Table 1.

Summary of PharmaPendium search

Category	n
No. of drugs with seizures reported in rats/dogs/monkeysa	390
No. of drugs with seizures reported in animals (rats/dogs/monkeys) and on FDA label	58a
No. of drugs with seizures reported in humans on FDA label	122
No. of drugs with convulsion reported on FDA label but no seizures reported in rats/dogs/monkeys	64
Seizure terms reported in micea only	7
Seizure terms reported as class effect only	1
Seizure terms reported as postmarketing report only	9
Seizure terms reported in clinical context with elevated convulsion risk (e.g., presence of comedication or neonatal age)	32
No. of drugs with seizure terms reported on FDA label, but not in animals and with no plausible clinical context associated with elevated convulsion risk	15

FDA, USA Food and Drug Administration; GLP, good laboratory practice.

Rats, dogs, and monkeys were the species of focus to check for seizure terms in animals because these species are often selected in GLP toxicology experiments.

^aAlso reported separately in 7 mice.

^bMice were considered separately because they are used less frequently in GLP toxicology studies.