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)
Mental disability26.01.01.001---
Middle insomnia17.15.03.003; 19.02.01.0030.012902%-
Muscle spasms15.05.03.0040.016697%
Myalgia15.05.02.001--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Nightmare19.02.03.0030.010246%-
Palpitations02.11.04.0120.008349%
Pancytopenia01.03.03.0030.005692%-
Photosensitivity reaction23.03.09.0030.008349%
Plasma cell myeloma01.14.02.004; 16.23.02.0040.003795%-
Pruritus23.03.12.0010.010246%
Rhabdomyolysis15.05.05.0020.003795%
Schizophrenia19.03.04.0010.003795%-
Seizure17.12.03.0010.011385%
Somnambulism17.15.02.004; 19.02.03.0060.012902%-
Somnolence17.02.04.006; 19.02.05.0030.052748%
Subarachnoid haemorrhage12.01.10.011; 17.08.01.010; 24.07.04.0040.005692%-
Suicide attempt19.12.01.0040.015179%
Thinking abnormal17.02.05.023; 19.10.03.001---
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary retention20.02.02.0110.005692%
Vomiting07.01.07.0030.014041%
Tubulointerstitial nephritis20.05.02.0020.003795%-
Musculoskeletal discomfort15.03.04.001---
Adverse event08.06.01.0100.003795%-
Brain neoplasm16.30.01.003; 17.20.01.0030.003795%-
Abnormal behaviour19.01.01.001---
Acute kidney injury20.01.03.0160.003795%
Ovarian cancer recurrent16.12.04.005; 21.11.01.0140.003795%-
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