Orbifloxacin Oral Suspension

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630 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
630
Total Reports
69
Deaths Reported
1100.0%
Death Rate

Active Ingredients

Orbifloxacin Oral Suspension

Administration Routes

UnknownOralOphthalmicTopicalSubcutaneous

Species Affected

Unknown 336
Cat 232
Dog 52
Human 5
Rabbit 2
Parrot 1
Guinea Pig 1
Hedgehog 1

Most Affected Breeds

Unknown 342
Domestic Shorthair 150
Domestic Longhair 19
Cat (unknown) 16
Crossbred Canine/dog 12
Domestic Mediumhair 12
Siamese 10
Chihuahua 7
Persian 5
Maltese 4

Most Reported Reactions

Containers, Damaged 103
Containers, Leaking 97
Blindness 47
Death by euthanasia 40
Appearance, Abnormal 36
Bottles, Damaged 34
Lethargy (see also Central nervous system depression in 'Neurological') 33
Underfilling, Container 32
Defect Unknown/Not Specified 31
Dilated pupils 30
Emesis (multiple) 29
Death 27

Outcome Breakdown

Ongoing
84 (28.6%)
Recovered/Normal
73 (24.8%)
Euthanized
40 (13.6%)
Outcome Unknown
38 (12.9%)
Recovered with Sequela
30 (10.2%)
Died
29 (9.9%)

Data Summary

Metric Value
Total adverse event reports 630
Reports involving death 69
Case-fatality rate (reported events) 1100.0%
Distinct species in reports 8
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Orbifloxacin Oral Suspension Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 630 adverse event reports referencing Orbifloxacin Oral Suspension, including 69 reports in which the animal died — a 1100.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Orbifloxacin Oral Suspension. Reported administration routes include Unknown, Oral, Ophthalmic, Topical. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Orbifloxacin Oral Suspension reports are Unknown (336 reports), Cat (232 reports), Dog (52 reports), with Unknown accounting for the largest share. Within those species, Unknown (342), Domestic Shorthair (150), Domestic Longhair (19) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Orbifloxacin Oral Suspension are Containers, Damaged (103), Containers, Leaking (97), Blindness (47), Death by euthanasia (40). Of the 294 reports with a coded outcome, Ongoing is the leading category at 28.6%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Orbifloxacin Oral Suspension.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial