ADReCS

Pharmaceutical Information

Drug Name	Topiramate
Drug ID	BADD_D02247
Description	Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines.[A175249] It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults.[A188309,L10544] Since 2012, the extended-release formulation has been approved in combination with [phentermine] for chronic weight management therapy in adults.[L10550] Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen.[A175249] Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug.[A188330]
Indications and Usage	Topiramate is indicated for the following conditions: 1)Monotherapy for partial onset or primary generalized tonic-clonic seizures for patients 2 years of age and above 2)Adjunctive therapy for partial onset seizures or primary generalized tonic-clonic seizures for both adult and pediatric patients above 2 years old 3)Adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients above 2 years of age 4)Prophylaxis of migraine in children 12 years of age and older and adults.[L10544] Topiramate is also used off-label as an adjunct therapy for weight management[L10550] and for mood disorders.[A188312]
Marketing Status	approved
ATC Code	N03AX11
DrugBank ID	DB00273
KEGG ID	D00537
MeSH ID	D000077236
PubChem ID	5284627
TTD Drug ID	D07VDZ
NDC Product Code	72603-121; 72603-123; 80425-0195; 0480-2357; 11014-0134; 11014-0136; 11014-0149; 12502-4677; 51927-0149; 10370-365; 66039-806; 47335-707; 47335-710; 50458-645; 51655-608; 61919-318; 61919-439; 62756-707; 65862-173; 68382-769; 68462-370; 70518-1937; 70518-2322; 70518-2419; 71205-187; 71335-0325; 71335-1143; 71610-493; 76282-280; 76420-279; 80425-0092; 11014-0145; 0904-6929; 12658-0410; 51927-4671; 10370-367; 10370-368; 29300-116; 31722-181; 43063-734; 50090-5853; 50458-640; 61919-679; 61919-823; 61919-883; 63187-228; 68084-342; 68382-004; 69097-124; 70518-3067; 70771-1315; 70771-1659; 71205-819; 71335-1147; 0615-8139; 76282-279; 0832-1075; 83008-012; 11014-0147; 11014-0306; 0904-6928; 38779-2443; 51927-0294; 53104-7532; 64162-0339; 16571-708; 43063-605; 43353-697; 51655-429; 55700-217; 62756-712; 63187-283; 65841-650; 65862-174; 68382-139; 68382-141; 68462-110; 68788-7468; 69097-819; 70518-2104; 70518-2391; 70518-2753; 70518-2899; 70518-3460; 71205-202; 71335-0548; 71335-1116; 53808-1132; 68382-138; 68462-374; 69097-122; 70518-0233; 76420-276; 80425-0208; 0832-1073; 83008-011; 50379-0007; 51552-1206; 0093-7336; 29300-118; 31722-183; 50090-5309; 52652-9001; 0245-1073; 60760-577; 61919-369; 61919-824; 63187-059; 63187-773; 65841-651; 65862-171; 68071-3012; 68084-343; 68462-153; 69097-817; 0480-2356; 70518-1180; 70518-1718; 70710-1041; 70710-1043; 71205-214; 0615-8138; 72603-120; 76282-281; 76420-280; 0832-1072; 11014-0146; 65841-134; 16571-705; 16571-707; 17772-101; 29300-115; 43063-729; 43063-998; 50458-641; 50458-642; 51655-606; 62756-711; 63187-963; 63629-4947; 65841-652; 65862-172; 68382-864; 70710-1042; 70771-1656; 71205-233; 71335-9727; 80425-0214; 80425-0288; 11014-0110; 11014-0135; 11014-0137; 17205-096; 16571-706; 31722-182; 43602-457; 50458-639; 0245-1071; 0245-1072; 55154-7142; 62756-710; 63187-060; 63187-479; 63187-696; 63187-801; 68084-345; 68788-7351; 70518-2517; 70518-3758; 70771-1317; 70771-1657; 70771-1658; 71335-0487; 71335-1684; 72603-124; 72789-004; 76282-278; 76420-278; 11014-0148; 10370-366; 43353-696; 50090-3926; 50458-647; 51655-746; 55700-596; 55700-995; 60760-094; 63187-118; 63629-6871; 65841-648; 68071-4760; 68462-109; 68462-373; 68788-7568; 69097-123; 0480-2359; 70518-1196; 70518-1503; 70771-1316; 71610-485; 72603-122; 0832-1071; 0832-1074; 11014-0305; 49452-7827; 65267-103; 65862-383; 71052-315; 31722-184; 43063-612; 43063-735; 43063-997; 0245-1075; 55700-894; 61919-212; 63187-077; 63187-758; 65841-647; 65841-649; 68084-344; 68382-140; 68382-863; 68462-108; 68788-7460; 69097-125; 69097-818; 0480-2358; 70518-0887; 70518-1953; 70518-2001; 70518-2498; 70710-1039; 70771-1660; 71205-195; 71335-0337; 71335-0925; 71610-486; 0615-8140; 11014-0307; 65977-0008; 17772-102; 17772-104; 43602-460; 45865-551; 47335-711; 47335-712; 51655-848; 0245-1074; 53002-1547; 55700-226; 55700-227; 68382-005; 68462-371; 68462-372; 69097-816; 70518-0625; 70518-2955; 70710-1040; 71610-492; 80425-0202; 11014-0308; 53747-097; 65129-1024; 65977-0095; 17772-103; 0093-7335; 29300-117; 43353-695; 43602-458; 43602-459; 53808-1131; 55154-7146
UNII	0H73WJJ391
Synonyms	Topiramate \| 2,3-4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate \| Epitomax \| McN 4853 \| McN-4853 \| McN4853 \| USL255 \| Topamax

