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 approved; investigational
ATC Code N05CH03
DrugBank ID DB09071
KEGG ID D09388
MeSH ID C478745
PubChem ID 10220503
TTD Drug ID D0Q5MQ
NDC Product Code 76397-019; 66499-0054; 69766-039; 69238-2548; 76397-015; 43068-220; 43068-304; 67651-0307; 0480-4490
UNII SHS4PU80D9
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
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)
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.000444%
Sleep disorder19.02.04.0010.005997%Not Available
Sleep terror17.15.02.006; 19.02.03.0080.001111%Not Available
Sluggishness08.01.01.0040.000444%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.000353%Not Available
Somnolence19.02.05.003; 17.02.04.0060.016856%
Therapeutic response unexpected08.06.01.0010.000889%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.000444%Not Available
Throat irritation07.05.05.037; 22.12.03.0290.000666%Not Available
Trismus17.01.03.004; 15.05.04.0040.000444%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence20.02.02.010; 17.05.01.0080.000444%
Urinary retention20.02.02.0110.000287%
Urinary tract disorder20.08.01.0010.000666%Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Withdrawal syndrome19.07.06.023; 08.06.02.0120.001176%Not Available
Hypoacusis04.02.01.0060.000131%
Seasonal allergy10.01.04.001; 06.04.01.013; 22.04.04.0080.000444%Not Available
Epigastric discomfort07.01.02.0040.000444%Not Available
Depressive symptom19.15.02.0030.000444%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000444%Not Available
Adverse event08.06.01.0100.002443%Not Available
Bladder disorder20.03.01.0020.000444%Not Available
Cardiac disorder02.11.01.0030.000327%Not Available
Abnormal sleep-related event19.02.03.009; 17.15.02.0070.000444%Not Available
Adverse drug reaction08.06.01.0090.002953%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.004286%Not Available
Dark circles under eyes08.01.03.054; 06.08.03.0190.000444%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000444%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000889%
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