This page reprints a manufacturer label. Everything below in quotation marks is copied from Veraflox™, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for Veraflox™ by Elanco US Inc, a pradofloxacin product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.
The label
Product: Veraflox™. Manufacturer: Elanco US Inc. FDA Structured Product Label set id bc23bafe-9f6e-4253-84d1-3ff69b0a1f05. Label effective 2025-11-11. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
VERAFLOX is indicated for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius.
Dosage and Administration
Shake well before use. To ensure a correct dosage, body weight should be determined as accurately as possible. The dose of VERAFLOX is 7.5 mg/kg (3.4 mg/lb) body weight once daily for 7 consecutive days. Use the syringe provided to ensure accuracy of dosing to the nearest 0.1 mL. Rinse syringe between doses. A sample of the lesion should be obtained for culture and susceptibility testing prior to beginning antibacterial therapy. Once results become available, continue with appropriate therapy. If acceptable response to treatment is not observed, or if no improvement is seen within 3 to 4 days, then the diagnosis should be re-evaluated and appropriate alternative therapy considered.
Contraindications
DO NOT USE IN DOGS. Pradofloxacin has been shown to cause bone marrow suppression in dogs. Dogs may be particularly sensitive to this effect, potentially resulting in severe thrombocytopenia and neutropenia. Quinolone-class drugs have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Pradofloxacin is contraindicated in cats with a known hypersensitivity to quinolones.
Warnings
Human Warnings: Not for human use. Keep out of reach of children. Individuals with a history of quinolone hypersensitivity should avoid this product. Avoid contact with eyes and skin. In case of ocular contact, immediately flush eyes with copious amounts of water. In case of dermal contact, wash skin with soap and water immediately for at least 20 seconds. Consult a physician if irritation persists following ocular or dermal exposure, or in case of accidental ingestion. In humans, there is a risk of photosensitization within a few hours after exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. Do not eat, drink or smoke while handling this product. It is recommended that used syringes be kept out of reach of children and disposed of properly. Animal Warnings: For use in cats only. The administration of pradofloxacin for longer than 7 days induced reversible leukocyte, neutrophil, and lymphocyte decreases in healthy, 12-week-old kittens (see Animal Safety section). If an unexplained drop in leukocyte, neutrophil, and/or lymphocyte counts is noted during pradofloxacin therapy, discontinuation of treatment is recommended.
Precautions
Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant animal pathogens. The use of fluoroquinolones in cats has been associated with the development of retinopathy and/or blindness. Such products should be used with caution in cats. Quinolones have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. The safety of pradofloxacin in immune-compromised cats (i.e., cats infected with feline leukemia virus and/or feline immunodeficiency virus) has not been evaluated. Quinolones should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation that may lead to convulsive seizures. The safety of pradofloxacin in cats younger than 12 weeks of age has not been evaluated. The safety of pradofloxacin in cats that are used for breeding or that are pregnant and/or lactating has not been evaluated. DRUG INTERACTIONS: Compounds (e.g., sucralfate, antacids and multivitamins) containing divalent and trivalent cations (e.g., iron, aluminum, calcium, magnesium, and zinc) may substantially interfere with the absorption of quinolones resulting in a decrease in product bioavailability. Therefore, the concomitant oral administration of quinolones with foods, supplements, or other preparations containing these compounds should be avoided. The dosage of theophylline should be reduced when used concurrently with quinolones. Cimetidine has been shown to interfere with the metabolism of quinolones and should be used with care when used concurrently. Concurrent use of quinolones with oral cyclosporine should be avoided. Concurrent administration of quinolones may increase the action of oral anticoagulants.
Adverse Reactions
In a multi-site field study, 282 cats (ages 0.3 to 19 years) were evaluated for safety when given either VERAFLOX at a dose of 7.5 mg/kg (3.4 mg/lb) or placebo (vehicle without active ingredient) at a dose of 0.14 mL/lb (0.3 mL/kg). Each group was treated once daily for 7 consecutive days. Adverse reactions are summarized in Table 1 . Table 1: Number of Adverse Reactions Among Cats Treated with Pradofloxacin (N=190) or Vehicle (N=92)* * Some cats may have experienced more than one adverse reaction or more than one occurrence of the same adverse reaction during the study. Adverse Reactions Pradofloxacin Vehicle Diarrhea / loose stools 7 2 Leukocytosis with neutrophilia 4 6 Elevated CPK levels 4 4 Sneezing 4 1 Hematuria 2 2 Hypersalivation 2 1 Pruritus 2 0 Inappetence 1 3 Lethargy 1 2 Cardiac murmur 1 1 Reclusive behavior 1 1 Vomiting 1 1 Bacteriuria 1 0 Lymphadenopathy 1 0 Polydipsia 1 0 Upper respiratory infection 1 0 The Safety Data Sheet (SDS) provides additional occupational safety information.
Description
Pradofloxacin is a fluoroquinolone antibiotic and belongs to the class of quinoline carboxylic acid derivatives. Its chemical name is: 7-[(4aS) octahydro-6H-pyrrolo [3, 4-b] pyridine-6yl]-8-cyano-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-3-quinoline carboxylic acid. Each mL of VERAFLOX Oral Suspension provides 25 mg of pradofloxacin. Chemical Structure of Pradofloxacin
Storage
Store below 30°C (86°F). After initial opening, VERAFLOX has demonstrated in-use stability of 60 days.
FDA adverse event reports
The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming pradofloxacin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.
These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.
Dogs: 15 reports
| VeDDRA reaction term | Reports |
|---|---|
| Behavioural disorder NOS | 3 |
| Adipsia | 2 |
| Corneal ulcer | 2 |
| Death by euthanasia | 2 |
| Hypersalivation | 2 |
| Lack of efficacy - NOS | 2 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 2 |
| Vomiting | 2 |
| Abnormal ultrasound finding | 1 |
| Alopecia NOS | 1 |
| Anisocoria | 1 |
| Anorexia | 1 |
| Appetite loss | 1 |
| Blepharospasm | 1 |
| Breathing difficulty | 1 |
Outcome as recorded by the reporter: Outcome Unknown 9; Recovered/Normal 5; Died 2; Euthanized 2; Ongoing 1.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Cats: 511 reports
| VeDDRA reaction term | Reports |
|---|---|
| Behavioural disorder NOS | 64 |
| Vomiting | 61 |
| Hypersalivation | 51 |
| Diarrhoea | 50 |
| Anorexia | 47 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 46 |
| Death by euthanasia | 45 |
| Death | 42 |
| Weight loss | 37 |
| Other abnormal test result NOS | 33 |
| Blindness | 31 |
| Lethargy (see also Central nervous system depression in Neurological) | 27 |
| Ataxia | 26 |
| Decreased appetite | 24 |
| Elevated blood urea nitrogen (BUN) | 23 |
Outcome as recorded by the reporter: Outcome Unknown 202; Recovered/Normal 158; Ongoing 61; Died 45; Euthanized 44; Recovered with Sequela 3.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- Veraflox™FDA · retrieved 2026-09-16
“Shake well before use. To ensure a correct dosage, body weight should be determined as accurately as possible. The dose of VERAFLOX is 7.5 mg/kg (3.4 mg/lb) body weight once daily for 7 consecutive days. Use the syringe” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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