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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.
For the management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight. Species commonly shown: Both, Dog.
For the management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight.
Place ointment directly on cornea or into the conjunctival sac. For ophthalmic use in dogs only. Safety of use in puppies, pregnant or breeding animals has not been determined. US Federal law restricts thiis drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian.ATOPICA is contraindicated for use in dogs with a history of neoplasia.For use in dogs only.Capsules should not be broken or opened. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use only in cats. The safety and effectiveness of ATOPICA for Cats has not been established in cats less than 6 months of age or less than 3 lbs (1.4 kg) body weight. ATOPICA for Cats is not for use in breeding cats, pregnant or lactating queens. Cats should be tested and found to be negative for FeLV and FIV infections before treatment.
Top reported reactions (openFDA): Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NOS, INEFFECTIVE, ATOPY CONTROL, Other abnormal test result NOS.
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Used for:
For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.
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 Cyclosporine; 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), Loss of appetite (1 reports), Elevated serum alkaline phosphatase (1 reports), Elevated gamma-glutamyl transferase (1 reports), Elevated aspartate aminotransferase (1 reports)
Digestive (2), Skin & allergy (2), Neurologic (1), Behavior (1)
Dog (24 reports), Cat (8 reports)
Domestic Shorthair (2), Cat (unknown) (2), Terrier - Boston (1), Shepherd Dog - German (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Cyclosporine 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.
Place ointment directly on cornea or into the conjunctival sac, For ophthalmic use in dogs only, Safety of use in puppies, pregnant or breeding animals has not been determined, For use only in cats, The safety and effectiveness of ATOPICA for Cats has not been established in cats less than 6 months
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.
Place ointment directly on cornea or into the conjunctival sac. For ophthalmic use in dogs only. Safety of use in puppies, pregnant or breeding animals has not been determined. US Federal law restricts thiis drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian.ATOPICA is contraindicated for use in dogs with a history of neoplasia.For use in dogs only.Capsules should not be broken or opened. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use only in cats. The safety and effectiveness of ATOPICA for Cats has not been established in cats less than 6 months of age or less than 3 lbs (1.4 kg) body weight. ATOPICA for Cats is not for use in breeding cats, pregnant or lactating queens. Cats should be tested and found to be negative for FeLV and FIV infections before treatment.
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 2025-12-19 · MSK · MSK
Received 2025-12-16 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-11-03 · 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 | |
| Digestive | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 |
Species coverage: Dog (24) Cat (8)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Skin & allergy | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | 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 | Non-serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | 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.
Official label / PI · Labeling
Official label / PI · Labeling
Official label / PI · Official label
Official label / PI · Official label
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.
For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.
Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.
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.
For the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight.
Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.
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.
Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.
The initial dose of Cyclosporine Capsules, USP MODIFIED is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily dose for 30 days. Following the initial daily treatment period, the dose of Cyclosporine Capsules, USP MODIFIED may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which will maintain the desired therapeutic effect. Cyclosporine Capsules, USP MODIFIED should be given at least one hour before or two hours after a meal. If a dose is missed, the next dose should be administered (without doubling) as soon as possible, but dosing should be no more frequent than once daily.
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.
For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.
The initial dose is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily dose for 30 days. Following this initial daily treatment period, the dose may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which will maintain the desired therapeutic effect. Atopica® should be given at least one hour before or two hours after a meal. If a dose is missed, the next dose should be administered (without doubling) as soon as possible, but dosing should be no more frequent than once daily.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.ATOPICA is contraindicated for use in dogs with a history of neoplasia.For use in dogs only.Capsules should not be broken or opened.
