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Roxee Meds Catalog

Mirtazapine

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

Both Catalog complete FDA data linked Rx required Transdermal ointment Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:00 a.m.

These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
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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Mirtazapine

Mirtazapine

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

Both Transdermal ointment 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.

Mirtazapine

For body weight gain in cats with a history of weight loss. Species commonly shown: Both, Cat, No Use Class Stated Or Implied.

Generic name
Mirtazapine
Brand names
Mirataz®, AX Pharmaceutical Corp, Mirataz, Mirtazapine Anhydrous
Manufacturer
Multiple FDA labelers
Species
Both, Cat, No Use Class Stated Or Implied
Dosage forms
Transdermal ointment
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Mirataz® AX Pharmaceutical Corp Mirataz Mirtazapine Anhydrous
Dosage forms
Transdermal ointment

Indications / Uses

For body weight gain in cats with a history of weight loss.

Side Effects

Top reported reactions (openFDA): Death by euthanasia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Decreased appetite, Diarrhoea.

FAQ

Both, Cat, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Transdermal ointment

Related Conditions

Pica Weight loss

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 body weight gain in cats with a history of weight loss.

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:

  • Loss of appetite (1 reports)
  • Diarrhea (1 reports)
  • Depression (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?
Major cautions & emergency warning signs

Side effects to monitor:

  • Loss of appetite
  • Diarrhea
  • Depression

Most reported reactions:

  • Loss of appetite (1 reports)
  • Diarrhea (1 reports)
  • Depression (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: Transdermal ointment
Identifiers:
NADA: 141481 NDC Package: 17033-060-05 NDC Package: 62157-466-01 NDC Package: 62157-506-01 NDC Package: 73377-003-01 NDC Package: 73377-090-01 NDC Package: 73377-090-02 NDC Package: 73377-090-04 NDC Package: 86032-071-01 NDC Product: 17033 NDC Product: 62157 NDC Product: 73377 NDC Product: 86032
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
24
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (1) · Alopecia local Neurologic (2) · Unsteady walking (ataxia), Depression Behavior (2) · Circling - behavioural disorder, Behavioral disorder (unspecified) Other (24) · Dehydration, Decreased mean corpuscular volume, Decreased haematocrit
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Digestive 1 Cat 1
Neurologic 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Cat (25) Dog (7)

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

0
No official label or package insert links yet.

SPL

5

FOI

1

Mirataz®

SPL · SPL

Open original
FDA Structured Product Label

Mirataz®

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, Ltd.
NADA
141-481
Status
RX
Form
Transdermal ointment
Route
Topical (transdermal)
Species
Cat, No Use Class Stated Or Implied
Composition / specifications
Each 1 g of Mirataz™ contains 20 mg of mirtazapine (2%).

Cats

Indication

For body weight gain in cats with a history of weight loss.

Dosage

Administer topically by applying a 1.5-inch ribbon of ointment (approximately 2 mg/cat) on the inner pinna of the cat’s ear once daily for 14 days.

Mirtazapine Anhydrous SPL

SPL · Structured Product Label

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

Mirtazapine anhydrous SPL

SPL · Structured Product Label

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

Mirataz SPL

SPL · Structured Product Label

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

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

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

FOI Summary oN 141-481 Approved May 4, 2018.pdf

FOI · FOI

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: AX Pharmaceutical Corp Mirataz Mirtazapine Anhydrous Mirtazapine anhydrous
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat
Rx/OTC: RX
Form/route: Transdermal ointment • Topical (transdermal)
Applications: NADA 141-481
NDC: Packages 17033-060-05 62157-466-01 73377-090-01 73377-090-02 73377-090-04 86032-071-01 • Products 17033 62157 73377 86032
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 21 • Cat 115 • View
Case summaries: 24 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Pica Weight loss
Linked using: Fda_Label (0.95), Fda_Label (0.95)
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
Loss of appetite (1) Diarrhea (1) Depression (1) Dehydration (1) Decreased haematocrit (1) Decreased appetite (1) Death by euthanasia (1) Death (1)

Identifiers & Packages

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

Identifiers
NADA: 141481 NDC Package: 17033-060-05 NDC Package: 62157-466-01 NDC Package: 62157-506-01 NDC Package: 73377-003-01 NDC Package: 73377-090-01 NDC Package: 73377-090-02 NDC Package: 73377-090-04 NDC Package: 86032-071-01 NDC Product: 17033 NDC Product: 62157 NDC Product: 73377 NDC Product: 86032
Package NDC Product NDC Form / Route Status
17033-060-05 17033 -
62157-466-01 62157 -
62157-506-01 62157 -
73377-003-01 73377 -
73377-090-01 73377 -
73377-090-02 73377 -
73377-090-04 73377 -
86032-071-01 86032 -

Enriched Documents

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

  • Mirtazapine Anhydrous SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Mirtazapine anhydrous SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Mirataz SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FOI Summary oN 141-481 Approved May 4, 2018.pdf • FOI summary • Official • Jan. 4, 2023
    FDA FOI summary for application 141481

Data Sources & Change Log

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

Official 28 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Death by euthanasia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Decreased a… (Clinical, 2026-04-11)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-05)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-03)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-02)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-29)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-28)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-27)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-26)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-25)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-22)
  • prescription_required: Rx required (Official, 2026-05-05)
  • prescription_required: Rx required (Official, 2026-05-03)
  • prescription_required: Rx required (Official, 2026-05-02)
  • prescription_required: Rx required (Official, 2026-04-29)
  • prescription_required: Rx required (Official, 2026-04-28)
  • prescription_required: Rx required (Official, 2026-04-27)
  • prescription_required: Rx required (Official, 2026-04-26)
  • prescription_required: Rx required (Official, 2026-04-25)
  • prescription_required: Rx required (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Death by euthanasia, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Decreased a… (Official, 2026-04-12)
Recent Revisions
  • side_effects 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
  • 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
  • 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
Mirataz®
RX
Mirtazapine
Transdermal ointment • Topical (transdermal)
Label highlights
Official documents
Dechra, Ltd. NADA 141-481 Approved Jan 4, 2023

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
Each 1 g of Mirataz™ contains 20 mg of mirtazapine (2%).
Cats
Indication

For body weight gain in cats with a history of weight loss.

