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Roxee Medication Guide

Cefpodoxime Proxetil

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 Tablet and Chewable Tablet Multiple FDA sponsors 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
Safety data refreshed
Jun 13, 2026, 11:29 a.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 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Cefpodoxime Proxetil

Cefpodoxime Proxetil

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

Both Tablet and Chewable Tablet Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

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

Cefpodoxime Proxetil

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis . For the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, S. aureus, Streptococcus canis (group G, beta-hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis . Species commonly shown: Both, Dog.

Generic name
Cefpodoxime Proxetil
Brand names
Simplicef®, Cefpodoxime Proxetil Tablets
Manufacturer
Multiple FDA sponsors
Species
Both, Dog
Dosage forms
Tablet and Chewable Tablet, Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Simplicef® Cefpodoxime Proxetil Tablets
Dosage forms
Tablet and Chewable Tablet Tablet

Indications / Uses

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , Staphylococcus aureus , Streptococcus canis (group G, ß hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis . For the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus intermedius , Staphylococcus aureus , Streptococcus canis (group G, ß hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , S. aureus , Streptococcus canis (group G, beta-hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis .

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian

Side Effects

Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NOS, Diarrhoea, Seizure NOS, Anorexia.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Tablet and Chewable Tablet, Tablet

Related Conditions

Abscesses (cat bite abscess)

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 skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , S. aureus , Streptococcus canis (group G, beta-hemolytic), Escherichia coli , Pasteurella mul...

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:

  • Loss of appetite (1 reports)
  • Lack of efficacy - NOS (1 reports)
  • Intestinal disorder NOS (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 Cefpodoxime Proxetil; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2019-US-038913
Safety signal coverage Reported signals

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.

Source: openFDA case USA-USFDACVM-2019-US-038913
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-2019-US-038913
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

Loss of appetite (1 reports), Lack of efficacy - NOS (1 reports), Intestinal disorder NOS (1 reports), Intentional misuse (1 reports), Inappropriate elimination NOS (1 reports)

Body systems represented Signal grouping

Digestive (2), Skin & allergy (1), Effectiveness (1), Other (28)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (24 reports), Cat (8 reports)

Breed metadata in reports Metadata only

['Retriever - Golden', 'Poodle (unspecified)'] (1), Cat (other) (1), Retriever - Labrador (1), ['Chihuahua', '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 Cefpodoxime Proxetil 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

Loss of appetite, Lack of efficacy - NOS, Intestinal disorder NOS

Call sooner if Escalation

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

Bottom line: Use this Cefpodoxime Proxetil 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-2019-US-038913 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · 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:

  • Loss of appetite
  • Lack of efficacy - NOS
  • Intestinal disorder NOS

Most reported reactions:

  • Loss of appetite (1 reports)
  • Lack of efficacy - NOS (1 reports)
  • Intestinal disorder NOS (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
Dog
Indication / use
For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , S. aureus , Streptococcus canis (group G, beta-hemol…
Form / route / dose
Form: Tablet, Tablet and Chewable Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug t…
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: Multiple FDA sponsors
Form: Tablet, Tablet and Chewable Tablet
Identifiers:
ANADA: 200543 ANADA: 200815 NADA: 141232 NDC Package: 11695-7040-1 NDC Package: 11695-7040-2 NDC Package: 11695-7041-1 NDC Package: 11695-7041-2 NDC Package: 17033-431-10 NDC Package: 17033-432-10 NDC Package: 54771-5228-1 NDC Package: 54771-5228-2 NDC Package: 54771-5229-1 NDC Package: 54771-5229-2 NDC Package: 73309-025-01 NDC Package: 73309-025-02 NDC Package: 73309-025-03 NDC Package: 73377-069-01 NDC Package: 73377-069-02 NDC Package: 73377-069-03 NDC Package: 86101-033-71
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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.

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
6
Matching reports
0
Active filters
2
Selected filters
Reaction: Alkaline urine Clear Body system: Digestive Clear
Reset
Drill into common report signals
Medication error NOS (2) Vomiting (2) Alkaline urine (1) Anorexia (1) Other (4) Digestive (3) Skin & allergy (2) Effectiveness (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
32
Reported cases
32
Serious reports
24
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Decreased appetite Skin & allergy (1) · Facial swelling (possible allergy) Effectiveness (1) · Lack of efficacy - NOS Other (28) · Intestinal disorder NOS, Intentional misuse, Inappropriate urination
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Effectiveness 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (24) Cat (8)

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

Cefpodoxime Proxetil Tablets SPL · SPL Cefpodoxime Proxetil Tablets SPL · SPL Simplicef® 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

3

FOI

4

Cefpodoxime Proxetil Tablets

SPL · SPL

Open original
FDA Structured Product Label

Cefpodoxime Proxetil Tablets

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

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-815
Status
RX
Form
Tablet
Route
Oral
Composition / specifications
100 mg and 200 mg

