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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.

ITACITINIB: 216 Adverse Event Reports & Safety Profile

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216
Total FAERS Reports
39 (18.1%)
Deaths Reported
187
Hospitalizations
216
As Primary/Secondary Suspect
36
Life-Threatening
4
Disabilities

First Report: 20120103 · Latest Report: 20241108

What Are the Most Common ITACITINIB Side Effects?

#1 Most Reported
Pneumonia
23 reports (10.6%)
#2 Most Reported
Febrile neutropenia
23 reports (10.6%)
#3 Most Reported
Diarrhoea
23 reports (10.6%)

All ITACITINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 23 10.7% 2 23
Febrile neutropenia 23 10.7% 4 23
Pneumonia 23 10.7% 8 21
Pyrexia 21 9.7% 4 21
Cytomegalovirus infection 19 8.8% 2 19
Thrombocytopenia 17 7.9% 4 14
Acute kidney injury 15 6.9% 7 14
Fatigue 15 6.9% 0 15
Platelet count decreased 15 6.9% 0 15
Abdominal pain 13 6.0% 0 13
Asthenia 13 6.0% 0 13
Sepsis 13 6.0% 10 13
Pancytopenia 12 5.6% 2 11
Septic shock 12 5.6% 9 9
Cytomegalovirus viraemia 9 4.2% 0 9
Hypotension 9 4.2% 6 7
White blood cell count increased 9 4.2% 0 9
Anaemia 8 3.7% 1 6
Aspergillus infection 8 3.7% 7 8
Cough 8 3.7% 1 8

Who Reports ITACITINIB Side Effects? Age & Gender Data

Gender: 33.2% female, 66.8% male. Average age: 55.0 years. Most reports from: US. View detailed demographics →

Is ITACITINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 0
2016 2 1 0
2017 4 0 4
2018 107 23 97
2019 27 3 25
2020 9 0 9
2021 29 8 27
2022 16 0 16
2023 2 0 1
2024 3 0 3

View full timeline →

What Is ITACITINIB Used For?

IndicationReports
Acute graft versus host disease 92
Chronic graft versus host disease 24
Bronchiolitis obliterans syndrome 20
Graft versus host disease 20
Prophylaxis against graft versus host disease 16
Diffuse large b-cell lymphoma 7
Acute graft versus host disease in skin 6
Product used for unknown indication 6

ITACITINIB vs Alternatives: Which Is Safer?

ITACITINIB vs ITRACONAZOLE ITACITINIB vs ITRACONAZOLE\SODIUM ITACITINIB vs IVABRADINE ITACITINIB vs IVACAFTOR ITACITINIB vs IVACAFTOR\LUMACAFTOR ITACITINIB vs IVACAFTOR\TEZACAFTOR ITACITINIB vs IVERMECTIN ITACITINIB vs IVOSIDENIB ITACITINIB vs IXABEPILONE ITACITINIB vs IXAZOMIB

Official FDA Label for ITACITINIB

Official prescribing information from the FDA-approved drug label.