Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lisdexamfetamine dimesylate
Drug ID BADD_D01299
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 D04747
MeSH ID D000069478
PubChem ID 11597697
TTD Drug ID D00DEF
NDC Product Code 65392-0118; 59417-106; 59116-3011; 61960-0300; 59417-104; 59417-116; 59417-107; 59417-115; 59417-119; 59116-3012; 59417-103; 51634-2058; 59417-102; 17180-1100; 59417-117; 59417-118; 59417-120; 59417-101; 59417-105; 59116-3013; 59116-3010
UNII SJT761GEGS
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 C17H33N3O7S2
CAS Registry Number 608137-33-3
SMILES CC(CC1=CC=CC=C1)NC(=O)C(CCCCN)N.CS(=O)(=O)O.CS(=O)(=O)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)
Gastrointestinal disorder07.11.01.001--Not Available
Hallucination19.10.04.003--
Headache17.14.01.001--
Heart rate increased13.14.04.002--Not Available
Hepatitis09.01.07.004--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Immune system disorder10.02.01.001--Not Available
Initial insomnia19.02.01.005; 17.15.03.005--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Irritability19.04.02.013; 08.01.03.011--
Libido decreased21.03.02.005; 19.08.03.001--
Logorrhoea19.19.02.001; 17.02.08.006--Not Available
Mania19.16.02.002--
Middle insomnia19.02.01.003; 17.15.03.003--Not Available
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Palpitations02.11.04.012--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Restlessness19.11.02.002; 17.02.05.021--
Seizure17.12.03.001--
Skin disorder23.03.03.007--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Sudden death08.04.01.003; 02.03.04.013--
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