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Roxee Medication Guide

Cyclosporine A

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference partial Not FDA-approved for animals AX Pharmaceutical Corp Official label facts Owner quick guide first

Veterinary professional?

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

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

Roxee has a partial reference profile for this medication. Some primary facts still need verification.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

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

Safety reports
No safety reports linked
No refresh timestamp yet

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Image coming soon
Cyclosporine A

Cyclosporine A

Drug type: Generic ingredient • Branded profile Not FDA-approved for animals

Both 65% reference complete

Species: Both

Approval status: Not FDA-approved as an animal drug. No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.

Medication Snapshot

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

Cyclosporine A

Generic name
Cyclosporine A
Brand names
X, Cyclosporine A
Manufacturer
AX Pharmaceutical Corp
Species
Both
Completeness
65%
Validation
Incomplete
Brand names
X Cyclosporine A

Side Effects

Top reported reactions (openFDA): Vomiting, Capsules, Abnormal, Odor, Abnormal, Tremor of limb.

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Roxee still has limited plain-language guidance for this medication. Use the official documents and your veterinarian's instructions for product-specific details.

Used for:

Your vet decides this. Here's what owners typically ask/watch for.

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:

  • Vomiting (1 reports)
  • Tremor of limb (1 reports)
  • Odor, Abnormal (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Cyclosporine A; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2013-US-003138
Safety signal coverage Reported signals

4 tracked reaction signals; 4 reported cases; 1 species group. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2013-US-003138
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2013-US-003138
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Vomiting (1 reports), Tremor of limb (1 reports), Odor, Abnormal (1 reports), Capsules, Abnormal (1 reports)

Body systems represented Signal grouping

Digestive (1), Neurologic (1), Other (2)

Species and breed lens

Species represented in reports Species lens

Dog (4 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Cyclosporine A fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Vomiting, Tremor of limb, Odor, Abnormal

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Cyclosporine A brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2013-US-003138 · adverse_reaction · adverse reactions
  2. Structured Product Label · document · documents
  3. Structured Product Label · document · documents
  4. Structured Product Label · document · documents
  5. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 15, 2026, 10:04 AM UTC

Safety & side effects

Side effects to monitor:

  • Vomiting
  • Tremor of limb
  • Odor, Abnormal

Most reported reactions:

  • Vomiting (1 reports)
  • Tremor of limb (1 reports)
  • Odor, Abnormal (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Not linked yet
Indication / use
Your vet decides this. Here's what owners typically ask/watch for.
Form / route / dose
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: AX Pharmaceutical Corp
Identifiers:
NDC Package: 62157-376-01 NDC Package: 73377-197-01 NDC Package: 73377-197-02 NDC Package: 73377-197-03 NDC Package: 73377-197-04 NDC Package: 73377-197-05 NDC Package: 73377-197-06 NDC Package: 73377-197-07 NDC Package: 73377-197-08 NDC Package: 73377-197-09 NDC Package: 73377-197-10 NDC Package: 73377-197-11 NDC Package: 73377-197-12 NDC Product: 62157 NDC Product: 73377

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
4
Reported cases
4
Serious reports
0
Species represented
1
Grouped by Body System
Digestive (1) · Vomiting Neurologic (1) · Tremor of limb Other (2) · Odor, Abnormal, Capsules, Abnormal
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 0
Neurologic 1 Dog 0
Other 1 Dog 0
Other 1 Dog 0

Species coverage: Dog (4)

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

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

4

FOI

0
No FOI links yet.

Cyclosporine A SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Cyclosporine A. Use the source link for the full official labeling record.

X SPL

SPL · Structured Product Label

FDA Structured Product Label XML for X. Use the source link for the full official labeling record.

Cyclosporine A SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Cyclosporine A. Use the source link for the full official labeling record.

Cyclosporine A SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Cyclosporine A. Use the source link for the full official labeling record.
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Cyclosporine A X
Manufacturer mapping: AX Pharmaceutical Corp
Catalog species: Both
NDC: Packages 62157-376-01 73377-197-01 73377-197-02 73377-197-03 73377-197-04 73377-197-05 Products 62157 73377
Safety (openFDA)
Top reactions: Dog 0 Cat 0 View
Case summaries: 0
openFDA reports are unverified and do not prove causation.

Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Top reaction signals
Vomiting (1) Tremor of limb (1) Odor, Abnormal (1) Capsules, Abnormal (1)

Identifiers & Packages

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

Identifiers
NDC Package: 62157-376-01 NDC Package: 73377-197-01 NDC Package: 73377-197-02 NDC Package: 73377-197-03 NDC Package: 73377-197-04 NDC Package: 73377-197-05 NDC Package: 73377-197-06 NDC Package: 73377-197-07 NDC Package: 73377-197-08 NDC Package: 73377-197-09 NDC Package: 73377-197-10 NDC Package: 73377-197-11 NDC Package: 73377-197-12 NDC Product: 62157 NDC Product: 73377
Package NDC Product NDC Form / Route Status
62157-376-01 62157 -
73377-197-01 73377 -
73377-197-02 73377 -
73377-197-03 73377 -
73377-197-04 73377 -
73377-197-05 73377 -
73377-197-06 73377 -
73377-197-07 73377 -
73377-197-08 73377 -
73377-197-09 73377 -
73377-197-10 73377 -
73377-197-11 73377 -
73377-197-12 73377 -

Enriched Documents

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

  • Cyclosporine A SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • X SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Cyclosporine A SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Cyclosporine A SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.

Data Sources & Change Log

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

Official 66 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Capsules, Abnormal, Odor, Abnormal, Tremor of limb. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Capsules, Abnormal, Odor, Abnormal, Tremor of limb. (Clinical, 2026-04-11)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-22)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-22)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-21)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-20)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-13)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-12)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-12)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-11)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-11)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-10)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-09)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-08)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-07)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-06)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-05)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-04)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-03)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-06-02)
Recent Revisions
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects 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

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published

Data source: FDA Animal Drugs @ FDA (public search export).

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

Showing top 5 for Digestive.

Neurologic
Tremor of limb (1) • Dog

Showing top 5 for Neurologic.

Other
Odor, Abnormal (1) • Dog Capsules, Abnormal (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.

No case-level openFDA reports are linked for this medication yet.

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.