Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Levetiracetam
Drug ID BADD_D01265
Description Levetiracetam is a drug within the pyrrolidine class that is used to treat various types of seizures stemming from epileptic disorders. It was first approved for use in the United States in 1999 and is structurally and mechanistically unrelated to other anti-epileptic drugs (AEDs).[L8606,L8600,L8615] Levetiracetam possesses a wide therapeutic index[L8615,A185918] and little-to-no potential to produce, or be subject to, pharmacokinetic interactions[L8606,L8600,L8615] - these characteristics make it a desirable choice over other AEDs, a class of drugs notorious for having generally narrow therapeutic indexes and a propensity for involvement in drug interactions.[A185927]
Indications and Usage Levetiracetam is indicated as an adjunctive therapy in the treatment of partial onset seizures in epileptic patients who are one month of age and older. Additionally, it is indicated as an adjunct in the treatment of myoclonic seizures in patients with juvenile myoclonic epilepsy who are 12 years of age and older, and in primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy who are 6 years of age and older.[L8606] Levetiracetam is also available as an orally dissolvable tablet that is indicated as an adjunct in the treatment of partial onset seizures in patients with epilepsy who are 4 years of age and older and weigh more than 20kg.[L8609]
Marketing Status approved
ATC Code N03AX14
DrugBank ID DB01202
KEGG ID D00709
MeSH ID D000077287
PubChem ID 5284583
TTD Drug ID D0E1XL
NDC Product Code 76494-528; 36998-5960; 0904-7265; 58032-0132; 66174-0044; 16729-064; 25021-780; 27808-263; 31722-537; 42385-956; 42385-957; 43063-499; 43063-617; 43485-102; 44567-501; 47335-573; 47335-576; 50090-1333; 50090-2456; 50405-302; 51224-013; 51672-4137; 51672-4143; 55150-177; 60687-668; 61919-559; 62135-548; 63739-019; 63739-787; 66689-030; 67296-1486; 67877-770; 67877-771; 68180-112; 68180-118; 69102-105; 70518-3317; 71930-064; 72205-037; 76282-248; 80705-101; 55111-870; 65862-245; 72643-025; 82623-501; 13668-015; 13668-017; 14789-110; 16571-789; 16571-790; 27808-264; 0121-4799; 43485-103; 43547-223; 43547-345; 44567-503; 51672-4142; 60687-657; 63187-360; 63739-158; 63739-411; 64980-362; 67296-1248; 68001-405; 0409-2011; 68382-168; 69102-106; 70518-1772; 70518-3742; 70518-3765; 71205-880; 0615-7979; 72205-095; 12666-0014; 28877-5950; 36998-0117; 51927-0088; 57572-0034; 64220-192; 65372-1148; 72640-004; 16714-537; 16729-067; 27808-266; 42385-954; 0143-9574; 43485-104; 50474-597; 51672-4136; 61919-552; 63629-4137; 63629-8315; 64980-364; 64980-365; 65862-247; 65862-250; 66689-029; 68001-113; 68083-152; 68084-882; 68084-893; 69367-332; 70860-602; 71093-144; 71335-0748; 71335-2098; 0615-7978; 71930-063; 72189-190; 64980-363; 65162-685; 65841-703; 65841-704; 66689-028; 67457-265; 67457-266; 68083-154; 68180-114; 68382-165; 68788-7430; 70518-1998; 72189-229; 76494-529; 82009-123; 0904-7124; 62512-0030; 65862-246; 65862-261; 65862-315; 75834-246; 13668-014; 16714-310; 16714-357; 16729-065; 24689-106; 0143-9673; 47133-574; 50228-473; 60429-349; 63629-4675; 0378-5615; 65162-538; 66689-102; 67877-769; 68084-859; 68180-113; 0409-1886; 0472-0235; 70518-1827; 71205-728; 71205-881; 71335-0139; 71335-0702; 72205-096; 72485-106; 76494-531; 82009-122; 36998-5950; 38779-2900; 51927-0155; 64220-152; 71901-605; 81414-001; 16729-066; 31722-539; 42385-955; 43547-454; 50228-470; 50405-303; 55111-181; 63739-795; 67877-768; 68001-403; 68071-4508; 68083-153; 68084-870; 68180-099; 68788-7884; 70518-1921; 71930-065; 72205-120; 72865-188; 76282-246; 76494-530; 36998-5980; 36998-5990; 42185-7039; 51552-1448; 52038-171; 69037-0074; 71052-043; 16714-034; 16714-035; 16714-355; 16714-356; 35208-031; 