Drug profile

The FDA adverse-event record for Romifidine Hydrochloride

19 FDA reports name Romifidine Hydrochloride, a lower-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#1870 of 2,679
by report volume (all drugs)
19
adverse-event reports
10.5%
death-coded share
Horse
most-reported species
Verify with FDA CVM →

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Romifidine Hydrochloride ranks #1827 of 2679 by total reports (19). 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)
#1827
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. Romifidine Hydrochloride has 19 reports now versus 19 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 Romifidine Hydrochloride changes

Signature read: 19 reports place Romifidine Hydrochloride in the lower third of FDA AER volume (#1870 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.
19
Total Reports
2
Deaths Reported
10.5%
Death-coded share of reports

Active Ingredients

Romifidine Hydrochloride

Administration Routes

IntravenousUnknownIntramuscularOral

Species Affected

Horse 15
Other 1
Donkey 1
Unknown 1
Dog 1

Most Affected Breeds

Quarter Horse 6
Unknown 2
Warmblood (unspecified) 2
Horse (unknown) 2
Paint 1
Donkey (unknown) 1
Pony (unspecified) 1
Tennessee Walking Horse 1
Crossbred Equine/horse 1
Terrier - Boston 1

Most Reported Reactions

Recumbency 2
Pruritus 2
Diarrhoea 2
Sedation 2
Swelling NOS 2
Bradycardia 2
Hypotension 2
Fever 1
Behavioural disorder NOS 1
Abdominal pain 1
Anaphylaxis 1
Sneezing 1

Outcome Breakdown

Recovered/Normal
9 (64.3%)
Outcome Unknown
3 (21.4%)
Euthanized
1 (7.1%)
Died
1 (7.1%)

Romifidine Hydrochloride: lower report volume 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 Romifidine Hydrochloride (#1870 of 2,679 by report volume); death-coded 10.5%. PlainBreed drug row · report volume stamp 19 · 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 →