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Roxee Meds Catalog

Cyclosporine

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

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Data freshness

Storefront facts
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FDA applications
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May 5, 2026, 10:00 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

Updated: February 12, 2026, 10:44 PM UTC

Sources:
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Cyclosporine

Cyclosporine

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Solution Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Cyclosporine

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, No Use Class Stated Or Implied, No Use Class Stated or Implied.

Generic name
Cyclosporine
Brand names
Optimmune®, Atopica™, Sporimune™, Cyclavance®
Manufacturer
Multiple FDA labelers
Species
Both, Dog, No Use Class Stated Or Implied, No Use Class Stated or Implied
Dosage forms
Solution, Ointment, Capsule
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Optimmune® Atopica™ Sporimune™ Cyclavance® MODULIS® for Dogs CYCLAVANCE Atopica Modulis for Dogs Sporimune Optimmune Ophthalmic
Dosage forms
Solution Ointment Capsule

Indications / Uses

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.

Warnings / Contraindications

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.

  • 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.

Side Effects

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.

FAQ

Both, Dog, No Use Class Stated Or Implied, No Use Class Stated or Implied

Yes. Roxee shows this as prescription-only.

Solution, Ointment, Capsule

Related Medications

Diphenhydramine Same category: Allergies / Itching Lokivetmab Same category: Allergies / Itching Oclacitinib Same category: Allergies / Itching Oclacitinib Maleate Same category: Allergies / Itching Prednisone Same category: Allergies / Itching Famotidine Same category: GI

Related Conditions

Atopic Dermatitis (Canine Atopy) Conjunctivitis Keratoconjunctivitis sicca (dry eye) Pica Alopecia (endocrine/seasonal/psychogenic)

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:

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:

  • 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 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
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Elevated serum alkaline phosphatase (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.

Regulatory restrictions are shown in Vet View.

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?
Major cautions & emergency warning signs

Side effects to monitor:

  • 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 of age or less than 3 lbs (1.4 kg) body weight

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Elevated serum alkaline phosphatase (1 reports)

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

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Capsule, Ointment, Solution
Identifiers:
ANADA: 200627 ANADA: 200692 ANADA: 200743 ANADA: 200744 NADA: 141052 NADA: 141218 NADA: 141329 NDC Package: 0061-1088-01 NDC Package: 13744-535-01 NDC Package: 13744-535-02 NDC Package: 13744-535-03 NDC Package: 13744-536-01 NDC Package: 13744-536-02 NDC Package: 17033-261-15 NDC Package: 17033-262-15 NDC Package: 17033-263-15 NDC Package: 51311-994-15 NDC Package: 51311-994-50 NDC Package: 58198-4351-1 NDC Package: 58198-4352-1
Source metadata:

Warnings / Contraindications

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.

  • High: 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.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

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

Tracked signals
32
Reported cases
32
Serious reports
22
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Diarrhea Skin & allergy (2) · Hair loss, Application site hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (1) · Behavioral disorder (unspecified) Other (26) · Elevated serum alkaline phosphatase, Elevated gamma-glutamyl transferase, Elevated aspartate aminotransferase
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (26) Cat (6)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Dog Serious - 1
Digestive Dog Serious - 1
Skin & allergy Dog Non-serious - 1
Other Dog 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
Source metadata:

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

4

SPL

10

FOI

8

CYCLAVANCE A200692.pdf

Official label / PI · Labeling

Open original

CYCLAVANCE A200692.pdf

Official label / PI · Labeling

Open original

ATOPICA N141329C0033.pdf

Official label / PI · Official label

Open original

ATOPICA N141329C0033.pdf

Official label / PI · Official label

Open original

MODULIS® for Dogs

SPL · SPL

Open original
FDA Structured Product Label

MODULIS® for Dogs

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

Sponsor
Ceva Sante Animale
ANADA
200-743
Status
RX
Form
Solution
Route
Oral
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
100 mg/mL

Dogs

Indication

For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage

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.

Cyclavance®

SPL · SPL

Open original
FDA Structured Product Label

Cyclavance®

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

Sponsor
Virbac AH, Inc.
ANADA
200-692
Status
RX
Form
Solution
Route
Oral
Species
No Use Class Stated or Implied
Composition / specifications
100 mg/mL

Dogs

Indication

For the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight.

Dosage

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.

Sporimune™

SPL · SPL

Open original
FDA Structured Product Label

Sporimune™

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

Sponsor
Dechra Veterinary Products LLC
ANADA
200-627
Status
RX
Route
Oral
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
10 mg, 25 mg, 50 mg, or 100 mg per capsule

Dogs

Indication

Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage

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.

