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Roxee Medication Guide

Tigilanol Tiglate

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 Injection Virbac AH Inc 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
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, 10:40 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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Tigilanol Tiglate

Tigilanol Tiglate

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

Both Injection Rx required 100% reference complete

Species: Both

Manufacturer: Virbac AH Inc

Medication Snapshot

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

Tigilanol Tiglate

For use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock Species commonly shown: Both, Dog.

Generic name
Tigilanol Tiglate
Brand names
STELFONTA®, STELFONTA 1 mg/mL
Manufacturer
Virbac AH Inc
Species
Both, Dog
Dosage forms
Injection, Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
STELFONTA® STELFONTA 1 mg/mL
Dosage forms
Injection Injectable Solution

Indications / Uses

For use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Injection site swelling, Wound, Injection site pain, Swelling NOS, Pain NOS.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Injection, Injectable Solution

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 use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock

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:

  • trouble breathing (1 reports)
  • Loss of appetite (1 reports)
  • Generalised skin slough (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • 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 Tigilanol Tiglate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-055759
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 30 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-055759
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-055759
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

Trouble breathing (dyspnea) (1 reports), Loss of appetite (1 reports), Generalised skin slough (1 reports), General pain (1 reports), Fixed pupil (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (1), Other (28)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (29 reports), Cat (3 reports)

Breed metadata in reports Metadata only

Bulldog - French (2), Retriever - Labrador (2), ['Spitz - German Pomeranian', 'Spitz - American Eskimo Dog'] (1), Pug (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 Tigilanol Tiglate 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

trouble breathing, Loss of appetite, Generalised skin slough

Call sooner if Escalation

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

Bottom line: Use this Tigilanol Tiglate 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-055759 · adverse_reaction · adverse reactions
  2. FDA application profile · official_label · quick facts
  3. Medication usage source · fda_animal_drugs · quick facts
  4. FOI · document · documents
  5. Labeling · document · documents
  6. Labeling · document · documents
  7. SPL · document · documents
  8. Structured Product Label · 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:

  • trouble breathing
  • Loss of appetite
  • Generalised skin slough

Most reported reactions:

  • Trouble breathing (dyspnea) (1 reports)
  • Loss of appetite (1 reports)
  • Generalised skin slough (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
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 use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock
Form / route / dose
Form: Injectable Solution
Route: Intratumoral
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
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: Both
Manufacturer: Virbac AH Inc
Form: Injectable Solution
Identifiers:
NADA: 141541 NDC Package: 51311-993-02 NDC Product: 51311
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
10
Matching reports
4
Active filters
1
Selected filters
Reaction: Swollen limb Clear
Reset
Drill into common report signals
Swollen limb (4) Bruising (3) Injection site reaction NOS (3) Lack of efficacy (neoplasia, no remission) (3) Other (9) Effectiveness (6) Skin & allergy (4) Digestive (1)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-075335

Received 2025-12-20 · MSK · MSK

Serious
Species
Dog
Breed
['Spitz - German Pomeranian', 'Spitz - American Eskimo Dog']
Size / weight
10-24 lb (6.35 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Neutered
Region
USA
Reactions
Injection site swellingReluctant to moveSwollen limbPartial anorexiaInjection site skin discolourationInjection site ulcerInjection site bleedingUncomfortableLimb non-weight bearingReddening of the skinLocal swelling (not application site)Walking slowlyLocalised oedema (not application site)Bruising
Body systems
Skin & allergyOtherDigestive
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-074617

Received 2025-12-17 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - French
Size / weight
25-49 lb (12.066 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (neoplasia, partial remission)Swollen limbWoundLocal erythemaBruising
Body systems
EffectivenessOther
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-073872

Received 2025-12-17 · MSK · MSK

Serious
Species
Dog
Breed
Pug
Size / weight
10-24 lb (9.344 Kilogram)
Age
4-7 years (6 Year)
Sex
Female Neutered
Region
USA
Reactions
Swollen limbLimb non-weight bearingPain NOSBruisingLocal erythemaInjection site skin discolouration
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-074096

Received 2025-12-15 · MSK · MSK

Serious
Species
Dog
Breed
Shepherd Dog - Australian
Size / weight
25-49 lb (21.772 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Intact
Region
USA
Reactions
Swollen limbLimb non-weight bearingInjection site reaction NOS
Body systems
Other
Outcomes
Ongoing

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

Tracked signals
32
Reported cases
32
Serious reports
30
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Drooling, Diarrhea Neurologic (1) · Convulsion Other (28) · Trouble breathing (dyspnea), Generalised skin slough, General pain
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (29) Cat (3)

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

STELFONTA N141541G0008.pdf Official label / PI · Labeling STELFONTA N141541G0008.pdf Official label / PI · Labeling STELFONTA® 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

