Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Norethindrone
Drug ID BADD_D01585
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 Norethisterone is indicated as an oral contraceptive when given as monotherapy[L9527] or in combination with an estrogen component, such as [ethinylestradiol] or [estradiol].[L10313,L10307] In combination with an estrogen component, oral norethisterone is also indicated as a hormone replacement therapy in the treatment of postmenopausal osteoporosis and moderate-to-severe vasomotor symptoms arising from menopause.[L10304] When applied via transdermal patch, the combination of norethisterone and estradiol is indicated for the treatment of hypoestrogenism, vulvovaginal atrophy, and moderate-severe vasomotor symptoms.[L10301] Norethisterone, taken in combination with intramuscular [leuprolide], is also indicated for the symptomatic treatment of endometriosis-related pain.[L10310]
Marketing Status approved
ATC Code G03DC02; G03AC01
DrugBank ID DB00717
KEGG ID D00182
MeSH ID D009640
PubChem ID 6230
TTD Drug ID D0GL7U
NDC Product Code 51862-886; 68180-876; 68462-303; 68462-305; 0378-7272; 68180-877; 50090-6161; 0378-7292; 70518-3113; 79929-015; 30007-829; 60870-0235; 16714-440; 63187-748; 51862-884; 52544-629; 65862-925; 69238-1583; 53002-1793; 59651-136; 65162-475; 71205-526; 50102-300; 16714-441; 42291-650
UNII T18F433X4S
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
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)
Deep vein thrombosis24.01.02.003---
Acute coronary syndrome02.02.02.015; 24.04.04.011---
Affect lability19.04.01.001---
Haemorrhage24.07.01.0020.000355%-
Genital discharge21.10.01.006---
Haemorrhagic ovarian cyst16.04.03.003; 21.11.01.007; 24.07.03.0140.000105%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.001045%
Breast disorder21.05.04.004---
Connective tissue disorder10.04.04.026; 15.06.01.006---
Embolism24.01.01.009--
Genital haemorrhage21.10.05.002; 24.07.03.007---
Lactation disorder18.06.02.003; 21.05.02.004--
Mental disorder19.07.01.002---
Therapeutic reaction time decreased08.06.01.015---
Adverse drug reaction08.06.01.0090.000230%-
Androgens13.10.05.008---
Hepatobiliary disease09.01.08.003---
Retinal vascular thrombosis06.10.01.004; 24.01.07.001---
Renal impairment20.01.03.010---
Poor quality sleep17.15.04.002; 19.02.05.005---
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.004---
Sexually active26.05.02.001---
Adnexal torsion21.11.02.0120.000157%-
Coeliac disease07.17.01.008; 10.04.04.012; 14.02.01.0070.000105%-
Borderline serous tumour of ovary16.12.06.007; 21.11.01.0180.000105%-
Heavy menstrual bleeding21.01.03.0050.000993%-
Intermenstrual bleeding21.01.01.0150.000763%-
Lactation insufficiency18.06.02.006; 21.05.02.006---
Pregnancy on oral contraceptive18.08.01.005---
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