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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

GARADACIMAB-GXII: 21 Adverse Event Reports & Safety Profile

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21
Total FAERS Reports
0
Deaths Reported
3
Hospitalizations
21
As Primary/Secondary Suspect
1
Life-Threatening
Prescription
Status

FDA Application: 761367 ·

First Report: 20240816 · Latest Report: 20250904

What Are the Most Common GARADACIMAB-GXII Side Effects?

#1 Most Reported
Hereditary angioedema
12 reports (57.1%)
#2 Most Reported
Abdominal pain
4 reports (19.0%)
#3 Most Reported
Drug ineffective
3 reports (14.3%)

All GARADACIMAB-GXII Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hereditary angioedema 12 57.1% 0 0

Who Reports GARADACIMAB-GXII Side Effects? Age & Gender Data

Gender: 81.8% female, 18.2% male. Average age: 45.3 years. Most reports from: US. View detailed demographics →

Is GARADACIMAB-GXII Getting Safer? Reports by Year

YearReportsDeathsHosp.
2024 1 0 0
2025 10 0 1

View full timeline →

What Is GARADACIMAB-GXII Used For?

IndicationReports
Hereditary angioedema 15
Prophylaxis 9

Official FDA Label for GARADACIMAB-GXII

Official prescribing information from the FDA-approved drug label.