Atopica™

SPL · SPL

Open original
FDA Structured Product Label

Atopica™

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
141-218
Status
RX
Form
Capsule
Route
Oral
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
10, 25, 50 and 100 mg capsules

Dogs

Indication

For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage

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.

Limitations

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.

Optimmune®

SPL · SPL

Open original
FDA Structured Product Label

Optimmune®

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

Sponsor
Intervet, Inc.
NADA
141-052
Status
RX
Form
Ointment
Route
Ophthalmic
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
Each gram of ointment contains 2 milligrams of cyclosporine.

Dogs

Indication
For the management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs.
Dosage
Apply a 1/4 inch strip of ointment to the affected eye(s) every 12 hours.
Limitations
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.

Modulis for Dogs SPL

SPL · Structured Product Label

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

Atopica SPL

SPL · Structured Product Label

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

Sporimune SPL

SPL · Structured Product Label

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

Optimmune Ophthalmic SPL

SPL · Structured Product Label

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

CYCLAVANCE SPL

SPL · Structured Product Label

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

FOI Summary oA 200-743 Approved March 21, 2023.pdf

FOI · FOI

Open original

FOI Summary oA 200-692 Approved October 29, 2020.pdf

FOI · FOI

Open original

FOI Summary oA 200-627 Approved November 1, 2018.pdf

FOI · FOI

Open original

ucm118025.pdf

FOI · FOI

Open original

N141052 Supp_8_26_1997.pdf

FOI · FOI

Open original

UCM488646.pdf

FOI · FOI

Open original

FOI Summary oA 200-744 Approved March 29, 2023.pdf

FOI · FOI summary

Open original

UCM287922.pdf

FOI · FOI summary

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
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Atopica CYCLAVANCE Modulis for Dogs Optimmune Ophthalmic Sporimune
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog, No Use Class Stated or Implied
Rx/OTC: RX
Form/route: Capsule, Ointment, Solution • Ophthalmic, Oral
Applications: ANADA 200-743 • ANADA 200-692 • ANADA 200-627 • NADA 141-218 • NADA 141-052
NDC: Packages 0061-1088-01 13744-535-01 13744-535-02 13744-535-03 17033-261-15 17033-262-15 • Products 0061 13744 17033 51311 58198
Documents: 8 (FOI: 6) • SPL: 5 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 52 • Cat 18 • View
Case summaries: 17 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: L20.9
Atopic dermatitis, unspecified

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
  • 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. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Elevated serum alkaline phosphatase (1) Elevated gamma-glutamyl transferase (1) Elevated aspartate aminotransferase (1) Elevated alanine aminotransferase (1) Distension of abdomen (1) Digestive tract stenosis and obstruction NOS (1)

Identifiers & Packages

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

Identifiers
ANADA: 200627 ANADA: 200692 ANADA: 200743 ANADA: 200744 NADA: 141052 NADA: 141218 NADA: 141329 NDC Package: 0061-1088-01 NDC Package: 13744-535-01 NDC Package: 13744-535-02 NDC Package: 13744-535-03 NDC Package: 13744-536-01 NDC Package: 13744-536-02 NDC Package: 17033-261-15 NDC Package: 17033-262-15 NDC Package: 17033-263-15 NDC Package: 51311-994-15 NDC Package: 51311-994-50 NDC Package: 58198-4351-1 NDC Package: 58198-4352-1 NDC Package: 58198-4353-1 NDC Package: 58198-4354-1 NDC Package: 58198-9725-1 NDC Package: 58198-9725-2
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 -

Enriched Documents

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

Data Sources & Change Log

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

Official 61 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NOS, INEFFEC… (Clinical, 2026-04-11)
  • contraindications: 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… (Official, 2026-04-12)
  • contraindications: 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… (Official, 2026-04-11)
  • contraindications: 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… (Official, 2026-02-12)
  • dosage_forms: Solution (Official, 2026-05-05)
  • dosage_forms: Solution (Official, 2026-05-03)
  • dosage_forms: Solution (Official, 2026-05-02)
  • dosage_forms: Solution (Official, 2026-04-29)
  • dosage_forms: Solution (Official, 2026-04-28)
  • dosage_forms: Solution (Official, 2026-04-27)
  • dosage_forms: Solution (Official, 2026-04-26)
  • dosage_forms: Solution (Official, 2026-04-25)
  • dosage_forms: Solution (Official, 2026-04-22)
  • indications: Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control o… (Official, 2026-05-05)
  • indications: Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control o… (Official, 2026-05-03)
  • indications: Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control o… (Official, 2026-05-02)
  • indications: Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control o… (Official, 2026-04-29)
  • indications: Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control o… (Official, 2026-04-28)
  • indications: Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control o… (Official, 2026-04-27)
  • indications: Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. For the control o… (Official, 2026-04-26)
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 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 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
MODULIS® for Dogs
RX
Cyclosporine
Solution • Oral
Label highlights
Official documents
Ceva Sante Animale ANADA 200-743 Approved Sep 1, 2023
Cyclavance®
RX
Cyclosporine
Solution • Oral
Label highlights
Official documents
Virbac AH, Inc. ANADA 200-692 Approved Sep 29, 2022
Sporimune™
RX
Cyclosporine
Oral
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-627 Approved Jul 6, 2022
Atopica™
RX
Cyclosporine
Capsule • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-218 Approved Mar 15, 2019
Optimmune®
RX
Cyclosporine
Ointment • Ophthalmic
Label highlights
Official documents
Intervet, Inc. NADA 141-052 Approved Dec 7, 2017

