Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric)

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29 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.
29
Total Reports
8
Deaths Reported
2760.0%
Death Rate

Active Ingredients

Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric)

Administration Routes

UnknownSubcutaneousIntramuscularOphthalmic

Species Affected

Cattle 16
Unknown 6
Dog 5
Sheep 1
Goat 1

Most Affected Breeds

Cattle (other) 10
Unknown 6
Dog (unknown) 2
Aberdeen Angus 2
Crossbred Bovine/Cattle 1
Holstein-Friesian also known as Holstein 1
Brangus 1
Terrier - Jack Russell 1
Simbrah 1
Sheep (unknown) 1

Most Reported Reactions

Lack of efficacy (bacteria) - NOS 10
Uncoded sign 6
Death 4
Color, Abnormal 3
Lack of efficacy - NOS 2
Inappropriate packaging or design 2
Foam in the mouth 2
Seizure NOS 2
Injection site inflammation 2
Injection site swelling 2
Injection site pain 2
Digestive tract disorder NOS 2

Outcome Breakdown

Outcome Unknown
14 (48.3%)
Died
8 (27.6%)
Ongoing
5 (17.2%)
Recovered/Normal
2 (6.9%)

Data Summary

Metric Value
Total adverse event reports 29
Reports involving death 8
Case-fatality rate (reported events) 2760.0%
Distinct species in reports 5
Distinct breeds in reports 13
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.

Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 29 adverse event reports referencing Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric), including 8 reports in which the animal died — a 2760.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric). Reported administration routes include Unknown, Subcutaneous, Intramuscular, Ophthalmic. 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 Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric) reports are Cattle (16 reports), Unknown (6 reports), Dog (5 reports), with Cattle accounting for the largest share. Within those species, Cattle (other) (10), Unknown (6), Dog (unknown) (2) 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 Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric) are Lack of efficacy (bacteria) - NOS (10), Uncoded sign (6), Death (4), Color, Abnormal (3). Of the 29 reports with a coded outcome, Outcome Unknown is the leading category at 48.3%. 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 Oxytetracycline Dihydrate ( Oxytetracycline Amphoteric).

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