11 reports)

Breed metadata in reports Metadata only

Terrier - Boston (1), Spaniel - King Charles Cavalier (1), Spaniel (unspecified) (1), ['Dachshund - Standard Long-haired', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Trilostane 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

Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches, Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors, Hearing affected, Haematuria, Gastrointestinal irritation

Call sooner if Escalation

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

Bottom line: Use this Trilostane 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-2025-US-069486 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. FOI · document · documents
  6. FOI · document · documents
  7. Labeling · document · documents
  8. SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 7:40 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches
  • Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors
  • Hearing affected
  • Haematuria
  • Gastrointestinal irritation

Most reported reactions:

  • Hearing affected (1 reports)
  • Haematuria (1 reports)
  • Gastrointestinal irritation (1 reports)
Explore reported case details

Emergency warning signs:

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

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.
Form / route / dose
Form: Capsule
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing …
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

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

Species: Dog
Manufacturer: Multiple FDA labelers
Form: Capsule
Identifiers:
NADA: 141291 NDC Package: 17033-105-30 NDC Package: 17033-110-30 NDC Package: 17033-111-30 NDC Package: 17033-112-30 NDC Package: 17033-130-30 NDC Package: 17033-160-30 NDC Package: 58597-7038-6 NDC Package: 62157-361-01 NDC Package: 62157-401-01 NDC Package: 62157-556-01 NDC Package: 62157-557-01 NDC Package: 62157-560-01 NDC Package: 62157-596-01 NDC Package: 62157-927-01 NDC Package: 62991-2736-1 NDC Package: 62991-2736-2 NDC Package: 62991-2736-3 NDC Package: 62991-2736-4 NDC Package: 62991-2736-5
Source metadata:

Warnings / Contraindications

Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors.

  • High: Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors.
Source metadata:

Adverse Reactions

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

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
12
Matching reports
2
Active filters
2
Selected filters
Reaction: Hypocortisolaemia Clear Body system: Other Clear
Reset
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-074687

Received 2025-12-11 · MSK · MSK

Serious
Species
Dog
Breed
['Maltese', 'Poodle - Miniature']
Size / weight
10-24 lb (4.75 Kilogram)
Age
8+ years (13 Year)
Sex
Female Neutered
Region
USA
Reactions
Elevated serum alkaline phosphatase (ALP)Seizure NOSHypocortisolaemiaAbnormal adrenocorticotropic hormone (ACTH) stimulation testSyncopeBarkingLying down
Body systems
OtherNeurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-069486

Received 2025-11-12 · MSK · MSK

Non-serious
Species
Dog
Breed
Havanese
Size / weight
10-24 lb (10.5 Kilogram)
Age
8+ years (12 Year)
Sex
Female Neutered
Region
USA
Reactions
Blood in urineHypocortisolaemiaAbnormal adrenocorticotropic hormone (ACTH) stimulation test
Body systems
Other
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
20
Species represented
2
Grouped by Body System
Digestive (4) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (1) · Head twitching Behavior (1) · Behavioral disorder (unspecified) Other (26) · Hearing affected, Haematuria, General illness
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (21) Cat (11)

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

Storage & Handling

Store at controlled room temperature (25°C / 77°F) with excursions allowed between 15–30°C (59–86°F). Keep capsules in original container, tightly closed, and handle with care.

Source Documents

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

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

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

1

SPL

22

FOI

2

VETORYL N141291C0048.pdf

Official label / PI · Labeling

VETORYL® CAPSULES

SPL · SPL

FDA Structured Product Label

VETORYL® CAPSULES

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra, Ltd.
NADA
141-291
Status
RX
Form
Capsule
Route
Oral
Species
Dog
Composition / specifications
Each capsule contains 5, 10, 20, 30, 60, or 120 mg trilostane.

Dogs

Indication

For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.

Dosage
The starting dose for the treatment of hyperadrenocorticism in dogs is 1.0 to 3.0 mg/lb (2.2 to 6.7 mg/kg) once a day based on body weight and capsule size. Capsules should be administered with food.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

TRILOSTANE SPL

SPL · Structured Product Label

FDA Structured Product Label XML for TRILOSTANE. Use the source link for the full official labeling record.

