Drug profile

The FDA adverse-event record for Gamithromycin 15% Injection

61 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Gamithromycin 15% Injection. See the species affected, top reactions, and outcomes below.

61
adverse-event reports
16.4%
death-coded share
Unknown
most-reported species
16
Containers, Damaged - 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.
61
Total Reports
10
Deaths Reported
16.4%
Death Rate

Active Ingredients

Gamithromycin 15% Injection

Administration Routes

UnknownSubcutaneousTopicalIntramuscularOral

Species Affected

Unknown 26
Cattle 25
Human 10

Most Affected Breeds

Unknown 36
Cattle (unknown) 10
Holstein-Friesian also known as Holstein 6
Aberdeen Angus 4
Cattle (other) 2
Crossbred Bovine/Cattle 2
Shorthorn (unspecified) 1

Most Reported Reactions

Containers, Damaged 16
Uncoded sign 15
Lack of efficacy (bacteria) - NOS 10
Death 8
Accidental exposure 8
Injection site swelling 6
DEATH-TREATMENT FAILURE 4
Lack of efficacy - NOS 4
Injection site reaction NOS 3
Containers, Abnormal 3
Injection site pain 3
Containers, Leaking 3

Outcome Breakdown

Outcome Unknown
20 (51.3%)
Died
10 (25.6%)
Recovered/Normal
8 (20.5%)
Ongoing
1 (2.6%)

Gamithromycin 15% Injection Adverse Event Insights

61 reports name Gamithromycin 15% Injection; 10 recorded a death outcome (16.4% of reported events, not a population-level mortality rate). Active ingredient: Gamithromycin 15% Injection. Administration routes: Unknown, Subcutaneous, Topical, Intramuscular.

By species: Unknown (26 reports), Cattle (25 reports), Human (10 reports). By breed: Unknown (36), Cattle (unknown) (10), Holstein-Friesian also known as Holstein (6).

Leading clinical signs: Containers, Damaged (16), Uncoded sign (15), Lack of efficacy (bacteria) - NOS (10), Death (8). Outcome, 39 coded reports: Outcome Unknown leads at 51.3%.

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.