FDA label
What is leucovorin used for?
The FDA-approved uses of leucovorin, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for leucovorin calcium (tablet) lists 2 uses: Reduction of Toxicity of Folic Acid Antagonists or Dihydrofolate Reductase Inhibitors; Cerebral Folate Transport Deficiency with Folate Receptor 1 Genetic Variant.
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Leucovorin Calcium, injection, powder, lyophilized, for solution
Indications and Usage, quoted from the label by Sagent Pharmaceuticals (ANDA200753). Cross-references to other label sections are left out.
Leucovorin rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium for Injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.
Leucovorin Calcium for Injection is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible.
Leucovorin Calcium for Injection is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer.
Source: DailyMed label, set id 9d0e5356-ff39-4a8e-944c-e808a21ef4b2, version 10, effective March 11, 2026. NDC 25021-813, one of 32 listings for this product.
Leucovorin Calcium, tablet
Indications and Usage, quoted from the label by Ingenus Pharmaceuticals, LLC (ANDA211132). Cross-references to other label sections are left out.
Reduction of Toxicity of Folic Acid Antagonists or Dihydrofolate Reductase Inhibitors
Leucovorin calcium tablets are indicated to reduce the toxicity of:
- Methotrexate in adult patients with impaired methotrexate elimination, and
- Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients.
Cerebral Folate Transport Deficiency with Folate Receptor 1 Genetic Variant
Leucovorin calcium tablets are indicated for the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD).
Limitations of Use
Leucovorin calcium tablets are not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate (5-MTHF).
Limitations of Use
Leucovorin calcium tablets are not indicated for the treatment of pernicious anemia or other megaloblastic anemias, due to the lack of vitamin B12, because of the risk of progression of neurologic manifestations despite hematologic remission.
Source: DailyMed label, set id 7409cdee-9093-47af-a4c4-2c55ce1b6361, version 5, effective March 18, 2026. NDC 50742-181, one of 22 listings for this product.
Leucovorin Calcium, injection, powder, lyophilized, for suspension
Indications and Usage, quoted from the label by Mylan Institutional LLC (ANDA203800). Cross-references to other label sections are left out.
Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent over dosages of folic acid antagonists.
Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible.
Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.
Source: DailyMed label, set id 1cb701ca-2478-4268-9d69-80293965d59d, version 4, effective June 1, 2022. NDC 67457-528, one of 3 listings for this product.
Questions
What is leucovorin used for?
The FDA label for leucovorin calcium (tablet) lists 2 uses: Reduction of Toxicity of Folic Acid Antagonists or Dihydrofolate Reductase Inhibitors; Cerebral Folate Transport Deficiency with Folate Receptor 1 Genetic Variant.
What drug class is leucovorin?
FDA lists leucovorin in the Folate Analog established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.