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LABELS · ce793f9e-0c20-43e6-9dc0-064e5c82e243

Conjugated Estrogens

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-02-27
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens ( 5.2 ) • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.1 , 5.3 ) • Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) ( 5.1 ) • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older ( 5.3 ) Estrogen Plus Progestin Therapy • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.1 , 5.3 ) • The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) ( 5.1 ) • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer ( 5.2 ) • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older ( 5.3 ) Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2) ]. Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3) , and Clinical Studies (14.5, 14.6) ] . The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) (0.625 mg)‑alone, relative to placebo [see Warnings and Precautions (5.1) , and Clinical Studies (14.5) ]. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , and Clinical Studies (14.6) ] . In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3) , and Clinical Studies (14.5 , 14.6) ]. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5) ] . The WHIMS estrogen plus progestin ancillary study of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , and Clinical Studies (14.6) ] . Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2) , and Clinical Studies (14.5) ]. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Conjugated Estrogens Tablets are a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease ( 1.4 ) • Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) ( 1.5 ) • Prevention of Postmenopausal Osteoporosis ( 1.6 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. 1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure 1.4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease 1.5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) 1.6 Prevention of Postmenopausal Osteoporosis Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
Full extracted label fields
application numbers
  1. NDA004782
boxed warning exact
  1. WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens ( 5.2 ) • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.1 , 5.3 ) • Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) ( 5.1 ) • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older ( 5.3 ) Estrogen Plus Progestin Therapy • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.1 , 5.3 ) • The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) ( 5.1 ) • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer ( 5.2 ) • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older ( 5.3 ) Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2) ]. Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3) , and Clinical Studies (14.5, 14.6) ] . The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) (0.625 mg)‑alone, relative to placebo [see Warnings and Precautions (5.1) , and Clinical Studies (14.5) ]. The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , and Clinical Studies (14.6) ] . In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3) , and Clinical Studies (14.5 , 14.6) ]. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5) ] . The WHIMS estrogen plus progestin ancillary study of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , and Clinical Studies (14.6) ] . Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2) , and Clinical Studies (14.5) ]. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
brand names
  1. Conjugated Estrogens
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ce793f9e-0c20-43e6-9dc0-064e5c82e243
generic names
  1. ESTROGENS, CONJUGATED
id
ce793f9e-0c20-43e6-9dc0-064e5c82e243
indications and usage exact
  1. 1 INDICATIONS AND USAGE Conjugated Estrogens Tablets are a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease ( 1.4 ) • Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) ( 1.5 ) • Prevention of Postmenopausal Osteoporosis ( 1.6 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. 1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure 1.4 Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease 1.5 Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) 1.6 Prevention of Postmenopausal Osteoporosis Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
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    matched search terms
    1. cancer
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    package ndcs
    1. 66993-295-02
    2. 66993-296-02
    3. 66993-297-02
    4. 66993-298-02
    5. 66993-299-02
    product ndcs
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    2. 66993-296
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    4. 66993-298
    5. 66993-299
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      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
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      spl effective date
      2026-02-27
      spl effective time
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      substance names
      1. ESTROGENS, CONJUGATED
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      Drugs@FDA application source records
      1. application number
        NDA004782
        payload
        all indexed label documents
        1. Appl No
          004782
          Application Docs Date
          2003-04-28 00:00:00
          Application Docs ID
          10665
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          115
          Submission Type
          SUPPL
        2. Appl No
          004782
          Application Docs Date
          2002-11-27 00:00:00
          Application Docs ID
          10666
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          128
          Submission Type
          SUPPL
        3. Appl No
          004782
          Application Docs Date
          2003-01-07 00:00:00
          Application Docs ID
          10667
          Application Docs Title
          0
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          2
          Submission No
          129
          Submission Type
          SUPPL
        4. Appl No
          004782
          Application Docs Date
          2004-05-04 00:00:00
          Application Docs ID
          10668
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          0
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          2
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        5. Appl No
          004782
          Application Docs Date
          2004-11-17 00:00:00
          Application Docs ID
          10669
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          136
          Submission Type
          SUPPL
        6. Appl No
          004782
          Application Docs Date
          2004-08-31 00:00:00
          Application Docs ID
          10670
