Adverse Drug Reaction Classification System

         

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)
Dementia Alzheimer's type19.20.03.001; 17.03.06.0010.000050%Not Available
Demyelination17.16.02.0010.000075%Not Available
Dental caries07.09.01.0010.000151%
Dependence19.07.06.0080.000075%Not Available
Depressed level of consciousness17.02.04.0020.000528%
Depressed mood19.15.02.0010.000427%Not Available
Depression19.15.01.0010.001850%
Dermatitis23.03.04.002--Not Available
Dermatitis atopic10.01.04.004; 23.03.04.016--Not Available
Dermatitis bullous23.03.01.0020.000050%
Developmental delay19.07.05.003; 08.01.03.0370.000126%Not Available
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diabetic neuropathy17.09.04.002; 14.07.04.003; 05.07.04.003--Not Available
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.0020.000297%Not Available
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.0150.000699%Not Available
Distractibility19.21.02.007--Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.001447%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.003714%
Dizziness postural24.06.02.008; 17.02.05.004; 02.11.04.008--Not Available
Drooling17.02.05.005--Not Available
Drug abuse19.07.06.0100.001116%Not Available
Drug hypersensitivity10.01.01.0010.009172%Not Available
Drug ineffective08.06.01.0060.014450%Not Available
Drug interaction08.06.03.0010.001065%Not Available
Drug withdrawal convulsions17.12.03.016; 08.06.02.0030.000126%Not Available
Dry eye06.08.02.001--
Dry mouth07.06.01.0020.000694%
Dysaesthesia23.03.03.077; 17.02.06.0030.000211%
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ADReCS-Target
Drug Name ADR Term Target
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