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Roxee Medication Guide

Levothyroxine Sodium

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

Both Reference complete FDA data linked Rx required Tablet Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.

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

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.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 Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Levothyroxine Sodium

Levothyroxine Sodium

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Tablet Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

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

Levothyroxine Sodium

For replacement therapy for diminished thyroid function in dogs. Species commonly shown: Both, Dog.

Generic name
Levothyroxine Sodium
Brand names
Thyro-Tabs® Canine, ThyroKare™
Manufacturer
Multiple FDA sponsors
Species
Both, Dog
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Thyro-Tabs® Canine ThyroKare™
Dosage forms
Tablet

Indications / Uses

For replacement therapy for diminished thyroid function in dogs.

Warnings / Contraindications

For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Overdose, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Panting, Lack of efficacy - NOS.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Tablet

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 replacement therapy for diminished thyroid function in dogs.

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:

  • For oral use in dogs only
  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Cyanotic mucous membranes (1 reports)

When to call the vet:

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

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

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

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
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 Levothyroxine Sodium; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-013066
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 23 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-013066
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-2026-US-013066
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

Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Cyanotic mucous membranes (1 reports), Confusion (1 reports), Complication of diabetes (1 reports)

Body systems represented Signal grouping

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

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (27 reports), Cat (5 reports)

Breed metadata in reports Metadata only

Retriever - Labrador (2), Dachshund - Miniature (1), Chihuahua (1), ['Terrier - Bull - American Pit', '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 Levothyroxine Sodium 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

For oral use in dogs only, wobbly/unsteady walking, Loss of appetite, Cyanotic mucous membranes

Call sooner if Escalation

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

Bottom line: Use this Levothyroxine Sodium 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-2026-US-013066 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
Safety & side effects

Side effects to monitor:

  • For oral use in dogs only
  • wobbly/unsteady walking
  • Loss of appetite
  • Cyanotic mucous membranes

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Cyanotic mucous membranes (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.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
For replacement therapy for diminished thyroid function in dogs.
Form / route / dose
Form: Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Tablet
Identifiers:
NADA: 141448 NADA: 141539 NDC Package: 11695-6957-1 NDC Package: 11695-6957-2 NDC Package: 11695-6958-1 NDC Package: 11695-6958-2 NDC Package: 11695-6959-1 NDC Package: 11695-6959-2 NDC Package: 11695-6960-1 NDC Package: 11695-6960-2 NDC Package: 11695-6961-1 NDC Package: 11695-6961-2 NDC Package: 11695-6962-1 NDC Package: 11695-6962-2 NDC Package: 11695-6963-1 NDC Package: 11695-6963-2 NDC Package: 11695-6964-1 NDC Package: 11695-6964-2 NDC Package: 11695-6965-1 NDC Package: 11695-6965-2
Source metadata:

Warnings / Contraindications

For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

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
18
Matching reports
1
Active filters
2
Selected filters
Reaction: Lethargy (see also Central nervous system depression in Neurological) Clear Body system: Digestive Clear
Reset
Drill into common report signals
Ataxia (3) Lethargy (see also Central nervous system depression in Neurological) (3) Medication error NOS (3) Abnormal cytology (2) Other (17) Neurologic (7) Digestive (3) Effectiveness (3)
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-013066

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
Samoyed
Size / weight
50-99 lb (24.948 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)ShakingPale mucous membraneCold feeling of extremityVomitingTachycardiaLaboured breathingTachypnoeaDehydrationWeak pulseTense abdomenHypochloraemiaHyponatremiaAzotaemiaHypocalcaemiaHypoglycaemiaHyperphosphataemiaHypoproteinaemiaHypoalbuminaemiaLow alanine aminotransferase (ALT)Elevated lactateIncreased percentage reticulocytesLymphocytosisMonocytosisAbnormal red blood cellHypotensionAbdominal effusionAspiration pneumoniaHeart murmurGastric perforationLateral recumbencySepticaemiaCoagulopathyHypernatraemiaHypercalcaemiaElevated serum alkaline phosphatase (ALP)NeutrophiliaStridor (Upper respiratory; for lower respiratory see also Bronchial rale)Unresponsive to stimuliCyanotic mucous membranesThrombosisOedema of the extremities (see also other SOCs for most applicable oedema)Pitting oedemaLamenessElevated aspartate aminotransferase (AST)Stertor
Body systems
NeurologicOtherDigestive
Outcomes
Ongoing

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 (1) · Loss of appetite Skin & allergy (1) · Hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (1) · Biting -aggression Other (28) · Cyanotic mucous membranes, Cough, Confusion
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
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

Species coverage: Dog (27) Cat (5)

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

ThyroKare™ SPL · SPL Thyro-Tabs® Canine SPL · SPL FOI Summary oN 141-539 Approved January 15, 2021.pdf FOI · FOI

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

2

FOI

2

ThyroKare™

SPL · SPL

Open original
FDA Structured Product Label

ThyroKare™

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

Sponsor
Neogen Corp.
NADA
141-539
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, or 1.0 mg of levothyroxine sodium per tablet

Dogs

Indication

For replacement therapy for diminished thyroid function in dogs.

