Roxee Medication Guide

Robenacoxib

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

Safety data refreshed

Jun 21, 2026, 5:14 a.m.

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

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 Mar 10, 2026, 10:01 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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Robenacoxib

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.

Robenacoxib

COX-2 selective NSAID used for short-term control of postoperative pain and inflammation in cats and dogs. Species commonly shown: Both, Cat, Dog.

Generic name

Robenacoxib

Brand names

onsior® Tablets for Cats, onsior® injection, onsior™, Robenacoxib Injection

Manufacturer

Multiple FDA labelers

Species

Both, Cat, Dog

Dosage forms

Tablet, Injection, Injectable Solution

Prescription

Prescription required

Completeness

100%

Validation

Complete

Brand names

onsior® Tablets for Cats onsior® injection onsior™ Robenacoxib Injection Robenacoxib OstiRobe Onsior

Dosage forms

Tablet Injection Injectable Solution

Indications / Uses

COX-2 selective NSAID used for short-term control of postoperative pain and inflammation in cats and dogs.

Administration / How To Give

Oral, Injectable

Storage

Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light.

Warnings / Contraindications

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.

Side Effects

May cause GI upset (vomiting, diarrhea), reduced appetite; rare cases of severe kidney or GI complications have been reported.

FAQ

Both, Cat, Dog

Yes. Roxee shows this as prescription-only.

Tablet, Injection, Injectable Solution

Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light.

Related Medications

Related Conditions

Pain (acute, chronic)

Source Transparency

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: /static/meds/images/robenacoxib.jpg
Last refreshed: Jun 22, 2026, 10:41 a.m.
Last verified: Feb 12, 2026, 7:40 p.m.
Validation status: Complete

Add to My Pet's Medications

Choose a pet, confirm current or past, and optionally add reminder notes.

Pet Owner Quick Guide

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

Used for:

ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats greaterThanEqualTo 4 months of age; for up...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction
Not recommended for pregnant or lactating animals
Loss of appetite (1 reports)
Discoloured urine (1 reports)
Diarrhea (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 Robenacoxib; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-070682

Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 25 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-070682

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-070682

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), Discoloured urine (1 reports), Diarrhea (1 reports), Dehydration (1 reports), Dehiscence (1 reports)

Body systems represented Signal grouping

Digestive (5), Neurologic (1), Behavior (1), Other (25)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (31 reports), Dog (1 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (3), Cat (unknown) (2), Maine Coon (1), Domestic Mediumhair (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 Robenacoxib fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe rena, Not recommended for pregnant or lactating animals, Loss of appetite, Discoloured urine, Diarrhea

Call sooner if Escalation

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

Bottom line: Use this Robenacoxib 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

openFDA case USA-USFDACVM-2025-US-070682 · adverse_reaction · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
FOI · document · documents
Labeling · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
onsior® Tablets for Cats · official_label
openFDA case USA-USFDACVM-2025-US-070682 · adverse_reaction

Safety & side effects

Side effects to monitor:

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction
Not recommended for pregnant or lactating animals
Loss of appetite
Discoloured urine
Diarrhea

Most reported reactions:

Loss of appetite (1 reports)
Discoloured urine (1 reports)
Diarrhea (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, Dog

Indication / use

ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats gr…

Form / route / dose

Form: Injectable Solution, Injection, Tablet
Route: Oral, Subcutaneous
Confirm product label and patient-specific plan.

Warnings

High: Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfuncti…

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

N-141443-C-0014-NL-AA_PI.pdf Official label / PI
A-200804-E-0004-OT-AA_PI.pdf Official label / PI
UCM304417.pdf Official label / PI

Quick Facts

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

Species: Both

Manufacturer: Multiple FDA labelers

Form: Injectable Solution, Injection, Tablet

Identifiers:

ANADA: 200804 ANADA: 200832 NADA: 141320 NADA: 141443 NADA: 141463 NDC Package: 11695-7047-1 NDC Package: 58198-4875-1 NDC Package: 58198-4886-1 NDC Package: 58198-5911-0 NDC Package: 73377-097-01 NDC Package: 86117-080-16 NDC Package: 86136-149-35 NDC Product: 11695 NDC Product: 58198 NDC Product: 73377 NDC Product: 86117 NDC Product: 86136

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141443 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200804 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.

