Spontaneous reporting of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with antiepileptic drugs

Eur Rev Med Pharmacol Sci. 2015;19(14):2732-7.


Objective: To assess the association between Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN) and antiepileptics including the most recently authorized drugs.

Methods: In the Spanish Pharmacovigilance database, we searched for spontaneous reports of SJS or TEN associated with antiepileptic drugs and analysed: a) reporting odds ratio (ROR), b) age and gender of the patient, c) evolution, d) latency and recovery periods and e) presence or absence of other suspected drugs.

Results: A total of 84 reports of SJS and 80 of TEN related to 9 antiepileptic drugs were studied. Reports were mainly associated with phenytoin (SJS: 28; TEN: 43), lamotrigine (SJS: 37; TEN: 20) and carbamazepine (SJS: 14; TEN: 16). Other antiepileptic drugs involved were: valproate, phenobarbital, oxcarbazepine, levetiracetam, primidone and gabapentin. Patients were of a median age of 40 [1-87] and 57.3% of them were women. Cases related to phenytoin were more common in older men and to lamotrigine in younger women. The latency period of SJS and TEN did not exceed the first month of treatment and, in most of the analysed reports, the outcome was recovery.

Conclusions: Our observations support the association of SJS or TEN with phenytoin, carbamazepine, valproate or phenobarbital and enlighten the role of lamotrigine and others such as oxcarbazepine or levetiracetam.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amines / adverse effects
  • Anticonvulsants / adverse effects*
  • Carbamazepine / adverse effects
  • Carbamazepine / analogs & derivatives
  • Child
  • Child, Preschool
  • Cyclohexanecarboxylic Acids / adverse effects
  • Databases, Factual*
  • Female
  • Gabapentin
  • Humans
  • Infant
  • Lamotrigine
  • Male
  • Middle Aged
  • Oxcarbazepine
  • Pharmacovigilance*
  • Phenobarbital / adverse effects
  • Spain / epidemiology
  • Stevens-Johnson Syndrome / diagnosis*
  • Stevens-Johnson Syndrome / epidemiology*
  • Triazines / adverse effects
  • Valproic Acid / adverse effects
  • Young Adult
  • gamma-Aminobutyric Acid / adverse effects


  • Amines
  • Anticonvulsants
  • Cyclohexanecarboxylic Acids
  • Triazines
  • Carbamazepine
  • gamma-Aminobutyric Acid
  • Valproic Acid
  • Gabapentin
  • Lamotrigine
  • Oxcarbazepine
  • Phenobarbital