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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.

HUMAN C1-ESTERASE INHIBITOR: 14,344 Adverse Event Reports & Safety Profile

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14,344
Total FAERS Reports
1,403 (9.8%)
Deaths Reported
3,966
Hospitalizations
14,344
As Primary/Secondary Suspect
1,312
Life-Threatening
1,098
Disabilities
Takeda Pharmaceuticals Amer...
Manufacturer

Drug Class: Decreased Vascular Permeability [PE] · Manufacturer: Takeda Pharmaceuticals America, Inc. ·

First Report: 19961201 · Latest Report: 20250912

What Are the Most Common HUMAN C1-ESTERASE INHIBITOR Side Effects?

#1 Most Reported
Hereditary angioedema
5,572 reports (38.8%)
#2 Most Reported
No adverse event
1,660 reports (11.6%)
#3 Most Reported
Off label use
1,614 reports (11.3%)

All HUMAN C1-ESTERASE INHIBITOR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hereditary angioedema 5,572 38.9% 26 1,443
No adverse event 1,660 11.6% 59 267
Off label use 1,614 11.3% 808 964
Drug ineffective 1,426 9.9% 520 745
Intentional product use issue 1,117 7.8% 534 566
Product use in unapproved indication 1,003 7.0% 502 518
Weight increased 897 6.3% 422 526
Maternal exposure during pregnancy 869 6.1% 583 525
Pain 822 5.7% 502 562
Condition aggravated 775 5.4% 527 505
Swelling 737 5.1% 523 541
Fatigue 716 5.0% 458 507
Nausea 715 5.0% 408 459
Headache 712 5.0% 384 451
Product use issue 701 4.9% 309 415
Rash 689 4.8% 514 495
Infusion related reaction 670 4.7% 578 521
Vomiting 664 4.6% 424 482
Dizziness 651 4.5% 460 413
Malaise 649 4.5% 329 417

Who Reports HUMAN C1-ESTERASE INHIBITOR Side Effects? Age & Gender Data

Gender: 79.1% female, 20.9% male. Average age: 42.7 years. Most reports from: US. View detailed demographics →

Is HUMAN C1-ESTERASE INHIBITOR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2006 1 0 1
2007 1 0 0
2008 4 0 0
2009 19 0 9
2010 42 1 14
2011 46 3 20
2012 47 1 22
2013 64 3 25
2014 301 9 114
2015 427 18 204
2016 292 6 95
2017 644 18 137
2018 1,458 7 180
2019 1,011 19 169
2020 589 11 140
2021 638 9 159
2022 666 29 178
2023 555 13 149
2024 390 9 128
2025 230 2 52

View full timeline →

What Is HUMAN C1-ESTERASE INHIBITOR Used For?

IndicationReports
Hereditary angioedema 10,446
Prophylaxis 5,950
Product used for unknown indication 1,992
Immune system disorder 387
Hereditary angioedema with c1 esterase inhibitor deficiency 373
Hereditary angioedema with normal c1 esterase inhibitor 244
Angioedema 187
Complement factor abnormal 69
Foetal exposure during pregnancy 61
Off label use 61

HUMAN C1-ESTERASE INHIBITOR vs Alternatives: Which Is Safer?

HUMAN C1-ESTERASE INHIBITOR vs HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX HUMAN C1-ESTERASE INHIBITOR vs HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN HUMAN C1-ESTERASE INHIBITOR vs HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN HUMAN C1-ESTERASE INHIBITOR vs HUMAN IMMUNOGLOBULIN G HUMAN C1-ESTERASE INHIBITOR vs HUMAN IMMUNOGLOBULIN G\HYALURONIDASE HUMAN C1-ESTERASE INHIBITOR vs HUMAN IMMUNOGLOBULIN G\HYALURONIDASE RECOMBINANT HUMAN HUMAN C1-ESTERASE INHIBITOR vs HUMAN PAPILLOMAVIRUS QUADRIVALENT VACCINE, RECOMBINANT HUMAN C1-ESTERASE INHIBITOR vs HUMAN RABIES VIRUS IMMUNE GLOBULIN HUMAN C1-ESTERASE INHIBITOR vs HUMAN RHO IMMUNE GLOBULIN HUMAN C1-ESTERASE INHIBITOR vs HUMIRA

Official FDA Label for HUMAN C1-ESTERASE INHIBITOR

Official prescribing information from the FDA-approved drug label.