Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tasimelteon
Drug ID BADD_D02118
Description Tasimelteon is a selective dual melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD). Occurring commonly in blind individuals without light perception, this condition is often characterized by periods of night-time insomnia and day-time sleepiness. In blind individuals, a lack of light stimulation causes an extension of the 24-hour circadian cycle and can lead to progressively delayed sleep onset. By activating melatonin receptors MT1 and MT2 in the suprachiasmatic nucleus of the brain, tasimelteon has been shown to improve sleep by resynchronizing the circadian rhythm through its "non-photic" mechanism. Tasimelteon is currently the only drug available for the treatment of N24HSWD and was granted orphan drug status by the FDA in 2010.
Indications and Usage Tasimelteon is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD).
Marketing Status Prescription
ATC Code N05CH03
DrugBank ID DB09071
KEGG ID D09388
MeSH ID C478745
PubChem ID 10220503
TTD Drug ID D0Q5MQ
NDC Product Code 69766-039; 43068-220; 43068-304; 66499-0054; 76397-015; 76397-019; 67651-0307
Synonyms tasimelteon | N-((2-(2,3-dihydro-4-benzofuranyl)cyclopropyl)methyl)propanamide | BMS 214778 | BMS214778 | BMS-214778
Chemical Information
Molecular Formula C15H19NO2
CAS Registry Number 609799-22-6
SMILES CCC(=O)NCC1CC1C2=C3CCOC3=CC=C2
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pain in extremity15.03.04.0100.002107%
Palpitations02.01.02.003--
Pancreatitis07.18.01.0010.000602%
Paraesthesia17.02.06.005--
Paranoia19.05.01.0050.000602%Not Available
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonia aspiration22.01.01.0050.000157%Not Available
Prostatic disorder21.04.01.0010.000602%Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash erythematous23.03.06.0030.000602%Not Available
Rash pruritic23.03.12.0020.000903%Not Available
Renal failure20.01.03.005--Not Available
Respiration abnormal22.02.08.0110.000602%Not Available
Respiratory disorder22.02.07.0020.000602%Not Available
Restlessness17.02.05.021; 19.11.02.0020.000903%
Sedation17.02.04.0050.000602%Not Available
Seizure17.12.03.001--
Sinusitis22.07.03.007; 11.01.13.0050.001505%
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.000602%
Sleep disorder19.02.04.0010.006020%Not Available
Sleep talking19.02.03.005; 17.15.02.0030.000602%Not Available
Sleep terror19.02.03.008; 17.15.02.0060.000602%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.000903%Not Available
Somnolence19.02.05.003; 17.02.04.0060.017759%
Stress19.06.02.0040.000602%Not Available
Suicidal ideation19.12.01.003--
Throat irritation22.02.05.013; 07.05.03.0040.000903%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.000602%
Tremor17.01.06.002--
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