Vetoryl SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Vetoryl. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

X SPL

SPL · Structured Product Label

FDA Structured Product Label XML for X. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

X SPL

SPL · Structured Product Label

FDA Structured Product Label XML for X. Use the source link for the full official labeling record.

TRILOSTANE SPL

SPL · Structured Product Label

FDA Structured Product Label XML for TRILOSTANE. Use the source link for the full official labeling record.

Trilostane SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Trilostane. Use the source link for the full official labeling record.

UCM173123.pdf

FOI · FOI

UCM508381.pdf

FOI · FOI

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 Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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 Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: AX Pharmaceutical Corp TRILOSTANE Trilostane Vetoryl X
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Dog FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Capsule Oral
Applications: NADA 141-291
NDC: Packages 17033-105-30 17033-110-30 17033-111-30 17033-112-30 17033-130-30 17033-160-30 Products 17033 58597 62157 62991 63732 69182
Documents: 3 (FOI: 2) • SPL: 1 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 25 Cat 6 View
Case summaries: 12 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Linked using: Fda_Label (0.95), Usage_Inferred (0.78), Usage_Inferred (0.78)

Diagnosis Codes
ICD10_CM: E24.9
Cushing syndrome, unspecified

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
  • Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors. (Contraindication, High)
Top reaction signals
Hearing affected (1) Haematuria (1) Gastrointestinal irritation (1) Enlarged kidney (1) Elevated serum alkaline phosphatase (1) Elevated alanine aminotransferase (1) Ear infection NOS (1) Drug prescribing error (1)

Identifiers & Packages

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

Identifiers
NADA: 141291 NDC Package: 17033-105-30 NDC Package: 17033-110-30 NDC Package: 17033-111-30 NDC Package: 17033-112-30 NDC Package: 17033-130-30 NDC Package: 17033-160-30 NDC Package: 58597-7038-6 NDC Package: 62157-361-01 NDC Package: 62157-401-01 NDC Package: 62157-556-01 NDC Package: 62157-557-01 NDC Package: 62157-560-01 NDC Package: 62157-596-01 NDC Package: 62157-927-01 NDC Package: 62991-2736-1 NDC Package: 62991-2736-2 NDC Package: 62991-2736-3 NDC Package: 62991-2736-4 NDC Package: 62991-2736-5 NDC Package: 63732-2018-4 NDC Package: 63732-2018-5 NDC Package: 63732-2018-6 NDC Package: 63732-2018-7
Package NDC Product NDC Form / Route Status
17033-105-30 17033 -
17033-110-30 17033 -
17033-111-30 17033 -
17033-112-30 17033 -
17033-130-30 17033 -
17033-160-30 17033 -
58597-7038-6 58597 -
62157-361-01 62157 -
62157-401-01 62157 -
62157-556-01 62157 -
62157-557-01 62157 -
62157-560-01 62157 -
62157-596-01 62157 -
62157-927-01 62157 -
62991-2736-1 62991 -
62991-2736-2 62991 -
62991-2736-3 62991 -
62991-2736-4 62991 -
62991-2736-5 62991 -
63732-2018-4 63732 -

Enriched Documents

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

  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • TRILOSTANE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Vetoryl SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • X SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • X SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • TRILOSTANE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Trilostane SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • VETORYL N141291C0048.pdf • Official label • Official • May 20, 2024
    FDA official labeling for application 141291
  • UCM508381.pdf • FOI summary • Official • May 20, 2024
    FDA FOI summary for application 141291
  • UCM173123.pdf • FOI summary • Official • May 20, 2024
    FDA FOI summary for application 141291

