Table 1.
Number of subjects | AE Type | AE Severity | Incidence | Range of AED doses |
---|---|---|---|---|
Carbamazepine | ||||
91–3011–3,5,6 | Somnolence Decreased appetite |
Mild/moderate | 8–36% 2% |
400–1200 mg/day |
91–37815, 16, 18–21 | Gastrointestinal | Mild/moderate | 4–29% | 400–2000 mg/day |
91–37815–20 | Rash | Mild/serious | 8–32% | 200–2000 mg/day |
20–23017, 21, 22 | Decreased white blood cells | Mild | Not reported | 200–1400 (5–24 mg/kg/day) |
Lamotrigine | ||||
8 – 33435, 39, 40 | Rash | Moderate/serious | 1%, 3%, 8% | 100–500 mg (serious), 100 mg (moderate) |
156 – 33437, 40 | Stevens-Johnson syndrome | Serious | 0. 1%, 1% | 300–400 mg, 300 mg/day, and 250 mg bid |
14136 | Grand mal seizures | Serious | 1% | 300–400 mg/day |
12638 | Diplopia | Serious | 1% | 250 mg |
33440 | Dizziness | Serious | 0. 6% | 100–500 mg |
33440 | Blurry vision | Serious | 0. 6% | 100–500 mg |
33440 | Ataxia | Serious | 0. 3% | 100–500 mg |
33440 | Nausea | Serious | 0. 3% | 100–500 mg |
Phenobarbital | ||||
11448 | Elevated GGT | Mild | 58% | NR |
18–124e-ref 82, e- ref 83 | Hypotension | NR | 11–49% | 10–30 mg/kg |
1854 | Intubation | Severe | 33% | 10–30 mg/kg |
10–143 e-ref 71, e- ref 78 | Somnolence | Mild | 30% | 8. 3–133. 3 mg/day |
14350 | Fatigue | Mild | 21% | 8. 3–133. 3 mg/day |
Phenytoin | ||||
127–15159, 60 | Rash | Moderate/serious | 19% (mild), 8% (moderate), 2% (serious) | 300 mg (serious) |
114e-ref 61 | Stevens-Johnson syndrome | Serious | 1% | 300 mg |
14159 | Suicide attempt | Serious | 1% | 300 mg |
67e-ref 62 | Myalgia | Moderate | 2% | 200–450 mg |
Valproate | ||||
112e-ref 76 | Somnolence | Mild | 10–15% | 1. 5–3. 0 mg/kg/min |
112e-ref 76 | Dizziness | Mild | 8–10% | 1. 5–3. 0 mg/kg/min |
112e-ref 76 | Nausea | Mild/moderate | 8–10% | 1. 5–3. 0 mg/kg/min |
112e-ref 76 | Paresthesia | Mild | 8% | 1. 5–3. 0 mg/kg/min |
GGT: gamma-glutamyl transpeptidase