High: Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

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

Matching reports

Active filters

Selected filters

Reaction: Lethargy (see also Central nervous system depression in Neurological) Clear

Species

Breed

Size / weight

Age

Sex

Seriousness

Outcome

Reaction

Body system

Region

Received after

Received before

Reset

Drill into common report signals

Lethargy (see also Central nervous system depression in Neurological) (9) Abnormal radiograph finding (5) Death by euthanasia (5) Fever (4) Other (22) Neurologic (12) Digestive (9) Skin & allergy (4)

Showing up to 50 matching reports.

USA-USFDACVM-2025-US-075237

Received 2025-12-23 · MSK · MSK

Serious

Species: Cat
Breed: Domestic Shorthair
Size / weight: Under 10 lb (3.08 Kilogram)
Age: Under 1 year (7 Month)
Sex: Female Neutered
Region: USA
Reactions: FeverCough, productiveWeight lossBreathing difficultyAbnormal radiograph findingPulmonary disorder NOSLethargy (see also Central nervous system depression in Neurological)SedationKidney atrophyBilirubinuriaElevated mean corpuscular haemoglobin concentration (MCHC)Enlarged kidney(s)Elevated mean corpuscular volume (MCV)EosinopeniaLow serum alkaline phosphatase (ALP)NeutropeniaDiscoloured urineMonocytosisLymphopeniaElevated amylaseElevated alanine aminotransferase (ALT)Low creatinineHyponatremiaOther abnormal test result NOSElevated total bilirubinHyperglycaemiaLymphocytosisNeutrophiliaLeucocytosis NOSBasophilia
Body systems: OtherNeurologic
Outcomes: Recovered/Normal

USA-USFDACVM-2025-US-074994

Received 2025-12-17 · MSK · MSK

Serious

Species: Cat
Breed: Maine Coon
Size / weight: 10-24 lb (6.58 Kilogram)
Age: 8+ years (13 Year)
Sex: Male Neutered
Region: USA
Reactions: TwitchingFocal seizureDeathLethargy (see also Central nervous system depression in Neurological)
Body systems: Skin & allergyNeurologicOther
Outcomes: Died

USA-USFDACVM-2025-US-074533

Received 2025-12-17 · MSK · MSK

Serious

Species: Cat
Breed: Domestic Shorthair
Size / weight: Under 10 lb (2.5 Kilogram)
Age: Under 1 year (4 Month)
Sex: Female Neutered
Region: USA
Reactions: HypersalivationTachypnoeaAbnormal radiograph findingHypothermiaHyperactivityNot eatingLethargy (see also Central nervous system depression in Neurological)Hiding
Body systems: DigestiveOtherNeurologic
Outcomes: Ongoing

USA-USFDACVM-2025-US-073489

Received 2025-12-16 · MSK · MSK

Serious

Species: Cat
Breed: Domestic Mediumhair
Size / weight: Under 10 lb (4.3 Kilogram)
Age: 1-3 years (1 Year)
Sex: Female Neutered
Region: USA
Reactions: DehydrationFeverLethargy (see also Central nervous system depression in Neurological)AnorexiaIncreased heart rateTachypnoeaDistressNot drinkingOther abnormal test result NOS
Body systems: OtherNeurologicDigestive
Outcomes: Recovered/Normal

USA-USFDACVM-2025-US-073476

Received 2025-12-02 · MSK · MSK

Non-serious

Species: Cat
Breed: Domestic Shorthair
Size / weight: Under 10 lb (2.3 Kilogram)
Age: Under 1 year (13 Week)
Sex: Male Intact
Region: USA
Reactions: Injection site painInjection site reaction NOSVocalisationLimb non-weight bearingDiarrhoeaVomitingLethargy (see also Central nervous system depression in Neurological)Emesis (multiple)
Body systems: OtherDigestiveNeurologic
Outcomes: Ongoing

