Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Divalproex sodium
Drug ID BADD_D00696
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 D00304
MeSH ID D014635
PubChem ID 23663956
TTD Drug ID D03LGY
NDC Product Code 0074-7325; 29300-381; 37662-0726; 37662-0729; 37662-0731; 51079-767; 55154-4679; 57237-048; 63187-742; 63187-743; 65841-638; 68001-554; 68084-310; 68180-266; 68788-7177; 70518-1138; 70518-1558; 70518-1749; 70518-1781; 70518-2513; 71610-031; 71610-032; 0615-8328; 0615-8377; 72789-286; 0904-6615; 68108-0234; 37662-0725; 50268-258; 55111-533; 55154-4154; 58118-0040; 61919-249; 65841-637; 68382-133; 70518-2665; 70518-3364; 71335-2124; 71610-201; 0615-8237; 0904-6363; 0904-7182; 65977-0114; 0074-6215; 27241-115; 29300-138; 50090-2007; 55111-530; 55111-534; 65841-639; 68001-556; 70518-1758; 70518-3055; 70934-949; 71335-2158; 71610-289; 0615-8376; 55154-5633; 65862-403; 65862-594; 68001-555; 68084-313; 68084-782; 68180-267; 68382-134; 70518-2003; 70518-3683; 70518-3754; 71335-0008; 71610-707; 0615-8327; 17349-0011; 55111-875; 0074-6114; 0074-6214; 29300-139; 55154-3552; 55154-4759; 55154-7145; 57237-106; 60687-211; 62756-798; 63629-4698; 68382-031; 68788-8358; 70518-2357; 70518-2626; 70518-3183; 70518-3457; 70934-948; 71335-1883; 71610-205; 0615-8326; 0904-6364; 23639-0001; 49452-2542; 70600-016; 0074-7327; 16714-484; 37662-0730; 55700-938; 57237-047; 62756-796; 63629-4278; 0378-0472; 68001-106; 68084-776; 68788-7183; 70518-2527; 70518-3620; 65862-975; 37662-2863; 37662-2867; 37662-2869; 50090-4409; 50090-4861; 51079-766; 55154-7640; 65162-755; 65841-634; 65862-959; 68001-473; 68180-265; 68382-033; 70518-2017; 70518-2036; 70518-3477; 71610-157; 0832-7124; 0904-6861; 66064-1001; 0074-3826; 0074-7326; 16714-485; 29300-380; 37662-0727; 37662-2862; 51655-365; 55111-532; 55700-939; 60687-654; 62756-797; 65841-635; 68084-415; 68382-032; 68382-106; 70518-0374; 70518-1556; 70518-2510; 71610-030; 0832-7122; 0832-7123; 0904-6860; 37662-0728; 37662-2865; 37662-2868; 50268-259; 55111-529; 55111-531; 55154-2336; 63739-995; 0378-0473; 65162-757; 65841-636; 65862-402; 68001-105; 68001-472; 68001-474; 68071-2717; 70518-3459; 0904-7181; 47621-006; 49169-1028; 0074-7402; 29300-140; 37662-0732; 37662-2864; 37662-2866; 50090-5842; 50090-6074; 50268-260; 55154-2345; 65862-595; 68180-260; 68180-261; 68788-8145; 70518-1897; 70518-2674; 70518-3431; 71610-249; 68925-0005; 0074-7126; 0074-7401
UNII 644VL95AO6
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 C16H31NaO4
CAS Registry Number 76584-70-8
SMILES CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
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)
Ear pain04.03.01.003--
Ecchymosis23.06.01.001; 01.01.03.001; 24.07.06.002--Not Available
Emotional disorder19.04.02.005--Not Available
Encephalopathy17.13.02.001--
Enuresis20.02.02.003; 19.07.04.001--Not Available
Eosinophilia01.02.04.001--
Epistaxis24.07.01.005; 22.04.03.001--
Eructation07.01.02.003--
Erythema multiforme23.03.01.003; 10.01.03.015--
Erythema nodosum23.07.02.001; 10.02.01.020--Not Available
Eye disorder06.08.03.001--Not Available
Eye pain06.08.03.002--
Face oedema23.04.01.004; 08.01.07.003; 10.01.05.002--
Fanconi syndrome20.05.03.009; 14.01.01.011; 03.06.01.001--Not Available
Flatulence07.01.04.002--
Folate deficiency14.12.02.006--Not Available
Fungal infection11.03.05.001--Not Available
Furuncle23.11.02.009; 11.02.05.008--Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Glossitis07.14.01.001--Not Available
Haematemesis07.12.02.002; 24.07.02.011--Not Available
Haematoma24.07.01.001--
Hallucination19.10.04.003--
Headache17.14.01.001--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hiccups22.12.01.001; 07.01.06.009--
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