Sleepiness - systemic disorder after Fluralaner (Bravecto) in dogs

The FDA has received 133 reports of sleepiness - systemic disorder in dogs after Fluralaner. That is 0.2% of all reports for this medicine, compared with 0.1% across reports for all dog medicines, so it is reported unusually often with this medicine.

133Reports

53%Marked serious

31%Recovered

5.3%Died or euthanised

Same dayTypical onset

How soon it started

Same day

52 50%

1–2 days

21 20%

3–7 days

9 8.7%

1–4 weeks

6 5.8%

Over a month

15 15%

How the animals did

Recovered

40 30%

Recovered with lasting effects

1 0.8%

Still unwell when reported

74 56%

Died

3 2.3%

Euthanised

4 3.0%

Not known

11 8.3%

Problems reported at the same time

54 41%

38 29%

38 29%

26 20%

23 17%

19 14%

18 14%

16 12%

Age of the animals

Under 1 year

1–3 years

4–7 years

8–11 years

12+ years

About this medicine

Fluralaner kills fleas and ticks for up to 12 weeks (chewable or spot-on).

Products with this ingredient include Bravecto. The FDA hides brand names in its public data, so these reports cover every product with the same active ingredients.

In 2018 the FDA alerted owners and vets that isoxazoline products have been associated with neurologic reactions such as muscle tremors, wobbliness (ataxia) and seizures, including in animals with no history of them.

Questions owners ask

Can Fluralaner cause sleepiness - systemic disorder in dogs?: 133 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).

Sleepiness - systemic disorder with similar medicines

Sleepiness - systemic disorder after Afoxolaner (NexGard) 71 reports · 0.1% of its reports
Sleepiness - systemic disorder after Sarolaner (Simparica) 31 reports · 0.2% of its reports
Sleepiness - systemic disorder after Lotilaner (Credelio) 39 reports · 0.4% of its reports
Sleepiness - systemic disorder after Lotilaner + Moxidectin + Praziquantel + Pyrantel (Credelio Quattro) 21 reports · 0.7% of its reports

All reported side effects of Fluralaner in dogs · Medicines most reported with sleepiness - systemic disorder