Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Norethindrone acetate
Drug ID BADD_D01586
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 Prescription; Discontinued
ATC Code G03AC01; G03DC02
DrugBank ID DB00717
KEGG ID D00953
MeSH ID D000077563
PubChem ID 5832
TTD Drug ID Not Available
NDC Product Code 0378-7291; 68462-304; 50742-267; 72969-099; 64918-1404; 60870-0236; 0555-0211; 51285-424; 16571-658
Synonyms Norethindrone Acetate | Norethisterone Acetate | Estr-4-en-3-one, 17-(acetyloxy)-17-ethynyl-, (17beta)- | Norethindrone Acetate, (17alpha)-(+-)-isomer | Aygestin | Norlutate | Norethindrone Acetate, (17alpha)-isomer
Chemical Information
Molecular Formula C22H28O3
CAS Registry Number 51-98-9
SMILES CC(=O)OC1(CCC2C1(CCC3C2CCC4=CC(=O)CCC34)C)C#C
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 distension07.01.04.001--
Abdominal pain07.01.05.002--
Acne23.02.01.001--Not Available
Affective disorder19.04.04.001--Not Available
Alanine aminotransferase abnormal13.03.01.001--Not Available
Alopecia23.02.02.001--
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Aspartate aminotransferase abnormal13.03.01.004--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Back pain15.03.04.005--
Blood pressure increased13.14.03.005--Not Available
Blood triglycerides increased13.12.03.001--Not Available
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast discharge21.05.05.001--Not Available
Breast enlargement21.05.04.001--Not Available
Breast pain21.05.05.003--
Breast tenderness21.05.05.004--Not Available
Cerebral thrombosis24.01.04.003; 17.08.01.006--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cervical discharge21.06.01.001--Not Available
Cervix disorder21.06.01.003--Not Available
Chloasma23.05.01.001; 18.08.02.002--Not Available
Chorea17.01.01.001--Not Available
Contact lens intolerance06.01.01.003--Not Available
Dementia19.20.02.001; 17.03.01.001--Not Available
Depression19.15.01.001--
Dermatitis allergic23.03.04.003; 10.01.03.014--Not Available
Diarrhoea07.02.01.001--
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