2

FOI

1

STELFONTA N141541G0008.pdf

Official label / PI · Labeling

Open original

STELFONTA N141541G0008.pdf

Official label / PI · Labeling

Open original

STELFONTA®

SPL · SPL

Open original
FDA Structured Product Label

STELFONTA®

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

Sponsor
QBiotics Group Ltd.
NADA
141-541
Status
RX
Form
Injectable Solution
Route
Intratumoral
Species
Dog
Composition / specifications
1 mg/mL

Dogs

Indication

For use in dogs for the treatment of:

  • non-metastatic cutaneous mast cell tumors
  • non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock
Dosage

Administer as an intratumoral injection at a dose of 0.5 mL per cm3 of tumor volume, as determined by the following calculations:

  • Determine the Tumor Volume in cm3:
    0.5 x [length (cm) x width (cm) x height (cm)]
  • Confirm the Tumor Volume does not exceed 10 cm3. Do not use STELFONTA® if tumor volume is > 10 cm3.
  • Calculate the Dose volume (mL) of STELFONTA® to inject: Tumor Volume x 0.5 mL
  • Confirm the dose of STELFONTA® does not exceed 0.25 mL/kg body weight.
  • Do not exceed 5 mL per dog, regardless of tumor volume or body weight.
  • The minimum dose of STELFONTA® is 0.1 mL, regardless of tumor volume or body weight. If the calculated dose is less than 0.1 mL, administer 0.1 mL.

STELFONTA 1 mg/mL SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for STELFONTA 1 mg/mL. Use the source link for the full official labeling record.

FOI Summary oN 141-541 Approved November 16, 2020.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, 10:40 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: STELFONTA 1 mg/mL
Manufacturer mapping: Virbac AH Inc
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Injectable Solution • Intratumoral
Applications: NADA 141-541
NDC: Packages 51311-993-02 • Products 51311
Documents: 3 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 38 • Cat 0 • View
Case summaries: 10 (showing 8) • View
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.

Top reaction signals
Trouble breathing (dyspnea) (1) Loss of appetite (1) Generalised skin slough (1) General pain (1) Fixed pupil (1) Enlarged lymph node (1) Elevated triglyceride (1) Elevated temperature (1)

Identifiers & Packages

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

Identifiers
NADA: 141541 NDC Package: 51311-993-02 NDC Product: 51311
Package NDC Product NDC Form / Route Status
51311-993-02 51311 -

Enriched Documents

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

Data Sources & Change Log

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

Official 123 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Injection site swelling, Wound, Injection site pain, Swelling NOS, Pain NOS. (Clinical, 2026-04-11)
  • dosage_forms: Injection (Official, 2026-06-22)
  • dosage_forms: Injection (Official, 2026-06-22)
  • dosage_forms: Injection (Official, 2026-06-21)
  • dosage_forms: Injection (Official, 2026-06-20)
  • dosage_forms: Injection (Official, 2026-06-13)
  • dosage_forms: Injection (Official, 2026-06-12)
  • dosage_forms: Injection (Official, 2026-06-12)
  • dosage_forms: Injection (Official, 2026-06-11)
  • dosage_forms: Injection (Official, 2026-06-11)
  • dosage_forms: Injection (Official, 2026-06-10)
  • dosage_forms: Injection (Official, 2026-06-09)
  • dosage_forms: Injection (Official, 2026-06-08)
  • dosage_forms: Injection (Official, 2026-06-07)
  • dosage_forms: Injection (Official, 2026-06-06)
  • dosage_forms: Injection (Official, 2026-06-05)
  • dosage_forms: Injection (Official, 2026-06-04)
  • dosage_forms: Injection (Official, 2026-06-03)
  • dosage_forms: Injection (Official, 2026-06-02)
  • dosage_forms: Injection (Official, 2026-06-01)
Recent Revisions
  • side_effects 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
  • 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
  • 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
STELFONTA®
RX
Tigilanol tiglate
Injectable Solution • Intratumoral
Label highlights
Official documents
QBiotics Group Ltd. NADA 141-541 Approved Oct 26, 2023

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
1 mg/mL
Dogs
Indication

For use in dogs for the treatment of:

  • non-metastatic cutaneous mast cell tumors
  • non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock
Dosage

Administer as an intratumoral injection at a dose of 0.5 mL per cm3 of tumor volume, as determined by the following calculations:

  • Determine the Tumor Volume in cm3:
    0.5 x [length (cm) x width (cm) x height (cm)]
  • Confirm the Tumor Volume does not exceed 10 cm3. Do not use STELFONTA® if tumor volume is > 10 cm3.
  • Calculate the Dose volume (mL) of STELFONTA® to inject: Tumor Volume x 0.5 mL
  • Confirm the dose of STELFONTA® does not exceed 0.25 mL/kg body weight.
  • Do not exceed 5 mL per dog, regardless of tumor volume or body weight.
  • The minimum dose of STELFONTA® is 0.1 mL, regardless of tumor volume or body weight. If the calculated dose is less than 0.1 mL, administer 0.1 mL.
Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock

Source: FDA Animal Drugs @ FDA • 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 Drooling (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Convulsion (1) • Dog

Showing top 5 for Neurologic.

