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)
Upper respiratory tract infection22.07.03.011; 11.01.13.0090.001505%
Urinary incontinence20.02.02.010; 17.05.01.0080.000602%
Urinary retention20.02.02.0110.000602%
Urinary tract disorder20.08.01.0010.000602%Not Available
Urinary tract infection20.08.02.001; 11.01.14.0040.004214%
Urticaria10.01.06.001; 23.04.02.001--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Withdrawal syndrome08.06.02.012; 19.07.02.0050.000602%Not Available
Peripheral swelling02.05.04.015; 08.01.03.0530.001505%Not Available
Balance disorder17.02.02.0070.000602%Not Available
Pruritus generalised23.03.12.0030.000602%Not Available
Epigastric discomfort07.01.02.0040.000602%Not Available
Hepatic enzyme increased13.03.01.0190.001204%Not Available
Bladder disorder20.03.01.0020.000602%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Renal impairment20.01.03.010--Not Available
Respiratory tract infection11.01.08.017; 22.07.07.0010.001204%Not Available
Unevaluable event08.01.03.051--Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.004515%Not Available
Dark circles under eyes08.01.03.054; 06.08.03.0190.000602%Not Available
Oropharyngeal discomfort22.02.05.027; 07.05.05.0080.000602%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.000903%
Terminal insomnia19.02.01.004; 17.15.03.0040.000602%Not Available
Irregular sleep phase19.02.06.003; 17.15.06.0030.000602%Not Available
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