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          137
          Submission Type
          SUPPL
        7. Appl No
          004782
          Application Docs Date
          2005-04-12 00:00:00
          Application Docs ID
          10671
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          139
          Submission Type
          SUPPL
        8. Appl No
          004782
          Application Docs Date
          2005-11-03 00:00:00
          Application Docs ID
          10672
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          142
          Submission Type
          SUPPL
        9. Appl No
          004782
          Application Docs Date
          2011-11-01 00:00:00
          Application Docs ID
          10673
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          164
          Submission Type
          SUPPL
        10. Appl No
          004782
          Application Docs Date
          2003-04-30 00:00:00
          Application Docs ID
          32917
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          130
          Submission Type
          SUPPL
        11. Appl No
          004782
          Application Docs Date
          2005-04-12 00:00:00
          Application Docs ID
          32918
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          138
          Submission Type
          SUPPL
        12. Appl No
          004782
          Application Docs Date
          2005-08-04 00:00:00
          Application Docs ID
          32919
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          141
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          100
          Submission Status
          AP
          Submission Status Date
          1995-12-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          101
          Submission Status
          AP
          Submission Status Date
          1998-02-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          102
          Submission Status
          AP
          Submission Status Date
          1996-06-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          103
          Submission Status
          AP
          Submission Status Date
          1996-06-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          104
          Submission Status
          AP
          Submission Status Date
          1998-05-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          108
          Submission Status
          AP
          Submission Status Date
          1998-10-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          109
          Submission Status
          AP
          Submission Status Date
          1999-06-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          113
          Submission Status
          AP
          Submission Status Date
          2000-07-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          115
          Submission Status
          AP
          Submission Status Date
          2003-04-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          116
          Submission Status
          AP
          Submission Status Date
          2001-04-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          120
          Submission Status
          AP
          Submission Status Date
          2001-08-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          004782
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          121
          Submission Status
          AP
          Submission Status Date
          2001-12-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA004782
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2025-04-22
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          004782
          Application Docs Date
          2025-04-25 00:00:00
          Application Docs ID
          81995
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          179
          Submission Type
          SUPPL
        official application record
        Appl No
        004782
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        WYETH PHARMS
        openfda application present
        true
        products
        1. Active Ingredient
          ESTROGENS, CONJUGATED
          Appl No
          004782
          Drug Name
          PREMARIN
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
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          1.25MG
          marketing status
          1. Prescription
        2. Active Ingredient
          ESTROGENS, CONJUGATED
          Appl No
          004782
          Drug Name
          PREMARIN
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
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          Reference Standard
          0
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          marketing status
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        3. Active Ingredient
          ESTROGENS, CONJUGATED
          Appl No
          004782
          Drug Name
          PREMARIN
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          0
          Strength
          0.3MG
          marketing status
          1. Prescription
        4. Active Ingredient
          ESTROGENS, CONJUGATED
          Appl No
          004782
          Drug Name
          PREMARIN
          Form
          TABLET;ORAL
          Product No
          004
          Reference Drug
          1
          Reference Standard
          1
          Strength
          0.625MG
          marketing status
          1. Prescription
        5. Active Ingredient
          ESTROGENS, CONJUGATED
          Appl No
          004782
          Drug Name
          PREMARIN
          Form
          TABLET;ORAL
          Product No
          005
          Reference Drug
          1
          Reference Standard
          1
          Strength
          0.9MG
          marketing status
          1. Prescription
        6. Active Ingredient
          ESTROGENS, CONJUGATED
          Appl No
          004782
          Drug Name
          PREMARIN
          Form
          TABLET;ORAL
          Product No
          006
          Reference Drug
          1
          Reference Standard
          0
          Strength
          0.45MG
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · indication intro context
      application numbers
      1. NDA004782
      brand names
      1. Conjugated Estrogens
      classification reasons
      1. explicit_positive_indication_predicate
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      294
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      true
      exact text
      1 INDICATIONS AND USAGE Conjugated Estrogens Tablets are a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Treatment of Hypoestrogenism due
      label id
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      unicode_code_points
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