Drug profile

The FDA adverse-event record for Pentosan Polysulfate Sodium

152 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Pentosan Polysulfate Sodium. See the species affected, top reactions, and outcomes below.

152
adverse-event reports
1.3%
death-coded share
Horse
most-reported species
54
Injection site swelling - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
152
Total Reports
2
Deaths Reported
1.3%
Death Rate

Active Ingredients

Pentosan Polysulfate Sodium

Administration Routes

IntramuscularUnknownIntra-ArticularSubcutaneousOther

Species Affected

Horse 144
Dog 7
Unknown 1

Most Affected Breeds

Quarter Horse 44
Horse (unknown) 20
Warmblood - Dutch 17
Thoroughbred 15
Horse (other) 9
Morgan 5
Hanovarian 5
Arab 4
Appaloosa 3
Selle Français 3

Most Reported Reactions

Injection site swelling 54
Hives (see also Skin) 19
Injection site pain 18
Injection site hair change 18
Lethargy (see also Central nervous system depression in Neurological) 10
Reluctant to move 9
Colic 8
Injection site reaction NOS 8
Injection site tenderness 7
Muscle stiffness 7
Not eating 6
Injection site lump 6

Outcome Breakdown

Recovered/Normal
74 (48.1%)
Outcome Unknown
66 (42.9%)
Ongoing
9 (5.8%)
Recovered with Sequela
3 (1.9%)
Died
2 (1.3%)

Pentosan Polysulfate Sodium Adverse Event Insights

152 reports name Pentosan Polysulfate Sodium; 2 recorded a death outcome (1.3% of reported events, not a population-level mortality rate). Active ingredient: Pentosan Polysulfate Sodium. Administration routes: Intramuscular, Unknown, Intra-Articular, Subcutaneous.

By species: Horse (144 reports), Dog (7 reports), Unknown (1 reports). By breed: Quarter Horse (44), Horse (unknown) (20), Warmblood - Dutch (17).

Leading clinical signs: Injection site swelling (54), Hives (see also Skin) (19), Injection site pain (18), Injection site hair change (18). Outcome, 154 coded reports: Recovered/Normal leads at 48.1%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.