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Roxee Medication Guide

Velagliflozin Proline Monohydrate

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 Solution Boehringer Ingelheim Animal Health USA Inc. Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:58 p.m.

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

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.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 Aug 6, 2026, 7:58 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed May 15, 2026, 10:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Velagliflozin Proline Monohydrate

Velagliflozin Proline Monohydrate

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

Both Solution Rx required 100% reference complete

Species: Both

Manufacturer: Boehringer Ingelheim Animal Health USA Inc.

Medication Snapshot

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

Velagliflozin Proline Monohydrate

To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Species commonly shown: Cats.

Generic name
Velagliflozin Proline Monohydrate
Brand names
Senvelgo®, Senvelgo
Medication class
branded
Manufacturer
Boehringer Ingelheim Animal Health USA Inc.
Species
Cat
Dosage forms
Solution
Strengths
15 mg/mL
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Senvelgo® Senvelgo
Dosage forms
Solution
Strengths
15 mg/mL

Indications / Uses

To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

Administration / How To Give

Give Senvelgo by mouth once daily at approximately the same time each day, with or without food, as directed by a veterinarian.

Warnings / Contraindications

Do not use Senvelgo in cats with diabetes mellitus who have previously been treated with insulin, are receiving insulin, or have insulin-dependent diabetes mellitus; do not start it in cats that are anorexic, dehydrated, or lethargic.

  • Cats treated with Senvelgo may be at increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis, which can result in death and requires prompt veterinary treatment.

Side Effects

Top reported reactions (openFDA): Overdose, Diarrhoea, Vomiting, Hypersalivation, Wound, Dermal cyst(s).

FAQ

Cats

Yes. Roxee shows this as prescription-only.

Solution

Related Conditions

Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus (Canine)

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

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:

  • Loss of appetite (1 reports)
  • Haemorrhage NOS (1 reports)
  • Glucosuria (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 Velagliflozin Proline Monohydrate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-003666
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 10 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-003666
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-2026-US-003666
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

Loss of appetite (1 reports), Haemorrhage NOS (1 reports), Glucosuria (1 reports), Diarrhea (1 reports), Diabetic ketoacidosis (1 reports)

Body systems represented Signal grouping

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

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (30 reports), Dog (2 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (5), Domestic Longhair (2), ['Domestic Shorthair', 'Cat (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 Velagliflozin Proline Monohydrate 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

Loss of appetite, Haemorrhage NOS, Glucosuria

Call sooner if Escalation

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

Bottom line: Use this Velagliflozin Proline Monohydrate 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-2026-US-003666 · adverse_reaction · adverse reactions
  2. FDA Dear Veterinarian safety warning for Senvelgo. · safety_warning · 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. SPL · document · documents
  8. Official label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: May 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Loss of appetite
  • Haemorrhage NOS
  • Glucosuria

Most reported reactions:

  • Loss of appetite (1 reports)
  • Haemorrhage NOS (1 reports)
  • Glucosuria (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.
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
Cat
Indication / use
To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
Form / route / dose
Form: Solution
Route: Oral
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: Boehringer Ingelheim Animal Health USA Inc.
Form: Solution
Identifiers:
NADA: 141568 NDC Package: 0010-4614-01 NDC Package: 0010-4614-02 NDC Product: 0010
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
30
Matching reports
3
Active filters
2
Selected filters
Reaction: Weight loss Clear Body system: Digestive Clear
Reset
Drill into common report signals
Diarrhoea (6) Vomiting (6) Weight loss (6) Death by euthanasia (5) Other (25) Digestive (12) Neurologic (4) Behavior (1)
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-010604

Received 2026-03-04 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Longhair
Size / weight
10-24 lb (6.12 Kilogram)
Age
8+ years (9.42 Year)
Sex
Male Neutered
Region
USA
Reactions
Weight lossLethargy (see also Central nervous system depression in Neurological)Decreased appetiteHyperglycaemiaElevated betahydroxybutyrate (BHBA)Anaemia NOSElevated liver enzymes NOSDecreased packed cell volume (PCV)Elevated symmetrical dimethylarginine (SDMA)Elevated creatinineDecreased haematocrit
Body systems
OtherNeurologicDigestive
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-003521