Dogs

Indication

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, S. aureus, Streptococcus canis (group G, beta-hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Dosage

5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

Cefpodoxime Proxetil Tablets

SPL · SPL

Open original
FDA Structured Product Label

Cefpodoxime Proxetil Tablets

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

Sponsor
Dechra Veterinary Products LLC
ANADA
200-543
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
100 mg, 200 mg

Label highlights

Indication

For the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis

Dosage
5-10 mg/kg (2.3-4.5 mg/lb) body weight once a day for 5-7 days or 2-3 days beyond the cessation of clinical signs, up to a maximum of 28 days. Treatment of acute infections should not be continued for more than 3-4 days if no response to therapy is seen
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

Simplicef®

SPL · SPL

Open original
FDA Structured Product Label

Simplicef®

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
141-232
Status
RX
Form
Tablet and Chewable Tablet
Route
Oral
Species
Dog

Dogs

Indication

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Dosage

5 to 10 milligram per kilogram (2.3 to 4.5 milligram per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOI Summary oA 200-815 Approved July 8, 2025.pdf

FOI · FOI

Open original

UCM338192.pdf

FOI · FOI

Open original

UCM433791.pdf

FOI · FOI

Open original

ucm118043.pdf

FOI · FOI

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 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 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 • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet, Tablet and Chewable Tablet • Oral
Applications: ANADA 200-815 • ANADA 200-543 • NADA 141-232
Documents: 4 (FOI: 4) • SPL: 3 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 26 • Cat 2 • View
Case summaries: 6 (showing 6) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Abscesses (cat bite abscess)
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
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian (Contraindication, High)
Top reaction signals
Loss of appetite (1) Lack of efficacy - NOS (1) Intestinal disorder NOS (1) Intentional misuse (1) Inappropriate elimination NOS (1) Icterus (1) Hypoproteinaemia (1) Heart murmur (1)

Identifiers & Packages

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

Identifiers
ANADA: 200543 ANADA: 200815 NADA: 141232 NDC Package: 11695-7040-1 NDC Package: 11695-7040-2 NDC Package: 11695-7041-1 NDC Package: 11695-7041-2 NDC Package: 17033-431-10 NDC Package: 17033-432-10 NDC Package: 54771-5228-1 NDC Package: 54771-5228-2 NDC Package: 54771-5229-1 NDC Package: 54771-5229-2 NDC Package: 73309-025-01 NDC Package: 73309-025-02 NDC Package: 73309-025-03 NDC Package: 73377-069-01 NDC Package: 73377-069-02 NDC Package: 73377-069-03 NDC Package: 86101-033-71 NDC Package: 86101-033-76 NDC Package: 86101-034-71 NDC Package: 86101-034-76 NDC Package: 86136-134-36
Package NDC Product NDC Form / Route Status
11695-7040-1 11695 -
11695-7040-2 11695 -
11695-7041-1 11695 -
11695-7041-2 11695 -
17033-431-10 17033 -
17033-432-10 17033 -
54771-5228-1 54771 -
54771-5228-2 54771 -
54771-5229-1 54771 -
54771-5229-2 54771 -
73309-025-01 73309 -
73309-025-02 73309 -
73309-025-03 73309 -
73377-069-01 73377 -
73377-069-02 73377 -
73377-069-03 73377 -
86101-033-71 86101 -
86101-033-76 86101 -
86101-034-71 86101 -
86101-034-76 86101 -

Enriched Documents

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

  • FOI Summary oA 200-815 Approved July 8, 2025.pdf • FOI summary • Official • July 31, 2025
    FDA FOI summary for application 200815
  • UCM338192.pdf • FOI summary • Official • March 16, 2019
    FDA FOI summary for application 200543
  • ucm118043.pdf • FOI summary • Official • March 15, 2019
    FDA FOI summary for application 141232
  • UCM433791.pdf • FOI summary • Official • March 15, 2019
    FDA FOI summary for application 141232

Data Sources & Change Log

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

Official 73 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NOS, Diarrhoea, Seizure… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed v… (Official, 2026-04-12)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed v… (Official, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed v… (Official, 2026-02-12)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-22)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-22)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-21)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-20)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-13)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-12)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-12)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-11)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-11)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-10)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-09)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-08)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-07)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-06)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-05)
  • indications: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus c… (Official, 2026-06-04)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • 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
Cefpodoxime Proxetil Tablets
RX
Cefpodoxime proxetil
Tablet • Oral
Label highlights
Official documents
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-815 Approved Jul 31, 2025
Cefpodoxime Proxetil Tablets
RX
Cefpodoxime proxetil
Tablet • Oral
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-543 Approved Mar 16, 2019
Simplicef®
RX
Cefpodoxime proxetil
Tablet and Chewable Tablet • Oral
Label highlights
Official documents
Zoetis Inc. NADA 141-232 Approved Mar 15, 2019

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
100 mg and 200 mg
Dogs
Indication

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, S. aureus, Streptococcus canis (group G, beta-hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Dosage

5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
100 mg, 200 mg
Label highlights
Indication

For the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis

Dosage
5-10 mg/kg (2.3-4.5 mg/lb) body weight once a day for 5-7 days or 2-3 days beyond the cessation of clinical signs, up to a maximum of 28 days. Treatment of acute infections should not be continued for more than 3-4 days if no response to therapy is seen
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Dogs
Indication

For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Dosage

5 to 10 milligram per kilogram (2.3 to 4.5 milligram per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

Limitations
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 skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , Staphylococcus aureus , Streptococcus canis (group G, ß hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis . For the treatment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus intermedius , Staphylococcus aureus , Streptococcus canis (group G, ß hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , S. aureus , Streptococcus canis (group G, beta-hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis .

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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 Decreased appetite (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Facial swelling (possible allergy) (1) • Dog

Showing top 5 for Skin & allergy.

Effectiveness
Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Intestinal disorder NOS (1) • Dog Intentional misuse (1) • Cat Inappropriate urination (1) • Cat Inappropriate elimination NOS (1) • Dog Icterus (1) • Dog
Show more (23)
Hypoproteinaemia (1) • Dog Heart murmur (1) • Dog Eye haemorrhage (1) • Dog Enlarged lymph node (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated liver enzymes NOS (1) • Dog Elevated alanine aminotransferase (1) • Dog Ear infection NOS (1) • Dog Dermal thickening (1) • Cat Decreased urine concentration (1) • Cat Decreased haematocrit (1) • Dog Decreased blood urea nitrogen (BUN) or creatinine (1) • Cat Death (1) • Dog Deafness (1) • Dog Crystalluria (1) • Dog Corneal oedema (1) • Dog Conjunctival oedema (1) • Dog Bloody stool (1) • Dog Blood loss NOS (1) • Dog Bacterial skin infection NOS (1) • Dog Allergic skin reaction (1) • Cat Alkaline urine (1) • Dog Abnormal cytology (1) • Cat

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, ['Retriever - Golden', 'Poodle (unspecified)'], Female, 12 year, 43.273 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Urinary tract infection, Medication error NOS, Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074070
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 43.273 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 dose per animal
  • Frequency: 1 per day
Reactions Reported:
Urinary tract infection Medication error NOS Lack of efficacy - NOS
Outcomes: Ongoing

Cat, Cat (other), Male, 16 year, 3.969 kilogram • Drug: MSK, Tablet, Oral, Dose: 200 Milligram per animal, Frequency: 12 per hour • Reactions: Neutropenia, Medication error NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074220
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 16.00 Year
  • Weight: 3.969 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 200 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Neutropenia Medication error NOS
Outcomes: Ongoing

Dog, Retriever - Labrador, Female, 4 year, 57.5 kilogram • Drug: MSK, Tablet, Oral, Dose: 300 Milligram per animal, Frequency: 24 per hour • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-075022
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 57.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 300 Milligram per animal
  • Frequency: 24 per hour
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

Dog, ['Chihuahua', 'Dog (unknown)'], Female, 20 week, 2.26 kilogram • Drug: MSK, Unknown • Reactions: Icterus, Death, Other abnormal test result NOS, Elevated liver enzymes NOS, Swollen joint… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-074897
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 20.00 Week
  • Weight: 2.260 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Icterus Death Other abnormal test result NOS Elevated liver enzymes NOS Swollen joint Localised hair loss Skin lesion NOS Conjunctival oedema Corneal oedema Skin scab Swollen limb Tiredness (lethargy) Loss of appetite Ear infection NOS Local swelling
Outcomes: Died

Dog, Corgi (unspecified), Male, 11 week, 3.175 kilogram • Drug: MSK, Tablet, Oral, Dose: 200 Milligram per animal • Reactions: Decreased haematocrit, Crystalluria, Proteinuria, Hypoproteinaemia, Overdose… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073099
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Week
  • Weight: 3.175 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 200 Milligram per animal
Reactions Reported:
Decreased haematocrit Crystalluria Proteinuria Hypoproteinaemia Overdose Alkaline urine
Outcomes: Ongoing

Dog, ['Plott', 'Dog (unknown)'], Male, 9 year, 22.27 kilogram • Drug: MSK, Tablet, Oral, Dose: 150 Milligram per animal, Frequency: 24 per hour • Reactions: Vomiting, Facial swelling (possible allergy) • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-072799
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 22.270 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 150 Milligram per animal
  • Frequency: 24 per hour
Reactions Reported:
Vomiting Facial swelling (possible allergy)
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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