Skip to main content
Start triage

Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Need urgent help? Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Meds A-Z

Cyclosporine

Detailed information about Cyclosporine

Official label facts Owner quick guide first Marketing clearly labeled
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Add to My Pet's Meds

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

Sign in to save this medication to your pet profile.

Sign in to continue

Reviewed / Updated / Sources

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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...

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
  • Vomiting (1 reports)
  • Hypokalaemia (1 reports)
  • Hypochloraemia (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 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?
Safety & side effects

What to watch:

  • 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:

  • Vomiting (1 reports)
  • Hypokalaemia (1 reports)
  • Hypochloraemia (1 reports)

When to call your vet:

  • 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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:02 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Image coming soon
Cyclosporine

Cyclosporine

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
Form: Capsule, Ointment, Oral Solution, 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
23
Species represented
2
Grouped by Body System
Digestive (2) · Vomiting, Diarrhea Skin & allergy (1) · Application site hair loss Other (29) · Hypokalaemia, Hypochloraemia, Hypocalcaemia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (24) Cat (8)

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

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (4)
  • CYCLAVANCE A200692.pdf · Labeling
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/884
  • CYCLAVANCE A200692.pdf · Labeling
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/885
  • ATOPICA N141329C0033.pdf · Labeling
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/881
  • ATOPICA N141329C0033.pdf · Labeling
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/882
SPL (7)
  • Modulis® for Cats · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13894/Modulis%C2%AE%20for%20Cats
  • MODULIS® for Dogs · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13854/MODULIS%C2%AE%20for%20Dogs
  • Cyclavance® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/10010/Cyclavance%C2%AE
  • Sporimune™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/5608/Sporimune%E2%84%A2
  • Atopica™ for Cats · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2248/Atopica%E2%84%A2%20for%20Cats
  • Atopica™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/493/Atopica%E2%84%A2
  • Optimmune® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1221/Optimmune%C2%AE
FOI (8)
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
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:20 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Atopica™ Atopica™ for Cats Cyclavance® MODULIS® for Dogs Modulis® for Cats Optimmune® Sporimune™
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog, No Use Class Stated or Implied
Rx/OTC: RX
Form/route: Capsule, Ointment, Oral Solution, Solution • Ophthalmic, Oral
Applications: ANADA 200-744 • ANADA 200-743 • ANADA 200-692 • ANADA 200-627 • NADA 141-329 • NADA 141-218 • NADA 141-052
Documents: 12 (FOI: 8) • SPL: 7 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 28 • Cat 19 • View
Case summaries: 10 (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
Vomiting (1) Hypokalaemia (1) Hypochloraemia (1) Hypocalcaemia (1) Hypoalbuminaemia (1) Hepatopathy (1) Hepatic necrosis (1) Heart murmur (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 15 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • 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)
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NOS, INEFFEC… (Official, 2026-02-12)
  • usage: For the management of chronic keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) in dogs. For the control of atopic dermatitis in dogs we… (Official, 2026-02-12)
Recent Revisions
  • 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 Cats
RX
Cyclosporine oral solution, USP Modified
Solution • Oral
Label highlights
Official documents
Ceva Sante Animale ANADA 200-744 Approved Sep 1, 2023
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™ for Cats
RX
Cyclosporine oral solution, USP Modified
Oral Solution • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-329 Approved May 17, 2021
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: Cat, No Use Class Stated Or Implied
Composition / specifications
100 mg/mL
Cats
Indication

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.

Dosage

Administer 3.2 mg/lb/day (7 mg/kg/day) orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or twice weekly to maintain the desired therapeutic effect.

Limitations

FDA page: Open in Animal Drugs @ FDA

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: Cat, No Use Class Stated Or Implied
Composition / specifications
100 mg/mL
Cats
Indication
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.
Dosage
Administer 7 mg/kg of body weight orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or twice weekly to maintain the desired therapeutic effect.
Limitations
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.

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

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary

    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.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Atopica® for Cats is indicated for the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), military 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.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the control of atopic dermatitis in dogs weighing at least 4 lbs body weight.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    To add the label claim for the management of chronic superficial keratitis (CSK) in dogs. In addition, the label claim for treatment of chronic keratoconjunctivis sicca (KCS) was changed to management of chronic KCS. The term management reflects the complexity of therapy for the two diseases.

  • Summary
    For the treatment of chronic keratoconjunctivitis sicca (KCS) in dogs.
SPL Packages

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
Vomiting (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

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

Showing top 5 for Skin & allergy.

