Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Riluzole
Drug ID BADD_D01942
Description A glutamate antagonist (receptors, glutamate) used as an anticonvulsant (anticonvulsants) and to prolong the survival of patients with amyotrophic lateral sclerosis. Riluzole is marketed as Rilutek by Sanofi.
Indications and Usage For the treatment of amyotrophic lateral sclerosis (ALS, Lou Gehrig's Disease)
Marketing Status approved; investigational
ATC Code N07XX02
DrugBank ID DB00740
KEGG ID D00775
MeSH ID D019782
PubChem ID 5070
TTD Drug ID D0H0KB
NDC Product Code 68462-381; 70510-2201; 42291-775; 0378-4145; 62756-538; 67877-286; 69076-200; 63278-1076; 65129-1011; 70515-700; 65977-0045; 66039-812
UNII 7LJ087RS6F
Synonyms Riluzole | 2-Amino-6-trifluoromethoxybenzothiazole | 2 Amino 6 trifluoromethoxybenzothiazole | Rilutek | RP-54274 | RP 54274 | RP54274 | PK-26124 | PK 26124 | PK26124
Chemical Information
Molecular Formula C8H5F3N2OS
CAS Registry Number 1744-22-5
SMILES C1=CC2=C(C=C1OC(F)(F)F)SC(=N2)N
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)
Psychotic disorder19.03.01.002--
Pulmonary function test decreased13.19.01.001---
Pulmonary toxicity12.03.01.013; 22.01.02.0070.001615%-
Hepatobiliary disease09.01.08.003---
Urine analysis abnormal13.13.02.008---
Congenital foot malformation03.11.07.002; 15.11.07.002---
Vulvovaginal mycotic infection11.03.05.004; 21.14.02.004---
Liver injury09.01.07.022; 12.01.17.012---
Adverse reaction08.06.01.018---
Skin mass23.07.04.014---
Traumatic liver injury09.01.08.010; 12.01.17.027---
Anorectal discomfort07.03.03.003---
Gastrointestinal tract irritation07.08.03.008---
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000538%-
Candida infection11.03.03.021--
Mesenteric vascular occlusion07.15.02.011; 24.04.08.014---
Respiratory symptom22.12.02.0130.000538%-
Multiple organ dysfunction syndrome08.01.03.0570.000808%
Anal incontinence07.01.06.029; 17.05.01.021--
Depersonalisation/derealisation disorder19.14.01.004---
Pancreatitis relapsing07.18.01.0110.001346%-
Pseudarthrosis12.04.02.010; 15.08.01.0010.000538%-
Haemorrhagic necrotic pancreatitis07.18.01.010; 24.07.02.0470.000538%-
Cervical spinal cord paralysis17.01.04.0220.000538%-
Dilated cardiomyopathy02.04.01.017---
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.027---
Intermenstrual bleeding21.01.01.015---
Progressive bulbar palsy17.05.05.0050.000538%-
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