Table 17.
Adverse events ‐ frequency of most commonly reported events
Event (general description)a,b,c | CBZ | PHB | PHT | VPS | LTG | OXC | TPM | GBP | LEV | ZNS | Total |
Accidental injury | 100 | 0 | 100 | 28 | 110 | 5 | 95 | 36 | 58 | 8 | 540 |
Anorexia or weight loss | 126 | 0 | 126 | 24 | 116 | 6 | 394 | 58 | 62 | 25 | 937 |
Anxiety/depression | 203 | 0 | 203 | 59 | 171 | 32 | 309 | 82 | 163 | 16 | 1238 |
Aphasia | 59 | 7 | 66 | 11 | 26 | 4 | 106 | 22 | 11 | 2 | 314 |
Asthenia | 59 | 1 | 60 | 26 | 41 | 1 | 31 | 33 | 37 | 10 | 299 |
Ataxia | 172 | 37 | 209 | 32 | 55 | 17 | 61 | 40 | 32 | 8 | 663 |
Cognitive (memory, concentration, confusion etc.) | 321 | 41 | 362 | 100 | 204 | 44 | 439 | 127 | 73 | 19 | 1730 |
Dental problems | 93 | 0 | 93 | 28 | 62 | 5 | 61 | 24 | 70 | 7 | 443 |
Dizziness/faintness | 617 | 0 | 617 | 171 | 348 | 140 | 269 | 160 | 394 | 23 | 2739 |
Drowsiness/fatigue | 1270 | 1 | 1271 | 422 | 539 | 233 | 628 | 326 | 477 | 33 | 5200 |
Fever or viral infection | 379 | 0 | 379 | 68 | 172 | 24 | 84 | 58 | 338 | 37 | 1539 |
Gastrointestinal disturbances | 683 | 20 | 703 | 246 | 394 | 33 | 236 | 142 | 284 | 42 | 2783 |
Hair loss | 47 | 0 | 47 | 130 | 22 | 15 | 39 | 8 | 16 | 3 | 327 |
Headache or migraine | 843 | 0 | 843 | 264 | 556 | 137 | 315 | 171 | 596 | 47 | 3772 |
Impotence | 90 | 24 | 114 | 13 | 17 | 0 | 27 | 32 | 11 | 3 | 331 |
Increased/worsened seizures | 151 | 0 | 151 | 31 | 164 | 6 | 58 | 48 | 140 | 6 | 755 |
Infection | 121 | 0 | 121 | 19 | 90 | 4 | 56 | 27 | 63 | 5 | 506 |
Laboratory results abnormal | 367 | 0 | 367 | 103 | 117 | 8 | 47 | 19 | 90 | 32 | 1150 |
Menstrual problems | 110 | 0 | 110 | 28 | 31 | 1 | 22 | 18 | 39 | 4 | 363 |
Mood or behavioural change | 279 | 41 | 320 | 128 | 163 | 25 | 415 | 121 | 121 | 15 | 1628 |
Nausea/vomiting | 413 | 1 | 414 | 167 | 233 | 53 | 132 | 92 | 142 | 20 | 1667 |
Pain | 345 | 1 | 346 | 65 | 250 | 6 | 154 | 48 | 251 | 25 | 1491 |
Paraesthesia or tingling | 56 | 0 | 56 | 22 | 33 | 2 | 708 | 34 | 28 | 7 | 946 |
Problems sleeping/nightmares | 108 | 1 | 109 | 46 | 197 | 16 | 147 | 31 | 101 | 14 | 770 |
Rash or skin disorder | 701 | 17 | 718 | 46 | 420 | 73 | 163 | 113 | 125 | 31 | 2407 |
Renal/urinary disorder | 152 | 0 | 152 | 27 | 78 | 2 | 92 | 57 | 93 | 21 | 674 |
Respiratory disorder | 233 | 0 | 233 | 53 | 124 | 4 | 190 | 23 | 131 | 17 | 1008 |
Tremor or twitch | 171 | 1 | 172 | 258 | 219 | 19 | 56 | 23 | 51 | 2 | 972 |
Visual disturbance/nystagmus | 199 | 0 | 199 | 53 | 96 | 33 | 86 | 59 | 33 | 8 | 766 |
Weight gain | 259 | 0 | 259 | 347 | 167 | 22 | 71 | 258 | 70 | 1 | 1454 |
CBZ: carbamazepine; GBP: gabapentin; LEV: levetiracetam; LTG: lamotrigine; OXC: oxcarbazepine; PHB: phenobarbitone; PHT: phenytoin; TPM: topiramate; VPS: sodium valproate; ZNS: zonisamide
aVerbatim or reported terms extracted from publications or provided in individual participant data were grouped under the definitions by one review author (SJN) and any uncertainties in definition were discussed with the senior clinical author (AGM).
bAdverse event data were provided as detailed individual participant data for 23 trials and we extracted summary adverse event information from 36 trial publications. No adverse event data were reported in 18 trial publications.
cSome trial publications reported only on the “most common” adverse events, the totals and frequencies are likely to be an underestimation of the true number of events and number of individuals experiencing events. Furthermore, detailed information was provided in the more recent trial publications and individual participant data requests of more recent trials, often involving newer antiepileptic drugs, such as LTG, LEV and TPM; which may indicate that these newer drugs are associated with more adverse events than older drugs such as PHB and PHT ,for which less detailed information was available.