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)
Phonophobia19.06.03.003; 04.03.01.0080.000136%Not Available
Dysphemia19.19.03.005; 17.02.08.0100.000050%Not Available
Necrotising enterocolitis neonatal18.04.11.002; 07.08.03.0110.000126%Not Available
Foetal death18.01.02.003; 08.04.01.0110.000176%
Haemorrhage24.07.01.002--Not Available
Fluid intake reduced14.05.10.001--Not Available
Vulvovaginal pruritus21.08.02.004; 23.03.12.0090.000050%Not Available
Gastrointestinal ulcer haemorrhage24.07.02.023; 07.04.04.0060.000050%Not Available
Temperature intolerance08.01.09.0220.000503%Not Available
Daydreaming19.21.02.0050.000101%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Paraesthesia oral17.02.06.008; 07.05.05.0350.000111%Not Available
Paranasal sinus hypersecretion22.04.06.004--Not Available
Anxiety disorder19.06.01.0020.000176%Not Available
Bipolar disorder19.16.01.003--Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.004373%
Major depression19.15.01.0030.000126%Not Available
Metabolic disorder14.11.01.0010.000075%Not Available
Dysgraphia17.02.03.0060.000101%Not Available
Tandem gait test abnormal13.07.03.011--Not Available
Vasodilation procedure25.03.01.001--Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000402%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Application site discolouration23.03.03.023; 12.07.01.030; 08.02.01.0300.000050%Not Available
Congenital eye disorder06.08.03.011; 03.01.01.002--Not Available
Angiopathy24.03.02.007--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
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ADReCS-Target
Drug Name ADR Term Target
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