Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Norethisterone
Drug ID BADD_D02427
Description Norethisterone, also known as norethindrone, is a synthetic progestational hormone belonging to the 19-nortestosterone-derived class of progestins.[A10367] It is further classified as a second-generation progestin, along with [levonorgestrel] and its derivatives, and is the active form of several other progestins including [norethynodrel] and [lynestrenol].[A10367] Norethisterone mimics the actions of endogenous [progesterone], albeit with a greater potency,[A188075] and is used on its own or in combination with estrogen derivatives in a variety of applications including contraception and hormone replacement therapy.[L9527,L10301,L10304,L10307] First derived in 1951 in Mexico City, norethisterone was originally intended for use as a remedy for irregular menstruation and endometriosis, and was not marketed for use as an oral contraceptive until 1962.[L10439]
Indications and Usage For the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
Marketing Status Not Available
ATC Code G03AC01; G03DC02
DrugBank ID DB00717
KEGG ID D00182
MeSH ID D009640
PubChem ID 6230
TTD Drug ID D0GL7U
NDC Product Code 12866-1013; 73774-005
Synonyms Norethindrone | Norpregneninolone | Norethisterone | 19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17alpha)- | Ethinylnortestosterone | Conceplan | Micronor | Norlutin | Nor-QD | Nor QD | NorQD | Norcolut | Norcolute | Norethindrone, (1 beta)-Isomer | Monogest
Chemical Information
Molecular Formula C20H26O2
CAS Registry Number 68-22-4
SMILES CC12CCC3C(C1CCC2(C#C)O)CCC4=CC(=O)CCC34
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)
Abdominal distension07.01.04.0010.000537%
Abdominal pain07.01.05.0020.000806%
Abdominal pain lower07.01.05.0100.000537%Not Available
Abdominal pain upper07.01.05.0030.000537%
Acne23.02.01.0010.000537%Not Available
Alopecia23.02.02.0010.000537%
Anxiety19.06.02.0020.001074%
Back pain15.03.04.0050.000537%
Cerebrovascular accident24.03.05.001; 17.08.01.0070.000537%
Chest pain08.01.08.002; 02.02.02.011; 22.02.08.0030.000806%Not Available
Depression19.15.01.0010.000806%
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.000806%
Dysmenorrhoea21.01.01.0020.000537%
Dyspnoea22.02.01.004; 02.01.03.0020.000537%
Endometriosis21.07.01.0040.001343%Not Available
Feeling abnormal08.01.09.0140.000537%Not Available
Headache17.14.01.0010.002685%
Hypersensitivity10.01.03.0030.000537%
Hypertension24.08.02.0010.000537%
Insomnia19.02.01.002; 17.15.03.0020.000537%
Irritability19.04.02.013; 08.01.03.0110.001074%
Malaise08.01.01.0030.000806%
Menorrhagia21.01.03.0020.001880%
Menstrual disorder21.01.01.0040.000806%Not Available
Metrorrhagia21.01.01.0060.001343%Not Available
Migraine24.03.05.003; 17.14.02.0010.001074%Not Available
Mood altered19.04.02.0070.000806%Not Available
Mood swings19.04.03.0010.000806%Not Available
Muscle spasms15.05.03.0040.001343%
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