Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Conjugated estrogens
Drug ID BADD_D00528
Description The conjugated estrogens are noncrystalline mixtures of purified female sex hormones obtained either by its isolation from the urine of pregnant mares or by synthetic generation from vegetal material. Both of these products are later conjugated to natrium sulfate by ester bonds in order to make them more water soluble.[L5605, T475] The conjugated estrogen product contains a mix of estrogen from which about 50% is represented by estrone sulfate followed by 25% of equilin sulfate, 15% of 17-alpha-dehydroequilenin sulfate, 3% of equilenin sulfate, 5% of 17-alpha and 17-beta-dihydroequilenin sulfate, 2% of 17-alpha-estradiolsulfate and 3% of 17-beta-estradiolsulfate. It also presents a large number of unidentified molecules with weak estrogenic activity as well as non-human molecules when it is obtained from pregnant mares urine.[T475] The conjugated estrogen mixture was approved for marketing in US in 1942 based on the efficacy against certain conditions. However, until 1986 official clinical trials were performed and this product was determined to be effective for the treatment of osteoporosis.[T484] The currently approved product of conjugated estrogens was developed by Wyeth Ayerst and FDA approved in 2003.[L5608]
Indications and Usage The conjugated estrogens are indicated for several different conditions including: - Treatment of moderate to severe vasomotor symptoms due to menopause. - Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. - Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - Palliative treatment of breast cancer in appropriately selected patients with metastatic disease. - Palliative treatment of androgen-dependent carcinoma of the prostate. - Preventive therapy of postmenopausal osteoporosis.[A38238]
Marketing Status approved
ATC Code G03CA57
DrugBank ID DB00286
KEGG ID D04070
MeSH ID D004966
PubChem ID 45357473
TTD Drug ID D0T0LU
NDC Product Code 42816-1100; 42816-1101; 70203-101; 0046-0749; 42816-0101; 42816-1103; 0046-0872; 42816-1104; 42816-1102
UNII Not Available
Synonyms Estrogens, Conjugated (USP) | Estrogenic Hormones, Conjugated | Conjugated Estrogenic Hormones | Estrogens, Conjugated | Estrogenic Substances, Conjugated | Conjugated Estrogenic Substances | Conjugated Estrogens | Conjugated Estrogen | Estrogen, Conjugated | Congest | Conjugated Equine Estrogens | Equine Estrogens, Conjugated | Conjugated Equine Estrogen | Equine Estrogen, Conjugated | Estrogen, Conjugated Equine | Dagynil | Oestrofeminal | Oestro-Feminal | Oestro Feminal | Estro-Feminal | Estro Feminal | Premarin | Climopax | Climarest | Presomen | Progens | Progen | Transannon | Femavit | Carentil | Prelestrin
Chemical Information
Molecular Formula C18H21NaO5S
CAS Registry Number 12126-59-9
SMILES CC12CCC3C(C1CCC2=O)CCC4=C3C=CC(=C4)OS(=O)(=O)[O-].[Na+]
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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Affective disorder19.04.04.001--Not Available
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--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 enlargement21.05.04.001--Not Available
Breast pain21.05.05.003--
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cervical discharge21.06.01.001--Not Available
Chloasma23.05.01.001; 18.08.02.002--Not Available
Chorea17.01.01.001--Not Available
Colitis ischaemic07.08.01.004; 24.04.08.012--Not Available
Contact lens intolerance06.01.01.003--Not Available
Cough22.02.03.001--
Dementia17.03.01.001; 19.20.02.001--Not Available
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Ectropion of cervix21.06.01.004--Not Available
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