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Roxee Medication Guide

Amitraz

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 Liquid Zoetis Inc. Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

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

Safety reports
No safety reports linked
No refresh timestamp yet

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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.
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Amitraz

Amitraz

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

Both Liquid Rx required 100% reference complete

Species: Both

Manufacturer: Zoetis Inc.

Medication Snapshot

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

Amitraz

For the treatment of generalized demodicosis (Demodex canis). Species commonly shown: Both, Dog.

Generic name
Amitraz
Brand names
Mitaban® Liquid Concentrate
Manufacturer
Zoetis Inc.
Species
Both, Dog
Dosage forms
Liquid
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Mitaban® Liquid Concentrate
Dosage forms
Liquid

Indications / Uses

For the treatment of generalized demodicosis (Demodex canis).

Warnings / Contraindications

Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lethargy (see also Central nervous system depression in 'Neurological'), Pruritus, Vomiting, Drug administration error, Alopecia general, Ataxia.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Liquid

Related Conditions

Demodicosis

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 the treatment of generalized demodicosis (Demodex canis).

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:

  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied
  • Do not use for treatment of localized demodicosis or scabies
  • wobbly/unsteady walking (1 reports)
  • Syncope (1 reports)
  • Stomach upset (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 Amitraz; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2018-US-019263
Safety signal coverage Reported signals

27 tracked reaction signals; 22 reported cases; 13 serious reports; 1 species group. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2018-US-019263
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-2018-US-019263
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), Syncope (1 reports), Stomach upset (1 reports), Polyneuritis (1 reports), Lack of efficacy (ectoparasite) - tick NOS (1 reports)

Body systems represented Signal grouping

Digestive (2), Skin & allergy (2), Neurologic (3), Behavior (2)

Species and breed lens

Species represented in reports Species lens

Dog (27 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Amitraz 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

Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or, Do not use for treatment of localized demodicosis or scabies, wobbly/unsteady walking, Syncope, Stomach upset

Call sooner if Escalation

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

Bottom line: Use this Amitraz 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-2018-US-019263 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied
  • Do not use for treatment of localized demodicosis or scabies
  • wobbly/unsteady walking
  • Syncope
  • Stomach upset

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Syncope (1 reports)
  • Stomach upset (1 reports)

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 the treatment of generalized demodicosis (Demodex canis).
Form / route / dose
Form: Liquid
Route: Topical
Confirm product label and patient-specific plan.
Warnings
  • High: Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments …
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Zoetis Inc.
Form: Liquid
Identifiers:
NADA: 120299
Source metadata:

Warnings / Contraindications

Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. 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.

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

Tracked signals
27
Reported cases
22
Serious reports
13
Species represented
1
Grouped by Body System
Digestive (2) · Loss of appetite, Vomiting Skin & allergy (2) · Itching, Alopecia general Neurologic (3) · Unsteady walking (ataxia), Tiredness (lethargy), Lethargy (see also Central nervous system depression in 'Neurological') Behavior (2) · Biting -aggression, Behavioral disorder (unspecified) Effectiveness (3) · Lack of efficacy (endoparasite) - NOS, Lack of efficacy (ectoparasite) - tick NOS, Lack of efficacy (ectoparasite) - flea Other (15) · Weight gain, Syncope, Stomach upset
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Effectiveness 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (27)

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

Mitaban® Liquid Concentrate SPL · SPL

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

1

FOI

0
No FOI links yet.

Mitaban® Liquid Concentrate

SPL · SPL

Open original
FDA Structured Product Label

Mitaban® Liquid Concentrate

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

Sponsor
Zoetis Inc.
NADA
120-299
Status
RX
Form
Liquid
Route
Topical
Species
Dog
Composition / specifications
Amitraz liquid contains 19.9 percent amitraz in an organic solvent.

Dogs

Indication
For the treatment of generalized demodicosis (Demodex canis).
Dosage
One 10.6 milliliter bottle per 2 gallons of warm water (250 parts per million) for each treatment, for a total of 3 to 6 treatments, 14 days apart.
Limitations
Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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 Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Liquid • Topical
Applications: NADA 120-299
Documents: • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Demodicosis
Linked using: Fda_Label (0.95)
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
  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. 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) Syncope (1) Stomach upset (1) Polyneuritis (1) Lack of efficacy (ectoparasite) - tick NOS (1) Drug administration error (1) Dilated pupils (1) Death by euthanasia (1)

Identifiers & Packages

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

Identifiers
NADA: 120299

Data Sources & Change Log

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

Official 5 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lethargy (see also Central nervous system depression in 'Neurological'), Pruritus, Vomiting, Drug administration error, Alope… (Clinical, 2026-04-11)
  • contraindications: Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatm… (Official, 2026-04-11)
  • contraindications: Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatm… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Lethargy (see also Central nervous system depression in 'Neurological'), Pruritus, Vomiting, Drug administration error, Alope… (Official, 2026-02-12)
  • usage: For the treatment of generalized demodicosis (Demodex canis). (Official, 2026-04-11)
  • usage: For the treatment of generalized demodicosis (Demodex canis). (Official, 2026-02-12)
Recent Revisions
  • 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
  • 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
Mitaban® Liquid Concentrate
RX
Amitraz
Liquid • Topical
Label highlights
Official documents
Zoetis Inc. NADA 120-299 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
Amitraz liquid contains 19.9 percent amitraz in an organic solvent.
Dogs
Indication
For the treatment of generalized demodicosis (Demodex canis).
Dosage
One 10.6 milliliter bottle per 2 gallons of warm water (250 parts per million) for each treatment, for a total of 3 to 6 treatments, 14 days apart.
Limitations
Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. 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 the treatment of generalized demodicosis (Demodex canis).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. 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 Vomiting • Dog

Showing top 5 for Digestive.

Skin & allergy
Itching • Dog Alopecia general • Dog

Showing top 5 for Skin & allergy.

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

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy (endoparasite) - NOS (1) • Dog Lack of efficacy (ectoparasite) - tick NOS (1) • Dog Lack of efficacy (ectoparasite) - flea • Dog

Showing top 5 for Effectiveness.

Other
Weight gain (1) • Dog Syncope (1) • Dog Stomach upset (1) • Dog Polyneuritis (1) • Dog Palpable mass NOS (1) • Dog
Show more (10)
Ocular discharge (1) • Dog Eyelid lump (1) • Dog Drug dose administration interval too short (1) • Dog Drug administration error (1) • Dog Dilated pupils (1) • Dog Death by euthanasia (1) • Dog Cognitive disorder NOS (1) • Dog Blindness (1) • Dog Anterior uveitis (1) • Dog Adipsia (1) • 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.

No case-level openFDA reports are linked for this medication yet.

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

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.