Drug profile

The FDA adverse-event record for Ear Medication (Unknown)

316 FDA reports name Ear Medication (Unknown), a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#403 of 2,679
by report volume (all drugs)
316
adverse-event reports
2.5%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Ear Medication (Unknown) ranks #402 of 2679 by total reports (316) and #951 of 1130 by death-coded share (2.5%). 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)
#402
This drug, reports of 2679
#951
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. Ear Medication (Unknown) has 316 reports now versus 314 in that prior snapshot: 2 more (0.6%).

Report change
+2
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 Ear Medication (Unknown) changes

Signature read: 316 reports place Ear Medication (Unknown) in the upper third of FDA AER volume (#403 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
316
Total Reports
8
Deaths Reported
2.5%
Death-coded share of reports

Active Ingredients

Ear Medication (Unknown)

Administration Routes

Auricular (Otic)UnknownTopicalOralOphthalmicIntraocular

Species Affected

Dog 298
Cat 17
Ferret 1

Most Affected Breeds

Retriever - Labrador 46
Retriever - Golden 23
Shih Tzu 15
Spaniel - Cocker American 14
Domestic Shorthair 13
Crossbred Canine/dog 12
Pug 11
Pit Bull 11
Shepherd Dog - German 10
Beagle 9

Most Reported Reactions

Emesis 122
Vomiting 57
Lethargy (see also Central nervous system depression in 'Neurological') 39
Lack of efficacy - NOS 27
Diarrhoea 17
Ear infection NOS 16
Behavioural disorder NOS 14
Seizure NOS 11
Emesis (multiple) 11
Anorexia 10
Ataxia 10
Lack of efficacy (ectoparasite) - flea 10

Outcome Breakdown

Recovered/Normal
205 (64.9%)
Outcome Unknown
63 (19.9%)
Ongoing
29 (9.2%)
Recovered with Sequela
11 (3.5%)
Died
7 (2.2%)
Euthanized
1 (0.3%)

Ear Medication (Unknown): 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 Ear Medication (Unknown), both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Ear Medication (Unknown)'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 Ear Medication (Unknown) (#403 of 2,679 by report volume); death-coded 2.5%. PlainBreed drug row · report volume stamp 316 · 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 →