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
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
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 |
|---|---|---|---|
| 0061-1088-01 | 0061 | - | |
| 13744-535-01 | 13744 | - | |
| 13744-535-02 | 13744 | - | |
| 13744-535-03 | 13744 | - | |
| 13744-536-01 | 13744 | - | |
| 13744-536-02 | 13744 | - | |
| 17033-261-15 | 17033 | - | |
| 17033-262-15 | 17033 | - | |
| 17033-263-15 | 17033 | - | |
| 51311-994-15 | 51311 | - | |
| 51311-994-50 | 51311 | - | |
| 58198-4351-1 | 58198 | - | |
| 58198-4352-1 | 58198 | - | |
| 58198-4353-1 | 58198 | - | |
| 58198-4354-1 | 58198 | - | |
| 58198-9725-1 | 58198 | - | |
| 58198-9725-2 | 58198 | - | |
| 62157-376-01 | 62157 | - | |
| 73377-197-01 | 73377 | - | |
| 73377-197-02 | 73377 | - |
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 |
|---|---|---|---|---|
|
MODULIS® for Dogs
RX
Cyclosporine
Solution
• Oral
|
Ceva Sante Animale | ANADA 200-743 | Approved | Sep 1, 2023 |
|
Cyclavance®
RX
Cyclosporine
Solution
• Oral
|
Virbac AH, Inc. | ANADA 200-692 | Approved | Sep 29, 2022 |
|
Sporimune™
RX
Cyclosporine
Oral
|
Dechra Veterinary Products LLC | ANADA 200-627 | Approved | Jul 6, 2022 |
|
Atopica™
RX
Cyclosporine
Capsule
• Oral
|
Elanco US Inc. | NADA 141-218 | Approved | Mar 15, 2019 |
|
Optimmune®
RX
Cyclosporine
Ointment
• Ophthalmic
|
Intervet, Inc. | NADA 141-052 | Approved | Dec 7, 2017 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.
Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.
FDA page: Open in Animal Drugs @ FDA
For the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight.
Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.
FDA page: Open in Animal Drugs @ FDA
Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.
The initial dose of Cyclosporine Capsules, USP MODIFIED is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily dose for 30 days. Following the initial daily treatment period, the dose of Cyclosporine Capsules, USP MODIFIED may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which will maintain the desired therapeutic effect. Cyclosporine Capsules, USP MODIFIED should be given at least one hour before or two hours after a meal. If a dose is missed, the next dose should be administered (without doubling) as soon as possible, but dosing should be no more frequent than once daily.
FDA page: Open in Animal Drugs @ FDA
For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.
The initial dose is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily dose for 30 days. Following this initial daily treatment period, the dose may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which will maintain the desired therapeutic effect. Atopica® should be given at least one hour before or two hours after a meal. If a dose is missed, the next dose should be administered (without doubling) as soon as possible, but dosing should be no more frequent than once daily.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.ATOPICA is contraindicated for use in dogs with a history of neoplasia.For use in dogs only.Capsules should not be broken or opened.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
For the management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight.
Source: FDA Animal Drugs @ FDA • Reference
Place ointment directly on cornea or into the conjunctival sac. For ophthalmic use in dogs only. Safety of use in puppies, pregnant or breeding animals has not been determined. US Federal law restricts thiis drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian.ATOPICA is contraindicated for use in dogs with a history of neoplasia.For use in dogs only.Capsules should not be broken or opened. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use only in cats. The safety and effectiveness of ATOPICA for Cats has not been established in cats less than 6 months of age or less than 3 lbs (1.4 kg) body weight. ATOPICA for Cats is not for use in breeding cats, pregnant or lactating queens. Cats should be tested and found to be negative for FeLV and FIV infections before treatment.
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.
Dog, Terrier - Boston, Female, 2 year, 8.16 kilogram • Drug: MSK, Capsule, Oral, Dose: 1 tablet per animal • Reactions: Rash, Hair loss • Outcome: Ongoing
Dog, Shepherd Dog - German, Female, 10.9 year, 44.45 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy - NOS, Seizure NOS, Other abnormal test result NOS, Unsteady walking (ataxia), Musculoskeletal disorder NOS… • Outcome: Ongoing
Cat, Domestic Shorthair, Male, 4.16 year, 6.12 kilogram • Drug: MSK, Solution, Oral, Dose: 43.20 Milligram per animal, Frequency: 1 per day • Reactions: Foaming at the mouth, UNPALATABLE, Behavioral disorder (unspecified) • Outcome: Recovered/Normal
Dog, ['Retriever - Labrador', 'Mastiff (unspecified)'], Male, 8 year, 57.606 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Falling, Lateral recumbency, Vomiting • Outcome: Ongoing
Dog, Spaniel - King Charles Cavalier, Male, 6.5 year • Drug: MSK, Capsule, Unknown • Reactions: Inflammatory bowel disorder, Atopic allergy NOS, Allergic skin reaction, Blepharitis • Outcome: Outcome Unknown
Cat, Cat (unknown), Unknown, 3.6 kilogram • Drug: MSK, Solution, Unknown, Dose: 1 dose per animal • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown
Cat, Cat (unknown), Unknown • Drug: MSK, Solution, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Behavioral disorder (unspecified) • Outcome: Outcome Unknown
Cat, Domestic Shorthair, Male, 11 year, 6.03 kilogram • Drug: MSK, Solution, Oral, Dose: 0.40 mL per animal • Reactions: Tremors, Shaking • Outcome: Outcome Unknown
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.