Meds A-Z
Levothyroxine Sodium
Detailed information about Levothyroxine Sodium
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Sign in to continueReviewed / Updated / Sources
Reviewed: Not available
Updated: February 12, 2026, 10:44 PM UTC
- FDA application profile · official_label
- FDA application profile · official_label
- Medication usage source · fda_animal_drugs
- openFDA case USA-USFDACVM-2025-US-055162 · adverse_reaction
- FOI · document
Pet Owner Quick Guide
Start here first for the simple next-step summary.
Used for:
For replacement therapy for diminished thyroid function in dogs.
What to watch for:
- For oral use in dogs only
- very low energy (1 reports)
- Leucocytosis NOS (1 reports)
- Hair loss (1 reports)
When to call the vet:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
- Facial swelling or hives.
- Blood in vomit or stool.
Regulatory restrictions are shown in Vet View.
What to ask your vet today:
- Is this medicine the right fit for my pet’s current symptoms?
- Which warning signs mean I should call back right away?
- How should I handle missed doses or refusal to take the medicine?
Safety & side effects
What to watch:
- For oral use in dogs only
- very low energy
- Leucocytosis NOS
- Hair loss
Most reported reactions:
- Tiredness (lethargy) (1 reports)
- Leucocytosis NOS (1 reports)
- Hair loss (1 reports)
When to call your vet:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
Data freshness: source data appears current.
Latest refresh: Mar 21, 2026, 10:01 a.m.
- Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Mar 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Mar 15, 2026, 10:05 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Levothyroxine Sodium
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Not available (source)
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141539 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141448 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
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.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
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.
Grouped by Body System
Most Reported Reactions
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Neurologic | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Skin & allergy | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Digestive | 1 | Dog | 1 |
Species coverage: Dog (18) Cat (14)
View detailed reaction table
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Effectiveness | Dog | Non-serious | - | 1 | |
| Effectiveness | Dog | Non-serious | - | 1 | |
| Effectiveness | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055162
Documents
Owner handouts and official technical documents are grouped for faster access.
Owner handouts (0)
- No owner handouts linked yet.
Official label / PI (0)
- No official label or package insert links yet.
SPL (2)
-
ThyroKare™
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/10370/ThyroKare%E2%84%A2
-
Thyro-Tabs® Canine
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2392/Thyro-Tabs%C2%AE%20Canine
FOI (2)
-
FOI Summary oN 141-539 Approved January 15, 2021.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/10310
-
UCM484490.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/937
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/10310 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/10370/ThyroKare%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/937 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2392/Thyro-Tabs%C2%AE%20Canine · document · SPL
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.
- Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Mar 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Mar 15, 2026, 10:05 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
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.
- For oral use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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.
-
FOI Summary oN 141-539 Approved January 15, 2021.pdf
• FOI summary • Official
• Feb. 1, 2021
FDA FOI summary for application 141539
-
UCM484490.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141448
Data Sources & Change Log
Every non-trivial field is expected to include provenance and update timestamps.
- 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, 2026-02-12)
- usage: For replacement therapy for diminished thyroid function in dogs. (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
FDA Products & Applications (Animal Drugs @ FDA)
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
ThyroKare™
RX
Levothyroxine sodium
Tablet
• Oral
|
Neogen Corp. | NADA 141-539 | Approved | Feb 1, 2021 |
|
Thyro-Tabs® Canine
RX
Levothyroxine sodium
Tablet
• Oral
|
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.
Composition / specifications
For replacement therapy for diminished thyroid function in dogs.
The initial dose is 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For replacement therapy for diminished thyroid function in dogs.
- ThyroKare™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM484490.pdf
Summary
For replacement therapy for diminished thyroid function in dogs.
- Thyro-Tabs® Canine (ZIP)
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).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Effectiveness.
Show more (19)
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, Unassigned, Unknown, Dose: 0.50 tablet per animal, Frequency: 24 per hour • Reactions: Partial lack of efficacy, Hair loss, Erythema, Papule, Excoriation… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055162
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 13.00 Year
- Weight: 6.120 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
- Dose: 0.50 tablet per animal
- Frequency: 24 per hour
Dog, Spitz - German Pomeranian, Male, 4 year, 4.205 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Shaking, Tiredness (lethargy), Tense abdomen, Swallowing disorder NOS, Diarrhea • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-053196
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 4.00 Year
- Weight: 4.205 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Dog, ['Boxer (German Boxer)', 'Dog (unknown)'], Male, 10 year, 35.153 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: General illness, Aspiration pneumonia, Cough, Not defecating • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-053209
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 35.153 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Dog, Crossbred Canine/dog, Female, 13 year, 24.5 kilogram • Drug: MSK, Oral • Reactions: Decreased appetite, Decreased drinking, Weakness, Lack of efficacy - NOS, Weight gain… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-047132
- Serious AE: No
- Treated For AE: Yes
- Sex: Female
- Age: 13.00 Year
- Weight: 24.500 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
Dog, ['Retriever - Labrador', 'Poodle (unspecified)'], Male, 10 year, 49.44 kilogram • Drug: MSK, Oral, Dose: 0.80 Milligram per animal • Reactions: Lack of efficacy (endoparasite) - hookworm • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-043985
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 10.00 Year
- Weight: 49.440 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Dose: 0.80 Milligram per animal
Cat, Domestic Shorthair, Male, 13 year, 5.12 kilogram • Drug: MSK, Pill, Oral, Dose: 0.10 Milligram per animal, Frequency: 1 per day • Reactions: Drooling, Not himself/herself, Dilated pupils, Agitation • Outcome: Ongoing
- Report ID: USA-USFDACVM-2023-US-045191
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 13.00 Year
- Weight: 5.120 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Pill
- Dose: 0.10 Milligram per animal
- Frequency: 1 per day
Cat, Female, 11 year, 4.7 kilogram • Drug: MSK, Tablet, Oral, Dose: 0.6870 Milligram per kilogram, Frequency: 1 per day • Reactions: Overdose, Accidental exposure, Elevated blood urea nitrogen, Elevated amylase, Leucocytosis NOS • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2021-US-016634
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 11.00 Year
- Weight: 4.700 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 0.6870 Milligram per kilogram
- Frequency: 1 per day
Cat, Maine Coon, Male, 6.5 year, 8.6 kilogram • Drug: MSK, Tablet, Oral, Dose: 0.0923 Milligram per kilogram, Frequency: 24 per hour • Reactions: Accidental exposure, Circumstance or info capable of leading to medication error • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2018-US-029183
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 6.50 Year
- Weight: 8.600 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 0.0923 Milligram per kilogram
- Frequency: 24 per hour
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.