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)
Disturbance in social behaviour19.05.01.0180.002642%Not Available
Accidental death12.01.08.040; 08.04.01.013--Not Available
Tachyphrenia19.10.03.010; 17.03.03.0070.000306%Not Available
Excessive eye blinking17.17.02.010; 06.05.01.0040.000236%Not Available
Decreased eye contact19.01.02.012; 17.02.05.0550.000153%Not Available
Fat tissue decreased08.01.03.0680.000236%Not Available
Defiant behaviour19.05.01.0170.000153%Not Available
Acute macular neuroretinopathy17.17.01.026; 06.10.02.0080.000174%Not Available
Attention deficit hyperactivity disorder19.21.04.0040.000800%Not Available
Behaviour disorder19.01.01.0050.000473%Not Available
Drug effect less than expected08.06.01.0360.000389%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000070%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Idiopathic intracranial hypertension17.07.02.0110.000070%Not Available
Illness08.01.03.091--Not Available
Oral administration complication12.07.04.035; 08.02.04.0350.000236%Not Available
Product intolerance08.06.01.045--Not Available
Sensitive skin23.03.03.097--Not Available
Suspected suicide attempt19.12.01.010--Not Available
Therapeutic product effect decreased08.06.01.0500.017857%Not Available
Therapeutic product effect delayed08.06.01.0510.000946%Not Available
Therapeutic product effect incomplete08.06.01.0520.002281%Not Available
Therapeutic product effect increased08.06.01.0530.003533%Not Available
Therapeutic product effect variable08.06.01.0550.004172%Not Available
Therapeutic response changed08.06.01.0590.000355%Not Available
Therapeutic response shortened08.06.01.0620.005459%Not Available
Xanthelasma23.03.03.103; 14.08.04.029--Not Available
Brain fog19.21.02.017; 17.02.05.077; 16.32.03.050--Not Available
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