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PlainMeds

Prescription medicine

Tagraxofusp Brand names: Elzonris

Tagraxofusp (Elzonris) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed
  • Boxed warning

Check it at the source: the tagraxofusp FDA label on DailyMed (effective December 9, 2024); every tagraxofusp label on DailyMed.

Highlights of the record

FDA label of December 9, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

CAPILLARY LEAK SYNDROME.

Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )]. WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS.

Used for

From the label: indications and usage

ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.

Forms and strengths

Injection (solution).

On the market

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)
No recall recorded
FAERS reports
520 through July 30, 2026

What is tagraxofusp used for?

From the label: indications and usage

ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older

FDA pharmacologic class: CD123 Interaction and Cytotoxin.

Source: FDA drug label (Elzonris), Stemline Therapeutics, Inc., effective December 9, 2024 (SPL set 80eb1080-fe20-4af0-b2a5-a67999923fa8), via openFDA; the full label on DailyMed

Is there a generic for tagraxofusp (Elzonris)?

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

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

What do FAERS reports show for tagraxofusp?

The FDA Adverse Event Reporting System holds 520 reports that list tagraxofusp among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 156 are coded as a death and 132 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

  • Capillary Leak Syndrome (named in the label)124
  • Pyrexia (named in the label)46
  • Off Label Use (a use or a product term, not a reaction)41
  • Death (an outcome recorded in the report)40
  • Disease Progression (a use or a product term, not a reaction)37
  • Thrombocytopenia35
  • Drug Ineffective (a use or a product term, not a reaction)28
  • Weight Increased28

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?

Tagraxofusp side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other