Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Estradiol
Drug ID BADD_D00821
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 D00105
MeSH ID D004958
PubChem ID 5757
TTD Drug ID D08QMX
NDC Product Code 76420-022; 0430-0721; 63629-4788; 43063-706; 0781-7119; 0169-5176; 70518-0920; 70934-541; 54348-702; 43063-717; 72189-183; 68788-7961; 38779-2261; 46144-400; 69238-1294; 0781-7104; 68025-066; 0378-4640; 70518-2595; 61919-195; 72189-198; 71335-0797; 50090-3645; 52483-9104; 0430-3754; 0023-5886; 0093-3223; 63083-1557; 42291-962; 60429-833; 0395-8065; 11014-0320; 11014-0321; 51862-334; 69238-1296; 0093-3541; 0574-2067; 65162-126; 68025-067; 65162-992; 0013-2150; 61919-278; 63629-8803; 42806-089; 0378-4641; 68788-7892; 70518-2829; 70934-215; 50261-110; 0378-3349; 68788-8063; 68968-6675; 69238-1295; 0378-4643; 49452-2801; 0078-0344; 0430-0722; 63539-021; 68788-7332; 68025-065; 12860-0218; 50090-5494; 0802-8065; 60429-834; 63629-8804; 0378-4620; 70934-506; 0781-7138; 68968-6637; 76420-680; 51862-332; 69238-1447; 68968-3437; 68071-2487; 71335-1973; 65162-993; 76420-023; 70518-2368; 0078-0343; 50419-453; 0378-4621; 0430-0720; 68025-083; 65162-995; 52483-9254; 0378-8770; 71335-1488; 52483-9504; 70518-2369; 0555-0887; 0078-0365; 68968-3410; 60870-0218; 24658-702; 0378-3361; 68462-711; 71335-0430; 24658-703; 0555-0899; 0378-3352; 51862-333; 69238-1629; 68968-3475; 0378-3360; 71335-0201; 48087-0159; 70934-927; 0781-7122; 66993-002; 71335-0226; 65162-989; 68968-6650; 54348-701; 17139-617; 68981-012; 65162-150; 65162-226; 60429-835; 47781-104; 0078-0345; 44132-009; 50419-455; 24658-704; 0378-4644; 0781-7133; 51552-0384; 50419-456; 69238-1631; 50090-1704; 50419-459; 76420-681; 53746-226; 50419-451; 0023-5887; 68025-086; 68071-2429; 0555-0886; 69238-1630; 63629-8802; 0781-7134; 65162-228; 76420-021; 68071-3394; 45541-1124; 70934-393; 50419-454; 0023-5888; 69238-1632; 68968-3450; 0378-4623; 50090-3327; 65162-997; 0781-7156; 68788-7102; 42291-426; 0378-3350; 42806-087; 0378-4642; 71335-0445; 69238-1293; 0115-1518; 0037-4801; 63629-8654; 0023-5885; 69238-1633; 0781-7136; 50261-104; 71335-1719; 70934-798; 63629-8713; 65162-148; 68968-6625; 0078-0346; 50419-452; 42806-088; 68968-6610; 38779-0869; 45802-097; 63187-741; 68981-013; 0781-7129; 0378-3351; 0378-4622; 76420-048; 50090-2321; 68968-3425; 65162-149; 70934-786; 0378-4619; 0781-7167; 70518-0834; 44132-001; 0781-7144
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 C18H24O2
CAS Registry Number 17916-67-5
SMILES CC12CCC3C(C1CCC2O)CCC4=C3C=CC(=C4)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
AdhesionVinculinP18206Not Available7929632; 9535896; 9706870; 2421880; 9826128; 2055945; 9724452; 3084501; 11822829
Blood luteinising hormone increasedAngiotensinogenP01019T644858462463; 10537146; 8119137; 7507825; 2293982; 8680436; 9725714; 7484438
Blood luteinising hormone increasedLutropin-choriogonadotropic hormone receptorP22888T794738462463; 10537146; 8119137; 7507825; 2293982; 8680436; 9725714; 7484438
Blood luteinising hormone increasedProgonadoliberin-1P01148T189508462463; 10537146; 8119137; 7507825; 2293982; 8680436; 9725714; 7484438
Endometrial cancerVascular endothelial growth factor AP15692T2076125608994
Endometrial cancerFibroblast growth factor 2P09038T3162125608994
High density lipoprotein decreasedEstrogen receptorP03372T8953411919305; 11997270; 16612068
High density lipoprotein decreasedEstrogen receptorP03372T8953410828826; 11746525; 10542244
KyphosisPrepronociceptinQ62923Not Available25677773
KyphosisNociceptin receptorP35370Not Available25677773
Lipid metabolism disorder3-hydroxy-3-methylglutaryl-coenzyme A reductaseP04035T535853921072
ProstatitisStromelysin-2P09238T4048815215045; 12782014; 1597166
Tumour necrosisProtransforming growth factor alphaP01135T0003310828826; 11746525; 10542244; 9611253
Tumour necrosisEstrogen receptorP03372T8953410828826; 11746525; 10542244
Tumour necrosisEstrogen receptorP03372T8953411919305; 11997270; 16612068
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.000974%
Abdominal pain07.01.05.0020.000904%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abortion incomplete18.01.01.0030.000139%Not Available
Acne23.02.01.0010.000139%Not Available
Affective disorder19.04.04.0010.000348%Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.0010.001391%
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia19.20.01.001; 17.03.02.0010.000278%
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.0020.000139%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anosmia22.04.03.006; 17.04.04.0010.000139%
Anxiety19.06.02.002--
Aphasia19.21.01.001; 17.02.03.0010.000139%
Application site erythema08.02.01.001; 23.03.06.005; 12.07.01.001--Not Available
Application site irritation08.02.01.003; 12.07.01.003--Not Available
Application site rash23.03.13.008; 12.07.01.016; 08.02.01.016--Not Available
Application site reaction12.07.01.006; 08.02.01.006--Not Available
Arthralgia15.01.02.0010.000904%
Arthritis15.01.01.0010.000139%
Arthropathy15.01.01.003--Not Available
Arthropod bite12.01.08.022--Not Available
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