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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
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

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

Bedinvetmab Same category: Pain & Arthritis Carprofen Same category: Pain & Arthritis Deracoxib Same category: Pain & Arthritis Gabapentin Same category: Pain & Arthritis Grapiprant Same category: Pain & Arthritis Meloxicam Same category: Pain & Arthritis

Related Conditions

Pain (acute, chronic)

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:

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
  1. openFDA case USA-USFDACVM-2025-US-070682 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. FOI · document · documents
  8. Labeling · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
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

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:

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:

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
22
Matching reports
0
Active filters
2
Selected filters
Reaction: Abnormal radiograph finding Clear Body system: Skin & allergy Clear
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)
No stored openFDA reports match the selected 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.

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

Tracked signals
32
Reported cases
32
Serious reports
25
Species represented
2
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
Reaction 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
Reaction 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:

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

0
No owner handouts linked yet.

Official label / PI

8

SPL

14

FOI

7

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

Official label / PI · Labeling

Open original

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

Official label / PI · Labeling

Open original

UCM304417.pdf

Official label / PI · Labeling

Open original

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

Official label / PI · Labeling

Open original

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

Official label / PI · Labeling

Open original

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

Official label / PI · Labeling

Open original

Onsior_PI.pdf

Official label / PI · Labeling

Open original

Onsior_CI.pdf

Official label / PI · Labeling

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

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 to a maximum of 3 days.

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
Composition / specifications
Each milliliter of solution contains 20 milligrams (mg) robenacoxib

Dogs

Indication

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

Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day.

Cats

Indication

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 to a maximum of 3 days.

Dosage

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

onsior® Tablets for Cats

SPL · SPL

Open original
FDA Structured Product Label

onsior® Tablets for Cats

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
141-320
Status
RX
Form
Tablet
Route
Oral
Species
Cat
Composition / specifications
Each tablet contains 6 mg robenacoxib.

Cats

Indication

ONSIOR tablets are indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

Dosage

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

Robenacoxib

SPL · SPL

Open original
FDA Structured Product Label

Robenacoxib

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

Sponsor
ZYVET AH, Inc.
ANADA
200-832
Status
RX
Form
Tablet
Route
Oral
Composition / specifications
6 mg robenacoxib per tablet

Cats

Indication

For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

Dosage

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

onsior™

SPL · SPL

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
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.

ROBENACOXIB SPL

SPL · Structured Product Label

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

OstiRobe SPL

SPL · Structured Product Label

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

ROBENACOXIB SPL

SPL · Structured Product Label

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

ROBENACOXIB SPL

SPL · Structured Product Label

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

Onsior SPL

SPL · Structured Product Label

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

Onsior SPL

SPL · Structured Product Label

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

Robenacoxib SPL

SPL · Structured Product Label

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

Onsior SPL

SPL · Structured Product Label

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

Onsior SPL

SPL · Structured Product Label

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

UCM532540.pdf

FOI · FOI

Open original

UCM461153.pdf

FOI · FOI

Open original

FOI Summary oA 200-804 Approved March 9, 2026.pdf

FOI · FOI

Open original

UCM388186.pdf

FOI · FOI

Open original

UCM256758.pdf

FOI · FOI

Open original

FOI Summary oA 200-832 Approved December 22, 2025.pdf

FOI · FOI

Open original

UCM504543.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 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
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
Package NDC Product NDC Form / Route 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

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 to a maximum of 3 days.

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).

Limitations
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).

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
Each milliliter of solution contains 20 milligrams (mg) robenacoxib
Dogs
Indication

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

Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day.

Limitations
Cats
Indication

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 to a maximum of 3 days.

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

ONSIOR tablets are indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

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

For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

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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