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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.

LANADELUMAB-FLYO: 1,493 Adverse Event Reports & Safety Profile

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1,493
Total FAERS Reports
35 (2.3%)
Deaths Reported
427
Hospitalizations
1,493
As Primary/Secondary Suspect
51
Life-Threatening
7
Disabilities
Prescription
Status

FDA Application: 761090 ·

First Report: 20110101 · Latest Report: 20250918

What Are the Most Common LANADELUMAB-FLYO Side Effects?

#1 Most Reported
Hereditary angioedema
794 reports (53.2%)
#2 Most Reported
Product dose omission issue
177 reports (11.9%)
#3 Most Reported
Inappropriate schedule of product administration
144 reports (9.6%)

All LANADELUMAB-FLYO Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hereditary angioedema 794 53.2% 13 311
Product dose omission issue 177 11.9% 4 92
Inappropriate schedule of product administration 144 9.7% 3 66
Drug ineffective 137 9.2% 3 48
Headache 126 8.4% 3 39
Weight decreased 125 8.4% 1 71
Weight increased 120 8.0% 3 72
Injection site pain 119 8.0% 0 33
Product use issue 114 7.6% 1 56
Malaise 90 6.0% 3 41
Nausea 77 5.2% 0 32
Stress 77 5.2% 1 41
Dizziness 76 5.1% 1 27
Pain 75 5.0% 2 31
No adverse event 73 4.9% 0 0
Treatment noncompliance 73 4.9% 2 29
Insurance issue 72 4.8% 1 35
Fatigue 68 4.6% 1 23
Covid-19 67 4.5% 0 36
Product availability issue 60 4.0% 1 23

Who Reports LANADELUMAB-FLYO Side Effects? Age & Gender Data

Gender: 77.3% female, 22.7% male. Average age: 45.0 years. Most reports from: US. View detailed demographics →

Is LANADELUMAB-FLYO Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 0
2013 2 0 1
2014 2 1 1
2015 7 1 5
2016 4 0 3
2017 10 1 8
2018 85 1 25
2019 159 4 44
2020 126 3 42
2021 108 5 52
2022 76 1 38
2023 66 0 22
2024 42 0 20
2025 16 1 7

View full timeline →

What Is LANADELUMAB-FLYO Used For?

IndicationReports
Product used for unknown indication 569
Hereditary angioedema 559
Immune system disorder 327
Hereditary angioedema with c1 esterase inhibitor deficiency 46
Angioedema 34
Prophylaxis 34
Hereditary angioedema with normal c1 esterase inhibitor 19

LANADELUMAB-FLYO vs Alternatives: Which Is Safer?

LANADELUMAB-FLYO vs LANREOTIDE LANADELUMAB-FLYO vs LANSOPRAZOLE LANADELUMAB-FLYO vs LANTHANUM LANADELUMAB-FLYO vs LANTUS LANADELUMAB-FLYO vs LANTUS SOLOSTAR LANADELUMAB-FLYO vs LAPATINIB LANADELUMAB-FLYO vs LAPATINIB DITOSYLATE LANADELUMAB-FLYO vs LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN LANADELUMAB-FLYO vs LARONIDASE LANADELUMAB-FLYO vs LAROTRECTINIB

Official FDA Label for LANADELUMAB-FLYO

Official prescribing information from the FDA-approved drug label.