Received 2026-01-19 · MSK · MSK

Serious
Species
Cat
Breed
['Domestic Shorthair', 'Cat (unknown)']
Size / weight
10-24 lb (4.96 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Weight lossDiarrhoeaAnorexiaVomitingDehydrationKetosisHypokalaemiaHypophosphataemiaSeizure NOSHypoglycaemiaDeath by euthanasia
Body systems
OtherDigestiveNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-005566

Received 2026-01-14 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.169 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
DiarrhoeaHypotensionVomitingIncreased respiratory rateWeight loss
Body systems
DigestiveOther
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
10
Species represented
2
Grouped by Body System
Digestive (5) · Loss of appetite, Drooling, Diarrhea Behavior (1) · Behavioral disorder (unspecified) Other (26) · Haemorrhage NOS, Haematuria, Haematemesis
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Digestive 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (30) Dog (2)

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

Source Documents

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

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

Senvelgo_CIS.pdf Official label / PI · Labeling Animal Drugs @ FDA search portal Official label / PI · Official label FDA Owner Guidance for Diabetes Drugs in Cats Official label / PI · Safety communication

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

5

SPL

2

FOI

1

Senvelgo_CIS.pdf

Official label / PI · Labeling

Open original

Animal Drugs @ FDA search portal

Official label / PI · Official label

Open original

This source does not expose a safe inline preview. Use the original source link for the full document.

Official FDA veterinary drug portal.

FDA Owner Guidance for Diabetes Drugs in Cats

Official label / PI · Safety communication

Open original

This source does not expose a safe inline preview. Use the original source link for the full document.

FDA owner-facing guidance for Bexacat and Senvelgo in diabetic cats.

FDA Dear Veterinarian Letter for Senvelgo

Official label / PI · Safety communication

Open original

This source does not expose a safe inline preview. Use the original source link for the full document.

FDA safety communication for veterinarians using Senvelgo.

FDA CVM Warning Letter (Senvelgo context)

Official label / PI · Safety communication

Open original

This source does not expose a safe inline preview. Use the original source link for the full document.

Official FDA communication referencing Senvelgo and sponsor.

Senvelgo®

SPL · SPL

Open original
FDA Structured Product Label

Senvelgo®

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

Sponsor
Boehringer Ingelheim Animal Health USA, Inc.
NADA
141-568
Status
RX
Form
Solution
Route
Oral
Species
Cat
Composition / specifications
15 mg/mL

Cats

Indication

To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

Dosage

Administer orally 0.45 mg per pound of body weight (1 mg per kilogram) velagliflozin once daily.

Senvelgo SPL

SPL · Structured Product Label

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

FOI Summary oN 141-568 Approved August 10, 2023.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 Aug 6, 2026, 7:58 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed May 15, 2026, 10:00 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Senvelgo
Manufacturer mapping: Boehringer Ingelheim Animal Health USA Inc.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat
Rx/OTC: RX
Form/route: Solution • Oral
Applications: NADA 141-568
NDC: Packages 0010-4614-01 0010-4614-02 • Products 0010
Documents: 2 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 64 • View
Case summaries: 30 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: E11.9
Type 2 diabetes mellitus without complications

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
Loss of appetite (1) Haemorrhage NOS (1) Glucosuria (1) Diarrhea (1) Diabetic ketoacidosis (1) Dehydration (1) Death by euthanasia (1) Crackles on auscultation (1)

Identifiers & Packages

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

Identifiers
NADA: 141568 NDC Package: 0010-4614-01 NDC Package: 0010-4614-02 NDC Product: 0010
Package NDC Product NDC Form / Route Status
0010-4614-01 0010 -
0010-4614-02 0010 -

