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Ketoconazole

Detailed information about Ketoconazole

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

Your vet decides this. Here's what owners typically ask/watch for.

What to watch for:

  • Vomiting (1 reports)
  • wobbly/unsteady walking (1 reports)
  • Localised skin reaction (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.

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:

  • Vomiting
  • wobbly/unsteady walking
  • Localised skin reaction

Most reported reactions:

  • Vomiting (1 reports)
  • Unsteady walking (ataxia) (1 reports)
  • Localised skin reaction (1 reports)

When to call your vet:

  • 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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • 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 11, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Image coming soon
Ketoconazole

Ketoconazole

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
Identifiers:
NDC Package: 11695-6973-1 NDC Package: 11695-6973-2 NDC Package: 11695-6973-3 NDC Package: 11695-6974-1 NDC Package: 11695-6975-1 NDC Package: 11695-6976-1 NDC Package: 11695-6979-1 NDC Package: 11695-6979-2 NDC Package: 13985-441-04 NDC Package: 13985-441-06 NDC Package: 13985-442-30 NDC Package: 13985-443-08 NDC Package: 13985-444-08 NDC Package: 13985-444-16 NDC Package: 13985-445-68 NDC Package: 17033-131-01 NDC Package: 17033-131-08 NDC Package: 17033-132-01 NDC Package: 17033-132-08 NDC Package: 17033-134-50

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
32
Reported cases
32
Serious reports
26
Species represented
2
Grouped by Body System
Digestive (2) · Vomiting, Decreased appetite Skin & allergy (1) · Application site itching Neurologic (1) · Unsteady walking (ataxia) Effectiveness (1) · Lack of efficacy - NOS Other (27) · Localised skin reaction, Leucopenia NOS, Lack of coordination
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Neurologic 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Effectiveness 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (25) Dog (7)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Serious - 1
Neurologic Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Effectiveness Dog Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Digestive Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
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
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • 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 11, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM 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 20 • Cat 8 • View
Case summaries: 10 (showing 8) • View
openFDA reports are unverified and do not prove causation.
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.

Top reaction signals
Vomiting (1) Unsteady walking (ataxia) (1) Localised skin reaction (1) Leucopenia NOS (1) Lack of efficacy - NOS (1) Lack of coordination (1) Increased skin sensitivity (1) Increased drinking (1)

Identifiers & Packages

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

Identifiers
NDC Package: 11695-6973-1 NDC Package: 11695-6973-2 NDC Package: 11695-6973-3 NDC Package: 11695-6974-1 NDC Package: 11695-6975-1 NDC Package: 11695-6976-1 NDC Package: 11695-6979-1 NDC Package: 11695-6979-2 NDC Package: 13985-441-04 NDC Package: 13985-441-06 NDC Package: 13985-442-30 NDC Package: 13985-443-08 NDC Package: 13985-444-08 NDC Package: 13985-444-16 NDC Package: 13985-445-68 NDC Package: 17033-131-01 NDC Package: 17033-131-08 NDC Package: 17033-132-01 NDC Package: 17033-132-08 NDC Package: 17033-134-50 NDC Package: 17033-142-02 NDC Package: 17033-142-08 NDC Package: 17033-143-08 NDC Package: 17033-191-04
Package NDC Product NDC Form / Route Status
11695-6973-1 11695 -
11695-6973-2 11695 -
11695-6973-3 11695 -
11695-6974-1 11695 -
11695-6975-1 11695 -
11695-6976-1 11695 -
11695-6979-1 11695 -
11695-6979-2 11695 -
13985-441-04 13985 -
13985-441-06 13985 -
13985-442-30 13985 -
13985-443-08 13985 -
13985-444-08 13985 -
13985-444-16 13985 -
13985-445-68 13985 -
17033-131-01 17033 -
17033-131-08 17033 -
17033-132-01 17033 -
17033-132-08 17033 -
17033-134-50 17033 -

Data Sources & Change Log

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

Official 1 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Other abnormal test result NOS, Diarrhoea, Lethargy (see also Central nervous system depres… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

