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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Multiple FDA labelers
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for a month (30 days) after infection. For the treatment and control of ascarids ( Toxocara canis, Toxascaris leonine ), and hookworms ( Ancylostoma caninum, A braziliense, and Uncinaria stenocephala ). Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala. Species commonly shown: Both, Dog, Excluding Under 6 Weeks Age, Dog.
To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for a month (30 days) after infection. For the treatment and control of ascarids ( Toxocara canis , Toxascaris leonine ), and hookworms ( Ancylostoma caninum , A braziliense , and Uncinaria stenocephala ). Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala.
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.
Top reported reactions (openFDA): Lack of efficacy (endoparasite) - heartworm, Vomiting, Lack of efficacy (endoparasite) - hookworm, INEFFECTIVE, HEARTWORM LARVAE, Medication error NOS, Seizure NOS.
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Used for:
Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara cani...
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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
Bloodwork changes are grouped in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Ivermectin, Pyrantel; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 24 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Trouble breathing (dyspnea) (1 reports), Elevated creatinine (1 reports), Elevated cholesterol (1 reports), Elevated alanine aminotransferase (1 reports), Dermal plaque (1 reports)
Digestive (4), Skin & allergy (1), Neurologic (1), Behavior (2)
Dog (22 reports), Cat (10 reports)
Retriever - Golden (2), Bulldog - American (1), Crossbred Canine/dog (1), Pointing Dog - German Short-haired (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Ivermectin, Pyrantel fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Use monthly, Recommended for dogs 6 weeks of age or older, All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD, immitis, Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a progr
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 22, 2026, 10:12 AM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2026-02-04 · MSK · MSK
Received 2025-12-17 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| 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 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (22) Cat (10)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Cat | 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 | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Behavior | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 |
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.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
FOI · FOI
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 0010-4012-01 | 0010 | - | |
| 0010-4012-02 | 0010 | - | |
| 0010-4012-03 | 0010 | - | |
| 0010-4012-04 | 0010 | - | |
| 0010-4013-01 | 0010 | - | |
| 0010-4013-02 | 0010 | - | |
| 0010-4013-03 | 0010 | - | |
| 0010-4013-04 | 0010 | - | |
| 0010-4014-01 | 0010 | - | |
| 0010-4014-02 | 0010 | - | |
| 0010-4014-03 | 0010 | - | |
| 0010-4014-04 | 0010 | - | |
| 0061-1339-03 | 0061 | - | |
| 0061-1346-04 | 0061 | - | |
| 0061-1353-03 | 0061 | - | |
| 13985-951-25 | 13985 | - | |
| 13985-969-50 | 13985 | - | |
| 13985-970-10 | 13985 | - | |
| 51311-170-20 | 51311 | - | |
| 51311-171-20 | 51311 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Tri-Heart Plus Chewable Tablets
RX
Ivermectin Pyrantel Pamoate
Tablet (Chewable)
• Oral
|
Diamond Animal Health, Inc. | ANADA 200-338 | Approved | Feb 8, 2024 |
|
Heartgard® Plus
RX
Ivermectin Pyrantel Pamoate
Tablet (Chewable)
• Oral
|
Boehringer Ingelheim Animal Health USA, Inc. | NADA 140-971 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for a month (30 days) after infection. For the treatment and control of ascarids ( Toxocara canis , Toxascaris leonine ), and hookworms ( Ancylostoma caninum , A braziliense , and Uncinaria stenocephala ). Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala.
Source: FDA Animal Drugs @ FDA • Reference
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis . Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.
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 Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Bulldog - American, Female, 10 year, 28.123 kilogram • Drug: MSK, Tablet, Oral, Dose: 272 Microgram per animal, Frequency: 1 per month • Reactions: Seizure NOS, Haematuria • Outcome: Ongoing
Dog, Crossbred Canine/dog, Male, 3 year, 7.484 kilogram • Drug: MSK, Tablet, Oral, Dose: 68 Microgram per animal, Frequency: 1 per month • Reactions: Vomiting • Outcome: Recovered/Normal
Dog, Pointing Dog - German Short-haired, Female, 7 year, 28.123 kilogram • Drug: MSK, Tablet, Oral, Dose: 272 Microgram per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing
Dog, Retriever - Golden, Male, 2 year, 39.19 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - hookworm • Outcome: Ongoing
Dog, Retriever - Labrador, Female, 9 year, 38.555 kilogram • Drug: MSK, Tablet, Oral, Dose: 272 Microgram per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing
Dog, Retriever - Golden, Male, 7 year, 34.927 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Vomiting, Unsteady walking (ataxia) • Outcome: Recovered/Normal
Dog, Maltese, Female, 16 year, 4.536 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Seizure NOS • Outcome: Outcome Unknown
Dog, Chihuahua, Female, 12 year, 7.938 kilogram • Drug: MSK, Tablet, chewable, Unknown • Reactions: Abnormal breathing, Heart pounding, Head tilt - neurological disorder, Other ear disorder NOS, Eye disorder NOS • Outcome: Recovered/Normal
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.