Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lisdexamfetamine
Drug ID BADD_D02440
Description Also known as _Vyvanse_, lisdexamfetamine (L-lysine-d-amphetamine) is a prodrug of the psychostimulant d-amphetamine [A40246]. It is paired with the essential amino acid _L-lysine_. Lisdexamfetamine dimesylate increases attention span and decreases restlessness in children and adults who are overactive/hyperactive, cannot concentrate for long periods, or are easily distracted or impulsive [A2230]. As a central nervous system stimulant, lisdexamfetamine is utilized as an adjunct therapy in the treatment of attention deficit hyperactivity disorder (ADHD). As a prodrug, lisdexamfetamine was specifically engineered as an abuse-resistant product [F2368]. The mechanism by which this occurs is through delayed release after ingestion (unlike some other psychostimulant drugs, which may be abused). After oral administration and absorption, enzyme hydrolysis after contact with red blood cells metabolize lisdexamfetamine into L- lysine, a naturally occurring essential amino acid and active _d-amphetamine_, which is responsible for the drug’s pharmacological effects. Gastrointestinal pH does not affect this conversion, and the addition of the L-lysine slows the amount of d-amphetamine available in the circulation and central nervous system [F2368].
Indications and Usage For the treatment of Attention-deficit/hyperactivity disorder (ADHD) and for moderate to severe binge eating disorder in adults [FDA label], [A40246]. This drug is not indicated for weight loss. Use of other sympathomimetic drugs for weight loss is associated with serious cardiovascular effects. The safety and effectiveness of this drug for the treatment of obesity have not yet been determined [FDA label].
Marketing Status approved; investigational
ATC Code N06BA12
DrugBank ID DB01255
KEGG ID D08130
MeSH ID D000069478
PubChem ID 11597698
TTD Drug ID D00DEF
NDC Product Code Not Available
UNII H645GUL8KJ
Synonyms Lisdexamfetamine Dimesylate | Dimesylate, Lisdexamfetamine | Lis-dexamfetamine Dimesylate | Dimesylate, Lis-dexamfetamine | Lis dexamfetamine Dimesylate | Vyvanse | Elvanse | Lisdexamfetamine | NRP104 | NRP-104 | NRP 104
Chemical Information
Molecular Formula C15H25N3O
CAS Registry Number 608137-32-2
SMILES CC(CC1=CC=CC=C1)NC(=O)C(CCCCN)N
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)
Sudden cardiac death08.04.01.008; 02.03.04.016--Not Available
Homicidal ideation19.05.01.0080.000104%Not Available
Muscle tightness15.05.03.0070.000188%Not Available
Impatience19.05.01.0140.000355%Not Available
Self-injurious ideation19.12.01.007--Not Available
Prostatomegaly21.04.01.0020.000236%Not Available
Ear discomfort04.03.01.0050.000236%Not Available
Eye pruritus06.04.05.0060.000236%Not Available
Drug tolerance08.06.01.0030.000389%Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.000236%Not Available
Growth retardation15.03.05.016; 14.03.02.031; 05.03.02.007--
Depressive symptom19.15.02.0030.000271%Not Available
Affect lability19.04.01.0010.000598%Not Available
Dysphemia19.19.03.005; 17.02.08.0100.000389%Not Available
Urine odour abnormal20.02.01.0200.000591%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000153%Not Available
Bipolar disorder19.16.01.0030.000174%Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Major depression19.15.01.003--Not Available
Nicotine dependence19.07.06.0170.000236%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000236%Not Available
Angiopathy24.03.02.0070.000153%Not Available
Adverse event08.06.01.0100.004214%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000779%Not Available
Cardiac disorder02.11.01.003--Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.000271%Not Available
Impulse-control disorder19.18.01.0020.000271%Not Available
Limb discomfort15.03.04.0140.000188%Not Available
Mental disorder19.07.01.002--Not Available
Abnormal behaviour19.01.01.0010.004861%Not Available
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