USA-USFDACVM-2025-US-071120

Received 2025-12-01 · MSK · MSK

Non-serious

Species: Cat
Breed: Maine Coon
Size / weight: 10-24 lb (5.942 Kilogram)
Age: 8+ years (8 Year)
Sex: Male Unknown
Region: USA
Reactions: Pain NOSLamenessNot eatingFeverHigh pancreatic-specific lipaseLethargy (see also Central nervous system depression in Neurological)VomitingLack of efficacy - NOS
Body systems: OtherNeurologicDigestiveEffectiveness
Outcomes: Recovered/Normal

USA-USFDACVM-2025-US-070899

Received 2025-11-20 · MSK · MSK

Serious

Species: Cat
Breed: Domestic Shorthair
Size / weight: 10-24 lb (6.713 Kilogram)
Age: 8+ years (10.4 Year)
Sex: Female Neutered
Region: USA
Reactions: Dry mucous membraneNot eatingLethargy (see also Central nervous system depression in Neurological)Fever
Body systems: OtherNeurologic
Outcomes: Recovered/Normal

USA-USFDACVM-2025-US-067000

Received 2025-11-14 · MSK · MSK

Serious

Species: Cat
Breed: Domestic Shorthair
Size / weight: Under 10 lb (3.992 Kilogram)
Age: 8+ years (13 Year)
Sex: Female Unknown
Region: USA
Reactions: DiarrhoeaDecreased appetiteLethargy (see also Central nervous system depression in Neurological)Bloody diarrhoeaDry mucous membraneOpen mouth breathingUnresponsive to stimuliDecreased haematocritIncreased percentage reticulocytesRegenerative anaemiaIntentional misuseUnderdoseThrombocytopeniaHeart murmurHypersalivation
Body systems: DigestiveNeurologicOther
Outcomes: Ongoing

USA-USFDACVM-2025-US-068543

Received 2025-11-12 · MSK · MSK

Non-serious

Species: Cat
Breed: Domestic Mediumhair
Size / weight: Under 10 lb (2.948 Kilogram)
Age: 8+ years (16.5 Year)
Sex: Male Neutered
Region: USA
Reactions: Digestive tract disorder NOSGaggingTongue disorder NOSWeight lossLethargy (see also Central nervous system depression in Neurological)WobblinessGeneral illnessBlood in urineSkin lesion NOSBarberingHair loss NOSReddening of the skinVasculitis
Body systems: OtherNeurologicSkin & allergy
Outcomes: Ongoing

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

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (5) · Loss of appetite, Diarrhea, Decreased appetite Neurologic (1) · Depression Behavior (1) · Behavioral disorder (unspecified) Other (25) · Discoloured urine, Digestive tract disorder NOS, Dehydration

Most Reported Reactions

Body system	Cases	Species	Serious cases
Digestive	1	Cat	1
Other	1	Cat	1
Digestive	1	Cat	1
Other	1	Cat	1
Other	1	Cat	1
Other	1	Cat	1
Digestive	1	Cat	1
Other	1	Cat	1

Species coverage: Cat (31) Dog (1)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Digestive	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Digestive	Cat	Serious	-	1
Neurologic	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Digestive	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Dog	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Digestive	Cat	Serious	-	1
Digestive	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Behavior	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-070682

Storage & Handling

Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light.

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.

N-141443-C-0014-NL-AA_PI.pdf Official label / PI · Labeling A-200804-E-0004-OT-AA_PI.pdf Official label / PI · Labeling UCM304417.pdf Official label / PI · Labeling

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

Owner handouts

No owner handouts linked yet.

Official label / PI

SPL

Open original

onsior® injection

SPL · SPL

Open original

FDA Structured Product Label

onsior® injection

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

Sponsor: Elanco US Inc.
NADA: 141-443
Status: RX
Form: Injection
Route: Subcutaneous
Species: Dog • Cat

Composition / specifications

20 mg/mL

Cats

Indication

Dosage

For subcutaneous injection in cats greaterThanEqualTo 4 months of age; for up to a maximum of 3 days. To ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended. The first dose should be administered approximately 30 minutes prior to surgery, at the same time as the pre-anesthetic agents are given.

Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in cats greaterThanEqualTo 5.5 lbs and greaterThanEqualTo 4 months of age, for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and ONSIOR tablet product insert).

Dogs

Indication

ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

Dosage

For subcutaneous injection in dogs greaterThanEqualTo 4 months of age; for up to a maximum of 3 days. The first dose should be administered approximately 45 minutes prior to surgery, at the same time as the pre-anesthetic agents are given.

Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in dogs greaterThanEqualTo 5.5 lbs and greaterThanEqualTo 4 months of age, for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and ONSIOR tablet product insert). If subsequent doses are given by subcutaneous injection, different sites for each injection should be used (See Adverse Reactions).

Robenacoxib Injection

SPL · SPL

Open original

FDA Structured Product Label

Robenacoxib Injection

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

Sponsor: Cronus Pharma Specialities India Private Ltd.
ANADA: 200-804
Status: RX
Form: Injectable Solution
Route: Subcutaneous

Open original

FDA Structured Product Label

onsior™

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

Sponsor: Elanco US Inc.
NADA: 141-463
Status: RX
Form: Tablet
Route: Oral
Species: Dog

Composition / specifications

Tablets contain 10, 20, or 40 mg of robenacoxib.

Dogs

Indication

For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greater at least 5.5 lbs (2.5 kg) and at least 4 months of age; for up to a maximum of 3 days.

Dosage

FOI · FOI

Open original

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/935 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/934 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/745 · document · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2349/onsior%C2%AE%20injection · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18230 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/2419 · document · Labeling
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18492/Robenacoxib%20Injection · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/877 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/876 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/14 · document · Labeling

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 Mar 10, 2026, 10:01 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: Onsior OstiRobe ROBENACOXIB Robenacoxib

Manufacturer mapping: Multiple FDA labelers

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Cat, Dog

Rx/OTC: RX

Form/route: Injectable Solution, Injection, Tablet • Oral, Subcutaneous

Applications: NADA 141-443 • ANADA 200-804 • NADA 141-320 • ANADA 200-832 • NADA 141-463

NDC: Packages 11695-7047-1 58198-4875-1 58198-4886-1 58198-5911-0 73377-097-01 86117-080-16 • Products 11695 58198 73377 86117 86136

Documents: 15 (FOI: 7) • SPL: 5 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 0 • Cat 136 • View

Case summaries: 22 (showing 8) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Pain (acute, chronic)

Linked using: Fda_Label (0.95)

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals. (Contraindication, High)

Top reaction signals

Loss of appetite (1) Discoloured urine (1) Diarrhea (1) Dehydration (1) Dehiscence (1) Decreased haematocrit (1) Decreased appetite (1) Decreased activity (1)

Identifiers & Packages

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

Identifiers

Package NDC	Product NDC	Status
11695-7047-1	11695	-
58198-4875-1	58198	-
58198-4886-1	58198	-
58198-5911-0	58198	-
73377-097-01	73377	-
86117-080-16	86117	-
86136-149-35	86136	-