Data Sources & Change Log

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

Official 137 Clinical 7 Manufacturer 0 Marketing 0
Current Field Facts
  • overdose_info: Overdose can cause acute adrenal insufficiency with signs of collapse, severe weakness, and gastrointestinal upset. Immediate emergency treatment with IV fluid… (Clinical, 2026-04-12)
  • overdose_info: Overdose can cause acute adrenal insufficiency with signs of collapse, severe weakness, and gastrointestinal upset. Immediate emergency treatment with IV fluid… (Clinical, 2026-04-11)
  • overdose_info: Overdose can cause acute adrenal insufficiency with signs of collapse, severe weakness, and gastrointestinal upset. Immediate emergency treatment with IV fluid… (Clinical, 2026-02-12)
  • side_effects: Common side effects include decreased appetite, vomiting, diarrhea, and lethargy; may lead to an Addisonian crisis if cortisol is overly suppressed. (Clinical, 2026-04-11)
  • storage_handling: Store at controlled room temperature (25°C / 77°F) with excursions allowed between 15–30°C (59–86°F). Keep capsules in original container, tightly closed, and … (Clinical, 2026-04-12)
  • storage_handling: Store at controlled room temperature (25°C / 77°F) with excursions allowed between 15–30°C (59–86°F). Keep capsules in original container, tightly closed, and … (Clinical, 2026-04-11)
  • storage_handling: Store at controlled room temperature (25°C / 77°F) with excursions allowed between 15–30°C (59–86°F). Keep capsules in original container, tightly closed, and … (Clinical, 2026-02-12)
  • contraindications: Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE … (Official, 2026-04-12)
  • contraindications: Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE … (Official, 2026-04-11)
  • contraindications: Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE … (Official, 2026-02-12)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-22)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-22)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-21)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-20)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-13)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-12)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-12)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-11)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-11)
  • indications: For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. (Official, 2026-06-10)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 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 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 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
VETORYL® CAPSULES
RX
Trilostane
Capsule Oral
Dechra, Ltd. NADA 141-291 Approved May 20, 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.

Species: Dog
Composition / specifications
Each capsule contains 5, 10, 20, 30, 60, or 120 mg trilostane.
Dogs
Indication

For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.

Dosage
The starting dose for the treatment of hyperadrenocorticism in dogs is 1.0 to 3.0 mg/lb (2.2 to 6.7 mg/kg) once a day based on body weight and capsule size. Capsules should be administered with food.
Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

Used to treat hyperadrenocorticism (Cushing’s disease) in dogs by inhibiting cortisol production. Requires regular monitoring via ACTH stimulation tests and electrolyte checks.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Do not use in dogs with acute or serious liver/kidney disease or in pregnant bitches. Avoid use with potassium-sparing diuretics and exercise caution with ACE inhibitors.

Side Effects

Common side effects include decreased appetite, vomiting, diarrhea, and lethargy; may lead to an Addisonian crisis if cortisol is overly suppressed.

Source: FDA openFDA • Reference

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) • Dog Diarrhea (1) • Dog Decreased appetite (1) • Dog Appetite loss (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Head twitching (1) • Dog

Showing top 5 for Skin & allergy.

Behavior
Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Other
Hearing affected (1) • Dog Haematuria (1) • Cat General illness (1) • Dog Gastrointestinal irritation (1) • Dog Error occurred in home (1) • Cat
Show more (21)
Enlarged kidney (1) • Cat Elevated serum alkaline phosphatase (1) • Dog Elevated blood urea nitrogen (1) • Dog Elevated alanine aminotransferase (1) • Dog Ear infection NOS (1) • Dog Drug prescribing error (1) • Cat Dilated renal pelvis (1) • Cat Diabetes mellitus (1) • Dog Dermal mass (1) • Dog Death by euthanasia (1) • Cat Death (1) • Dog Collapse NOS (1) • Dog Cataract (1) • Dog Blood in urine (1) • Dog Barking (1) • Dog Azotaemia (1) • Cat Anisocoria (1) • Cat Accidental exposure (1) • Cat Abnormal ultrasound finding (1) • Cat Abnormal movement NOS (1) • Dog Abnormal adrenocorticotropic hormone (ACTH) stimulation test (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 - Boston, Male, 10 year, 16.14 kilogram • Drug: MSK, Capsule, Oral, Dose: 20 Milligram per animal, Frequency: 12 per hour • Reactions: Skin disorders NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075125
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 16.140 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 20 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Skin disorders NOS
Outcomes: Outcome Unknown

