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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.

ISATUXIMAB-IRFC: 608 Adverse Event Reports & Safety Profile

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608
Total FAERS Reports
73 (12.0%)
Deaths Reported
151
Hospitalizations
608
As Primary/Secondary Suspect
38
Life-Threatening
15
Disabilities
Prescription
Status

FDA Application: 761113 ·

First Report: 20150101 · Latest Report: 20250901

What Are the Most Common ISATUXIMAB-IRFC Side Effects?

#1 Most Reported
Infusion related reaction
48 reports (7.9%)
#2 Most Reported
Dyspnoea
42 reports (6.9%)
#3 Most Reported
Off label use
35 reports (5.8%)

All ISATUXIMAB-IRFC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Infusion related reaction 48 7.9% 1 10
Dyspnoea 42 6.9% 3 13
Off label use 35 5.8% 2 6
Neutropenia 30 4.9% 7 17
Anaemia 23 3.8% 2 6
Disease progression 23 3.8% 16 4
Pyrexia 23 3.8% 5 14
Plasma cell myeloma 22 3.6% 6 3
Thrombocytopenia 22 3.6% 2 2
Diarrhoea 21 3.5% 0 10
Pneumonia 20 3.3% 2 10
Weight increased 18 3.0% 0 0
Weight decreased 17 2.8% 1 1
Nausea 16 2.6% 1 5
Hypertension 15 2.5% 0 4
Death 14 2.3% 14 0
Acute kidney injury 13 2.1% 0 6
Cough 13 2.1% 1 1
Renal impairment 12 2.0% 1 1
Vomiting 12 2.0% 1 6

Who Reports ISATUXIMAB-IRFC Side Effects? Age & Gender Data

Gender: 46.5% female, 53.5% male. Average age: 66.8 years. Most reports from: US. View detailed demographics →

Is ISATUXIMAB-IRFC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2015 3 0 0
2016 5 0 0
2019 1 0 1
2020 20 1 3
2021 66 12 27
2022 89 7 29
2023 61 10 21
2024 58 5 24
2025 40 8 10

View full timeline →

What Is ISATUXIMAB-IRFC Used For?

IndicationReports
Plasma cell myeloma 317
Product used for unknown indication 78
Plasma cell myeloma refractory 64
Plasma cell myeloma in remission 5

ISATUXIMAB-IRFC vs Alternatives: Which Is Safer?

ISATUXIMAB-IRFC vs ISAVUCONAZOLE ISATUXIMAB-IRFC vs ISAVUCONAZONIUM ISATUXIMAB-IRFC vs ISCALIMAB ISATUXIMAB-IRFC vs ISENTRESS ISATUXIMAB-IRFC vs ISOFLURANE ISATUXIMAB-IRFC vs ISONIAZID ISATUXIMAB-IRFC vs ISONIAZID\PYRAZINAMIDE\RIFAMPIN ISATUXIMAB-IRFC vs ISONIAZID\PYRIDOXINE\SULFAMETHOXAZOLE\TRIMETHOPRIM ISATUXIMAB-IRFC vs ISONIAZID\RIFAMPIN ISATUXIMAB-IRFC vs ISOPROPANOLAMINE

Official FDA Label for ISATUXIMAB-IRFC

Official prescribing information from the FDA-approved drug label.