Drug profile

The FDA adverse-event record for Romifidine Hydrochloride

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

18
adverse-event reports
11.1%
death-coded share
Horse
most-reported species
2
Recumbency - 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.
18
Total Reports
2
Deaths Reported
11.1%
Death Rate

Active Ingredients

Romifidine Hydrochloride

Administration Routes

IntravenousUnknownIntramuscularOral

Species Affected

Horse 14
Other 1
Donkey 1
Unknown 1
Dog 1

Most Affected Breeds

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

Most Reported Reactions

Recumbency 2
Pruritus 2
Diarrhoea 2
Sedation 2
Swelling NOS 2
Fever 1
Behavioural disorder NOS 1
Abdominal pain 1
Anaphylaxis 1
Sneezing 1
Increased respiratory rate 1
Lung sound 1

Outcome Breakdown

Recovered/Normal
8 (61.5%)
Outcome Unknown
3 (23.1%)
Euthanized
1 (7.7%)
Died
1 (7.7%)

Romifidine Hydrochloride Adverse Event Insights

18 reports name Romifidine Hydrochloride; 2 recorded a death outcome (11.1% of reported events, not a population-level mortality rate). Active ingredient: Romifidine Hydrochloride. Administration routes: Intravenous, Unknown, Intramuscular, Oral.

By species: Horse (14 reports), Other (1 reports), Donkey (1 reports). By breed: Quarter Horse (6), Unknown (2), Warmblood (unspecified) (2).

Leading clinical signs: Recumbency (2), Pruritus (2), Diarrhoea (2), Sedation (2). Outcome, 13 coded reports: Recovered/Normal leads at 61.5%.

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.