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Roxee Medication Guide

Ivermectin 68Mcg Pyrantel 57Mg

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 Regulatory linkage incomplete Owner quick guide first
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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
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 Jul 22, 2026, 7:08 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • 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
Ivermectin 68Mcg Pyrantel 57Mg

Ivermectin 68Mcg Pyrantel 57Mg

Drug type: Generic ingredient • Generic profile • Regulatory linkage incomplete

Both 77% reference complete

Species: Both

Approval status: Official document linked, regulatory match incomplete. An official source document is available, but Roxee has not linked this row to a confirmed FDA animal-drug application or product record yet.

Medication Snapshot

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

Ivermectin 68Mcg Pyrantel 57Mg

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.

Generic name
Ivermectin 68Mcg Pyrantel 57Mg
Species
Both
Completeness
77%
Validation
Incomplete

Indications / Uses

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.

Warnings / Contraindications

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.

  • 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.

Side Effects

Top reported reactions (openFDA): Vomiting, Diarrhoea, INEFFECTIVE, HEARTWORM LARVAE, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy (endoparasite) - hookworm, Underdose.

FAQ

Both

Related Conditions

Heartworm Disease

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:

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 , Toxasca...

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:

  • 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 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
  • Weight loss (1 reports)
  • Medication error NOS (1 reports)
  • Lack of efficacy - heartworm (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 Ivermectin 68Mcg Pyrantel 57Mg; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2026-US-013526
Safety signal coverage Reported signals

27 tracked reaction signals; 24 reported cases; 3 serious reports; 1 species group. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2026-US-013526
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-013526
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

Weight loss (1 reports), Medication error NOS (1 reports), Lack of efficacy (endoparasite) - heartworm (1 reports), Vomiting (1 reports), Unsteady walking (ataxia) (1 reports)

Body systems represented Signal grouping

Digestive (4), Neurologic (2), Behavior (1), Effectiveness (5)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (27 reports)

Breed metadata in reports Metadata only

Retriever - Labrador (2), Crossbred Canine/dog (2), Rottweiler (1), ['Hound - Basset', '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 Ivermectin 68Mcg Pyrantel 57Mg 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

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

Call sooner if Escalation

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

Bottom line: Use this Ivermectin 68Mcg Pyrantel 57Mg 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-013526 · adverse_reaction · adverse reactions
  2. Medication contraindications · safety_warning · warnings contraindications
  3. FOI summary · document · documents
  4. FOI summary · document · documents
  5. FOI summary · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 11, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • 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 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

Most reported reactions:

  • Weight loss (1 reports)
  • Medication error NOS (1 reports)
  • Lack of efficacy (endoparasite) - heartworm (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
Not linked yet
Indication / use
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 contr…
Form / route / dose
Confirm product label and patient-specific plan.
Warnings
  • High: Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of…
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: Manufacturer not confirmed
Identifiers:
ANADA: 200338 NADA: 140971

Warnings / Contraindications

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.

  • High: 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.
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
9
Matching reports
0
Active filters
2
Selected filters
Reaction: Ataxia Clear Body system: Digestive Clear
Reset
Drill into common report signals
Lack of efficacy (endoparasite) - heartworm (5) Elevated serum alkaline phosphatase (ALP) (2) Anal and rectal disorder NOS (1) Ataxia (1) Effectiveness (7) Other (6) Digestive (1) Neurologic (1)
No stored openFDA reports match the selected 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.

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

Tracked signals
27
Reported cases
24
Serious reports
3
Species represented
1
Grouped by Body System
Digestive (4) · Vomiting, Loss of appetite, Excessive appetite Neurologic (2) · Unsteady walking (ataxia), Lethargy (see also Central nervous system depression in 'Neurological') Behavior (1) · Behavioral disorder (unspecified) Effectiveness (5) · Lack of efficacy - NOS, Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (endoparasite) - hookworm Other (15) · Weight loss, Paraphimosis, Neutropenia
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Effectiveness 1 Dog 1
Digestive 1 Dog 0
Neurologic 1 Dog 0
Other 1 Dog 0
Other 1 Dog 0
Digestive 1 Dog 0

Species coverage: Dog (27)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Dog Serious - 1
Digestive Dog Non-serious - 1
Neurologic Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Serious - 1
Effectiveness Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Unknown - -
Neurologic Dog Unknown - -
Behavior Dog Unknown - -
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Only technical FDA review documents are linked right now. Owner handouts, official label / PI, and SPL documents are not linked yet.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

ucm061802.pdf FOI · FOI summary UCM487710.pdf FOI · FOI summary UCM487711.pdf FOI · FOI summary

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

0
No SPL links yet.

FOI

3

ucm061802.pdf

FOI · FOI summary

Open original

UCM487710.pdf

FOI · FOI summary

Open original

UCM487711.pdf

FOI · FOI summary

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 Jul 22, 2026, 7:08 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • 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
Safety (openFDA)
Top reactions: Dog 19 • Cat 0 • View
Case summaries: 9 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Heartworm Disease
Linked using: Usage_Inferred (0.78)
Diagnosis Codes
ICD10_CM: B74.8
Other filariases

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
  • 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. (Contraindication, High)
Top reaction signals
Weight loss (1) Medication error NOS (1) Lack of efficacy (endoparasite) - heartworm (1) Vomiting (1) Unsteady walking (ataxia) (1) Paraphimosis (1) Neutropenia (1) Loss of appetite (1)

