Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Valproic acid
Drug ID BADD_D02329
Description Valproic acid, or valproate, is an fatty acid derivative and anticonvulsant originally synthesized in 1881 by Beverly S. Burton.[A178051] It enjoyed use as a popular organic solvent in industry and pharmaceutical manufacturing for nearly a century. In 1963, a serendipitous discovery was made by George Carraz during his investigations into the anticonvulsant effects of khelline when he found that all of his samples, dissolved in valproic acid, exerted a similar degree of anticonvulsive activity. It first received approval on February 28, 1978 from the FDA under the trade name Depakene.[L6190] Since then, it has been investigated for neuroprotective, anti-manic, and anti-migraine effects. It is currently a compound of interest in the field of oncology for its anti-proliferative effects and is the subject of many clinical trials in a variety of cancer types.
Indications and Usage **Indicated** for:[Label] 1) Use as monotherapy or adjunctive therapy in the management of complex partial seizures and simple or complex absence seizures. 2) Adjunctive therapy in the management of multiple seizure types that include absence seizures. 3) Prophylaxis of migraine headaches. 4) Acute management of mania associated with bipolar disorder. **Off-label** uses include: 1) Maintenance therapy for bipolar disorder.[A177919] 2) Treatment for acute bipolar depression.[A177928,A177931,A177934] 3) Emergency treatment of status epilepticus.[A177955]
Marketing Status approved; investigational
ATC Code N03AG01
DrugBank ID DB00313
KEGG ID D00399
MeSH ID D014635
PubChem ID 3121
TTD Drug ID D03LGY
NDC Product Code 11014-0050; 17349-0005; 68925-0002; 17856-0675; 43353-107; 60432-621; 63739-253; 70518-0730; 10888-8132; 11014-0054; 68108-0203; 68094-701; 0615-8205; 60687-262; 72189-010; 0832-0310; 17856-0792; 0121-0675; 0527-5250; 23639-0003; 43353-085; 0121-4675; 62135-196; 63629-2454; 71930-057; 72189-267; 43353-279; 63629-7597; 68094-193; 49452-8092; 0121-1350; 68071-2702; 0591-4012; 66064-8001; 63739-086; 69452-150; 70518-0079; 50383-792
UNII 614OI1Z5WI
Synonyms Valproic Acid | 2-Propylpentanoic Acid | 2 Propylpentanoic Acid | Divalproex | Depakene | Convulsofin | Depakote | Dipropyl Acetate | Divalproex Sodium | Semisodium Valproate | Vupral | Valproic Acid, Sodium Salt (2:1) | Propylisopropylacetic Acid | Ergenyl | Magnesium Valproate | Valproate | Valproate Sodium | Sodium Valproate | Calcium Valproate | Valproate Calcium | Depakine
Chemical Information
Molecular Formula C8H16O2
CAS Registry Number 99-66-1
SMILES CCCC(CCC)C(=O)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)
Idiopathic generalised epilepsy17.12.03.0260.000100%Not Available
Seizure cluster17.12.03.0290.000100%Not Available
Encephalitis autoimmune10.04.10.012; 17.06.05.002; 16.32.01.0060.000150%Not Available
Postural tremor17.01.06.0090.000220%Not Available
Lower respiratory tract congestion22.12.01.0040.000150%Not Available
Unmasking of previously unidentified disease08.01.03.0800.000100%Not Available
Fine motor skill dysfunction17.01.02.0200.001248%Not Available
Selective eating disorder19.09.01.012; 14.03.02.0240.000200%Not Available
Abortion early18.01.01.0060.000100%Not Available
Attention deficit hyperactivity disorder19.21.04.0040.004443%Not Available
Autoimmune encephalopathy17.13.02.013; 10.04.10.0180.000100%Not Available
Behaviour disorder19.01.01.0050.003495%Not Available
Brief resolved unexplained event22.11.02.012; 18.04.15.006; 17.02.05.0660.000100%Not Available
Central auditory processing disorder19.21.01.012; 17.02.03.0190.000150%Not Available
Congestive hepatopathy09.01.06.027; 02.05.04.0180.000100%Not Available
Cytotoxic lesions of corpus callosum17.02.10.030; 12.03.01.0620.000100%Not Available
Deformity thorax15.10.06.002; 22.09.01.0050.000200%Not Available
Dependent personality disorder19.05.04.0020.000150%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.038--Not Available
Drug-disease interaction08.06.03.0120.000200%Not Available
Dyscalculia19.21.01.013; 17.02.03.0200.000200%Not Available
Ear, nose and throat disorder22.02.07.021; 04.03.01.0190.001148%Not Available
Elbow deformity15.10.03.0120.000100%Not Available
Eosinophilic pleural effusion22.05.02.009; 01.02.04.0230.000919%Not Available
Focal dyscognitive seizures17.12.02.0050.000250%Not Available
Foetal vascular malperfusion24.01.05.014; 18.05.02.0080.000100%Not Available
Gastric volvulus07.13.04.0040.000100%Not Available
Giant cell arteritis24.12.02.003; 17.08.02.033; 10.02.02.032; 06.07.02.0100.000100%Not Available
Haemoperitoneum24.07.02.065; 12.01.17.007; 07.07.02.0070.000100%Not Available
Haemophagocytic lymphohistiocytosis16.32.03.038; 10.02.01.077; 01.05.01.0260.000200%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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