Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ramelteon
Drug ID BADD_D01908
Description Ramelteon is the first in a new class of sleep agents that selectively binds to the melatonin receptors in the suprachiasmatic nucleus (SCN). It is used for insomnia, particularly delayed sleep onset. Ramelteon has not been shown to produce dependence and has shown no potential for abuse.
Indications and Usage For the treatment of insomnia characterized by difficulty with sleep onset.
Marketing Status approved; investigational
ATC Code N05CH02
DrugBank ID DB00980
KEGG ID D02689
MeSH ID C495910
PubChem ID 208902
TTD Drug ID D0U0KW
NDC Product Code 0591-2191; 59651-505; 63629-8531; 70010-028; 71205-918; 72189-369; 63415-0150; 50268-708; 42571-375; 43598-741; 52817-235; 64764-805; 72189-484; 60687-692; 70771-1495; 42413-0180; 73435-003; 50436-3980; 71335-2186; 14501-0030; 76397-021; 76397-032; 55700-874; 63629-8264; 59651-469; 66332-0014; 72189-153; 0832-1250; 42291-776; 70710-1344; 80425-0203; 80425-0343; 70700-272; 72319-005; 71335-1853; 58159-050
UNII 901AS54I69
Synonyms ramelteon | (S)-N-(2-(1,6,7,8-tetrahydro-2H-indeno-(5,4)furan-8-yl)ethyl)propionamide | TAK-375 | Rozerem
Chemical Information
Molecular Formula C16H21NO2
CAS Registry Number 196597-26-9
SMILES CCC(=O)NCCC1CCC2=C1C3=C(C=C2)OCC3
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)
Altered state of consciousness19.07.01.003; 17.02.04.0010.003795%Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Completed suicide19.12.01.001; 08.04.01.0100.003795%Not Available
Condition aggravated08.01.03.0040.010246%Not Available
Delirium19.13.02.0010.011385%
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.014800%
Drug ineffective08.06.01.0060.130922%Not Available
Dysgeusia17.02.07.003; 07.14.03.001--
Epilepsy17.12.03.0020.005692%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.016697%Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.003795%
Hallucination19.10.04.0030.021251%
Hangover08.01.09.0180.012902%Not Available
Headache17.14.01.001--
Hepatic failure09.01.03.0020.005692%
Hepatic function abnormal09.01.02.0010.007590%Not Available
Hypersomnia19.02.05.001; 17.15.01.0010.008349%
Hypokalaemia14.05.03.0020.003795%
Ileus07.13.01.0010.005692%
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.0020.008349%
Interstitial lung disease22.01.02.003; 10.02.01.0330.003795%Not Available
Loss of consciousness17.02.04.0040.005692%Not Available
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