Drug profile

The FDA adverse-event record for Phytosphingosine Salicyloyl + Pramoxine Hydrochloride

20 FDA reports name Phytosphingosine Salicyloyl + Pramoxine Hydrochloride, a lower-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#1814 of 2,679
by report volume (all drugs)
20
adverse-event reports
5.0%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Phytosphingosine Salicyloyl + Pramoxine Hydrochloride ranks #1778 of 2679 by total reports (20). Death-coded-share rank requires at least 50 reports. 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)
#1778
This drug, reports of 2679

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 Salicyloyl + Pramoxine Hydrochloride has 20 reports now versus 20 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
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 Salicyloyl + Pramoxine Hydrochloride changes

Signature read: death-coded report count at 1 is the most distinctive stamp on Phytosphingosine Salicyloyl + Pramoxine Hydrochloride's FDA AER row.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
20
Total Reports
1
Deaths Reported
5.0%
Death-coded share of reports

Active Ingredients

Phytosphingosine SalicyloylPramoxine Hydrochloride

Administration Routes

TopicalOphthalmic

Species Affected

Dog 16
Human 3
Cat 1

Most Affected Breeds

Unknown 3
Retriever - Golden 3
Retriever - Labrador 2
Dachshund (unspecified) 1
Maltese 1
Spaniel - Cocker American 1
Domestic Shorthair 1
Shepherd Dog - German 1
Brittany 1
Dog (unknown) 1

Most Reported Reactions

Pruritus 4
Erythema (for urticaria see Immune SOC) 3
Glaucoma 3
Hives (see also 'Skin') 2
Application site erythema 2
Application site pruritus 2
Lack of efficacy - NOS 2
Urticaria 2
Accidental exposure 1
Red eye 1
Eye irritation 1
Application site reddening 1

Outcome Breakdown

Recovered/Normal
9 (45.0%)
Ongoing
6 (30.0%)
Outcome Unknown
4 (20.0%)
Euthanized
1 (5.0%)

Phytosphingosine Salicyloyl + Pramoxine 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.

What to do with this drug

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 Salicyloyl + Pramoxine Hydrochloride (#1814 of 2,679 by report volume); death-coded 5.0%. PlainBreed drug row · death-coded report count stamp 1 · 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 →