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Roxee Medication Guide

Ceftiofur Sodium

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 (Solution) 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
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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Ceftiofur Sodium

Ceftiofur Sodium

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

Both Liquid (Solution) 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.

Ceftiofur Sodium

For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus . Species commonly shown: Both, Dog, Horse, Not For Meat Production.

Generic name
Ceftiofur Sodium
Brand names
Naxcel® Sterile Powder, Ceftiofur for Injection
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, Horse, Goat
Dosage forms
Liquid (Solution), Powder-Sterile
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Naxcel® Sterile Powder Ceftiofur for Injection
Dosage forms
Liquid (Solution) Powder-Sterile

Indications / Uses

For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida , and Histophilus somni in beef and dairy cattle For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus .

Side Effects

Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Leucocytosis NOS, Anaemia NOS, Elevated amylase.

FAQ

Both, Dog, Horse, Not For Meat Production, Goat, Beef, Dairy, Day old poults, 1 day-old broiler chicks, Sheep, Swine, Cattle, Turkey, Poults, Day Old, Day-Old Chicks

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Powder-Sterile

Related Conditions

Pneumonia (aspiration, bacterial, viral) Pododermatitis Urinary tract infection (cystitis)

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 treatment of respiratory infections in horses associated with Streptococcus zooepidemicus .

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:

  • wobbly/unsteady walking (1 reports)
  • trouble breathing (1 reports)
  • Loss of appetite (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
  • Blood in vomit or stool.

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 Ceftiofur Sodium; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2024-US-062683
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 30 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2024-US-062683
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-2024-US-062683
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), Trouble breathing (dyspnea) (1 reports), Loss of appetite (1 reports), Dull reflexes (1 reports), Dilated pupils (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (1), Behavior (2), Other (26)

Species and breed lens

Species represented in reports Species lens

Dog (25 reports), Cat (7 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Ceftiofur Sodium 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

wobbly/unsteady walking, trouble breathing, Loss of appetite

Call sooner if Escalation

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

Bottom line: Use this Ceftiofur Sodium 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-2024-US-062683 · adverse_reaction · adverse reactions
  2. FDA application profile · official_label · quick facts
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. FOI · document · documents
  6. FOI · document · documents
  7. FOI · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:07 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • wobbly/unsteady walking
  • trouble breathing
  • Loss of appetite

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Trouble breathing (dyspnea) (1 reports)
  • Loss of appetite (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
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
1 day-old broiler chicks, Beef, Cattle, Dairy, Day old poults, Day-Old Chicks, Dog, Goat, Horse, Sheep, Swine, Turkey
Indication / use
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus .
Form / route / dose
Form: Liquid (Solution), Powder-Sterile
Route: Intramuscular, Subcutaneous
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
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: Multiple FDA sponsors
Form: Liquid (Solution), Powder-Sterile
Identifiers:
ANADA: 200421 NADA: 140338 NDC Package: 54771-3362-1 NDC Package: 54771-3362-2 NDC Package: 58597-8170-9 NDC Package: 62157-171-01 NDC Package: 62157-396-01 NDC Product: 54771 NDC Product: 58597 NDC Product: 62157
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
32
Reported cases
32
Serious reports
30
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Diarrhea, Decreased appetite Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Behavioral disorder (unspecified), Anxiety Other (26) · Trouble breathing (dyspnea), Dull reflexes, Drug administration error
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Other 1 Cat 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Dog (25) Cat (7)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Cat Serious - 1
Other Cat Serious - 1
Digestive Dog Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Digestive Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog 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 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
Other Dog Serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog 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.

140-338 Official label / PI · EA 140-338 Official label / PI · FONSI 140-338 Official label / PI · EA

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

4

SPL

2

FOI

15

140-338

Official label / PI · EA

Open original

140-338

Official label / PI · FONSI

Open original

140-338

Official label / PI · EA

Open original

140-338

Official label / PI · FONSI

Open original

Naxcel® Sterile Powder

SPL · SPL

Open original
FDA Structured Product Label

Naxcel® Sterile Powder

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
140-338
Status
RX
Form
Liquid (Solution)
Route
Intramuscular, Subcutaneous
Species
Dog • Horse • Goat • Beef • Dairy • Day old poults • 1 day-old broiler chicks • Sheep
Composition / specifications
Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.

Horses

Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.

Cattle

Indication
Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Indication

For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

Swine

Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.

Sheep

Indication
For treatment of sheep respiratory disease (pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

Chickens (Day Old Chicks)

Indication
For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks.
Dosage
0.08 to 0.20 mg as a single subcutaneous injection in the neck.

Turkeys (Day Old Poults)

Indication
For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults.
Dosage
0.17 to 0.5 mg as a single subcutaneous injection in the neck.

Dogs

Indication
Treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis.
Dosage
1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared, for 5 to 14 days.

Goats

Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.

Ceftiofur for Injection

SPL · SPL

Open original
FDA Structured Product Label

Ceftiofur for Injection

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

Sponsor
Hospira, Inc.
ANADA
200-421
Status
RX
Form
Powder-Sterile
Route
Subcutaneous, Intramuscular
Species
Dog • Goat • Swine • Cattle • Turkey • Day-Old Chicks • Sheep

<strong>Cattle</strong>

Indication
For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.  Also, for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments

<strong>Swine</strong>

Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
1.36 to 2.27 mg per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconstituted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.

<strong>Sheep</strong>

Indication
For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mL reconstituted sterile solution per 100 lbs body weight).  Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.

<strong>Goats</strong>

Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.

<strong>Horses</strong>

Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
1.0 to 2.0 mg per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lb body weight). A maximum of 10 mL may be administered per injection site.  Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared and should not exceed 10 days.

<strong>Dogs</strong>

Indication
For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
Dosage
1.0 mg per pound 2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24 hour intervals for 5-14 days.

<strong>Day-Old Chicks</strong>

Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
Dosage
0.08 to 0.20 mg/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks.

<strong>Day-Old Turkey Poults</strong>

Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.
Dosage
0.17 to 0.5 mg/poult. 1 ml of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults.

ucm049847.pdf

FOI · FOI

Open original

ucm049846.pdf

FOI · FOI

Open original

ucm049844.pdf

FOI · FOI

Open original

ucm049843.pdf

FOI · FOI

Open original

ucm049842.pdf

FOI · FOI

Open original

ucm049841.pdf

FOI · FOI

Open original

N140338_Supp_10_25_96.pdf

FOI · FOI

Open original

UCM470933.pdf

FOI · FOI

Open original

N140338_Supp_08-24-1995.pdf

FOI · FOI

Open original

UCM539438.pdf

FOI · FOI

Open original

N140338_Supp_08_04_1992.pdf

FOI · FOI

Open original

N140338_Supp_03-15-1991.pdf

FOI · FOI

Open original

UCM490826.pdf

FOI · FOI

Open original

UCM478009.pdf

FOI · FOI

Open original

UCM307677.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.
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: 1 day-old broiler chicks, Beef, Cattle, Dairy, Day old poults, Day-Old Chicks, Dog, Goat, Horse, Sheep, Swine, Turkey
Rx/OTC: RX
Form/route: Liquid (Solution), Powder-Sterile • Intramuscular, Subcutaneous
Applications: NADA 140-338 • ANADA 200-421
Documents: 19 (FOI: 15) • SPL: 2 • 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
Linked using: Fda_Label (0.95), Fda_Label (0.95), 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.

Top reaction signals
Unsteady walking (ataxia) (1) Trouble breathing (dyspnea) (1) Loss of appetite (1) Dull reflexes (1) Dilated pupils (1) Diabetic ketoacidosis (1) Dehydration (1) Decreased percentage of reticulocytes (1)

Identifiers & Packages

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

Identifiers
ANADA: 200421 NADA: 140338 NDC Package: 54771-3362-1 NDC Package: 54771-3362-2 NDC Package: 58597-8170-9 NDC Package: 62157-171-01 NDC Package: 62157-396-01 NDC Product: 54771 NDC Product: 58597 NDC Product: 62157
Package NDC Product NDC Form / Route Status
54771-3362-1 54771 -
54771-3362-2 54771 -
58597-8170-9 58597 -
62157-171-01 62157 -
62157-396-01 62157 -