Enriched Documents

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

ROBENACOXIB SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
OstiRobe SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
ROBENACOXIB SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
ROBENACOXIB SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Onsior SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Onsior SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Robenacoxib SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Onsior SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Onsior SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
N-141443-C-0014-NL-AA_PI.pdf • Official label • Official • June 4, 2026
FDA official labeling for application 141443
UCM461153.pdf • FOI summary • Official • June 4, 2026
FDA FOI summary for application 141443
UCM532540.pdf • FOI summary • Official • June 4, 2026
FDA FOI summary for application 141443
A-200804-E-0004-OT-AA_PI.pdf • Official label • Official • April 1, 2026
FDA official labeling for application 200804
FOI Summary oA 200-804 Approved March 9, 2026.pdf • FOI summary • Official • April 1, 2026
FDA FOI summary for application 200804
N-141320-C-0047-NL-AA_PI.pdf • Official label • Official • March 16, 2026
FDA official labeling for application 141320
UCM304417.pdf • Official label • Official • March 16, 2026
FDA official labeling for application 141320
UCM256758.pdf • FOI summary • Official • March 16, 2026
FDA FOI summary for application 141320
UCM388186.pdf • FOI summary • Official • March 16, 2026
FDA FOI summary for application 141320
A-200832-A-0000-OT-AA_CIS.pdf • Official label • Official • Jan. 21, 2026
FDA official labeling for application 200832
A-200832-A-0000-OT-AA_PI.pdf • Official label • Official • Jan. 21, 2026
FDA official labeling for application 200832
FOI Summary oA 200-832 Approved December 22, 2025.pdf • FOI summary • Official • Jan. 21, 2026
FDA FOI summary for application 200832
Onsior_CI.pdf • Official label • Official • March 8, 2018
FDA official labeling for application 141463
Onsior_PI.pdf • Official label • Official • March 8, 2018
FDA official labeling for application 141463
UCM504543.pdf • FOI summary • Official • March 8, 2018
FDA FOI summary for application 141463

Data Sources & Change Log

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

Official 137 Clinical 7 Manufacturer 0 Marketing 0

Current Field Facts

overdose_info: Overdose may result in severe GI ulceration, vomiting (possibly with blood), or renal failure. Urgent supportive care is required. (Clinical, 2026-04-12)
overdose_info: Overdose may result in severe GI ulceration, vomiting (possibly with blood), or renal failure. Urgent supportive care is required. (Clinical, 2026-04-11)
overdose_info: Overdose may result in severe GI ulceration, vomiting (possibly with blood), or renal failure. Urgent supportive care is required. (Clinical, 2026-02-12)
side_effects: May cause GI upset (vomiting, diarrhea), reduced appetite; rare cases of severe kidney or GI complications have been reported. (Clinical, 2026-04-11)
storage_handling: Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light. (Clinical, 2026-04-12)
storage_handling: Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light. (Clinical, 2026-04-11)
storage_handling: Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light. (Clinical, 2026-02-12)
contraindications: Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lact… (Official, 2026-04-12)
contraindications: Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lact… (Official, 2026-04-11)
contraindications: Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lact… (Official, 2026-02-12)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-22)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-22)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-21)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-20)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-13)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-12)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-12)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-11)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-11)
indications: Dogs: Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo … (Official, 2026-06-10)

Recent Revisions

side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

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

Product	Sponsor	Application	Status	Published
onsior® injection RX Robenacoxib Injection • Subcutaneous Label highlights Official documents	Elanco US Inc.	NADA 141-443	Approved	Jun 4, 2026
Robenacoxib Injection RX Robenacoxib Injectable Solution • Subcutaneous Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-804	Approved	Apr 1, 2026
onsior® Tablets for Cats RX Robenacoxib Tablet • Oral Label highlights Official documents	Elanco US Inc.	NADA 141-320	Approved	Mar 16, 2026
Robenacoxib RX Robenacoxib Tablet • Oral Label highlights Official documents	ZYVET AH, Inc.	ANADA 200-832	Approved	Jan 21, 2026
onsior™ RX Robenacoxib Tablet • Oral Label highlights Official documents	Elanco US Inc.	NADA 141-463	Approved	Mar 8, 2018

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 • Cat

Composition / specifications

20 mg/mL

Cats

Indication

Dosage

Limitations

Dogs

Indication

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications

Each milliliter of solution contains 20 milligrams (mg) robenacoxib

Dogs

Indication

Dosage

Limitations

Cats

Indication

Dosage

Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Cat

Composition / specifications

Each tablet contains 6 mg robenacoxib.

Cats

Indication

Dosage

The dose of ONSIOR tablets is 0.45 mg/lb (1 mg/kg) orally once daily, for a maximum of 3 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications

6 mg robenacoxib per tablet

Cats

Indication

Dosage

Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog

Composition / specifications

Tablets contain 10, 20, or 40 mg of robenacoxib.

Dogs

Indication

For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greater at least 5.5 lbs (2.5 kg) and at least 4 months of age; for up to a maximum of 3 days.

