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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Multiple FDA labelers
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
The drug is indicated in the treatment of dogs for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. The drug is indicated in the treatment of cats for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. The drug is indicated in the treatment of horses for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. Species commonly shown: Both, Dog, Horse, Not For Meat Production.
The drug is indicated in the treatment of dogs for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. The drug is indicated in the treatment of cats for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. The drug is indicated in the treatment of horses for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered late in pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Top reported reactions (openFDA): Loss of hearing, Vomiting, Deafness, Lack of efficacy - NOS, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea.
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Used for:
It is used in treatment of dogs when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary.
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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Prednisolone; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 22 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Unsteady walking (ataxia) (1 reports), Trouble breathing (dyspnea) (1 reports), Loss of appetite (1 reports), Decreased body temperature (1 reports), Death by euthanasia (1 reports)
Digestive (3), Skin & allergy (1), Neurologic (1), Behavior (3)
Dog (25 reports), Cat (7 reports)
Domestic Shorthair (4), Dog (unknown) (1), ['Bichon Frise', 'Chihuahua'] (1), ['Chihuahua', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Prednisolone fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Not for use in horses intended for food, Clinical and experimental data have demonstrated that corticosteroids administered orally or parente, wobbly/unsteady walking, trouble breathing, Loss of appetite
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 10:44 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered late in pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-23 · MSK · MSK
Received 2025-12-19 · MSK · MSK
Received 2025-12-17 · MSK · MSK
Received 2025-12-16 · MSK · MSK
Received 2025-12-15 · MSK · MSK
Received 2025-12-12 · MSK · MSK
Received 2025-12-12 · MSK · MSK
Received 2025-12-12 · MSK · MSK
Received 2025-12-11 · MSK · MSK
Received 2025-12-09 · MSK · MSK
Received 2025-12-04 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-11-10 · MSK · MSK
Received 2025-11-05 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (25) Cat (7)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
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.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · SPL
This source does not expose a safe inline preview. Use the original source link for the full document.
SPL · SPL
This source does not expose a safe inline preview. Use the original source link for the full document.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
FOI · FOI
FOI · FOI summary
FOI · FOI summary
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 11695-4469-1 | 11695 | - | |
| 11695-4470-1 | 11695 | - | |
| 11695-7043-1 | 11695 | - | |
| 11695-7043-2 | 11695 | - | |
| 11789-248-10 | 11789 | - | |
| 11789-249-10 | 11789 | - | |
| 50989-163-53 | 50989 | - | |
| 50989-286-52 | 50989 | - | |
| 54771-1613-1 | 54771 | - | |
| 54771-1614-1 | 54771 | - | |
| 54771-3547-1 | 54771 | - | |
| 54771-8550-1 | 54771 | - | |
| 54771-8550-2 | 54771 | - | |
| 57319-441-16 | 57319 | - | |
| 58198-0813-1 | 58198 | - | |
| 58198-0813-2 | 58198 | - | |
| 62157-152-01 | 62157 | - | |
| 62157-413-01 | 62157 | - | |
| 62157-414-01 | 62157 | - | |
| 69043-042-10 | 69043 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Prednis-A-Vet Injection
RX
Prednisolone Sodium Phosphate
Liquid (Solution)
• Intravenous
|
Bimeda Animal Health Ltd. | NADA 98288 | Approved | Oct 2, 2018 |
|
PrednisTab®
RX
Prednisolone
Tablet
• Oral
|
Lloyd, Inc. | NADA 140-921 | Approved | May 17, 2017 |
|
Meticortelone Acetate
RX
Prednisolone Acetate
Liquid (Suspension)
• Intramuscular, Intra-Articular
|
Intervet, Inc. | NADA 10312 | Approved | Jun 1, 2016 |
|
Prednisolone Aqueous Suspension
RX
Prednisolone Acetate
|
Akorn, Inc. | NADA 12444 | W | Jun 1, 2016 |
|
Prednisolone Sodium Succinate for Injection
RX
Prednisolone Sodium Succinate
|
Watson Laboratories, Inc. | NADA 117-973 | W | Jun 1, 2016 |
|
Solu-Delta Cortef® Sterile Powder
RX
Prednisolone Sodium Succinate
Liquid
• Intravenous, Intramuscular
|
Zoetis Inc. | NADA 11593 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
The drug is indicated in the treatment of dogs for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. The drug is indicated in the treatment of cats for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. The drug is indicated in the treatment of horses for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition.
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered late in pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Cat, Domestic Shorthair, Male, 9.5 year, 5.09 kilogram • Drug: MSK, Oral • Reactions: Application site hair loss, Application site bleeding, Application site reddening • Outcome: Outcome Unknown
Dog, Dog (unknown), Male, 4 year, 32.5 kilogram • Drug: MSK, Unknown, Dose: 2.50 Milligram per animal, Frequency: 1 per day • Reactions: Anxiety, Elevated serum alkaline phosphatase, Hypercalcaemia, Lack of efficacy - NOS, Aggression… • Outcome: Ongoing
Cat, Domestic Shorthair, Male, 11 year, 6.03 kilogram • Drug: MSK, Unknown, Dose: 0.50 Milligram per kilogram, Frequency: 1 per day • Reactions: Tremors, Shaking • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Female, 9 year, 5.67 kilogram • Drug: MSK, Oral, Frequency: 1 per day • Reactions: Diarrhea • Outcome: Ongoing
Dog, ['Bichon Frise', 'Chihuahua'], Female, 15 year, 3.493 kilogram • Drug: MSK, Unassigned, Unknown, Frequency: 1 per day • Reactions: Seizure NOS, Unsteady walking (ataxia), Urinary incontinence • Outcome: Ongoing
Dog, ['Chihuahua', 'Dog (unknown)'], Female, 20 week, 2.26 kilogram • Drug: MSK, Unknown • Reactions: Icterus, Death, Other abnormal test result NOS, Elevated liver enzymes NOS, Swollen joint… • Outcome: Died
Dog, Retriever - Labrador, Male, 11 year, 37.83 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Anaphylaxis, Seizure NOS, Vomiting, Collapse NOS, Loose bowel… • Outcome: Recovered/Normal
Cat, Domestic Shorthair, Male, 3.16 year, 7.25 kilogram • Drug: MSK, Unknown • Reactions: Seizure NOS • Outcome: Recovered/Normal
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.