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 44 Clinical 83 Manufacturer 0 Marketing 0
Current Field Facts
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-05-01)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-30)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-14)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-12)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-10)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-10)
Recent Revisions
  • monitoring updated 2026-08-06 19:58 by curated_loader • FDA monitoring and urgent-action guidance for Senvelgo.
  • contraindications updated 2026-08-06 19:58 by curated_loader • FDA contraindication and warning summary for Senvelgo.
  • prescription_required updated 2026-08-06 19:58 by curated_loader • FDA original approval lists Senvelgo marketing status as Rx.
  • administration updated 2026-08-06 19:58 by curated_loader • FDA owner-facing guidance for giving Bexacat or Senvelgo.
  • strengths updated 2026-08-06 19:58 by curated_loader • FDA original approval lists Senvelgo concentration as 15 mg/mL.
  • dosage_forms updated 2026-08-06 19:58 by curated_loader • FDA original approval lists Senvelgo drug form as solution.
  • species updated 2026-08-06 19:58 by curated_loader • FDA original approval lists Senvelgo species as cats.
  • usage updated 2026-08-06 19:58 by curated_loader • FDA original approval indication for Senvelgo.
  • drug_profile_type updated 2026-08-06 19:58 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-08-06 19:58 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-08-06 19:58 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-08-06 19:58 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-08-05 10:11 by curated_loader • FDA monitoring and urgent-action guidance for Senvelgo.
  • contraindications updated 2026-08-05 10:11 by curated_loader • FDA contraindication and warning summary for Senvelgo.
  • prescription_required updated 2026-08-05 10:11 by curated_loader • FDA original approval lists Senvelgo marketing status as Rx.
  • administration updated 2026-08-05 10:11 by curated_loader • FDA owner-facing guidance for giving Bexacat or Senvelgo.
  • strengths updated 2026-08-05 10:11 by curated_loader • FDA original approval lists Senvelgo concentration as 15 mg/mL.
  • dosage_forms updated 2026-08-05 10:11 by curated_loader • FDA original approval lists Senvelgo drug form as solution.
  • species updated 2026-08-05 10:11 by curated_loader • FDA original approval lists Senvelgo species as cats.
  • usage updated 2026-08-05 10:11 by curated_loader • FDA original approval indication for Senvelgo.

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
Senvelgo®
RX
Velagliflozin
Solution • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 141-568 Approved May 14, 2026

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: Cat
Composition / specifications
15 mg/mL
Cats
Indication

To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

Dosage

Administer orally 0.45 mg per pound of body weight (1 mg per kilogram) velagliflozin once daily.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

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) • Cat Drooling (1) • Cat Diarrhea (1) • Cat Decreased appetite (1) • Cat Bloody diarrhoea (1) • Cat

Showing top 5 for Digestive.

Behavior
Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Other
Haemorrhage NOS (1) • Cat Haematuria (1) • Cat Haematemesis (1) • Cat Glucosuria (1) • Cat Frequent urination (1) • Dog
Show more (21)
Foaming at the mouth (1) • Cat Fever (1) • Cat Eosinopenia (1) • Cat Elevated symmetrical dimethylarginine (1) • Cat Elevated liver enzymes NOS (1) • Cat Elevated fructosamine (1) • Cat Elevated creatinine (1) • Cat Elevated betahydroxybutyrate (1) • Cat Diabetic ketoacidosis (1) • Cat Dehydration (1) • Cat Decreased percentage of reticulocytes (1) • Cat Decreased packed cell volume (1) • Cat Decreased haematocrit (1) • Cat Decreased activity (1) • Cat Death by euthanasia (1) • Cat Crackles on auscultation (1) • Cat Cough (1) • Cat Chronic kidney disease (1) • Cat Blood in urine (1) • Dog Anaemia NOS (1) • Cat Abnormal ultrasound finding (1) • Cat

Showing top 5 for Other.