Dosage

Administer topically by applying a 1.5-inch ribbon of ointment (approximately 2 mg/cat) on the inner pinna of the cat’s ear once daily for 14 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For body weight gain in cats with a history of weight loss.

Source: FDA Animal Drugs @ FDA • Reference

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) • Cat Diarrhea (1) • Cat Decreased appetite (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Alopecia local (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat Depression (1) • Cat

Showing top 5 for Neurologic.

Behavior
Circling - behavioural disorder (1) • Dog Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Dehydration (1) • Cat Decreased mean corpuscular volume (1) • Dog Decreased haematocrit (1) • Cat Death by euthanasia (1) • Dog Death (1) • Cat
Show more (19)
Crust (1) • Cat Constipation (1) • Cat Collapse NOS (1) • Cat Cardiac enlargement (1) • Cat Bloody stool (1) • Cat Bladder distension (1) • Cat Bilirubinuria (1) • Cat Basophilia (1) • Cat Ascites (1) • Cat Arthritis (1) • Dog Application site skin scaling (1) • Cat Anaemia NOS (1) • Cat Active urine sediment (1) • Dog Accidental exposure (1) • Cat Abrasion (1) • Cat Abnormal ultrasound finding (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal cytology (1) • Cat Abdominal pain (1) • Cat

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, Cat (unknown), Male, 17 year, 4.98 kilogram • Drug: MSK, Unknown • Reactions: Accidental exposure, Behavioral disorder (unspecified) • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074713
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 17.00 Year
  • Weight: 4.980 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Accidental exposure Behavioral disorder (unspecified)
Outcomes: Ongoing

Cat, ['Cat (unknown)', 'Cat (unknown)'], Female, 17 year, 3.58 kilogram • Drug: MSK, Unknown, Frequency: 1 per month • Reactions: Vomiting, Collapse NOS, Decreased haematocrit • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073852
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 17.00 Year
  • Weight: 3.580 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Frequency: 1 per month
Reactions Reported:
Vomiting Collapse NOS Decreased haematocrit
Outcomes: Outcome Unknown

Cat, Domestic Longhair, Female, 11 year, 5.05 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Crust, Abrasion, Skin irritation, Alopecia local, Local erythema… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072694
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 5.050 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Crust Abrasion Skin irritation Alopecia local Local erythema Skin ulcer Skin scab
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 11.3 year, 37.8 kilogram • Drug: MSK, Unassigned, Oral, Frequency: 12 per hour • Reactions: Wound, Lick granuloma, External ear disorder NOS, Perianal inflammation, Musculoskeletal disorder NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074363
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.30 Year
  • Weight: 37.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
  • Frequency: 12 per hour
Reactions Reported:
Wound Lick granuloma External ear disorder NOS Perianal inflammation Musculoskeletal disorder NOS Heavy breathing Panting Decreased appetite Scooting Active urine sediment Fungal skin infection NOS Skin lesion NOS Lack of efficacy - NOS
Outcomes: Ongoing

Cat, ['British cat', 'Cat (unknown)'], Female, 13 year, 6.73 kilogram • Drug: MSK, Ointment, Transdermal, Dose: 1.50 Other per animal, Frequency: 24 per hour • Reactions: Application site skin scaling • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074835
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 6.730 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Transdermal
  • Form: Ointment
  • Dose: 1.50 Other per animal
  • Frequency: 24 per hour
Reactions Reported:
Application site skin scaling
Outcomes: Outcome Unknown

Dog, Collie - Border, Female, 11 year, 17.23 kilogram • Drug: MSK, Unknown • Reactions: Gagging, Drooling, Arthritis, UNPALATABLE, Medication error NOS… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073622
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 17.230 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Gagging Drooling Arthritis UNPALATABLE Medication error NOS INEFFECTIVE, OTHER DRUG
Outcomes: Outcome Unknown

Cat, American Curl Shorthair, Male, 4 year, 5.62 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Anaemia NOS, Leucocytosis NOS, Monocytosis, Basophilia, Neutrophilia… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073181
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 4.00 Year
  • Weight: 5.620 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Anaemia NOS Leucocytosis NOS Monocytosis Basophilia Neutrophilia Lymphocytosis Ascites Abnormal cytology Cardiac enlargement Vascular disorder NOS Pleural effusion Peritoneal fluid, abnormal NOS Intentional misuse
Outcomes: Outcome Unknown

Cat, Domestic Mediumhair, Female, 2 year, 4.627 kilogram • Drug: MSK, Unassigned, Topical • Reactions: Vomiting, Not eating, Hiding, Hyperglycaemia, Fever… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072755
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 4.627 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Unassigned
Reactions Reported:
Vomiting Not eating Hiding Hyperglycaemia Fever Tachycardia Tachypnoea Bloody stool Weight loss Gall bladder & bile duct disorder NOS Gastric distension Intestinal thickening 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.

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