Drug profile

The FDA adverse-event record for Phytosphingosine Hydrochloride

127 FDA reports name Phytosphingosine Hydrochloride, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#690 of 2,679
by report volume (all drugs)
127
adverse-event reports
0.0%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Phytosphingosine Hydrochloride ranks #687 of 2679 by total reports (127) and #1101 of 1130 by death-coded share (0.0%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#687
This drug, reports of 2679
#1101
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Phytosphingosine Hydrochloride has 127 reports now versus 124 in that prior snapshot: 3 more (2.4%).

Report change
+3
Death-coded reports
+0
Death-coded share
+0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Phytosphingosine Hydrochloride changes

Signature read: Phytosphingosine Hydrochloride's 0.0% death-coded share is among the lowest in the openFDA drug corpus.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
127
Total Reports
0
Deaths Reported
0.0%
Death-coded share of reports

Active Ingredients

Phytosphingosine Hydrochloride

Administration Routes

TopicalAuricular (Otic)OphthalmicUnknown

Species Affected

Dog 97
Cat 22
Human 8

Most Affected Breeds

Crossbred Canine/dog 12
Domestic Shorthair 12
Mixed (Dog) 9
Unknown 8
Dog (unknown) 7
Shih Tzu 6
Retriever - Labrador 5
Shepherd Dog - German 4
Terrier - Yorkshire 4
Beagle 3

Most Reported Reactions

Application site erythema 19
Pruritus 11
Erythema (for urticaria see Immune SOC) 9
Application site pruritus 9
Ataxia 6
Emesis 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Ear discharge 5
Hives (see also 'Skin') 5
Vomiting 5
Application site dermatitis 5
Lack of efficacy - NOS 5

Outcome Breakdown

Recovered/Normal
54 (42.5%)
Ongoing
47 (37.0%)
Outcome Unknown
18 (14.2%)
Recovered with Sequela
8 (6.3%)

Phytosphingosine Hydrochloride: low death-coded share in the FDA AER row

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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Phytosphingosine Hydrochloride, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Phytosphingosine Hydrochloride's report volume and death-coded share against similar drugs nationwide. See similar drugs
  • Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
  • Browse the full drug directory to compare report counts across products. All drugs

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

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

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Phytosphingosine Hydrochloride (#690 of 2,679 by report volume); death-coded 0.0%. PlainBreed drug row · death-coded share stamp 0.0% · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →