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Roxee Medication Guide

Terbinafine Hydrochloride

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

Both Source review pending Not FDA-approved for animals 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
Source review pending
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Roxee is still reviewing source support for this medication profile.

FDA applications
Regulatory match pending
No refresh timestamp yet

Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.

Safety reports
Safety data refreshed
May 30, 2026, 10:02 a.m.

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, 10:45 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Terbinafine Hydrochloride

Terbinafine Hydrochloride

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

Both 80% 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.

Terbinafine Hydrochloride

Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. Species commonly shown: Both.

Generic name
Terbinafine Hydrochloride
Species
Both
Completeness
80%
Validation
Incomplete

Indications / Uses

Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus.

FAQ

Both

Source Transparency

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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:

  • Loss of appetite (1 reports)
  • Eosinophilia (1 reports)
  • Eosinopenia (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 Terbinafine Hydrochloride; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-072174
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 13 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-072174
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-2025-US-072174
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

Loss of appetite (1 reports), Eosinophilia (1 reports), Eosinopenia (1 reports), Enamel disorder (1 reports), Decreased activity (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (2), Neurologic (2), Behavior (1)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (17 reports), Cat (15 reports)

Breed metadata in reports Metadata only

Terrier - Yorkshire (1), ['Terrier (unspecified)', 'Dog (unknown)'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Terbinafine Hydrochloride 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

Loss of appetite, Eosinophilia, Eosinopenia

Call sooner if Escalation

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

Bottom line: Use this Terbinafine Hydrochloride 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-2025-US-072174 · adverse_reaction · adverse reactions
  2. 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:

  • Loss of appetite
  • Eosinophilia
  • Eosinopenia

Most reported reactions:

  • Loss of appetite (1 reports)
  • Eosinophilia (1 reports)
  • Eosinopenia (1 reports)
Explore reported case details

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
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.

Quick Facts

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

Species: Both
Manufacturer: Manufacturer not confirmed
Identifiers:
NDC Package: 86032-057-01 NDC Product: 86032

Adverse Reactions

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

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
2
Matching reports
1
Active filters
2
Selected filters
Reaction: Behavioural disorder NOS Clear Body system: Effectiveness Clear
Reset
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-070191

Received 2025-11-21 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
10-24 lb (5.987 Kilogram)
Age
Under 1 year (5 Month)
Sex
Female Unknown
Region
USA
Reactions
AlopeciaBacterial skin infection NOSRingwormVomitingCoughBloody diarrhoeaBehavioural disorder NOSLack of efficacy (bacteria) - Anaplasma
Body systems
Skin & allergyOtherDigestiveBehaviorEffectiveness
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
13
Species represented
2
Grouped by Body System
Digestive (4) · Loss of appetite, Decreased appetite, Bloody diarrhoea Skin & allergy (2) · Hair loss at application site, Hair loss Neurologic (2) · Unsteady walking (ataxia), Circling - neurological disorder Behavior (1) · Behavioral disorder (unspecified) Other (23) · General pain, Falling, Excoriation
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 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
Other 1 Cat 1

Species coverage: Dog (17) Cat (15)

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

1

FOI

0
No FOI links yet.

Terbinafine Hydrochloride SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Terbinafine Hydrochloride. 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, 10:45 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Manufacturer mapping: Evereen Shanghai Biotechnology Ltd.
Case-reported brands (openFDA): MSK
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 14 Cat 0 View
Case summaries: 2 (showing 2) View
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
Loss of appetite (1) Eosinophilia (1) Eosinopenia (1) Enamel disorder (1) Decreased activity (1) Deafness (1) Claw / hoof / nail disorder NOS (1) Basophilia (1)

Identifiers & Packages

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

Identifiers
NDC Package: 86032-057-01 NDC Product: 86032
Package NDC Product NDC Form / Route Status
86032-057-01 86032 -

Enriched Documents

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

  • Terbinafine Hydrochloride 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 72 Clinical 8 Manufacturer 0 Marketing 0
Current Field Facts
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Clinical, 2026-04-11)
  • manufacturer_name: Evereen Shanghai Biotechnology Ltd. (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-22)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-22)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-21)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-20)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-13)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-12)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-12)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-11)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-11)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-10)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ataxia, Head tilt - ear disorder, Vomiting, Corneal ulcer, Nystagmus. (Official, 2026-06-08)
Recent Revisions
  • side_effects updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-11 19:22 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-11 18:40 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-10 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-08 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-07 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-06 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-04 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-01 10:40 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-01 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-31 10:05 by etl_backfill • Backfilled from existing medication fields

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 Decreased appetite (1) • Cat Bloody diarrhoea (1) • Dog Appetite disorder NOS (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Dog Hair loss (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Circling - neurological disorder (1) • Cat

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
General pain (1) • Cat Falling (1) • Cat Excoriation (1) • Dog Erythema (1) • Dog Eosinophilia (1) • Dog
Show more (18)
Eosinopenia (1) • Cat Enamel disorder (1) • Dog Elevated temperature (1) • Dog Dull (1) • Dog Dilated pupils (1) • Dog Decreased activity (1) • Dog Deafness (1) • Dog Cough (1) • Dog Claw / hoof / nail disorder NOS (1) • Cat Basophilia (1) • Cat Balance problem (1) • Cat Balance impaired (1) • Cat Bacterial skin infection NOS (1) • Dog Application site haemorrhage (1) • Cat Application site erythema (1) • Cat Anisocoria (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal cytology (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 - Yorkshire, Female, 13 year, 6.12 kilogram • Drug: MSK, Unknown • Reactions: Partial lack of efficacy, Hair loss, Erythema, Papule, Excoriation… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072174
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 6.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Partial lack of efficacy Hair loss Erythema Papule Excoriation Skin scab Bacterial skin infection NOS Abnormal cytology
Outcomes: Ongoing

Dog, ['Terrier (unspecified)', 'Dog (unknown)'], Female, 5 month, 5.987 kilogram • Drug: MSK, Unknown • Reactions: Hair loss, Bacterial skin infection NOS, Ringworm, Vomiting, Cough… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-070191
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Month
  • Weight: 5.987 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Hair loss Bacterial skin infection NOS Ringworm Vomiting Cough Bloody diarrhoea Behavioral disorder (unspecified) Lack of efficacy (bacteria) - Anaplasma
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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