Drug profile

The FDA adverse-event record for Ophytrium

72 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Ophytrium. See the species affected, top reactions, and outcomes below.

72
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
18
Application site pruritus - top reaction
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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
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Ophytrium

Administration Routes

TopicalUnknown

Species Affected

Dog 63
Human 5
Cat 4

Most Affected Breeds

Crossbred Canine/dog 15
Unknown 7
Dog (unknown) 6
Pit Bull 5
Shepherd Dog - German 4
Retriever - Labrador 4
Shih Tzu 3
Spaniel - Springer (unspecified) 3
Doberman Pinscher 2
Mixed (Dog) 2

Most Reported Reactions

Application site pruritus 18
Application site erythema 16
Hives (see also Skin) 6
Vomiting 5
Application site hair loss 5
Pruritus 4
Application site reddening 4
Bumps on skin 4
Application site irritation 3
Application site residue 3
Chest tightness 2
Desquamation 2

Outcome Breakdown

Ongoing
30 (41.7%)
Recovered/Normal
30 (41.7%)
Outcome Unknown
12 (16.7%)

Ophytrium Adverse Event Insights

72 reports name Ophytrium; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Ophytrium. Administration routes: Topical, Unknown.

By species: Dog (63 reports), Human (5 reports), Cat (4 reports). By breed: Crossbred Canine/dog (15), Unknown (7), Dog (unknown) (6).

Leading clinical signs: Application site pruritus (18), Application site erythema (16), Hives (see also Skin) (6), Vomiting (5). Outcome, 72 coded reports: Ongoing leads at 41.7%.

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.