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)
Muscle twitching15.05.03.0050.000410%Not Available
Mydriasis17.02.11.003; 06.05.03.0040.000814%Not Available
Myocarditis02.04.03.0010.000104%
Nasal congestion22.04.04.0010.000389%
Neck pain15.03.04.0090.000257%
Negativism19.05.01.0120.000980%Not Available
Nervousness19.06.02.0030.001711%Not Available
Nightmare19.02.03.0030.000376%Not Available
Nonspecific reaction08.01.03.0400.000236%Not Available
Obsessive-compulsive disorder19.06.05.0020.000459%Not Available
Oral mucosal blistering07.05.05.0170.000188%Not Available
Oral pain07.05.05.0340.000389%
Pain in jaw15.02.01.0030.000188%Not Available
Pain of skin23.03.03.003--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Palpitations02.11.04.0120.002295%
Pancytopenia01.03.03.003--Not Available
Panic attack19.06.04.0010.000528%Not Available
Panic reaction19.06.04.0030.000271%Not Available
Paranoia19.05.01.0050.001599%Not Available
Parosmia22.04.03.007; 17.04.04.0020.000355%Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012--
Peripheral coldness08.01.09.010; 23.06.04.008; 24.04.03.0060.000779%Not Available
Personality change19.05.01.006; 17.02.05.0190.000932%
Photophobia17.17.02.006; 06.01.01.0040.000153%
Polydipsia05.03.03.002; 14.05.02.0010.000153%Not Available
Poor peripheral circulation24.04.03.0130.000389%Not Available
Pressure of speech19.19.03.006--Not Available
Psychomotor hyperactivity17.01.02.011; 19.11.02.0030.004332%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
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