Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a

Provera

Open original source → · Download preserved record

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
2026-06-29
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR 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 CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia .) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (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 conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders . ) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study 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 CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use .) Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant Neoplasm, Breast Cancer . ) 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. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  2. What is the most important information I should know about PROVERA (a progestin hormone)? • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). • Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older. • You and your healthcare provider should talk regularly about whether you still need treatment with PROVERA.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
Full extracted label fields
application numbers
  1. NDA011839
boxed warning exact
  1. WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR 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 CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia .) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (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 conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders . ) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study 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 CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use .) Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant Neoplasm, Breast Cancer . ) 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. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  2. What is the most important information I should know about PROVERA (a progestin hormone)? • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). • Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older. • You and your healthcare provider should talk regularly about whether you still need treatment with PROVERA.
brand names
  1. Provera
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a586be28-96af-4fed-a13f-9b94fd4c7405
generic names
  1. MEDROXYPROGESTERONE ACETATE
id
ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
indications and usage exact
  1. INDICATIONS AND USAGE PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Pharmacia & Upjohn Company LLC
    matched search terms
    1. cancer
    package ndcs
    1. 0009-0065-01
    2. 0009-0287-01
    3. 0009-0051-01
    product ndcs
    1. 0009-0051
    2. 0009-0065
    3. 0009-0287
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1000114
      2. 1000124
      3. 1000135
      4. 1000139
      5. 1000141
      6. 1000145
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.json
      meta
      disclaimer
      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
      results
      limit
      100
      skip
      700
      total
      830
      sha256
      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a%22
      spl effective date
      2026-06-29
      spl effective time
      20260629
      spl set id
      a586be28-96af-4fed-a13f-9b94fd4c7405
      spl version
      27
      substance names
      1. MEDROXYPROGESTERONE ACETATE
      uniis
      1. C2QI4IOI2G
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        NDA011839
        payload
        all indexed label documents
        1. Appl No
          011839
          Application Docs Date
          2007-10-04 00:00:00
          Application Docs ID
          10781
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          71
          Submission Type
          SUPPL
        2. Appl No
          011839
          Application Docs Date
          2015-05-08 00:00:00
          Application Docs ID
          10782
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          79
          Submission Type
          SUPPL
        3. Appl No
          011839
          Application Docs Date
          2015-05-08 00:00:00
          Application Docs ID
          10783
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          80
          Submission Type
          SUPPL
        4. Appl No
          011839
          Application Docs Date
          2023-10-30 00:00:00
          Application Docs ID
          75983
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          78
          Submission Type
          SUPPL
        5. Appl No
          011839
          Application Docs Date
          2024-02-20 00:00:00
          Application Docs ID
          77563
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          83
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          011839
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1959-06-18 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          011839
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          25
          Submission Status
          AP
          Submission Status Date
          1973-10-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          011839
          Review Priority
          STANDARD
          Submission Class Code ID
          21
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          1975-10-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          011839
          Review Priority
          Submission Class Code ID
          2
          Submission No
          35
          Submission Status
          AP
          Submission Status Date
          1979-06-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          011839
          Review Priority
          Submission Class Code ID
          2
          Submission No
          39
          Submission Status
          AP
          Submission Status Date
          1979-07-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          011839
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          46
          Submission Status
          AP
          Submission Status Date
          1985-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          011839
          Review Priority
          Submission Class Code ID
          3
          Submission No
          50
          Submission Status
          AP
          Submission Status Date
          1987-10-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          011839
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          52
          Submission Status
          AP
          Submission Status Date
          1988-06-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          011839
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          53
          Submission Status
          AP
          Submission Status Date
          1989-10-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          011839
          Review Priority
          Submission Class Code ID
          3
          Submission No
          58
          Submission Status
          AP
          Submission Status Date
          1991-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          011839