Dosage

0.91 mg/lb (2mg/kg) orally once daily, for a maximum of three days.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

COX-2 selective NSAID used for short-term control of postoperative pain and inflammation in cats and dogs.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Do not use in animals with known hypersensitivity to NSAIDs, gastrointestinal ulcers, or severe renal/hepatic dysfunction. Not recommended for pregnant or lactating animals.

Side Effects

May cause GI upset (vomiting, diarrhea), reduced appetite; rare cases of severe kidney or GI complications have been reported.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive

Loss of appetite (1) • Cat Diarrhea (1) • Cat Decreased appetite (1) • Cat Bloody diarrhoea (1) • Cat Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Neurologic

Depression (1) • Cat

Showing top 5 for Neurologic.

Behavior

Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Other

Discoloured urine (1) • Cat Digestive tract disorder NOS (1) • Cat Dehydration (1) • Cat Dehiscence (1) • Cat Decreased pulse oxygenation (1) • Cat

Show more (20)

Decreased haematocrit (1) • Cat Decreased body temperature (1) • Cat Decreased activity (1) • Cat Death by euthanasia (1) • Cat Death (1) • Cat Cough, productive (1) • Cat Constipation (1) • Cat Cardiac arrest (1) • Dog Breathing difficulty (1) • Cat Bone marrow suppression (1) • Cat Blood in urine (1) • Cat Blood clot (1) • Cat Bilirubinuria (1) • Cat Basophilia (1) • Cat Barbering (1) • Cat Anaphylaxis (1) • Cat Anaemia NOS (1) • Cat Agitation (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal cytology (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, 7 month, 3.08 kilogram • Drug: MSK, Injection, Subcutaneous, Dose: 0.31 mL per animal • Reactions: Fever, Cough, productive, Weight loss, Breathing difficulty, Abnormal radiograph finding… • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-075237
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 7.00 Month
Weight: 3.080 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Subcutaneous
Form: Injection
Dose: 0.31 mL per animal

Reactions Reported:

Fever Cough, productive Weight loss Breathing difficulty Abnormal radiograph finding Pulmonary disorder NOS Tiredness (lethargy) Sedation Kidney atrophy Bilirubinuria Elevated mean corpuscular haemoglobin concentration Enlarged kidney Elevated mean corpuscular volume Eosinopenia Low serum alkaline phosphatase Neutropenia Discoloured urine Monocytosis Lymphopenia Elevated amylase Elevated alanine aminotransferase Low creatinine Hyponatremia Other abnormal test result NOS Elevated total bilirubin Hyperglycaemia Lymphocytosis Neutrophilia Leucocytosis NOS Basophilia

Outcomes: Recovered/Normal

Cat, Cat (unknown), Male, 6 year, 3.6 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Loss of appetite, Neurological signs NOS, Seizure NOS, Death • Outcome: Died

Report ID: USA-USFDACVM-2025-US-075000
Serious AE: Yes
Treated For AE: No
Sex: Male
Age: 6.00 Year
Weight: 3.600 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet
Dose: 1 tablet per animal
Frequency: 1 per day

Reactions Reported:

Loss of appetite Neurological signs NOS Seizure NOS Death

Outcomes: Died

Cat, Cat (unknown), Unknown, 3.49 kilogram • Drug: MSK, Injection, Unknown, Dose: 0.35 mL per animal • Reactions: Pulmonary congestion, Decreased body temperature, Drowsiness - systemic disorder, Disorientation, Unable to stand… • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-074695
Serious AE: Yes
Treated For AE: Yes
Sex: Unknown
Weight: 3.490 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Injection
Dose: 0.35 mL per animal

Reactions Reported:

Pulmonary congestion Decreased body temperature Drowsiness - systemic disorder Disorientation Unable to stand Dysphoria

Outcomes: Recovered/Normal

Cat, Maine Coon, Male, 13 year, 6.58 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal • Reactions: Twitching, Focal seizure, Death, Tiredness (lethargy) • Outcome: Died

Report ID: USA-USFDACVM-2025-US-074994
Serious AE: Yes
Treated For AE: No
Sex: Male
Age: 13.00 Year
Weight: 6.580 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet
Dose: 1 tablet per animal

