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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.

ALPHA.1-PROTEINASE INHIBITOR HUMAN: 7,110 Adverse Event Reports & Safety Profile

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7,110
Total FAERS Reports
635 (8.9%)
Deaths Reported
2,049
Hospitalizations
7,110
As Primary/Secondary Suspect
82
Life-Threatening
37
Disabilities
Takeda Pharmaceuticals Amer...
Manufacturer

Drug Class: Human alpha-1 Proteinase Inhibitor [EPC] · Manufacturer: Takeda Pharmaceuticals America, Inc. ·

First Report: 1994 · Latest Report: 20250924

What Are the Most Common ALPHA.1-PROTEINASE INHIBITOR HUMAN Side Effects?

#1 Most Reported
Dyspnoea
1,011 reports (14.2%)
#2 Most Reported
Pneumonia
681 reports (9.6%)
#3 Most Reported
Fatigue
669 reports (9.4%)

All ALPHA.1-PROTEINASE INHIBITOR HUMAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 1,011 14.2% 57 440
Pneumonia 681 9.6% 71 487
Fatigue 669 9.4% 22 121
Headache 631 8.9% 8 95
Death 456 6.4% 454 108
Cough 447 6.3% 12 168
Product dose omission issue 397 5.6% 45 203
Nausea 385 5.4% 14 90
Malaise 367 5.2% 16 120
Dizziness 314 4.4% 5 63
Pain 287 4.0% 15 96
Pyrexia 270 3.8% 11 103
Covid-19 255 3.6% 20 155
Fall 248 3.5% 30 140
Nasopharyngitis 243 3.4% 8 76
Bronchitis 237 3.3% 12 87
Chronic obstructive pulmonary disease 237 3.3% 39 172
Diarrhoea 232 3.3% 9 59
Sinusitis 226 3.2% 7 72
Productive cough 218 3.1% 13 92

Who Reports ALPHA.1-PROTEINASE INHIBITOR HUMAN Side Effects? Age & Gender Data

Gender: 58.2% female, 41.8% male. Average age: 61.3 years. Most reports from: US. View detailed demographics →

Is ALPHA.1-PROTEINASE INHIBITOR HUMAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 2 0 0
2004 1 0 0
2005 5 0 1
2006 1 0 0
2007 4 0 0
2008 1 0 0
2009 6 1 2
2010 10 0 2
2011 20 1 12
2012 34 6 15
2013 93 6 38
2014 199 25 73
2015 402 33 134
2016 468 22 174
2017 345 20 112
2018 400 36 111
2019 454 15 92
2020 325 27 56
2021 253 26 63
2022 285 43 94
2023 230 29 81
2024 324 40 107
2025 221 44 104

View full timeline →

What Is ALPHA.1-PROTEINASE INHIBITOR HUMAN Used For?

IndicationReports
Alpha-1 antitrypsin deficiency 2,984
Alpha-1 anti-trypsin deficiency 2,937
Product used for unknown indication 591
Emphysema 240
Chronic obstructive pulmonary disease 141
Obstructive airways disorder 39
Asthma 34
Graft versus host disease 26
Immune system disorder 24
Supplementation therapy 24

ALPHA.1-PROTEINASE INHIBITOR HUMAN vs Alternatives: Which Is Safer?

ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALPRAZOLAM ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALPROSTADIL ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALTEPLASE ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALTERNARIA ALTERNATA ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALTHIAZIDE ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALTHIAZIDE\SPIRONOLACTONE ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALUMINUM ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALUMINUM HYDROXIDE ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALUMINUM HYDROXIDE\DIMETHICONE\MAGNESIUM HYDROXIDE ALPHA.1-PROTEINASE INHIBITOR HUMAN vs ALUMINUM HYDROXIDE\MAGNESIUM

Official FDA Label for ALPHA.1-PROTEINASE INHIBITOR HUMAN

Official prescribing information from the FDA-approved drug label.