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)
Hand-eye coordination impaired17.02.02.0190.000200%Not Available
Hepatic cytolysis09.01.07.0360.000749%Not Available
Hypertensive urgency24.08.01.0050.000100%Not Available
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.000200%Not Available
Impaired reasoning19.10.03.0130.000449%Not Available
Intermenstrual bleeding21.01.01.015--Not Available
Joint laxity15.01.08.0200.000998%Not Available
Juvenile myoclonic epilepsy17.12.03.0370.000100%Not Available
Lacrimal gland enlargement06.06.04.0270.000100%Not Available
Ligament laxity15.01.08.0220.000300%Not Available
Loose associations19.10.03.0140.000100%Not Available
Malpositioned teeth07.09.05.0180.000100%Not Available
Mixed anxiety and depressive disorder19.15.01.0100.000150%Not Available
Myelosuppression01.03.03.0150.000200%Not Available
Neonatal cardiac failure18.04.07.013; 02.05.01.0150.000100%Not Available
Neonatal hypoacusis18.04.01.024; 04.02.01.0180.000100%Not Available
Neonatal respiratory distress22.11.02.015; 18.04.10.0040.000150%Not Available
Neonatal seizure18.04.04.019; 17.12.03.0380.000100%Not Available
Neuropsychological symptoms19.07.03.010; 17.02.05.0730.000100%Not Available
Orthostatic tremor17.01.06.0130.000100%Not Available
Pelvic deformity15.10.06.0030.000100%Not Available
Post-injection delirium sedation syndrome19.13.02.004; 17.02.04.024; 12.02.05.0570.000200%Not Available
Renal tubular injury20.01.07.0200.000100%Not Available
Right ventricular dilatation02.04.02.0500.000100%Not Available
Sensory processing disorder19.22.02.005; 17.02.03.0250.000200%Not Available
Sever's disease15.07.03.0110.000100%Not Available
Social (pragmatic) communication disorder19.07.05.0040.000349%Not Available
Suspected suicide19.12.01.009; 08.04.01.0170.000100%Not Available
Therapeutic product ineffective08.06.01.057--Not Available
Therapeutic response changed08.06.01.0590.000200%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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