Drug profile

The FDA adverse-event record for Ivermectin, Praziquantel

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

459
adverse-event reports
2.4%
death-coded share
Horse
most-reported species
199
Lip oedema (see also 'Skin') - 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.
459
Total Reports
11
Deaths Reported
2.4%
Death Rate

Active Ingredients

Ivermectin, Praziquantel

Administration Routes

OralUnknownTopicalSubcutaneous

Species Affected

Horse 390
Unknown 37
Dog 24
Human 2
Donkey 2
Cat 2
Chicken 2

Most Affected Breeds

Horse (unknown) 160
Thoroughbred 59
Unknown 39
Quarter Horse 39
Crossbred Equine/horse 25
Arab 23
Mixed (Horse) 19
Horse (other) 11
Paint 10
Appaloosa 8

Most Reported Reactions

Lip oedema (see also 'Skin') 199
Application site swelling 186
Hypersalivation 75
Tongue oedema 61
Anaphylaxis 53
Anaphylactoid reaction 46
Anorexia 44
Stomatitis 33
Abdominal pain 30
Facial oedema 27
Depression 25
Application site lesion 24

Outcome Breakdown

Recovered/Normal
27 (43.5%)
Outcome Unknown
20 (32.3%)
Died
11 (17.7%)
Ongoing
4 (6.5%)

Ivermectin, Praziquantel Adverse Event Insights

459 reports name Ivermectin, Praziquantel; 11 recorded a death outcome (2.4% of reported events, not a population-level mortality rate). Active ingredient: Ivermectin, Praziquantel. Administration routes: Oral, Unknown, Topical, Subcutaneous.

By species: Horse (390 reports), Unknown (37 reports), Dog (24 reports). By breed: Horse (unknown) (160), Thoroughbred (59), Unknown (39).

Leading clinical signs: Lip oedema (see also 'Skin') (199), Application site swelling (186), Hypersalivation (75), Tongue oedema (61). Outcome, 62 coded reports: Recovered/Normal leads at 43.5%.

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.