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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.

UMBRALISIB: 293 Adverse Event Reports & Safety Profile

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293
Total FAERS Reports
30 (10.2%)
Deaths Reported
97
Hospitalizations
293
As Primary/Secondary Suspect
10
Life-Threatening
8
Disabilities
Feb 5, 2021
FDA Approved
Discontinued
Status

FDA Application: 213176 ·

Patent Expires: May 26, 2035 · First Report: 20120101 · Latest Report: 20230720

What Are the Most Common UMBRALISIB Side Effects?

#1 Most Reported
Diarrhoea
47 reports (16.0%)
#2 Most Reported
Nausea
36 reports (12.3%)
#3 Most Reported
Fatigue
30 reports (10.2%)

All UMBRALISIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 47 16.0% 2 5
Nausea 36 12.3% 1 5
Disease progression 30 10.2% 2 3
Fatigue 30 10.2% 1 0
Covid-19 16 5.5% 3 13
Nervous system disorder 15 5.1% 0 0
Death 14 4.8% 14 4
Asthenia 13 4.4% 1 2
Off label use 13 4.4% 1 0
Product dose omission issue 12 4.1% 0 3
Anaemia 11 3.8% 0 0
Decreased appetite 11 3.8% 1 2
Pyrexia 11 3.8% 0 0
Dizziness 10 3.4% 0 3
Drug ineffective 10 3.4% 0 0
Dyspnoea 10 3.4% 1 6
Headache 10 3.4% 0 1
Pneumonia 10 3.4% 1 7
Vomiting 10 3.4% 1 3
Abdominal pain 9 3.1% 0 2

Who Reports UMBRALISIB Side Effects? Age & Gender Data

Gender: 43.8% female, 56.2% male. Average age: 69.0 years. Most reports from: US. View detailed demographics →

Is UMBRALISIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 0
2016 1 0 1
2017 7 0 2
2018 2 0 2
2019 5 0 2
2020 19 3 13
2021 107 16 46
2022 42 5 19
2023 1 0 1

View full timeline →

What Is UMBRALISIB Used For?

IndicationReports
Chronic lymphocytic leukaemia 66
Non-hodgkin's lymphoma 50
Follicular lymphoma 48
Product used for unknown indication 42
Diffuse large b-cell lymphoma 20
Marginal zone lymphoma 20
B-cell lymphoma 18
Lymphoma 9

UMBRALISIB vs Alternatives: Which Is Safer?

UMBRALISIB vs UMECLIDINIUM UMBRALISIB vs UMECLIDINIUM\VILANTEROL TRIFENATATE UMBRALISIB vs UMIFENOVIR UMBRALISIB vs UNSPECIFIED INGREDIENT UMBRALISIB vs UPADACITINIB UMBRALISIB vs URAPIDIL UMBRALISIB vs UREA UMBRALISIB vs URIDINE TRIACETATE UMBRALISIB vs UROFOLLITROPIN UMBRALISIB vs URSODIOL

Official FDA Label for UMBRALISIB

Official prescribing information from the FDA-approved drug label.