This page reprints a manufacturer label. Everything below in quotation marks is copied from Galliprant TM, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for Galliprant TM by Elanco US Inc, a grapiprant product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.
The label
Product: Galliprant TM. Manufacturer: Elanco US Inc. FDA Structured Product Label set id a38cc5c6-93e8-4c90-aabc-33bc8423beab. Label effective 2025-08-11. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
GALLIPRANT (grapiprant tablets) is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Dosage and Administration
Always provide “ Information for Dog Owners ” Sheet with prescription. Carefully consider the potential benefits and risks of GALLIPRANT and other treatment options before deciding to use GALLIPRANT. Use the lowest effective dose for the shortest duration consistent with individual response. The dose of GALLIPRANT (grapiprant tablets) is 0.9 mg/lb (2 mg/kg) once daily. Only the 20 mg and 60 mg tablets of GALLIPRANT are scored. The dosage should be calculated in half tablet increments. Dogs less than 8 lbs. (3.6 kgs) cannot be accurately dosed. Dosing Chart Dose Weight in pounds Weight in kilograms 20 mg tablet 60 mg tablet 100 mg tablet 0.9 mg/lb (2 mg/kg) once daily 8-15 3.6-6.8 0.5 15.1-30 6.9-13.6 1 30.1-45 13.7-20.4 0.5 45.1-75 20.5-34 1 75.1-150 34.1-68 1 The 100 mg tablet is not scored and should not be broken in half. Breaking the 100 mg tablet in half will not guarantee that half of the active ingredient is contained within each half of the tablet. For dogs larger than 150 lbs (68 kgs), use a combination of tablet and half tablets to achieve the appropriate dose.
Contraindications
GALLIPRANT should not be used in dogs that have a hypersensitivity to grapiprant.
Warnings
Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans. For use in dogs only. All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to and periodically during administration of any NSAID is recommended. Owners should be advised to observe for signs of potential drug toxicity (see
Precautions
The safe use of GALLIPRANT has not been evaluated in dogs younger than 9 months of age and less than 8 lbs (3.6 kgs), dogs used for breeding, or in pregnant or lactating dogs. Adverse reactions in dogs receiving GALLIPRANT may include vomiting, diarrhea, decreased appetite, mucoid, watery or bloody stools, and decreases in serum albumin and total protein (see
Adverse Reactions
, Post-Approval Experience , and
Description
GALLIPRANT (grapiprant tablets) is a prostaglandin E 2 (PGE 2 ) EP4 receptor antagonist; a non-cyclooxygenase (COX) inhibiting, non-steroidal anti-inflammatory drug (NSAID) in the piprant class. GALLIPRANT is a flavored, oval, biconvex, beige to brown in color tablet debossed with a “G” that contains grapiprant and desiccated pork liver as the flavoring agent. The 20 mg and 60 mg tablets are scored. The 100 mg tablet is not scored. The molecular weight of grapiprant is 491.61 Daltons. The empirical formula is C 26 H 29 N 5 O 3 S. Grapiprant is N-[[[2-[4-(2-Ethyl-4,6-dimethyl-1H-imidazo[4,5-c] pyridin-1-yl)phenyl]ethyl]amino]carbonyl]-4 methylbenzenesulfonamide. The structural formula is: Structural Formula
Information for Owners
Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include diarrhea, vomiting, decreased appetite, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, jaundice (yellowing of gums, skin or white of the eye), lethargy, incoordination, seizures, and behavioral changes such as depression or restlessness. Serious adverse reactions associated with this drug class can occur without warning and, in some cases, result in death (see
Storage
Store at or below 86° F (30° C)
FDA adverse event reports
The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming grapiprant as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.
These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.
Dogs: 7,556 reports
| VeDDRA reaction term | Reports |
|---|---|
| Vomiting | 1,425 |
| Diarrhoea | 1,256 |
| Lack of efficacy - NOS | 958 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 659 |
| Elevated alanine aminotransferase (ALT) | 508 |
| Death by euthanasia | 476 |
| Not eating | 466 |
| Decreased appetite | 428 |
| Bloody diarrhoea | 392 |
| Weight loss | 347 |
| Elevated blood urea nitrogen (BUN) | 340 |
| Elevated serum alkaline phosphatase (SAP) | 317 |
| Elevated creatinine | 301 |
| Anorexia | 287 |
| Lethargy (see also Central nervous system depression in Neurological) | 284 |
Outcome as recorded by the reporter: Ongoing 2,558; Outcome Unknown 2,552; Recovered/Normal 1,671; Euthanized 476; Died 269; Recovered with Sequela 38.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Cats: 15 reports
| VeDDRA reaction term | Reports |
|---|---|
| Elevated blood urea nitrogen (BUN) | 4 |
| Hiding | 4 |
| Death by euthanasia | 3 |
| Elevated creatinine | 3 |
| Lack of efficacy - NOS | 3 |
| Vomiting | 3 |
| Weight loss | 3 |
| Decreased activity | 2 |
| Decreased appetite | 2 |
| Not eating | 2 |
| Accidental exposure | 1 |
| Agitation | 1 |
| Anaemia NOS | 1 |
| Behavioural disorder NOS | 1 |
| Diarrhoea | 1 |
Outcome as recorded by the reporter: Outcome Unknown 5; Ongoing 4; Euthanized 3; Recovered/Normal 3.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- Galliprant TMFDA · retrieved 2026-09-16
“Always provide “ Information for Dog Owners ” Sheet with prescription.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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