35208-032; 0121-1598; 42571-331; 43547-221; 43547-222; 50090-6378; 50228-190; 50228-471; 50268-470; 50474-002; 50474-598; 50474-599; 55111-182; 55111-183; 55154-4171; 55154-5782; 60505-3517; 60505-3518; 63323-400; 0378-5619; 65162-528; 65162-529; 68001-404; 68788-8254; 69102-107; 70518-1108; 70518-2109; 70518-3534; 70860-604; 71335-0694; 72572-360; 72865-189; 82009-124; 28877-5960; 68225-021; 13668-016; 14789-330; 16571-787; 16714-358; 0121-0799; 43547-224; 43547-346; 44567-502; 50090-3889; 50228-189; 60429-350; 60505-3280; 60687-249; 63629-9615; 65162-539; 68180-117; 70518-3769; 70860-603; 71930-062; 72205-097; 72789-152; 80705-100; 82009-121; 0904-7125; 62991-3189; 16571-788; 31722-574; 44567-500; 47133-575; 50090-2875; 50090-6086; 50383-241; 50405-301; 51079-821; 51672-4141; 55154-5699; 63629-7516; 0378-5617; 67457-255; 68001-114; 68001-402; 68180-115; 69102-108; 69339-157; 69367-333; 70518-0947; 70518-1796; 70518-1901; 70518-2230; 75834-245; 76282-247; 28877-0117; 28877-5970; 50683-0322; 62350-0059; 68554-0065; 14789-220; 16714-354; 31722-536; 39822-4000; 50228-472; 50405-300; 51655-325; 58118-1112; 61919-685; 67457-790; 70518-3770; 71335-0048; 0615-7976; 0615-7977; 72205-094; 72865-187; 72865-190; 0904-7123; 36998-5940; 36998-5970; 62331-010; 67835-0006; 27808-265; 31722-538; 0121-2397; 43485-101; 50474-001; 50474-594; 50474-595; 50474-596; 51991-651; 55111-248; 55154-3367
UNII 44YRR34555
Synonyms Levetiracetam | Etiracetam, S-isomer | Etiracetam, S isomer | S-isomer Etiracetam | Ucb L059 | Ucb-L059 | UCB 6474 | UCB-6474 | UCB6474 | Etiracetam, R-isomer | Etiracetam, R isomer | R-isomer Etiracetam | Etiracetam, (R)- | Keppra | Etiracetam | alpha-ethyl-2-oxo-1-Pyrrolidineacetamide | alpha ethyl 2 oxo 1 Pyrrolidineacetamide | Ucb L060 | Ucb-L060 | UcbL060
Chemical Information
Molecular Formula C8H14N2O2
CAS Registry Number 102767-28-2
SMILES CCC(C(=O)N)N1CCCC1=O
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)
Head titubation17.01.06.0060.000079%Not Available
Bone marrow failure01.03.03.005--
Suicidal behaviour19.12.01.0060.000715%Not Available
Iron overload14.13.03.002; 12.02.08.0050.000079%
Hypersexuality19.08.03.0050.000159%Not Available
Mixed liver injury09.01.07.0150.000358%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000517%Not Available
Regurgitation07.01.07.0040.000079%Not Available
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.0060.000318%Not Available
Low birth weight baby18.04.02.0030.002584%Not Available
Community acquired infection11.07.02.003--Not Available
Brain injury19.07.03.007; 17.11.01.0030.000238%Not Available
Cholestatic liver injury09.01.07.0160.000199%Not Available
Intellectual disability17.03.07.001; 19.21.06.0010.000437%Not Available
Hypertransaminasaemia09.01.02.0050.000358%Not Available
Oropharyngeal discomfort07.05.05.008; 22.12.03.015--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Neurological decompensation17.02.05.0300.000079%Not Available
Toe walking17.02.05.048; 15.03.05.032; 19.01.02.0110.000079%Not Available
Terminal insomnia19.02.01.004; 17.15.03.0040.000079%Not Available
Acute kidney injury20.01.03.0160.005398%
Hypoxic-ischaemic encephalopathy24.04.06.021; 22.02.02.011; 17.13.02.0060.000079%Not Available
Foetal growth restriction18.03.01.0020.000994%
Gestational hypertension24.08.07.004; 18.02.03.0040.000318%Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.000278%
Drug-induced liver injury12.03.01.044; 09.01.07.0230.001510%Not Available
Substance-induced psychotic disorder12.03.01.053; 19.03.01.0070.001312%Not Available
White matter lesion24.04.06.027; 17.11.01.0090.000079%Not Available
Platelet dysfunction01.08.03.0030.000358%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.021; 12.03.01.0640.004213%Not Available
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