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

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, Domestic Shorthair, Female, 12 year, 4.8 kilogram • Drug: MSK, Solution, Oral, Dose: 1 Milligram per kilogram, Frequency: 1 per day • Reactions: Not eating, Tiredness (lethargy), Ketosis, Hypokalaemia, Weight loss… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014654
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 4.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 Milligram per kilogram
  • Frequency: 1 per day
Reactions Reported:
Not eating Tiredness (lethargy) Ketosis Hypokalaemia Weight loss Ketonuria Diabetic ketoacidosis
Outcomes: Ongoing

Cat, Domestic Longhair, Male, 9.42 year, 6.12 kilogram • Drug: MSK, Unknown • Reactions: Weight loss, Tiredness (lethargy), Decreased appetite, Hyperglycaemia, Elevated betahydroxybutyrate… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-010604
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.42 Year
  • Weight: 6.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Weight loss Tiredness (lethargy) Decreased appetite Hyperglycaemia Elevated betahydroxybutyrate Anaemia NOS Elevated liver enzymes NOS Decreased packed cell volume Elevated symmetrical dimethylarginine Elevated creatinine Decreased haematocrit
Outcomes: Outcome Unknown

Cat, Domestic Longhair, Male, 6 year, 5.14 kilogram • Drug: MSK, Solution, Oral, Dose: 1 Milligram per kilogram, Frequency: 1 per day • Reactions: Hard stool, Vomiting, Inappropriate defecation • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-009415
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 6.00 Year
  • Weight: 5.140 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 Milligram per kilogram
  • Frequency: 1 per day
Reactions Reported:
Hard stool Vomiting Inappropriate defecation
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 13 year, 3.221 kilogram • Drug: MSK, Solution, Oral, Dose: 1 Milligram per kilogram, Frequency: 1 per day • Reactions: Pemphigus foliaceus • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-007943
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 3.221 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 Milligram per kilogram
  • Frequency: 1 per day
Reactions Reported:
Pemphigus foliaceus
Outcomes: Outcome Unknown

Cat, ['Domestic Shorthair', 'Cat (unknown)'], Male, 13 year, 4.96 kilogram • Drug: MSK, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Weight loss, Diarrhea, Loss of appetite, Vomiting, Dehydration… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-003521
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 4.960 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Weight loss Diarrhea Loss of appetite Vomiting Dehydration Ketosis Hypokalaemia Hypophosphataemia Seizure NOS Hypoglycaemia Death by euthanasia
Outcomes: Euthanized

Cat, Domestic Shorthair, Male, 10 year, 6.169 kilogram • Drug: MSK, Solution, Oral, Dose: 1 Milligram per kilogram, Frequency: 1 per day • Reactions: Diarrhea, Hypotension, Vomiting, Increased respiratory rate, Weight loss • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-005566
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 6.169 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 Milligram per kilogram
  • Frequency: 1 per day
Reactions Reported:
Diarrhea Hypotension Vomiting Increased respiratory rate Weight loss
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 9 year, 4.59 kilogram • Drug: MSK, Solution, Oral, Dose: 1 Milligram per kilogram, Frequency: 1 per day • Reactions: Pulmonary neoplasm, Increased lung sounds, Tachypnoea, Laboured breathing, Weak pulse… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-003666
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 4.590 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 Milligram per kilogram
  • Frequency: 1 per day
Reactions Reported:
Pulmonary neoplasm Increased lung sounds Tachypnoea Laboured breathing Weak pulse Crackles on auscultation Death by euthanasia Abnormal ultrasound finding Haemorrhage NOS
Outcomes: Euthanized

Cat, Domestic Shorthair, Male, 7 year, 5.1 kilogram • Drug: MSK, Solution, Oral, Dose: 1 Milligram per kilogram, Frequency: 1 per day • Reactions: Vomiting, Weight gain • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-004182
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 5.100 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 Milligram per kilogram
  • Frequency: 1 per day
Reactions Reported:
Vomiting Weight gain
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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