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) • Cat Decreased appetite (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Application site itching (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Localised skin reaction (1) • Cat Leucopenia NOS (1) • Dog Lack of coordination (1) • Cat Increased weight (1) • Dog Increased skin sensitivity (1) • Cat
Show more (22)
Increased drinking (1) • Cat Head tilt - ear disorder (1) • Cat Head shake - ear disorder (1) • Cat Hair shedding (1) • Cat Gait abnormality (1) • Cat Faecal incontinence (1) • Cat Eosinopenia (1) • Dog Elevated globulins (1) • Dog Ear pain (1) • Cat Ear canal erythema (1) • Cat Dry heaving (1) • Cat Difficulty eating NOS (1) • Cat Dehydration (1) • Cat Decreased drinking (1) • Cat Decreased bowel movements (1) • Cat Brain damage NOS (1) • Cat Bradycardia (1) • Dog Balance problem (1) • Cat Application site reddening (1) • Cat Application site inflammation (1) • Cat Application site erythema (1) • Cat Anaemia NOS (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.

Dog, Shepherd Dog - German, Male, 4.9 year, 35.11 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055356
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 4.90 Year
  • Weight: 35.110 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Ongoing

Dog, ['Poodle (unspecified)', 'Dog (unknown)'], Female, 5.5 year, 9.84 kilogram • Drug: MSK, Unassigned, Unknown, Dose: 100 Milligram per animal, Frequency: 1 per day • Reactions: Increased weight • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055066
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 5.50 Year
  • Weight: 9.840 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
  • Dose: 100 Milligram per animal
  • Frequency: 1 per day
Reactions Reported:
Increased weight
Outcomes: Ongoing

Dog, Terrier - Bull - American Pit, Male, 3.3 year, 30 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-054739
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.30 Year
  • Weight: 30.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Beagle, Male, 4.5 year, 10.932 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Lack of efficacy - NOS, Leucopenia NOS, Neutropenia, Eosinopenia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-053285
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 4.50 Year
  • Weight: 10.932 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Lack of efficacy - NOS Leucopenia NOS Neutropenia Eosinopenia
Outcomes: Ongoing

Dog, ['Hound (unspecified)', 'Dog (unknown)'], Male, 11 year, 25.764 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Seizure NOS, Vomiting, Urinary incontinence, Stiffness NOS, Bradycardia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-053364
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 25.764 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Seizure NOS Vomiting Urinary incontinence Stiffness NOS Bradycardia Muscle wasting Anaemia NOS Thrombocytopenia Elevated globulins Lymphopenia
Outcomes: Ongoing

Cat, Rex - Devon, Male, 1 year, 4.082 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 application per animal, Frequency: 1 per day • Reactions: Application site erythema, Application site inflammation, Skin lesion NOS, Hair shedding, Itching • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-023775
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 4.082 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 application per animal
  • Frequency: 1 per day
Reactions Reported:
Application site erythema Application site inflammation Skin lesion NOS Hair shedding Itching
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 11.91 year, 5.44 kilogram • Drug: MSK • Reactions: Dehydration, Brain damage NOS, Neoplasia NOS, Ear canal erythema, Ear pain… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-019265
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.91 Year
  • Weight: 5.440 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
Reactions Reported:
Dehydration Brain damage NOS Neoplasia NOS Ear canal erythema Ear pain Tense abdomen Weight gain Tympanic rupture Dry heaving Decreased drinking Urinary tract disorder NOS Increased drinking Otitis media Rotatory nystagmus Gait abnormality Head tilt - ear disorder Lack of coordination Walking difficulty Decreased appetite Unsteady walking (ataxia)
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 2.4 year, 5.7 kilogram • Drug: MSK • Reactions: Nystagmus, Weight loss, Faecal incontinence, Unable to walk, Difficulty eating NOS… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2024-US-067755
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 2.40 Year
  • Weight: 5.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
Reactions Reported:
Nystagmus Weight loss Faecal incontinence Unable to walk Difficulty eating NOS Decreased bowel movements Urinary incontinence Unsteady walking (ataxia) Unable to stand Head tilt - ear disorder Balance problem Not drinking
Outcomes: Outcome Unknown

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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