Identifiers & Packages

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

Identifiers
ANADA: 200338 NADA: 140971

Enriched Documents

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

  • ucm061802.pdf • FOI summary • Official • Feb. 8, 2024
    FDA FOI summary for application 200338
  • UCM487710.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 140971
  • UCM487711.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 140971

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 3 Clinical 120 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: 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 test… (Clinical, 2026-07-22)
  • contraindications: 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 test… (Clinical, 2026-07-22)
  • contraindications: 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 test… (Clinical, 2026-07-22)
  • contraindications: 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 test… (Clinical, 2026-07-20)
  • contraindications: 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 test… (Clinical, 2026-07-19)
  • contraindications: 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 test… (Clinical, 2026-07-16)
  • contraindications: 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 test… (Clinical, 2026-07-16)
  • contraindications: 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 test… (Clinical, 2026-07-13)
  • contraindications: 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 test… (Clinical, 2026-07-12)
  • contraindications: 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 test… (Clinical, 2026-07-11)
  • contraindications: 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 test… (Clinical, 2026-07-11)
  • contraindications: 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 test… (Clinical, 2026-07-11)
  • contraindications: 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 test… (Clinical, 2026-07-10)
  • contraindications: 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 test… (Clinical, 2026-07-07)
  • contraindications: 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 test… (Clinical, 2026-07-06)
  • contraindications: 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 test… (Clinical, 2026-07-06)
  • contraindications: 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 test… (Clinical, 2026-07-03)
  • contraindications: 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 test… (Clinical, 2026-07-03)
  • contraindications: 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 test… (Clinical, 2026-07-02)
  • contraindications: 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 test… (Clinical, 2026-07-01)
Recent Revisions
  • side_effects updated 2026-07-22 19:08 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-22 19:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-22 19:08 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-22 18:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-22 18:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-22 18:40 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-22 08:29 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-22 08:29 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-22 08:29 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-20 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-20 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-20 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-19 13:48 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-19 13:48 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-19 13:48 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-16 16:34 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-16 16:34 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-07-16 16:34 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-07-16 15:43 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-07-16 15:43 by etl_backfill • Backfilled from existing medication fields

Usage

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.

Contraindications

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)

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

Digestive
Vomiting (1) • Dog Loss of appetite (1) • Dog Excessive appetite (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Dog Tiredness (lethargy) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder • Dog

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (endoparasite) - roundworm NOS (1) • Dog Lack of efficacy (endoparasite) - hookworm (1) • Dog Lack of efficacy (endoparasite) - heartworm (1) • Dog Lack of efficacy (1) • Dog

Showing top 5 for Effectiveness.

Other
Weight loss (1) • Dog Paraphimosis (1) • Dog Neutropenia (1) • Dog Medication error NOS (1) • Dog Limb weakness (1) • Dog
Show more (10)
INEFFECTIVE, HEARTWORM LARVAE (1) • Dog Hyposthenuria (1) • Dog Hypochloraemia (1) • Dog Hyperproteinaemia (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated cholesterol (1) • Dog Ear canal inflammation (1) • Dog Dermal mass (1) • Dog Anal and rectal disorder NOS (1) • Dog Underdose • 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, Rottweiler, Male, 8 year, 39.372 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - heartworm, Weight loss • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014448
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 39.372 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 dose per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm Weight loss
Outcomes: Ongoing

Dog, Retriever - Labrador, Female, 3 year, 23.587 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Lack of efficacy (endoparasite) - heartworm, Medication error NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013474
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.00 Year
  • Weight: 23.587 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm Medication error NOS
Outcomes: Ongoing

Dog, ['Hound - Basset', 'Dog (unknown)'], Male, 12.67 year, 18.597 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Elevated cholesterol, Elevated serum alkaline phosphatase, Hyposthenuria, Paraphimosis, Limb weakness… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012947
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 12.67 Year
  • Weight: 18.597 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Elevated cholesterol Elevated serum alkaline phosphatase Hyposthenuria Paraphimosis Limb weakness Unsteady walking (ataxia)
Outcomes: Ongoing

Dog, ['Beagle', 'Dog (unknown)'], Female, 8 year, 22.044 kilogram • Drug: MSK, Unknown, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (endoparasite) - hookworm, Excessive appetite, Anal and rectal disorder NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013526
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 22.044 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS Lack of efficacy (endoparasite) - hookworm Excessive appetite Anal and rectal disorder NOS
Outcomes: Ongoing

Dog, Spaniel - Cocker American, Female, 2 year, 10.4 kilogram • Drug: MSK, Unknown • Reactions: Neutropenia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012303
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 10.400 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Neutropenia
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Male, 3 year, 31.389 kilogram • Drug: MSK, Tablet, chewable, Oral, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012257
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 31.389 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
Outcomes: Ongoing

Dog, Retriever - Labrador, Female, 6 year, 41.549 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Lack of efficacy - NOS, Dermal mass, Ear canal inflammation, Elevated serum alkaline phosphatase, Hyperproteinaemia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-006293
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 6.00 Year
  • Weight: 41.549 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
Reactions Reported:
Lack of efficacy - NOS Dermal mass Ear canal inflammation Elevated serum alkaline phosphatase Hyperproteinaemia Hypochloraemia
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Male, 3 year, 31.389 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Lack of efficacy (endoparasite) - heartworm • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-005936
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 31.389 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
Reactions Reported:
Lack of efficacy (endoparasite) - heartworm
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

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