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--Not Available
Middle insomnia19.02.01.003; 17.15.03.0030.012902%Not Available
Muscle spasms15.05.03.0040.016697%
Myalgia15.05.02.001--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nightmare19.02.03.0030.010246%Not Available
Palpitations02.11.04.0120.008349%
Pancytopenia01.03.03.0030.005692%Not Available
Photosensitivity reaction23.03.09.0030.008349%
Plasma cell myeloma16.23.02.004; 01.14.02.0040.003795%Not Available
Pruritus23.03.12.0010.010246%
Rhabdomyolysis15.05.05.0020.003795%
Schizophrenia19.03.04.0010.003795%Not Available
Seizure17.12.03.0010.011385%
Somnambulism19.02.03.006; 17.15.02.0040.012902%Not Available
Somnolence19.02.05.003; 17.02.04.0060.052748%
Subarachnoid haemorrhage12.01.10.011; 24.07.04.004; 17.08.01.0100.005692%Not Available
Suicide attempt19.12.01.0040.015179%
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary retention20.02.02.0110.005692%
Vomiting07.01.07.0030.014041%
Tubulointerstitial nephritis20.05.02.0020.003795%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Adverse event08.06.01.0100.003795%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.003795%Not Available
Abnormal behaviour19.01.01.001--Not Available
Acute kidney injury20.01.03.0160.003795%
Ovarian cancer recurrent16.12.04.005; 21.11.01.0140.003795%Not Available
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