Reactions Reported:

Twitching Focal seizure Death Tiredness (lethargy)

Outcomes: Died

Cat, Domestic Shorthair, Female, 4 month, 2.5 kilogram • Drug: MSK, Unknown • Reactions: Drooling, Tachypnoea, Abnormal radiograph finding, Hypothermia, Hyperactivity… • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-074533
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 4.00 Month
Weight: 2.500 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown

Reactions Reported:

Drooling Tachypnoea Abnormal radiograph finding Hypothermia Hyperactivity Not eating Tiredness (lethargy) Hiding

Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 1 year, 6.2 kilogram • Drug: MSK, Injection, Subcutaneous • Reactions: Non-regenerative anaemia, Pancytopenia, Death by euthanasia, Lack of efficacy (virus) - feline leukaemia, Bone marrow suppression… • Outcome: Euthanized

Report ID: USA-USFDACVM-2025-US-073810
Serious AE: Yes
Treated For AE: No
Sex: Male
Age: 1.00 Year
Weight: 6.200 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Subcutaneous
Form: Injection

Reactions Reported:

Non-regenerative anaemia Pancytopenia Death by euthanasia Lack of efficacy (virus) - feline leukaemia Bone marrow suppression Anaemia NOS

Outcomes: Euthanized

Cat, Domestic Mediumhair, Female, 1 year, 4.3 kilogram • Drug: MSK, Injection, Parenteral • Reactions: Dehydration, Fever, Tiredness (lethargy), Loss of appetite, Increased heart rate… • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-073489
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 1.00 Year
Weight: 4.300 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Parenteral
Form: Injection

Reactions Reported:

Dehydration Fever Tiredness (lethargy) Loss of appetite Increased heart rate Tachypnoea Distress Not drinking Other abnormal test result NOS

Outcomes: Recovered/Normal

Cat, Domestic Longhair, Male, 2 year, 4.5 kilogram • Drug: MSK, Oral, Dose: 6 Milligram per dose • Reactions: Vomiting, Not urinating, Not defecating, Mouth ulcer, Not eating… • Outcome: Euthanized

Report ID: USA-USFDACVM-2025-US-073590
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 2.00 Year
Weight: 4.500 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Dose: 6 Milligram per dose

Reactions Reported:

Vomiting Not urinating Not defecating Mouth ulcer Not eating Not drinking Renal failure Medication error NOS Blood in vomit Death by euthanasia

Outcomes: Euthanized

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

Overdose Information

Overdose may result in severe GI ulceration, vomiting (possibly with blood), or renal failure. Urgent supportive care is required.

Storage & Handling

Store at controlled room temperature (15–25°C); keep tablets in their blister pack, protected from moisture and light.

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Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Robenacoxib

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Robenacoxib

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USA-USFDACVM-2025-US-075237

USA-USFDACVM-2025-US-074994

USA-USFDACVM-2025-US-074533

USA-USFDACVM-2025-US-073489

USA-USFDACVM-2025-US-073476

USA-USFDACVM-2025-US-071120

USA-USFDACVM-2025-US-070899

USA-USFDACVM-2025-US-067000

USA-USFDACVM-2025-US-068543

Grouped by Body System

Most Reported Reactions

Storage & Handling

Source Documents

Owner handouts

Official label / PI

SPL

FOI

N-141443-C-0014-NL-AA_PI.pdf

A-200804-E-0004-OT-AA_PI.pdf

UCM304417.pdf

N-141320-C-0047-NL-AA_PI.pdf

A-200832-A-0000-OT-AA_PI.pdf

A-200832-A-0000-OT-AA_CIS.pdf

Onsior_PI.pdf

Onsior_CI.pdf

onsior® injection

onsior® injection

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Robenacoxib Injection

Dogs

Cats

onsior® Tablets for Cats

onsior® Tablets for Cats

Cats

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Robenacoxib

Cats

onsior™

onsior™

Dogs

ROBENACOXIB SPL

OstiRobe SPL

ROBENACOXIB SPL

ROBENACOXIB SPL