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)
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Emotional distress19.04.02.008--Not Available
General physical health deterioration08.01.03.018--Not Available
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.003--Not Available
Contusion23.03.11.002; 12.01.06.001; 15.03.05.007; 24.07.06.001--
Platelet aggregation inhibition01.08.03.002--Not Available
Hypofibrinogenaemia01.01.01.010--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Congenital aplastic anaemia03.15.04.001; 01.03.03.011--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.001--Not Available
Affect lability19.04.01.001--Not Available
Transaminases increased13.03.04.036--Not Available
Haemorrhage24.07.01.002--Not Available
Cutaneous lupus erythematosus10.04.03.007; 23.03.02.008; 15.06.02.007--Not Available
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Epidermal necrosis23.03.03.035--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Psychotic disorder19.03.01.002--
Bone marrow failure01.03.03.005--
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.006--Not Available
Nail atrophy23.02.05.010--Not Available
Anal incontinence17.05.01.021; 07.01.06.029--
Hyperglycinaemia14.14.04.011; 03.08.04.011; 18.04.04.016; 17.13.01.014--Not Available
Intermenstrual bleeding21.01.01.015--Not Available
Neuropsychological symptoms19.07.03.010; 17.02.05.073--Not Available
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