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          59
          Submission Status
          AP
          Submission Status Date
          1992-06-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          011839
          Review Priority
          Submission Class Code ID
          3
          Submission No
          60
          Submission Status
          AP
          Submission Status Date
          1991-11-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA011839
        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
        2024-02-15
        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
          011839
          Application Docs Date
          2024-02-20 00:00:00
          Application Docs ID
          77563
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          83
          Submission Type
          SUPPL
        official application record
        Appl No
        011839
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        PFIZER
        openfda application present
        true
        products
        1. Active Ingredient
          MEDROXYPROGESTERONE ACETATE
          Appl No
          011839
          Drug Name
          PROVERA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          2.5MG
          marketing status
          1. Prescription
        2. Active Ingredient
          MEDROXYPROGESTERONE ACETATE
          Appl No
          011839
          Drug Name
          PROVERA
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          0
          Strength
          5MG
          marketing status
          1. Prescription
        3. Active Ingredient
          MEDROXYPROGESTERONE ACETATE
          Appl No
          011839
          Drug Name
          PROVERA
          Form
          TABLET;ORAL
          Product No
          004
          Reference Drug
          1
          Reference Standard
          1
          Strength
          10MG
          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 · positive indication candidate
      application numbers
      1. NDA011839
      brand names
      1. Provera
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      410
      end exclusive
      true
      exact text
      INDICATIONS AND USAGE PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
      label id
      ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      03e3ea548c6c215a7e53c0eaca468a6567ea2cc4150c41be92d7c5e6d5ea298e
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-4f3280753680b58a820b
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. MEDROXYPROGESTERONE ACETATE
      id
      ind-span-a4ef133c23bfc7f2839a
      label id
      ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
      positive predicate support span
      end
      51
      end exclusive
      true
      exact text
      are indicated
      label id
      ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      03e3ea548c6c215a7e53c0eaca468a6567ea2cc4150c41be92d7c5e6d5ea298e
      start
      38
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
          source defined aliases
            source span
            end
            222
            end exclusive
            true
            exact text
            INDICATIONS AND USAGE PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.
            label id
            ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            03e3ea548c6c215a7e53c0eaca468a6567ea2cc4150c41be92d7c5e6d5ea298e
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a%22
            spl effective date
            2026-06-29
            spl set id
            a586be28-96af-4fed-a13f-9b94fd4c7405
            spl version
            27
            structured fields status
            not_extracted_no_values_inferred_from_mentions
            structured indication
            age
            Source null
            approval pathway
            Source null
            biomarker and test
            Source null
            disease stage
            Source null
            limitations
            Source null
            line
            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
            use intent
            tumor_directed_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. NDA011839
            brand names
            1. Provera
            classification reasons
            1. explicit_positive_indication_predicate
            2. no_tumor_directed_keyword_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            410
            end exclusive
            true
            exact text
            ROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
            label id
            ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            03e3ea548c6c215a7e53c0eaca468a6567ea2cc4150c41be92d7c5e6d5ea298e
            start
            23
            current approval status
            not_reconciled
            duplicate text group
            dup-54564578c72b09c4d546
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. MEDROXYPROGESTERONE ACETATE
            id
            ind-span-c29471073cc2b804d547
            label id
            ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
            positive predicate support span
            end
            246
            end exclusive
            true
            exact text
            are also indicated
            label id
            ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            03e3ea548c6c215a7e53c0eaca468a6567ea2cc4150c41be92d7c5e6d5ea298e
            start
            228
            qualifier mentions
              regulatory links
                schema version
                0.1.0
                source batch sha256
                24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                source defined aliases
                  source span
                  end
                  410
                  end exclusive
                  true
                  exact text
                  They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
                  label id
                  ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  03e3ea548c6c215a7e53c0eaca468a6567ea2cc4150c41be92d7c5e6d5ea298e
                  start
                  223
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%22ebcdf2fb-760c-4a9a-80a1-a0c6b21a891a%22
                  spl effective date
                  2026-06-29
                  spl set id
                  a586be28-96af-4fed-a13f-9b94fd4c7405
                  spl version
                  27
                  structured fields status
                  not_extracted_no_values_inferred_from_mentions
                  structured indication
                  age
                  Source null
                  approval pathway
                  Source null
                  biomarker and test
                  Source null
                  disease stage
                  Source null
                  limitations
                  Source null
                  line
                  Source null
                  prior therapy
                  Source null
                  regimen
                  Source null
                  tumor histology
                  Source null
                  use intent
                  non_oncology_or_unclear_candidate

                  Preserved source evidence · Not medical advice