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PlainMeds

Prescription medicine

Sargramostim Brand names: Leukine

Sargramostim (Leukine) is a prescription medicine with an FDA approval on record since 1991. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the sargramostim FDA label on DailyMed (effective December 6, 2024, Partner Therapeutics, Inc.); the BLA 103362 record on Drugs@FDA; every sargramostim label on DailyMed.

Highlights of the record

FDA label of December 6, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).

Forms and strengths

Injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file
March 5, 1991 Leukine, Berlex Labs; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
1 since 2021 0 Class I among all firms' recalls; latest June 23, 2021
FAERS reports
1,703 through July 30, 2026

What is sargramostim used for?

From the label: indications and usage

LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. […]

FDA pharmacologic class: Leukocyte Growth Factor.

Source: FDA drug label (Leukine), BLA103362 (Berlex Labs), as published by Partner Therapeutics, Inc., effective December 6, 2024 (SPL set bb9a3820-f31a-4dd9-bef4-97094c01a398), via openFDA; the full label on DailyMed

Is there a generic for sargramostim (Leukine)?

No generic sargramostim is approved (Drugs@FDA, October 8, 2026).

  • 1991 earliest approval on file
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has sargramostim been recalled?

The FDA's Enforcement Report lists 1 recall naming sargramostim since 2021: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
June 23, 2021Class IIIPartner Therapeutics IncFAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the sargramostim label say about other medicines?

The sargramostim label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Lithiumdrug interactionsDRUG INTERACTIONS Use with caution in patients receiving drugs that may potentiate LEUKINE's myeloproliferative effects, such as lithium and corticosteroids.

Check sargramostim against other medicines

Source: FDA drug label (Leukine), BLA103362 (Berlex Labs), as published by Partner Therapeutics, Inc., effective December 6, 2024 (SPL set bb9a3820-f31a-4dd9-bef4-97094c01a398), via openFDA; the full label on DailyMed

What do FAERS reports show for sargramostim?

The FDA Adverse Event Reporting System holds 1,703 reports that list sargramostim among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 568 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Pyrexia157
  • Off Label Use (a use or a product term, not a reaction)143
  • Nausea (named in the label)123
  • Pain113
  • Hypotension (named in the label)112
  • Dyspnoea (named in the label)111
  • Fatigue94
  • Diarrhoea (named in the label)87

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other leukocyte growth factors
the pharmacologic class, with prices and generics
Sargramostim side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other