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LABELS · d83d6225-65ea-436f-aba2-d83d748c8fde

Gadavist

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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
2026-05-01
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. GADAVIST is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GADAVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2) ]. WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning. Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. GADAVIST is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GADAVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. ( 5.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ( 1 )
Full extracted label fields
application numbers
  1. NDA201277
boxed warning exact
  1. WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. GADAVIST is not approved for intrathecal use [see Warnings and Precautions (5.1) ]. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GADAVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.2) ]. WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning. Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. GADAVIST is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GADAVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. ( 5.2 )
brand names
  1. Gadavist
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bd28560f-de4d-4140-874e-31df823f4dbb
generic names
  1. GADOBUTROL
id
d83d6225-65ea-436f-aba2-d83d748c8fde
indications and usage exact
  1. 1 INDICATIONS AND USAGE GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Bayer HealthCare Pharmaceuticals Inc.
    matched search terms
    1. malignant
    package ndcs
    1. 50419-325-14
    2. 50419-325-15
    product ndcs
    1. 50419-325
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Warnings and Precautions, Acute Respiratory Distress Syndrome ( 5.4 ) 3/2025
    record type
    complete_spl_indications_section_candidate
    routes
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      spl effective date
      2026-05-01
      spl effective time
      20260501
      spl set id
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      spl version
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      substance names
      1. GADOBUTROL
      uniis
      1. 1BJ477IO2L
      verification flags
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      Drugs@FDA application source records
      1. application number
        NDA201277
        payload
        all indexed label documents
        1. Appl No
          201277
          Application Docs Date
          2015-09-21 00:00:00
          Application Docs ID
          18997
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        2. Appl No
          201277
          Application Docs Date
          2016-05-05 00:00:00
          Application Docs ID
          18998
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        3. Appl No
          201277
          Application Docs Date
          2011-03-15 00:00:00
          Application Docs ID
          40055
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        4. Appl No
          201277
          Application Docs Date
          2013-10-21 00:00:00
          Application Docs ID
          40056
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        5. Appl No
          201277
          Application Docs Date
          2015-01-05 00:00:00
          Application Docs ID
          40057
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        6. Appl No
          201277
          Application Docs Date
          2018-04-27 00:00:00
          Application Docs ID
          53854
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        7. Appl No
          201277
          Application Docs Date
          2018-07-27 00:00:00
          Application Docs ID
          55022
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        8. Appl No
          201277
          Application Docs Date
          2018-11-06 00:00:00
          Application Docs ID
          56305
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        9. Appl No
          201277
          Application Docs Date
          2019-07-12 00:00:00
          Application Docs ID
          59324
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        10. Appl No
          201277
          Application Docs Date
          2020-08-03 00:00:00
          Application Docs ID
          64181
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        11. Appl No
          201277
          Application Docs Date
          2022-05-20 00:00:00
          Application Docs ID
          71103
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        12. Appl No
          201277
          Application Docs Date
          2024-01-29 00:00:00
          Application Docs ID
          77338
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          23
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2026-07-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          28
          Submission Status
          AP
          Submission Status Date
          2025-03-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2024-07-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          25
          Submission Status
          AP
          Submission Status Date
          2026-02-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2024-01-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2022-04-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2020-07-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2019-07-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2018-11-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2018-07-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2018-04-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          201277
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2015-11-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA201277
        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
        2026-07-28
        latest label selection rule
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        latest posted label documents
        1. Appl No
          201277
          Application Docs Date
          2026-07-29 00:00:00
          Application Docs ID
          86735
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        official application record
        Appl No
        201277
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BAYER HLTHCARE
        openfda application present
        true
        products
        1. Active Ingredient
          GADOBUTROL
          Appl No
          201277
          Drug Name
          GADAVIST
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          4.5354GM/7.5ML (604.72MG/ML)
          marketing status
          1. Prescription
        2. Active Ingredient
          GADOBUTROL
          Appl No
          201277
          Drug Name
          GADAVIST
          Form
          SOLUTION;INTRAVENOUS
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          6.0472GM/10ML (604.72MG/ML)
          marketing status
          1. Prescription
        3. Active Ingredient
          GADOBUTROL
          Appl No
          201277
          Drug Name
          GADAVIST
          Form
          SOLUTION;INTRAVENOUS
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          9.0708GM/15ML (604.72MG/ML)
          marketing status
          1. Prescription
        4. Active Ingredient
          GADOBUTROL
          Appl No
          201277
          Drug Name
          GADAVIST
          Form
          SOLUTION;INTRAVENOUS
          Product No
          004
          Reference Drug
          1
          Reference Standard
          1
          Strength
          18.1416GM/30ML (604.72MG/ML)
          marketing status
          1. Prescription
        5. Active Ingredient
          GADOBUTROL
          Appl No
          201277
          Drug Name
          GADAVIST
          Form
          SOLUTION;INTRAVENOUS
          Product No
          005
          Reference Drug
          1
          Reference Standard
          1
          Strength
          39.3068GM/65ML (604.72MG/ML)
          marketing status
          1. Prescription
        6. Active Ingredient
          GADOBUTROL
          Appl No
          201277
          Drug Name
          GADAVIST
          Form
          SOLUTION;INTRAVENOUS
          Product No
          006
          Reference Drug
          1
          Reference Standard
          1
          Strength
          1.20944GM/2ML (604.72MG/ML)
          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. NDA201277
      brand names
      1. Gadavist
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      exact text
      1 INDICATIONS AND USAGE GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ( 1 )
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          1 INDICATIONS AND USAGE GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ( 1 )
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          diagnostic_candidate

          Preserved source evidence · Not medical advice