Other
Trouble breathing (1) • Dog Generalised skin slough (1) • Dog General pain (1) • Dog Fixed pupil (1) • Dog Enlarged lymph node (1) • Dog
Show more (23)
Elevated triglyceride (1) • Dog Elevated temperature (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated cholesterol (1) • Dog Dilated pupils (1) • Dog Dermal nodule (1) • Dog Death by euthanasia (1) • Dog Death (1) • Cat Cyanotic mucous membranes (1) • Dog Coma (1) • Dog Cellulitis (1) • Dog Cardiorespiratory arrest (1) • Dog Cardiac arrest (1) • Cat Bruising (1) • Dog Breathing difficulty (1) • Dog Bradycardia (1) • Cat Bacterial skin infection NOS (1) • Dog Asystole (1) • Dog Arthritis (1) • Dog Application site skin slough (1) • Dog Application site scar (1) • Dog Application site dry skin (1) • Dog Acid-base disorder (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, ['Spitz - German Pomeranian', 'Spitz - American Eskimo Dog'], Female, 6 year, 6.35 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.25 Milligram per kilogram, Frequency: 1 per day • Reactions: Injection site swelling, Reluctant to move, Swollen limb, Partial anorexia, Injection site skin discolouration… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075335
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 6.350 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
  • Dose: 0.25 Milligram per kilogram
  • Frequency: 1 per day
Reactions Reported:
Injection site swelling Reluctant to move Swollen limb Partial anorexia Injection site skin discolouration Injection site ulcer Injection site bleeding Uncomfortable Limb non-weight bearing Reddening of the skin Local swelling Walking slowly Localised oedema Bruising
Outcomes: Outcome Unknown

Dog, Bulldog - French, Female, 11 year, 12.066 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.28 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy, Swollen limb, Wound, Local erythema, Bruising • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074617
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 12.066 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
  • Dose: 0.28 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy Swollen limb Wound Local erythema Bruising
Outcomes: Outcome Unknown

Dog, Pug, Female, 6 year, 9.344 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1.50 mL per dose, Frequency: 1 per day • Reactions: Swollen limb, Limb non-weight bearing, Pain NOS, Bruising, Local erythema… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073872
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 9.344 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
  • Dose: 1.50 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Swollen limb Limb non-weight bearing Pain NOS Bruising Local erythema Injection site skin discolouration
Outcomes: Ongoing

Dog, Bulldog - French, Female, 5 year, 11.34 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1.30 mL per dose, Frequency: 1 per day • Reactions: Injection site swelling, Local swelling, Local skin slough, Enlarged lymph node, Application site skin slough… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074498
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 11.340 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
  • Dose: 1.30 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Injection site swelling Local swelling Local skin slough Enlarged lymph node Application site skin slough Injection site reaction NOS Wound Injection site skin change NOS Injection site mucopurulent discharge Skin reaction NOS Pain NOS Injection site bleeding
Outcomes: Ongoing

Dog, Shepherd Dog - Australian, Male, 5 year, 21.772 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.70 mL per dose, Frequency: 1 per day • Reactions: Swollen limb, Limb non-weight bearing, Injection site reaction NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074096
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 21.772 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
  • Dose: 0.70 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Swollen limb Limb non-weight bearing Injection site reaction NOS
Outcomes: Ongoing

Dog, ['Pointing Dog - Hungarian Short-haired (Vizsla)', 'Retriever - Labrador'], Male, 8 year, 40.415 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.10 mL per dose, Frequency: 1 per day • Reactions: Application site scar, Injection site alopecia, Injection site reaction NOS, Injection site nodule, Mast cell tumour… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073513
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 40.415 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
  • Dose: 0.10 mL per dose
  • Frequency: 1 per day
Reactions Reported:
Application site scar Injection site alopecia Injection site reaction NOS Injection site nodule Mast cell tumour Lack of efficacy
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Male, 12 year, 28.576 kilogram • Drug: MSK, Intralesional, Dose: 4.90 mL per other • Reactions: Application site dry skin, Lack of efficacy, Injection site hair loss, Injection site scab, Mast cell tumour… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074135
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 28.576 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intralesional
  • Dose: 4.90 mL per other
Reactions Reported:
Application site dry skin Lack of efficacy Injection site hair loss Injection site scab Mast cell tumour Local swelling Swollen eye
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Female, 6.5 year, 29.484 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Lack of efficacy • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-069220
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 6.50 Year
  • Weight: 29.484 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
  • Dose: 1 dose per animal
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy
Outcomes: Outcome Unknown

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

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