Dosage

The initial dose is 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.

Thyro-Tabs® Canine

SPL · SPL

Open original
FDA Structured Product Label

Thyro-Tabs® Canine

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

Sponsor
Lloyd, Inc.
NADA
141-448
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, or 1.0 mg of levothyroxine sodium per tablet

Dogs

Indication
For replacement therapy for diminished thyroid function in dogs.
Dosage
Administer by mouth 0.1 mg/10 pounds of body weight (0.022 mg/kilogram) as a single dose every 24 hours or as a divided dose every 12 hours.
Limitations
For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOI Summary oN 141-539 Approved January 15, 2021.pdf

FOI · FOI

Open original

UCM484490.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
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet • Oral
Applications: NADA 141-539 • NADA 141-448
Documents: 2 (FOI: 2) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 106 • Cat 11 • View
Case summaries: 18 (showing 8) • 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.

Owner-facing counseling points
  • For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Cyanotic mucous membranes (1) Confusion (1) Complication of diabetes (1) Collapse of leg (1) Cold feeling of extremity (1) Coagulopathy (1)

Identifiers & Packages

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

Identifiers
NADA: 141448 NADA: 141539 NDC Package: 11695-6957-1 NDC Package: 11695-6957-2 NDC Package: 11695-6958-1 NDC Package: 11695-6958-2 NDC Package: 11695-6959-1 NDC Package: 11695-6959-2 NDC Package: 11695-6960-1 NDC Package: 11695-6960-2 NDC Package: 11695-6961-1 NDC Package: 11695-6961-2 NDC Package: 11695-6962-1 NDC Package: 11695-6962-2 NDC Package: 11695-6963-1 NDC Package: 11695-6963-2 NDC Package: 11695-6964-1 NDC Package: 11695-6964-2 NDC Package: 11695-6965-1 NDC Package: 11695-6965-2 NDC Package: 11695-7014-1 NDC Package: 11695-7014-2 NDC Package: 11789-048-10 NDC Package: 11789-048-20
Package NDC Product NDC Form / Route Status
11695-6957-1 11695 -
11695-6957-2 11695 -
11695-6958-1 11695 -
11695-6958-2 11695 -
11695-6959-1 11695 -
11695-6959-2 11695 -
11695-6960-1 11695 -
11695-6960-2 11695 -
11695-6961-1 11695 -
11695-6961-2 11695 -
11695-6962-1 11695 -
11695-6962-2 11695 -
11695-6963-1 11695 -
11695-6963-2 11695 -
11695-6964-1 11695 -
11695-6964-2 11695 -
11695-6965-1 11695 -
11695-6965-2 11695 -
11695-7014-1 11695 -
11695-7014-2 11695 -

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 11 Clinical 8 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Clinical, 2026-04-16)
  • contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Clinical, 2026-04-15)
  • contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Overdose, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Panting, Lack of effi… (Clinical, 2026-04-11)
  • usage: For replacement therapy for diminished thyroid function in dogs. (Clinical, 2026-04-16)
  • usage: For replacement therapy for diminished thyroid function in dogs. (Clinical, 2026-04-15)
  • usage: For replacement therapy for diminished thyroid function in dogs. (Clinical, 2026-04-11)
  • contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-22)
  • contraindications: For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Overdose, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Panting, Lack of effi… (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Overdose, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Panting, Lack of effi… (Official, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Overdose, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Panting, Lack of effi… (Official, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Overdose, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), Panting, Lack of effi… (Official, 2026-02-12)
  • usage: For replacement therapy for diminished thyroid function in dogs. (Official, 2026-04-22)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-16)
  • usage: For replacement therapy for diminished thyroid function in dogs. (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage 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
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
ThyroKare™
RX
Levothyroxine sodium
Tablet • Oral
Label highlights
Official documents
Neogen Corp. NADA 141-539 Approved Feb 1, 2021
Thyro-Tabs® Canine
RX
Levothyroxine sodium
Tablet • Oral
Label highlights
Official documents
Lloyd, Inc. NADA 141-448 Approved Jun 1, 2016

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

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog
Composition / specifications
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, or 1.0 mg of levothyroxine sodium per tablet
Dogs
Indication

For replacement therapy for diminished thyroid function in dogs.

Dosage

The initial dose is 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, or 1.0 mg of levothyroxine sodium per tablet
Dogs
Indication
For replacement therapy for diminished thyroid function in dogs.
Dosage
Administer by mouth 0.1 mg/10 pounds of body weight (0.022 mg/kilogram) as a single dose every 24 hours or as a divided dose every 12 hours.
Limitations
For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For replacement therapy for diminished thyroid function in dogs.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

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

Digestive
Loss of appetite (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog

Showing top 5 for Behavior.

