Drug profile

The FDA adverse-event record for Ivermectin(1.55%)/Praziquantel(7.75%) Paste

781 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Ivermectin(1.55%)/Praziquantel(7.75%) Paste. See the species affected, top reactions, and outcomes below.

781
adverse-event reports
2.0%
death-coded share
Horse
most-reported species
211
Swollen mouth - 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.
781
Total Reports
16
Deaths Reported
2.0%
Death Rate

Active Ingredients

Ivermectin(1.55%)/Praziquantel(7.75%) Paste

Administration Routes

OralUnknownOther

Species Affected

Horse 629
Unknown 94
Dog 41
Human 7
Donkey 7
Goat 2
Mule 1

Most Affected Breeds

Horse (unknown) 174
Quarter Horse 135
Unknown 125
Thoroughbred 86
Arab 37
Paint 29
Tennessee Walking Horse 17
Hanovarian 16
Warmblood - Dutch 14
Appaloosa 13

Most Reported Reactions

Swollen mouth 211
Application site swelling 181
Swollen lip (see also 'Skin') 133
Anaphylactoid reaction 126
Uncoded sign 91
Swollen tongue 73
Drooling 69
Hypersalivation 55
Application site erythema 55
Not eating 51
Colic 47
Locking Mechanism Abnormal 43

Outcome Breakdown

Outcome Unknown
395 (56.8%)
Recovered/Normal
237 (34.1%)
Ongoing
46 (6.6%)
Died
11 (1.6%)
Euthanized
5 (0.7%)
Recovered with Sequela
1 (0.1%)

Ivermectin(1.55%)/Praziquantel(7.75%) Paste Adverse Event Insights

781 reports name Ivermectin(1.55%)/Praziquantel(7.75%) Paste; 16 recorded a death outcome (2.0% of reported events, not a population-level mortality rate). Active ingredient: Ivermectin(1.55%)/Praziquantel(7.75%) Paste. Administration routes: Oral, Unknown, Other.

By species: Horse (629 reports), Unknown (94 reports), Dog (41 reports). By breed: Horse (unknown) (174), Quarter Horse (135), Unknown (125).

Leading clinical signs: Swollen mouth (211), Application site swelling (181), Swollen lip (see also 'Skin') (133), Anaphylactoid reaction (126). Outcome, 695 coded reports: Outcome Unknown leads at 56.8%.

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.