Meds A-Z
Emodepside
Detailed information about Emodepside
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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
- Medication usage source · fda_animal_drugs
- openFDA case USA-USFDACVM-2025-US-055792 · adverse_reaction
- FOI · document
- SPL · document
Pet Owner Quick Guide
Start here first for the simple next-step summary.
Used for:
For the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and...
What to watch for:
- Safe use of this product has not been evaluated in cats less that 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy, or in lactating queens
- Oral ingestion or exposure should be avoided
- very low energy (1 reports)
- Sleepiness - systemic disorder (1 reports)
- Moist dermatitis (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:
- Safe use of this product has not been evaluated in cats less that 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy, or in lactating queens
- Oral ingestion or exposure should be avoided
- very low energy
- Sleepiness - systemic disorder
- Moist dermatitis
Most reported reactions:
- Tiredness (lethargy) (1 reports)
- Sleepiness - systemic disorder (1 reports)
- Moist dermatitis (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 17, 2026, 10:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:42 PM UTC
Emodepside
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/141275 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Safe use of this product has not been evaluated in cats less that 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy, or in lactating queens. Oral ingestion or exposure should be avoided.
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Safe use of this product has not been evaluated in cats less that 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy, or in lactating queens. Oral ingestion or exposure should be avoided.
- 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 | Cat | 0 | |
| Other | 1 | Cat | 0 | |
| Other | 1 | Cat | 0 | |
| Effectiveness | 1 | Dog | 0 | |
| Effectiveness | 1 | Cat | 0 | |
| Effectiveness | 1 | Dog | 0 | |
| Other | 1 | Cat | 0 | |
| Other | 1 | Cat | 0 |
Species coverage: Cat (15) Dog (6)
View detailed reaction table
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Effectiveness | Dog | Non-serious | - | 1 | |
| Effectiveness | Cat | Non-serious | - | 1 | |
| Effectiveness | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Behavior | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Skin & allergy | Cat | Unknown | - | - | |
| Other | Dog | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055792
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 (1)
-
Profender™
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/211/Profender%E2%84%A2
FOI (1)
-
ucm062332.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/834
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 17, 2026, 10:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:42 PM 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.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. Safe use of this product has not been evaluated in cats less that 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy, or in lactating queens. Oral ingestion or exposure should be avoided. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 58198-0059-1 | 58198 | - | |
| 58198-0059-2 | 58198 | - | |
| 58198-0059-3 | 58198 | - | |
| 58198-0060-1 | 58198 | - | |
| 58198-0060-2 | 58198 | - | |
| 58198-0060-3 | 58198 | - | |
| 58198-0061-1 | 58198 | - | |
| 58198-0061-2 | 58198 | - | |
| 58198-0061-3 | 58198 | - | |
| 58198-0062-1 | 58198 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
ucm062332.pdf
• FOI summary • Official
• April 29, 2021
FDA FOI summary for application 141275
Data Sources & Change Log
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Safe use of this product has not been evaluated in cats less that 8 weeks… (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Lack of efficacy (endoparasite) - hookworm, Incorrect route of drug administration, Vomiting, Accidental exposure, Administra… (Official, 2026-02-12)
- usage: For the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections … (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 |
|---|---|---|---|---|
|
Profender™
RX
Emodepside Praziquantel
Liquid
• Topical
|
Elanco US Inc. | NADA 141-275 | Approved | Apr 29, 2021 |
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
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
FOI ucm062332.pdf
Summary
PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.
- Profender™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
For the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults).
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Safe use of this product has not been evaluated in cats less that 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy, or in lactating queens. Oral ingestion or exposure should be avoided.
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 Behavior.
Showing top 5 for Effectiveness.
Show more (7)
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, Domestic Shorthair, Male, 1.66 year, 4.536 kilogram • Drug: MSK, Solution, Topical, Dose: 1 dose per animal • Reactions: Application site scratching, Application site hair loss, Application site irritation, Application site reddening, Application site inflammation… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055503
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 1.66 Year
- Weight: 4.536 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Topical
- Form: Solution
- Dose: 1 dose per animal
Cat, Domestic Shorthair, Male, 14.5 week, 1.87 kilogram • Drug: MSK, Solution, Topical, Dose: 1 dose per animal • Reactions: Lack of efficacy (endoparasite) - tapeworm • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055700
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 14.50 Week
- Weight: 1.870 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Topical
- Form: Solution
- Dose: 1 dose per animal
Cat, Domestic Shorthair, Male, 7 week, 0.73 kilogram • Drug: MSK, Solution, Topical, Dose: 1 dose per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - tapeworm • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055999
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 7.00 Week
- Weight: 0.730 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Topical
- Form: Solution
- Dose: 1 dose per animal
- Frequency: 1 per month
Dog, Mixed (Dog), Mixed, 1.6 year, 19.7 kilogram • Drug: MSK, Solution, Topical, Dose: 3 Milligram per kilogram • Reactions: Application site dermatitis, Administration error NOS • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-055792
- Serious AE: No
- Treated For AE: Yes
- Sex: Mixed
- Age: 1.60 Year
- Weight: 19.700 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Topical
- Form: Solution
- Dose: 3 Milligram per kilogram
Dog, Mixed (Dog), Mixed, 1.6 year, 19.7 kilogram • Drug: MSK, Solution, Oral, Dose: 1 Milligram per kilogram • Reactions: Drooling • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-055777
- Serious AE: No
- Treated For AE: No
- Sex: Mixed
- Age: 1.60 Year
- Weight: 19.700 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Solution
- Dose: 1 Milligram per kilogram
Dog, Dog (unknown), Male • Drug: MSK, Solution, Oral • Reactions: Lack of efficacy - NOS, Administration error NOS • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055779
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Solution
Cat, Domestic Shorthair, Male, 4.33 year, 6.5 kilogram • Drug: MSK, Solution, Topical, Dose: 1 tube per animal • Reactions: Application site hair loss, Application site irritation, Moist dermatitis, Application site weeping • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-050212
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 4.33 Year
- Weight: 6.500 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Topical
- Form: Solution
- Dose: 1 tube per animal
Dog, Foxhound - American, Mixed, 1 year • Drug: MSK, Solution, Oral, Dose: 1 dose per animal • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-051638
- Serious AE: No
- Treated For AE: No
- Sex: Mixed
- Age: 1.00 Year
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Solution
- Dose: 1 dose per animal
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Storage & Handling
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Share Your Thoughts
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This medication has not been reviewed by a veterinarian yet.