Chemical Information

Molecular Formula	C12H21NO8S
CAS Registry Number	97240-79-4
SMILES	CC1(OC2COC3(C(C2O1)OC(O3)(C)C)COS(=O)(=O)N)C
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)
Oral disorder	07.05.01.005	0.000176%		Not Available
Brain injury	19.07.03.007; 17.11.01.003	0.000151%		Not Available
Intellectual disability	17.03.07.001; 19.21.06.001	-	-	Not Available
Burning mouth syndrome	17.02.06.016; 07.05.05.013	0.000101%		Not Available
Hypertransaminasaemia	09.01.02.005	0.000101%		Not Available
Terminal insomnia	19.02.01.004; 17.15.03.004	-	-	Not Available
Osmotic demyelination syndrome	17.16.02.004	0.000251%		Not Available
Injury associated with device	12.01.08.035; 08.07.01.012	-	-	Not Available
Foetal growth restriction	18.03.01.002	0.000201%
Slow speech	19.19.02.004; 17.02.08.016	0.000126%		Not Available
Macular fibrosis	06.09.03.014	0.000050%		Not Available
Drug-induced liver injury	12.03.01.044; 09.01.07.023	0.000226%		Not Available
Substance-induced psychotic disorder	12.03.01.053; 19.03.01.007	0.000075%		Not Available
Action tremor	17.01.06.007	-	-	Not Available
Medication overuse headache	17.14.01.015; 08.06.02.015	0.000161%		Not Available
Drug reaction with eosinophilia and systemic symptoms	12.03.01.064; 23.03.05.005; 10.01.01.021	0.000503%		Not Available
Ketogenic diet	25.01.05.002	-	-	Not Available
Candida infection	11.03.03.021	-	-
Foetal heart rate deceleration abnormality	18.03.02.012; 02.03.02.022	0.000075%		Not Available
Language disorder	19.19.01.006; 17.02.08.015	0.000136%		Not Available
Mouth swelling	23.04.01.020; 10.01.05.020; 07.05.04.007	0.000171%		Not Available
Cardiovascular symptom	02.11.04.002; 24.03.02.025	-	-	Not Available
Anal incontinence	17.05.01.021; 07.01.06.029	0.000126%
Liver function test increased	13.03.04.031	-	-	Not Available
Depersonalisation/derealisation disorder	19.14.01.004	0.000050%		Not Available
Ureterolithiasis	20.04.03.003	0.000075%		Not Available
Abnormal loss of weight	14.03.02.019	0.000211%		Not Available
Alexia	19.21.01.008; 17.02.03.014	0.000201%		Not Available
Alice in wonderland syndrome	19.03.03.003	0.000126%		Not Available
Alopecia scarring	23.02.02.009	0.000075%		Not Available

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