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Roxee Medication Guide

Toceranib Phosphate

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

Both Reference complete FDA data linked Rx required Tablet Multiple FDA labelers Official label facts Owner quick guide first
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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
No safety reports linked
No refresh timestamp yet

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).
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Toceranib Phosphate

Toceranib Phosphate

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

Both Tablet Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Toceranib Phosphate

For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. Species commonly shown: Both, Dog.

Generic name
Toceranib Phosphate
Brand names
Palladia®, Toceranib Phosphate, Palladia
Manufacturer
Multiple FDA labelers
Species
Both, Dog
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Palladia® Toceranib Phosphate Palladia
Dosage forms
Tablet

Indications / Uses

For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.

Warnings / Contraindications

For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

  • For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Diarrhoea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Neutropenia, Leucopenia NOS.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Tablet

Related Conditions

Mast Cell Tumor (MCT)

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 Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement 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:

  • For oral use in dogs only
  • Do not use in dogs used for breeding, or for pregnant or lactating bitches
  • Do not split tablets
  • Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian
  • Vomiting (1 reports)
  • Loss of appetite (1 reports)
  • Increased respiratory rate (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

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

Source: openFDA case USA-USFDACVM-2025-US-021348
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 28 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-021348
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-021348
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

Vomiting (1 reports), Loss of appetite (1 reports), Increased respiratory rate (1 reports), Increased heart rate (1 reports), Hypoalbuminaemia (1 reports)

Body systems represented Signal grouping

Digestive (5), Neurologic (1), Other (26)

Species and breed lens

Species represented in reports Species lens

Dog (19 reports), Cat (13 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Toceranib Phosphate 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 oral use in dogs only, Do not use in dogs used for breeding, or for pregnant or lactating bitches, Do not split tablets, Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian, Vomiting

Call sooner if Escalation

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

Bottom line: Use this Toceranib Phosphate 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-021348 · 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. Labeling · 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, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • For oral use in dogs only
  • Do not use in dogs used for breeding, or for pregnant or lactating bitches
  • Do not split tablets
  • Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian
  • Vomiting

Most reported reactions:

  • Vomiting (1 reports)
  • Loss of appetite (1 reports)
  • Increased respiratory rate (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
Dog
Indication / use
For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.
Form / route / dose
Form: Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tab…
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: Multiple FDA labelers
Form: Tablet
Identifiers:
NADA: 141295 NDC Package: 54771-1690-1 NDC Package: 54771-1691-1 NDC Package: 54771-1692-1 NDC Package: 71052-210-10 NDC Package: 71052-210-25 NDC Package: 72969-072-10 NDC Package: 73309-089-01 NDC Package: 73309-089-02 NDC Package: 73309-089-03 NDC Package: 73377-156-01 NDC Package: 73377-156-02 NDC Package: 82774-003-01 NDC Package: 82774-003-02 NDC Package: 86032-034-01 NDC Package: 86197-007-01 NDC Product: 54771 NDC Product: 71052 NDC Product: 72969 NDC Product: 73309
Source metadata:

Warnings / Contraindications

For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) 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
28
Species represented
2
Grouped by Body System
Digestive (5) · Vomiting, Loss of appetite, Diarrhea Neurologic (1) · Convulsion Other (26) · Increased respiratory rate, Increased heart rate, Hypoalbuminaemia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Digestive 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Dog (19) Cat (13)

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

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.

PALLADIA N141295C0016.pdf Official label / PI · Labeling PALLADIA N141295C0016.pdf Official label / PI · Labeling Palladia® SPL · SPL

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

2

SPL

9

FOI

1

PALLADIA N141295C0016.pdf

Official label / PI · Labeling

Open original

PALLADIA N141295C0016.pdf

Official label / PI · Labeling

Open original

Palladia®

SPL · SPL

Open original
FDA Structured Product Label

Palladia®

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

Sponsor
Zoetis Inc.
NADA
141-295
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
Each tablet contains 10, 15, or 50 mg toceranib as toceranib phosphate.

Dogs

Indication
For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.
Dosage
Administer an initial dosage of 3.25 mg/kg (1.48 mg/lb) body weight, orally every other day.
Limitations
For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Toceranib Phosphate SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Toceranib Phosphate. Use the source link for the full official labeling record.

Toceranib Phosphate SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Toceranib Phosphate. Use the source link for the full official labeling record.

Toceranib Phosphate SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Toceranib Phosphate. Use the source link for the full official labeling record.

Toceranib phosphate SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Toceranib phosphate. Use the source link for the full official labeling record.

Toceranib Phosphate SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Toceranib Phosphate. Use the source link for the full official labeling record.

Palladia SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Palladia. Use the source link for the full official labeling record.

Toceranib Phosphate SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Toceranib Phosphate. Use the source link for the full official labeling record.

TOCERANIB PHOSPHATE SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for TOCERANIB PHOSPHATE. Use the source link for the full official labeling record.

