Sodium Hyaluronate

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72 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.
72
Total Reports
3
Deaths Reported
420.0%
Death Rate

Active Ingredients

Sodium Hyaluronate

Administration Routes

UnknownAuricular (Otic)Intra-ArticularOral

Species Affected

Unknown 49
Horse 16
Dog 7

Most Affected Breeds

Unknown 64
Schnauzer (unspecified) 5
Rottweiler 1
Thoroughbred 1
Warmblood (unspecified) 1

Most Reported Reactions

Product syringe issue 18
No sign 17
Broken components, medical device 9
Joint swelling 7
Lameness 4
Appearance, Abnormal 3
Injection site infection 3
Death by euthanasia 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Device breakage/fracture 2
Joint effusion 2
Injection site swelling 1

Outcome Breakdown

Outcome Unknown
15 (65.2%)
Recovered/Normal
5 (21.7%)
Euthanized
3 (13.0%)

Data Summary

Metric Value
Total adverse event reports 72
Reports involving death 3
Case-fatality rate (reported events) 420.0%
Distinct species in reports 3
Distinct breeds in reports 5
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.

Sodium Hyaluronate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 72 adverse event reports referencing Sodium Hyaluronate, including 3 reports in which the animal died — a 420.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Sodium Hyaluronate. Reported administration routes include Unknown, Auricular (Otic), Intra-Articular, Oral. 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 Sodium Hyaluronate reports are Unknown (49 reports), Horse (16 reports), Dog (7 reports), with Unknown accounting for the largest share. Within those species, Unknown (64), Schnauzer (unspecified) (5), Rottweiler (1) 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 Sodium Hyaluronate are Product syringe issue (18), No sign (17), Broken components, medical device (9), Joint swelling (7). Of the 23 reports with a coded outcome, Outcome Unknown is the leading category at 65.2%. 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 Sodium Hyaluronate.

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