Other
Hypokalaemia (1) • Dog Hypochloraemia (1) • Dog Hypocalcaemia (1) • Dog Hypoalbuminaemia (1) • Dog Hyperactivity (1) • Cat
Show more (24)
Hiding (1) • Cat Hepatopathy (1) • Dog Hepatic necrosis (1) • Dog Heart murmur (1) • Dog Foaming at the mouth (1) • Cat Fever (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated aspartate aminotransferase (1) • Dog Elevated alanine aminotransferase (1) • Dog Distension of abdomen (1) • Dog Digestive tract stenosis and obstruction NOS (1) • Cat Dermal thickening (1) • Dog Defect Unknown/Not Specified (1) • Cat Decreased urine concentration (1) • Dog Decreased cholesterol (1) • Dog Death by euthanasia (1) • Dog Death (1) • Cat Bone and joint disorder NOS (1) • Dog Application site scab (1) • Cat Anaemia NOS (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal posture NOS (1) • Dog 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.

Cat, Burmese, Female, 2 year • Drug: MSK, Solution, Oral, Dose: 0.90 mL per animal • Reactions: Vomiting, Foaming at the mouth, Hyperactivity, Hiding, Not eating… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055773
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 2.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 0.90 mL per animal
Reactions Reported:
Vomiting Foaming at the mouth Hyperactivity Hiding Not eating Defect Unknown/Not Specified
Outcomes: Recovered/Normal

Cat, Cat (unknown), Unknown • Drug: MSK, Capsule, Unknown • Reactions: Unclassifiable adverse event • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-054375
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Capsule
Reactions Reported:
Unclassifiable adverse event
Outcomes: Outcome Unknown

Cat, Domestic Longhair, Female, 4 year, 3.856 kilogram • Drug: MSK, Capsule, Oral • Reactions: Application site scab, Application site hair loss • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-054544
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 3.856 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
Reactions Reported:
Application site scab Application site hair loss
Outcomes: Ongoing

Cat, Cat (unknown), Female, 12 year, 4.36 kilogram • Drug: MSK, Solution, Oral, Dose: 100 Milligram per ml • Reactions: Not eating, Not defecating, Seizure NOS, Digestive tract stenosis and obstruction NOS, Not urinating… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-054337
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 4.360 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 100 Milligram per ml
Reactions Reported:
Not eating Not defecating Seizure NOS Digestive tract stenosis and obstruction NOS Not urinating Death
Outcomes: Died

Cat, Domestic Shorthair, Female, 5 year, 4.98 kilogram • Drug: MSK, Capsule, Oral, Dose: 1 tablet per animal, Frequency: 2 per day • Reactions: Vomiting, UNPALATABLE, Intentional misuse • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055560
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 4.980 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 1 tablet per animal
  • Frequency: 2 per day
Reactions Reported:
Vomiting UNPALATABLE Intentional misuse
Outcomes: Recovered/Normal

Dog, Havanese, Female, 4 year, 9.616 kilogram • Drug: MSK, Capsule, Oral • Reactions: Loose stool, Vomiting, Abnormal posture NOS, Unsteady gait, Lack of efficacy - NOS… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-055514
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 9.616 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
Reactions Reported:
Loose stool Vomiting Abnormal posture NOS Unsteady gait Lack of efficacy - NOS Tense abdomen Distension of abdomen Abdominal effusion Hypoalbuminaemia Reduced globulins Elevated aspartate aminotransferase Elevated alanine aminotransferase Low creatinine Hypocalcaemia Hypomagnesaemic condition Decreased cholesterol Leucocytosis NOS Neutrophilia Monocytosis Lymphopenia Intestinal disorder NOS Proteinuria Weight loss Fever Anaemia NOS Thrombocytosis Hypokalaemia Hypochloraemia Heart murmur Decreased urine concentration Abnormal breathing Death by euthanasia Abnormal radiograph finding Increased band neutrophilia Lymphoplasmacytic enteritis Necropsy performed Hepatic necrosis Hepatopathy Pulmonary congestion Pulmonary oedema Pleural effusion
Outcomes: Euthanized

Dog, ['Schnauzer (unspecified)', 'Mixed (Dog)'], Female, 3 year, 17.23 kilogram • Drug: MSK, Capsule, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Skin lesion NOS, Dermal thickening • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055513
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.00 Year
  • Weight: 17.230 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Skin lesion NOS Dermal thickening
Outcomes: Ongoing

Dog, ['Shih Tzu', 'Dog (unknown)'], Male, 10.83 year, 7.394 kilogram • Drug: MSK, Capsule, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Elevated serum alkaline phosphatase, Diarrhea • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-054258
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 10.83 Year
  • Weight: 7.394 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Capsule
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Elevated serum alkaline phosphatase Diarrhea
Outcomes: Ongoing

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.