UCM164091.pdf

FOI · FOI

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 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).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Palladia TOCERANIB PHOSPHATE Toceranib Phosphate Toceranib phosphate
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet • Oral
Applications: NADA 141-295
NDC: Packages 54771-1690-1 54771-1691-1 54771-1692-1 71052-210-10 71052-210-25 72969-072-10 • Products 54771 71052 72969 73309 73377 82774
Documents: 3 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Mast Cell Tumor (MCT)
Linked using: Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: C96.A
Mast cell neoplasm

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
  • For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Vomiting (1) Loss of appetite (1) Increased respiratory rate (1) Increased heart rate (1) Hypoalbuminaemia (1) Haematochezia (1) Gut pain (1) Fixed pupil (1)

Identifiers & Packages

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

Identifiers
NADA: 141295 NDC Package: 54771-1690-1 NDC Package: 54771-1691-1 NDC Package: 54771-1692-1 NDC Package: 71052-210-10 NDC Package: 71052-210-25 NDC Package: 72969-072-10 NDC Package: 73309-089-01 NDC Package: 73309-089-02 NDC Package: 73309-089-03 NDC Package: 73377-156-01 NDC Package: 73377-156-02 NDC Package: 82774-003-01 NDC Package: 82774-003-02 NDC Package: 86032-034-01 NDC Package: 86197-007-01 NDC Product: 54771 NDC Product: 71052 NDC Product: 72969 NDC Product: 73309 NDC Product: 73377 NDC Product: 82774 NDC Product: 86032 NDC Product: 86197
Package NDC Product NDC Form / Route Status
54771-1690-1 54771 -
54771-1691-1 54771 -
54771-1692-1 54771 -
71052-210-10 71052 -
71052-210-25 71052 -
72969-072-10 72969 -
73309-089-01 73309 -
73309-089-02 73309 -
73309-089-03 73309 -
73377-156-01 73377 -
73377-156-02 73377 -
82774-003-01 82774 -
82774-003-02 82774 -
86032-034-01 86032 -
86197-007-01 86197 -

Enriched Documents

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

  • Toceranib Phosphate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Toceranib Phosphate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Toceranib Phosphate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Toceranib phosphate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Toceranib Phosphate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Palladia SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Toceranib Phosphate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • TOCERANIB PHOSPHATE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • PALLADIA N141295C0016.pdf • Official label • Official • May 17, 2021
    FDA official labeling for application 141295
  • PALLADIA N141295C0016.pdf • Official label • Official • May 17, 2021
    FDA official labeling for application 141295
  • UCM164091.pdf • FOI summary • Official • May 17, 2021
    FDA FOI summary for application 141295

Data Sources & Change Log

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

Official 129 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Diarrhoea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Neutropenia, Leucopen… (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Diarrhoea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Neutropenia, Leucopen… (Clinical, 2026-04-11)
  • contraindications: For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this d… (Official, 2026-05-02)
  • contraindications: For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this d… (Official, 2026-04-30)
  • contraindications: For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this d… (Official, 2026-04-11)
  • contraindications: For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this d… (Official, 2026-02-12)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-22)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-22)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-21)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-20)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-13)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-12)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-12)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-11)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-11)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-10)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-09)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-08)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-07)
  • indications: For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs. (Official, 2026-06-06)
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 2026-04-11 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

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
Palladia®
RX
Toceranib Phosphate
Tablet • Oral
Label highlights
Official documents
Zoetis Inc. NADA 141-295 Approved May 17, 2021

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 tablet contains 10, 15, or 50 mg toceranib as toceranib phosphate.
Dogs
Indication
For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.
Dosage
Administer an initial dosage of 3.25 mg/kg (1.48 mg/lb) body weight, orally every other day.
Limitations
For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

For oral use in dogs only. Do not use in dogs used for breeding, or for pregnant or lactating bitches. Do not split tablets. Federal (USA) 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 Loss of appetite (1) • Cat Diarrhea (1) • Cat Decreased appetite (1) • Dog Appetite loss (1) • Cat

Showing top 5 for Digestive.

Neurologic
Convulsion (1) • Dog

Showing top 5 for Neurologic.

Other
Increased respiratory rate (1) • Dog Increased heart rate (1) • Dog Hypoalbuminaemia (1) • Dog Haematochezia (1) • Dog Gut pain (1) • Cat
Show more (21)
Fixed pupil (1) • Dog Eye neoplasm NOS (1) • Cat Elevated temperature (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated renal parameters (1) • Cat Dilated pupils (1) • Dog Digestive tract neoplasm NOS (1) • Cat Digestive tract disorder NOS (1) • Cat Decreased red blood cell count (1) • Cat Death by euthanasia (1) • Cat Death (1) • Cat Cyanotic mucous membranes (1) • Dog Crystalluria (1) • Dog Coma (1) • Dog Chronic renal failure (1) • Cat Cellulitis (1) • Dog Cardiorespiratory arrest (1) • Dog Bloody stool (1) • Dog Asystole (1) • Dog Allergic dermatitis (1) • Dog Abdominal mass (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.