Gonadorelin Diacetate Tetrahydrate

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158 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.
158
Total Reports
1
Deaths Reported
60.0%
Death Rate

Active Ingredients

Gonadorelin Diacetate Tetrahydrate

Administration Routes

UnknownIntramuscularTopicalParenteralSubcutaneous

Species Affected

Unknown 112
Cattle 38
Human 8

Most Affected Breeds

Unknown 120
Mixed (Cattle) 11
Aberdeen Angus 10
Cattle (other) 9
Cattle (unknown) 4
Brangus 1
Hereford cattle 1
Red Angus 1
Holstein-Friesian also known as Holstein 1

Most Reported Reactions

Vials, Damaged 54
Lack of efficacy - NOS 19
Seal, Abnormal 18
INEFFECTIVE, ESTRUS SYNCHRONIZ 16
Unclassifiable adverse event 11
Containers, Damaged 11
Underfilling, Vials 8
Containers, Abnormal 8
Accidental exposure 7
Closure, Abnormal 7
Physical label missing 5
Vials, Leaking 5

Outcome Breakdown

Outcome Unknown
32 (91.4%)
Recovered/Normal
2 (5.7%)
Died
1 (2.9%)

Data Summary

Metric Value
Total adverse event reports 158
Reports involving death 1
Case-fatality rate (reported events) 60.0%
Distinct species in reports 3
Distinct breeds in reports 9
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.

Gonadorelin Diacetate Tetrahydrate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 158 adverse event reports referencing Gonadorelin Diacetate Tetrahydrate, including 1 reports in which the animal died — a 60.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Gonadorelin Diacetate Tetrahydrate. Reported administration routes include Unknown, Intramuscular, Topical, Parenteral. 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 Gonadorelin Diacetate Tetrahydrate reports are Unknown (112 reports), Cattle (38 reports), Human (8 reports), with Unknown accounting for the largest share. Within those species, Unknown (120), Mixed (Cattle) (11), Aberdeen Angus (10) 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 Gonadorelin Diacetate Tetrahydrate are Vials, Damaged (54), Lack of efficacy - NOS (19), Seal, Abnormal (18), INEFFECTIVE, ESTRUS SYNCHRONIZ (16). Of the 35 reports with a coded outcome, Outcome Unknown is the leading category at 91.4%. 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 Gonadorelin Diacetate Tetrahydrate.

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