Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Estradiol hemihydrate
Drug ID BADD_D00824
Description Estradiol is a naturally occurring hormone circulating endogenously in females. It is commercially available in several hormone therapy products for managing conditions associated with reduced estrogen, such as vulvovaginal atrophy and hot flashes. Some available forms of estradiol include oral tablets, injections, vaginal rings, transdermal patches, sprays, gels, and creams.[L11485,L11488,L11491, L11494,L11497,L11500,L11503] When used for oral or IM administration, estradiol is commonly synthesized as a pro-drug ester (such as [DB13952], [DB13953], [DB13954], [DB13955], and [DB13956]). Because it has a low oral bioavailability on its own, estradiol is commonly formulated with an ester side-chain. [DB00977] (EE) is a synthetic form of estradiol commonly used as the estrogenic component of most combination oral contraceptive pills (OCPs). Ethinyl estradiol is different from estradiol due to its higher biovailability and increased resistance to metabolism, rendering it more suitable for oral administration.
Indications and Usage Estradiol is indicated for the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy due to menopause, for the treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and for the prevention of post-menopausal osteoarthritis. It is also used for the treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease, and for the treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Marketing Status Prescription; Discontinued
ATC Code G03CA03
DrugBank ID DB00783
KEGG ID D07918
MeSH ID D004958
PubChem ID 154274
TTD Drug ID D08QMX
NDC Product Code 22552-0033; 79572-016; 51552-1587; 60722-0032; 60592-206; 51927-4981; 60722-3003; 24823-903; 73377-079; 51927-5011
Synonyms Estradiol | Estradiol-17 beta | Estradiol 17 beta | Estradiol Anhydrous | Oestradiol | Estradiol-17beta | Estradiol 17beta | 17 beta-Estradiol | 17 beta Estradiol | 17 beta-Oestradiol | 17 beta Oestradiol | Progynova | Estradiol, (9 beta,17 alpha)-Isomer | Estradiol, (9 beta,17 beta)-Isomer | Estradiol, Monosodium Salt | Estradiol, Sodium Salt | Vivelle | Aerodiol | Estrace | Estraderm TTS | Estradiol Hemihydrate | Estradiol Hemihydrate, (17 alpha)-Isomer | Estradiol Monohydrate | Estradiol, (+-)-Isomer | Estradiol, (-)-Isomer | Estradiol, (16 alpha,17 alpha)-Isomer | Estradiol, (16 alpha,17 beta)-Isomer | Estradiol, (8 alpha,17 beta)-(+-)-Isomer | Estradiol, (8 alpha,17 beta)-Isomer | Estradiol Valerate | Estradiol Valeriante | Progynon-Depot | Progynon Depot | Delestrogen | Estradiol-17 alpha | Estradiol 17 alpha | Estradiol, (17-alpha)-Isomer | Ovocyclin
Chemical Information
Molecular Formula C36H50O5
CAS Registry Number 35380-71-3
SMILES CC12CCC3C(C1CCC2O)CCC4=C3C=CC(=C4)O.CC12CCC3C(C1CCC2O)CCC4=C3C=CC(=C4)O.O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
AdhesionVinculinP18206Not AvailableNot Available
Blood luteinising hormone increasedAngiotensinogenP01019T64485Not Available
Blood luteinising hormone increasedLutropin-choriogonadotropic hormone receptorP22888T79473Not Available
Blood luteinising hormone increasedProgonadoliberin-1P01148T18950Not Available
Endometrial cancerFibroblast growth factor 2P09038T31621Not Available
Endometrial cancerVascular endothelial growth factor AP15692T20761Not Available
High density lipoprotein decreasedEstrogen receptorP03372T89534Not Available
KyphosisNociceptin receptorP35370Not AvailableNot Available
KyphosisPrepronociceptinQ62923Not AvailableNot Available
Lipid metabolism disorder3-hydroxy-3-methylglutaryl-coenzyme A reductaseP04035T53585Not Available
ProstatitisStromelysin-2P09238T40488Not Available
Tumour necrosisEstrogen receptorP03372T89534Not Available
Tumour necrosisProtransforming growth factor alphaP01135T00033Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Fibrocystic breast disease21.05.01.002; 16.14.01.003--Not Available
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gallbladder disorder09.03.02.001--Not Available
Haemangioma24.03.06.004; 16.02.01.002--Not Available
Haemorrhagic disorder01.01.03.004; 24.07.01.021--Not Available
Headache17.14.01.001--
Hirsutism23.02.04.001; 05.05.01.005--
Hypocalcaemia14.04.01.004--
Infection11.01.08.002--Not Available
Irritability19.04.02.013; 08.01.03.011--
Jaundice cholestatic09.01.01.005--Not Available
Metrorrhagia21.01.01.006--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood altered19.04.02.007--Not Available
Muscle spasms15.05.03.004--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Ovarian cancer21.11.01.003; 16.12.04.001--Not Available
Pain08.01.08.004--
Pancreatitis07.18.01.001--
Porphyria03.08.01.001; 14.14.01.001--Not Available
Premenstrual syndrome21.01.01.007; 19.04.02.009--Not Available
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Rash23.03.13.001--Not Available
Sinusitis11.01.13.005; 22.07.03.007--
Tenderness08.01.08.005--Not Available
Thrombophlebitis24.01.02.001--Not Available
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