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)
Overweight14.03.02.0210.000349%Not Available
Pulmonary valve stenosis02.07.04.0050.000150%Not Available
Reading disorder19.21.05.0030.000549%Not Available
School refusal19.07.05.0020.000100%Not Available
Shoulder dystocia18.03.04.0020.000100%Not Available
Slow response to stimuli17.02.05.0630.000100%Not Available
Small for dates baby18.04.02.0020.000200%Not Available
Social anxiety disorder19.06.03.0100.000150%Not Available
Speech disorder developmental19.19.01.003; 17.02.08.0110.005492%Not Available
Symptom masked08.01.03.0780.000200%Not Available
Tooth development disorder07.09.08.0050.000100%
Vesicoureteric reflux20.03.05.0020.000150%Not Available
Vision abnormal neonatal18.04.01.021; 06.02.06.0190.000100%Not Available
Hypertonia neonatal18.04.01.016; 17.05.02.017; 15.05.04.0190.000150%Not Available
Cerebral ventricle dilatation17.11.01.0130.000549%Not Available
Arachnoid cyst17.18.05.001; 16.09.05.0010.000100%Not Available
Live birth18.08.02.0070.011243%Not Available
Feeling guilty19.15.02.0100.001098%Not Available
Consciousness fluctuating17.02.04.0190.000100%Not Available
Right ventricular hypertrophy02.04.02.0340.000349%Not Available
Tongue biting12.01.17.023; 17.02.05.064; 07.14.01.0130.000100%Not Available
Tracheal stenosis22.04.07.0100.000100%
Prognathism15.10.05.0070.000150%Not Available
Retrognathia15.10.05.0080.000250%Not Available
Palatal disorder07.05.01.0190.000250%Not Available
Bronchopulmonary disease22.01.02.0210.000150%Not Available
Tracheomalacia22.04.07.011; 08.07.02.0020.000150%Not Available
Oppositional defiant disorder19.21.04.0030.000499%Not Available
Poor sucking reflex18.04.04.011; 17.02.01.0080.000100%Not Available
Sopor19.02.04.002; 17.02.04.0210.000649%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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