Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fenfluramine
Drug ID BADD_D02555
Description Dravet syndrome is a pediatric encephalopathy that typically manifests within the first year of life following exposure to elevated temperatures. It is characterized by recurrent pharmacoresistant seizures, which increase in frequency and severity with disease progression. Concomitantly with these seizures, patients typically display delayed development and neurocognitive impairment.[A214694, A214709, A214712, A214715] Fenfluramine is a serotonergic phenethylamine originally used as an appetite suppressant until concerns regarding cardiotoxicity in obese patients lead to its withdrawal from the market in 1997.[A214694, A214718, A11906] Through its ability to modulate neurotransmission, fenfluramine has reemerged as an effective therapy against pharmacoresistant seizures, such as those involved in Dravet syndrome.[A214688, A214691, A214700] Fenfluramine was granted initial FDA approval in 1973 prior to its withdrawal; it was granted a new FDA approval on June 25, 2020, for treatment of Dravet syndrome patients through the restricted FINTEPLA REMS program. It is currently sold under the name FINTEPLA® by Zogenix INC.[L14522]
Indications and Usage Fenfluramine is indicated for the treatment of seizures in Dravet syndrome patients aged two years and older.[L14522]
Marketing Status approved; illicit; investigational; withdrawn
ATC Code A08AA02; N03AX26
DrugBank ID DB00574
KEGG ID D07945
MeSH ID D005277
PubChem ID 3337
TTD Drug ID D09WNK
NDC Product Code 70600-024; 43376-322
UNII 2DS058H2CF
Synonyms Fenfluramine | Fenfluramine Hydrochloride | Hydrochloride, Fenfluramine | Fenfluramine Hydrochloride, (+-)-Isomer | Pondimin | Fenfluramine, (+-)-Isomer | Fenfluramine, R-Isomer | Fenfluramine, R Isomer | Isomeride | Fintepla | Fenfluramine Hydrochloride, R-Isomer | Fenfluramine Hydrochloride, R Isomer
Chemical Information
Molecular Formula C12H16F3N
CAS Registry Number 458-24-2
SMILES CCNC(C)CC1=CC(=CC=C1)C(F)(F)F
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)
Paraesthesia17.02.06.005; 23.03.03.094--
Pulmonary hypertension22.06.01.001; 24.08.03.002--
Pyrexia08.05.02.0030.000693%
Seizure17.12.03.0010.006079%
Sleep disorder19.02.04.001---
Somnolence17.02.04.006; 19.02.05.0030.000772%
Status epilepticus17.12.03.0050.000236%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Tremor17.01.06.0020.000535%
Tricuspid valve incompetence02.07.05.0010.000551%-
Urinary retention20.02.02.011--
Vomiting07.01.07.0030.000614%
Peripheral swelling02.05.04.015; 08.01.03.0530.000535%-
Left ventricular dysfunction02.04.02.0110.000157%
Cardiac valve disease02.07.02.001---
Abnormal behaviour19.01.01.0010.001071%-
Decreased appetite08.01.09.028; 14.03.01.0050.002378%
Adverse drug reaction08.06.01.0090.000535%-
Atonic seizures17.12.03.0200.000535%-
Seizure cluster17.12.03.0290.000535%-
Drug effect less than expected08.06.01.0360.000535%-
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