Clodronate Disodium

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299 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.
299
Total Reports
13
Deaths Reported
430.0%
Death Rate

Active Ingredients

Clodronate Disodium

Administration Routes

IntramuscularUnknownOralAuricular (Otic)

Species Affected

Horse 291
Unknown 5
Human 2
Dog 1

Most Affected Breeds

Quarter Horse 139
Horse (unknown) 35
Thoroughbred 27
Warmblood - Dutch 19
Paint 14
Arab 10
Unknown 7
Oldenburg 6
Warmblood (unspecified) 5
Horse (other) 5

Most Reported Reactions

Elevated creatinine 82
Elevated blood urea nitrogen (BUN) 75
Polyuria 65
Polydipsia 60
Colic 57
Hypercalcaemia 33
Lethargy (see also Central nervous system depression in 'Neurological') 32
Hyperkalaemia 29
Anorexia 25
Pawing 24
Other abnormal test result NOS 21
Hypochloraemia 20

Outcome Breakdown

Recovered/Normal
155 (52.7%)
Outcome Unknown
114 (38.8%)
Euthanized
12 (4.1%)
Ongoing
10 (3.4%)
Recovered with Sequela
2 (0.7%)
Died
1 (0.3%)

Data Summary

Metric Value
Total adverse event reports 299
Reports involving death 13
Case-fatality rate (reported events) 430.0%
Distinct species in reports 4
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.

Clodronate Disodium Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 299 adverse event reports referencing Clodronate Disodium, including 13 reports in which the animal died — a 430.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Clodronate Disodium. Reported administration routes include Intramuscular, Unknown, Oral, Auricular (Otic). 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 Clodronate Disodium reports are Horse (291 reports), Unknown (5 reports), Human (2 reports), with Horse accounting for the largest share. Within those species, Quarter Horse (139), Horse (unknown) (35), Thoroughbred (27) 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 Clodronate Disodium are Elevated creatinine (82), Elevated blood urea nitrogen (BUN) (75), Polyuria (65), Polydipsia (60). Of the 294 reports with a coded outcome, Recovered/Normal is the leading category at 52.7%. 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 Clodronate Disodium.

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