Enriched Documents

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

  • UCM478009.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM490826.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_03-15-1991.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_08_04_1992.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM539438.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_08-24-1995.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM470933.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_10_25_96.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049841.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049842.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049843.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049844.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049846.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049847.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM307677.pdf • FOI summary • Official • Jan. 16, 2018
    FDA FOI summary for application 200421

Data Sources & Change Log

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

Official 82 Clinical 6 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Leucocytosis NOS, Anaemia NOS, Elev… (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Leucocytosis NOS, Anaemia NOS, Elev… (Clinical, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Leucocytosis NOS, Anaemia NOS, Elev… (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Leucocytosis NOS, Anaemia NOS, Elev… (Clinical, 2026-04-11)
  • usage: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumo… (Clinical, 2026-04-15)
  • usage: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumo… (Clinical, 2026-04-11)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-22)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-22)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-21)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-20)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-13)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-12)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-12)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-11)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-11)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-10)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-09)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-08)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-07)
  • indications: Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus s… (Official, 2026-06-06)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects 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
  • 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
Naxcel® Sterile Powder
RX
Ceftiofur Sodium
Liquid (Solution) • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 140-338 Approved Sep 6, 2022
Ceftiofur for Injection
RX
Ceftiofur Sodium
Powder-Sterile • Subcutaneous, Intramuscular
Label highlights
Official documents
Hospira, Inc. ANADA 200-421 W Jan 16, 2018

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 • Horse • Goat • Beef • Dairy • Day old poults • 1 day-old broiler chicks • Sheep
Composition / specifications
Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.
Horses
Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.
Limitations
Cattle
Indication
Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Indication

For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.
Limitations
Sheep
Indication
For treatment of sheep respiratory disease (pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Chickens (Day Old Chicks)
Indication
For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks.
Dosage
0.08 to 0.20 mg as a single subcutaneous injection in the neck.
Limitations
Turkeys (Day Old Poults)
Indication
For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults.
Dosage
0.17 to 0.5 mg as a single subcutaneous injection in the neck.
Limitations
Dogs
Indication
Treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis.
Dosage
1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared, for 5 to 14 days.
Limitations
Goats
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Goat • Swine • Cattle • Turkey • Day-Old Chicks • Sheep
<strong>Cattle</strong>
Indication
For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.  Also, for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments
Limitations
<strong>Swine</strong>
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
1.36 to 2.27 mg per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconstituted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
<strong>Sheep</strong>
Indication
For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mL reconstituted sterile solution per 100 lbs body weight).  Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
<strong>Goats</strong>
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
<strong>Horses</strong>
Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
1.0 to 2.0 mg per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lb body weight). A maximum of 10 mL may be administered per injection site.  Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared and should not exceed 10 days.
Limitations
<strong>Dogs</strong>
Indication
For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
Dosage
1.0 mg per pound 2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24 hour intervals for 5-14 days.
Limitations
<strong>Day-Old Chicks</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
Dosage
0.08 to 0.20 mg/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks.
Limitations
<strong>Day-Old Turkey Poults</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.
Dosage
0.17 to 0.5 mg/poult. 1 ml of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults.
Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida , and Histophilus somni in beef and dairy cattle For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus .

Source: FDA Animal Drugs @ FDA • Reference

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 Diarrhea (1) • Cat Decreased appetite (1) • Cat

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Trouble breathing (1) • Cat Dull reflexes (1) • Dog Drug administration error (1) • Cat Dilated pupils (1) • Dog Diabetic ketoacidosis (1) • Dog
Show more (21)
Dehydration (1) • Cat Decreased percentage of reticulocytes (1) • Dog Death by euthanasia (1) • Dog Death (1) • Dog Crackles on auscultation (1) • Dog Cough (1) • Dog Constipation (1) • Dog Collapse NOS (1) • Dog Coagulopathy (1) • Dog Circulatory shock (1) • Dog Cholecystitis (1) • Dog Cardiac enlargement (1) • Dog Bruising (1) • Dog Bloated stomach (1) • Dog Apnoea (1) • Dog Anaphylaxis (1) • Dog Anaemia NOS (1) • Cat Adrenal gland disorder NOS (1) • Dog ABNORMAL TEST RESULT, THYROID NOS (1) • Dog Abnormal pupil light reflex (1) • Dog Abdominal pain (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.

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