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PlainMeds

Prescription medicine

Garadacimab Brand names: Andembry

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

  • No generic listed

Check it at the source: the garadacimab FDA label on DailyMed (effective June 30, 2025); every garadacimab label on DailyMed.

Highlights of the record

FDA label of June 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

Forms and strengths

  • 200 mg/1.2ml

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
507 through July 30, 2026

What is garadacimab used for?

From the label: indications and usage

ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

Source: FDA drug label (ANDEMBRY), CSL, effective June 30, 2025 (SPL set 07b0b671-db81-49f0-a402-0c0219db7fa2), via openFDA; the full label on DailyMed

Is there a generic for garadacimab (Andembry)?

No generic garadacimab 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 garadacimab?

The FDA Adverse Event Reporting System holds 507 reports that list garadacimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 127 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

  • Hereditary Angioedema (a use or a product term, not a reaction)344
  • Drug Ineffective (a use or a product term, not a reaction)58
  • Product Dose Omission Issue (a use or a product term, not a reaction)56
  • Stress46
  • Product Use Issue (a use or a product term, not a reaction)41
  • Weight Decreased38
  • Weight Increased36
  • Fatigue33

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?

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