Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Stiripentol
Drug ID BADD_D02069
Description Stiripentol is an anticonvulsant drug used in the treatment of epilepsy as an adjunct therapy along with [DB00349] and [DB00313]. This drug is currently approved in the USA, Canada, and European countries as oral tablets marketed as Diacomit. FDA approval of this drug was granted on August 20, 2018 [L4352], [F1240]. Unrelated to other anticonvulsants, stiripentol belongs to the group of aromatic allylic alcohols and may potentiate the effect of other antiepileptic drugs (AEDs) due to pharmacokinetic interactions. It elevates the levels of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter that regulates electrical activity in the central nervous system.
Indications and Usage Indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate.
Marketing Status approved
ATC Code N03AX17
DrugBank ID DB09118
KEGG ID D05928
MeSH ID C021092
PubChem ID 5311454
TTD Drug ID D02XSA
NDC Product Code 69766-075; 42765-058; 68418-7941; 58159-069; 68418-7940; 68418-7942; 68418-7939
UNII R02XOT8V8I
Synonyms stiripentol | Diacomit | D-306
Chemical Information
Molecular Formula C14H18O3
CAS Registry Number 49763-96-4
SMILES CC(C)(C)C(C=CC1=CC2=C(C=C1)OCO2)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Aggression19.05.01.001---
Agitation17.02.05.012; 19.06.02.001--
Asthenia08.01.01.0010.000187%-
Ataxia08.01.02.004; 17.02.02.001--
Condition aggravated08.01.03.0040.000187%-
Dermatitis23.03.04.002---
Dermatitis allergic10.01.03.014; 23.03.04.003---
Dermatitis atopic10.01.04.004; 23.03.04.016---
Diplopia06.02.06.002; 17.17.01.005---
Drug ineffective08.06.01.0060.000187%-
Drug interaction08.06.03.0010.000125%-
Encephalopathy17.13.02.0010.000125%
Epilepsy17.12.03.0020.000187%-
Eye disorder06.08.03.001---
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.001---
Hepatic adenoma09.04.01.002; 16.06.01.0020.000125%-
Hepatic failure09.01.03.0020.000125%
Hyperammonaemia09.01.02.002; 14.10.01.0010.000125%-
Hyperkinesia17.01.02.008---
Hypotonia15.05.04.008; 17.05.02.002---
Insomnia17.15.03.002; 19.02.01.002--
Irritability08.01.03.011; 19.04.02.013--
Liver function test abnormal13.03.04.030---
Muscle rigidity15.05.04.001; 17.05.02.0050.000125%-
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Neutropenia01.02.03.0040.000249%-
Photosensitivity reaction23.03.09.003--
Psychomotor retardation19.15.02.0020.000125%-
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