Other
Cyanotic mucous membranes (1) • Dog Cough (1) • Dog Confusion (1) • Dog Complication of diabetes (1) • Dog Collapse of leg (1) • Dog
Show more (23)
Cold feeling of extremity (1) • Dog Coagulopathy (1) • Dog Circumstance or info capable of leading to medication error (1) • Cat Cataract (1) • Dog Bumping into walls (1) • Dog Bloody stool (1) • Dog Blindness (1) • Dog Bilirubinuria (1) • Dog Basophilia (1) • Dog Bacterial skin infection NOS (1) • Dog Azotaemia (1) • Dog Aspiration pneumonia (1) • Dog Arthritis (1) • Dog Anaemia NOS (1) • Dog Allergic reaction (1) • Cat Alkaline urine (1) • Dog Agitation (1) • Cat Acidic urine (1) • Dog Accidental exposure (1) • Cat Abnormal ultrasound finding (1) • Dog Abnormal red blood cell (1) • Dog Abnormal cytology (1) • Dog Abdominal effusion (1) • Dog

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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, Retriever - Labrador, Female, 12 year, 33.11 kilogram • Drug: MSK, Unknown • Reactions: Thrombocytopenia, Tiredness (lethargy) • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014118
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 33.110 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Thrombocytopenia Tiredness (lethargy)
Outcomes: Outcome Unknown

Dog, Dachshund - Miniature, Male, 14 year, 5.897 kilogram • Drug: MSK, Unassigned, Oral, Frequency: 12 per hour • Reactions: Seizure NOS, Obtunded, Twitching, Restlessness, Walking difficulty… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-013212
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 5.897 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
  • Frequency: 12 per hour
Reactions Reported:
Seizure NOS Obtunded Twitching Restlessness Walking difficulty Proprioception deficit Death by euthanasia
Outcomes: Euthanized

Dog, Chihuahua, Female, 16 year, 5.987 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Medication error NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-013403
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 16.00 Year
  • Weight: 5.987 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting Medication error NOS
Outcomes: Recovered/Normal

Dog, ['Terrier - Bull - American Pit', 'Dog (unknown)'], Male, 13 year • Drug: MSK, Unassigned, Unknown • Reactions: Head down, Walking difficulty • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013220
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 13.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Head down Walking difficulty
Outcomes: Ongoing

Dog, Bulldog - French, Female, 7 year, 12.3 kilogram • Drug: MSK, Oral • Reactions: Skin lesion NOS, Skin hyperaemia, Folliculitis, Skin ulcer, Lack of efficacy (bacteria) - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014532
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 12.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
Reactions Reported:
Skin lesion NOS Skin hyperaemia Folliculitis Skin ulcer Lack of efficacy (bacteria) - NOS
Outcomes: Ongoing

Dog, Samoyed, Male, 9 year, 24.948 kilogram • Drug: MSK, Tablet, Oral, Dose: 0.50 Milligram per animal, Frequency: 12 per hour • Reactions: Tiredness (lethargy), Shaking, Pale mucous membrane, Cold feeling of extremity, Vomiting… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013066
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 24.948 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 0.50 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Tiredness (lethargy) Shaking Pale mucous membrane Cold feeling of extremity Vomiting Tachycardia Laboured breathing Tachypnoea Dehydration Weak pulse Tense abdomen Hypochloraemia Hyponatremia Azotaemia Hypocalcaemia Hypoglycaemia Hyperphosphataemia Hypoproteinaemia Hypoalbuminaemia Low alanine aminotransferase Elevated lactate Increased percentage reticulocytes Lymphocytosis Monocytosis Abnormal red blood cell Hypotension Abdominal effusion Aspiration pneumonia Heart murmur Gastric perforation Lateral recumbency Septicaemia Coagulopathy Hypernatraemia Hypercalcaemia Elevated serum alkaline phosphatase Neutrophilia Stridor Unresponsive to stimuli Cyanotic mucous membranes Thrombosis Oedema of the extremities Pitting oedema Lameness Elevated aspartate aminotransferase Stertor
Outcomes: Ongoing

Dog, ['Shepherd Dog - German', 'Dog (unknown)'], Male, 13 year, 33.974 kilogram • Drug: MSK, Unassigned, Unknown, Dose: 0.30 Milligram per animal, Frequency: 12 per hour • Reactions: Injection site swelling, Panting, Warm feeling to the touch, Paralysis NOS, Biting -aggression… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-011831
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 33.974 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
  • Dose: 0.30 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Injection site swelling Panting Warm feeling to the touch Paralysis NOS Biting -aggression Uncomfortable Limb non-weight bearing
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 10 year, 42.003 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Weakness, Medication error NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-011394
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 42.003 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Weakness Medication error NOS
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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This medication has not been reviewed by a veterinarian yet.