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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.

COPANLISIB: 355 Adverse Event Reports & Safety Profile

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355
Total FAERS Reports
45 (12.7%)
Deaths Reported
213
Hospitalizations
355
As Primary/Secondary Suspect
30
Life-Threatening
Sep 14, 2017
FDA Approved
Discontinued
Status

FDA Application: 209936 ·

Patent Expires: Oct 22, 2029 · First Report: 20070101 · Latest Report: 20231201

What Are the Most Common COPANLISIB Side Effects?

#1 Most Reported
Pyrexia
58 reports (16.3%)
#2 Most Reported
Off label use
43 reports (12.1%)
#3 Most Reported
Hyperglycaemia
27 reports (7.6%)

All COPANLISIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pyrexia 58 16.3% 10 53
Off label use 43 12.1% 1 20
Hyperglycaemia 27 7.6% 2 18
Hypertension 24 6.8% 1 12
Rash maculo-papular 24 6.8% 4 16
Pneumonia 20 5.6% 6 15
Sepsis 19 5.4% 8 12
Diarrhoea 18 5.1% 2 5
Rash 16 4.5% 3 10
Febrile neutropenia 15 4.2% 6 8
Neutropenia 15 4.2% 3 5
Neutropenic sepsis 15 4.2% 2 14
Anaemia 14 3.9% 4 12
Dyspnoea 14 3.9% 6 12
Cytopenia 13 3.7% 0 11
Neutrophil count decreased 13 3.7% 1 8
Device related infection 12 3.4% 2 11
Platelet count decreased 12 3.4% 5 9
Covid-19 11 3.1% 3 3
Cytomegalovirus infection 11 3.1% 3 11

Who Reports COPANLISIB Side Effects? Age & Gender Data

Gender: 39.3% female, 60.7% male. Average age: 64.1 years. Most reports from: US. View detailed demographics →

Is COPANLISIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 1
2016 2 0 2
2017 11 0 11
2018 53 6 39
2019 47 6 33
2020 38 4 25
2021 64 7 48
2022 42 6 35
2023 18 3 11

View full timeline →

What Is COPANLISIB Used For?

IndicationReports
Follicular lymphoma 42
B-cell lymphoma 38
Marginal zone lymphoma 29
Product used for unknown indication 23
Non-hodgkin's lymphoma recurrent 20
Diffuse large b-cell lymphoma 17
Non-hodgkin's lymphoma 11
B-cell lymphoma recurrent 10
Diffuse large b-cell lymphoma recurrent 10
Non-hodgkin's lymphoma unspecified histology indolent 6

COPANLISIB vs Alternatives: Which Is Safer?

COPANLISIB vs COPAXONE COPANLISIB vs COPEGUS COPANLISIB vs COPPER COPANLISIB vs CORDARONE COPANLISIB vs CORICIDIN HBP COLD AND FLU COPANLISIB vs CORTICOSTEROID NOS COPANLISIB vs CORTICOTROPIN COPANLISIB vs CORTISONE COPANLISIB vs CORTISONE\HYDROCORTISONE COPANLISIB vs COSMETICS

Official FDA Label for COPANLISIB

Official prescribing information from the FDA-approved drug label.