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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.

CAPLACIZUMAB-YHDP: 1,397 Adverse Event Reports & Safety Profile

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1,397
Total FAERS Reports
59 (4.2%)
Deaths Reported
270
Hospitalizations
1,397
As Primary/Secondary Suspect
13
Life-Threatening
19
Disabilities
Prescription
Status

FDA Application: 761112 ·

First Report: 19971114 · Latest Report: 20250920

What Are the Most Common CAPLACIZUMAB-YHDP Side Effects?

#1 Most Reported
Product use in unapproved indication
465 reports (33.3%)
#2 Most Reported
Adamts13 activity decreased
136 reports (9.7%)
#3 Most Reported
Off label use
133 reports (9.5%)

All CAPLACIZUMAB-YHDP Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product use in unapproved indication 465 33.3% 5 55
Adamts13 activity decreased 136 9.7% 2 27
Off label use 133 9.5% 1 26
Platelet count decreased 126 9.0% 4 53
Epistaxis 123 8.8% 2 29
Fatigue 110 7.9% 0 21
Contusion 86 6.2% 0 17
Injection site pain 74 5.3% 0 5
Headache 71 5.1% 1 15
Adamts13 activity abnormal 63 4.5% 0 8
Injection site bruising 63 4.5% 0 8
Thrombotic thrombocytopenic purpura 63 4.5% 7 26
Condition aggravated 60 4.3% 9 28
Hospitalisation 50 3.6% 0 50
Platelet count abnormal 50 3.6% 0 12
Haemoglobin decreased 46 3.3% 2 16
Gingival bleeding 40 2.9% 0 5
Haemorrhage 40 2.9% 0 9
Asthenia 39 2.8% 0 23
Platelet count increased 39 2.8% 2 9

Who Reports CAPLACIZUMAB-YHDP Side Effects? Age & Gender Data

Gender: 70.4% female, 29.6% male. Average age: 46.1 years. Most reports from: US. View detailed demographics →

Is CAPLACIZUMAB-YHDP Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 0
2019 73 0 30
2020 125 7 27
2021 119 3 31
2022 163 6 35
2023 169 11 33
2024 187 9 38
2025 129 2 20

View full timeline →

What Is CAPLACIZUMAB-YHDP Used For?

IndicationReports
Thrombotic microangiopathy 854
Thrombotic thrombocytopenic purpura 380
Immune thrombocytopenia 33
Thrombocytopenia 10
Thrombocytopenic purpura 6

CAPLACIZUMAB-YHDP vs Alternatives: Which Is Safer?

CAPLACIZUMAB-YHDP vs CAPMATINIB CAPLACIZUMAB-YHDP vs CAPREOMYCIN CAPLACIZUMAB-YHDP vs CAPSAICIN CAPLACIZUMAB-YHDP vs CAPTOPRIL CAPLACIZUMAB-YHDP vs CARBAMAZEPINE CAPLACIZUMAB-YHDP vs CARBETOCIN CAPLACIZUMAB-YHDP vs CARBIDOPA CAPLACIZUMAB-YHDP vs CARBIDOPA\ENTACAPONE\LEVODOPA CAPLACIZUMAB-YHDP vs CARBIDOPA\LEVODOPA CAPLACIZUMAB-YHDP vs CARBIMAZOLE

Official FDA Label for CAPLACIZUMAB-YHDP

Official prescribing information from the FDA-approved drug label.