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, No Use Class Stated Or Implied
Composition / specifications
100 mg/mL
Dogs
Indication

For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated or Implied
Composition / specifications
100 mg/mL
Dogs
Indication

For the control of atopic dermatitis in dogs weighing at least 4 lbs (1.8 kg) body weight.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
10 mg, 25 mg, 50 mg, or 100 mg per capsule
Dogs
Indication

Cyclosporine Capsules, USP MODIFIED are indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
10, 25, 50 and 100 mg capsules
Dogs
Indication

For the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage

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.

Limitations

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

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each gram of ointment contains 2 milligrams of cyclosporine.
Dogs
Indication
For the management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs.
Dosage
Apply a 1/4 inch strip of ointment to the affected eye(s) every 12 hours.
Limitations
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.

FDA page: Open in Animal Drugs @ FDA

Usage

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

Contraindications

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)

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

Digestive
Loss of appetite (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog Application site hair loss (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Elevated serum alkaline phosphatase (1) • Dog Elevated gamma-glutamyl transferase (1) • Cat Elevated aspartate aminotransferase (1) • Dog Elevated alanine aminotransferase (1) • Dog Distension of abdomen (1) • Dog
Show more (21)
Digestive tract stenosis and obstruction NOS (1) • Cat Dermal thickening (1) • Dog Defect Unknown/Not Specified (1) • Cat Decreased urine concentration (1) • Dog Decreased haematocrit (1) • Dog Decreased cholesterol (1) • Dog Death by euthanasia (1) • Dog Death (1) • Dog Deafness (1) • Dog Bone and joint disorder NOS (1) • Dog Blepharitis (1) • Dog Atopic allergy NOS (1) • Dog Application site scab (1) • Cat Anaemia NOS (1) • Dog Allergic skin reaction (1) • Dog Agglutination test, positive (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal posture NOS (1) • Dog Abnormal cytology (1) • Cat Abnormal breathing (1) • Dog Abdominal effusion (1) • Dog

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.

Dog, Terrier - Boston, Female, 2 year, 8.16 kilogram • Drug: MSK, Capsule, Oral, Dose: 1 tablet per animal • Reactions: Rash, Hair loss • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075064
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 8.160 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 1 tablet per animal
Reactions Reported:
Rash Hair loss
Outcomes: 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

  • Report ID: USA-USFDACVM-2025-US-075291
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.90 Year
  • Weight: 44.450 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Lack of efficacy - NOS Seizure NOS Other abnormal test result NOS Unsteady walking (ataxia) Musculoskeletal disorder NOS Elevated serum alkaline phosphatase
Outcomes: 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

  • Report ID: USA-USFDACVM-2025-US-074793
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 4.16 Year
  • Weight: 6.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 43.20 Milligram per animal
  • Frequency: 1 per day
Reactions Reported:
Foaming at the mouth UNPALATABLE Behavioral disorder (unspecified)
Outcomes: Recovered/Normal

Dog, ['Retriever - Labrador', 'Mastiff (unspecified)'], Male, 8 year, 57.606 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Falling, Lateral recumbency, Vomiting • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075362
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 57.606 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Falling Lateral recumbency Vomiting
Outcomes: 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

  • Report ID: USA-USFDACVM-2025-US-074702
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 6.50 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Capsule
Reactions Reported:
Inflammatory bowel disorder Atopic allergy NOS Allergic skin reaction Blepharitis
Outcomes: 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

  • Report ID: USA-USFDACVM-2025-US-075225
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Weight: 3.600 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
  • Dose: 1 dose per animal
Reactions Reported:
Lack of efficacy - NOS
Outcomes: 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

  • Report ID: USA-USFDACVM-2025-US-074991
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Behavioral disorder (unspecified)
Outcomes: 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

  • Report ID: USA-USFDACVM-2025-US-074916
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 6.030 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 0.40 mL per animal
Reactions Reported:
Tremors Shaking
Outcomes: Outcome Unknown

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

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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