Restlessness or agitation after Pyrantel + Sarolaner (Simparica Trio) in dogs

The FDA has received 456 reports of restlessness or agitation in dogs after Pyrantel + Sarolaner. That is 0.9% of all reports for this medicine, compared with 1.6% across reports for all dog medicines, so it is reported less often than average with this medicine.

456Reports

44%Marked serious

29%Recovered

1.8%Died or euthanised

Same dayTypical onset

How soon it started

Same day

241 55%

1–2 days

104 24%

3–7 days

34 7.7%

1–4 weeks

30 6.8%

Over a month

32 7.3%

How the animals did

Recovered

130 29%

Recovered with lasting effects

1 0.2%

Still unwell when reported

187 41%

Died

1 0.2%

Euthanised

7 1.5%

Not known

130 29%

Problems reported at the same time

98 21%

87 19%

79 17%

78 17%

72 16%

71 16%

70 15%

69 15%

Age of the animals

Under 1 year

103

1–3 years

131

4–7 years

8–11 years

12+ years

About this medicine

Pyrantel treats roundworms and hookworms. Sarolaner kills fleas, ticks and some mites; monthly.

Products with this combination include Simparica Trio (which also contains moxidectin). The FDA hides brand names in its public data, so these reports cover every product with the same active ingredients.

Questions owners ask

Can Pyrantel + Sarolaner cause restlessness or agitation in dogs?: 456 reports link the two, but a report alone does not prove the medicine was the cause: other illnesses, other medicines or coincidence can be involved. Your vet can judge it for your animal.
How soon after a dose was it reported?: In half of the reports with dates, it started within the same day of the first dose.
What should I do?: Don't give another dose until you've spoken to your vet, and keep the packaging so you can tell them the product and dose. Your vet can also report it to the FDA (or you can, through the manufacturer or FDA form 1932a).

Restlessness or agitation with similar medicines

Restlessness or agitation after Febantel + Praziquantel + Pyrantel (Drontal Plus) 443 reports · 6.6% of its reports
Restlessness or agitation after Fenbendazole 253 reports · 4.3% of its reports
Restlessness or agitation after Pyrantel 60 reports · 1.3% of its reports
Restlessness or agitation after Praziquantel + Pyrantel 76 reports · 2.1% of its reports

All reported side effects of Pyrantel + Sarolaner in dogs · Medicines most reported with restlessness or agitation