Dog, Spaniel - King Charles Cavalier, Male, 14 year, 12.1 kilogram • Drug: MSK, Capsule, Oral, Dose: 5 Milligram per animal, Frequency: 12 per hour • Reactions: Ear infection NOS, Polyp, Decreased appetite • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075124
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 12.100 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 5 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Ear infection NOS Polyp Decreased appetite
Outcomes: Outcome Unknown

Dog, Spaniel (unspecified), Female, 8.6 year, 13 kilogram • Drug: MSK, Capsule, Oral, Dose: 5 Milligram per animal, Frequency: 12 per hour • Reactions: Diabetes mellitus, Hyperglycaemia, Cataract • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075123
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.60 Year
  • Weight: 13.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 5 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Diabetes mellitus Hyperglycaemia Cataract
Outcomes: Ongoing

Dog, ['Dachshund - Standard Long-haired', 'Dog (unknown)'], Female, 11 year, 9 kilogram • Drug: MSK, Capsule, Oral, Dose: 15 Milligram per animal, Frequency: 24 per hour • Reactions: Hyperglycaemia • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075122
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 9.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 15 Milligram per animal
  • Frequency: 24 per hour
Reactions Reported:
Hyperglycaemia
Outcomes: Outcome Unknown

Dog, ['Terrier - Silky', 'Dog (unknown)'], Male, 13.5 year, 6.078 kilogram • Drug: MSK, Capsule, Oral, Dose: 10 Milligram per animal, Frequency: 12 per hour • Reactions: Diarrhea, Polyuria, Hyperglycaemia, Elevated blood urea nitrogen, Hyperkalaemia… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075121
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 13.50 Year
  • Weight: 6.078 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 10 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Diarrhea Polyuria Hyperglycaemia Elevated blood urea nitrogen Hyperkalaemia Low sodium-potassium ratio
Outcomes: Outcome Unknown

Dog, Greyhound, Male, 11 year, 30.9 kilogram • Drug: MSK, Capsule, Oral, Dose: 20 Milligram per animal, Frequency: 24 per hour • Reactions: Decreased appetite, Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075120
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 30.900 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 20 Milligram per animal
  • Frequency: 24 per hour
Reactions Reported:
Decreased appetite Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Greyhound - Italian, Female, 9 year, 5.18 kilogram • Drug: MSK, Capsule, Oral, Dose: 30 Milligram per animal, Frequency: 24 per hour • Reactions: Weight loss, Inappetence • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075119
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 9.00 Year
  • Weight: 5.180 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 30 Milligram per animal
  • Frequency: 24 per hour
Reactions Reported:
Weight loss Inappetence
Outcomes: Outcome Unknown

Dog, ['Maltese', 'Poodle - Miniature'], Female, 13 year, 4.75 kilogram • Drug: MSK, Capsule, Oral, Dose: 10 Milligram per animal, Frequency: 24 per hour • Reactions: Elevated serum alkaline phosphatase, Seizure NOS, Hypocortisolaemia, Abnormal adrenocorticotropic hormone (ACTH) stimulation test, Syncope… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074687
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 4.750 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 10 Milligram per animal
  • Frequency: 24 per hour
Reactions Reported:
Elevated serum alkaline phosphatase Seizure NOS Hypocortisolaemia Abnormal adrenocorticotropic hormone (ACTH) stimulation test Syncope Barking Lying down
Outcomes: Outcome Unknown

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

Overdose Information

Overdose can cause acute adrenal insufficiency with signs of collapse, severe weakness, and gastrointestinal upset. Immediate emergency treatment with IV fluids and corticosteroids is required.

Storage & Handling

Store at controlled room temperature (25°C / 77°F) with excursions allowed between 15–30°C (59–86°F). Keep capsules in original container, tightly closed, and handle with care.

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