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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.

ACLARUBICIN: 314 Adverse Event Reports & Safety Profile

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314
Total FAERS Reports
60 (19.1%)
Deaths Reported
73
Hospitalizations
314
As Primary/Secondary Suspect
33
Life-Threatening
8
Disabilities

Active Ingredient: ACLARUBICIN HYDROCHLORIDE ·

First Report: 2007 · Latest Report: 20250720

What Are the Most Common ACLARUBICIN Side Effects?

#1 Most Reported
Myelosuppression
80 reports (25.5%)
#2 Most Reported
Bone marrow failure
73 reports (23.2%)
#3 Most Reported
Off label use
38 reports (12.1%)

All ACLARUBICIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Myelosuppression 80 25.5% 3 20
Bone marrow failure 73 23.3% 14 7
Off label use 38 12.1% 6 4
Nausea 35 11.2% 1 2
Infection 26 8.3% 2 1
Acute myeloid leukaemia 24 7.6% 11 8
Product use in unapproved indication 22 7.0% 1 1
Platelet count decreased 21 6.7% 5 9
Febrile neutropenia 19 6.1% 8 5
Pneumonia 19 6.1% 11 5
Thrombocytopenia 18 5.7% 4 4
Anaemia 17 5.4% 3 3
Alopecia 16 5.1% 0 0
Diarrhoea 16 5.1% 2 2
Drug-induced liver injury 16 5.1% 2 0
Haemorrhage 16 5.1% 1 1
Myelodysplastic syndrome 16 5.1% 11 5
Neutropenia 16 5.1% 1 3
Vomiting 16 5.1% 1 0
White blood cell count decreased 16 5.1% 1 9

Who Reports ACLARUBICIN Side Effects? Age & Gender Data

Gender: 47.2% female, 52.8% male. Average age: 51.1 years. Most reports from: CN. View detailed demographics →

Is ACLARUBICIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 2 1 2
2012 3 3 0
2013 1 1 0
2014 3 1 2
2015 9 1 1
2016 3 1 2
2017 3 0 1
2018 4 2 1
2019 13 3 11
2020 4 0 3
2021 13 0 7
2022 10 2 5
2023 13 1 3
2024 12 0 6
2025 13 0 10

View full timeline →

What Is ACLARUBICIN Used For?

IndicationReports
Acute myeloid leukaemia 168
Myelodysplastic syndrome 18
Acute myeloid leukaemia refractory 15
Chemotherapy 13
Acute leukaemia 11
Acute myeloid leukaemia recurrent 11
T-cell type acute leukaemia 10
Product used for unknown indication 9
Myelodysplastic syndrome with excess blasts 8
Acute promyelocytic leukaemia 7

ACLARUBICIN vs Alternatives: Which Is Safer?

ACLARUBICIN vs ACLIDINIUM ACLARUBICIN vs ACLIDINIUM\FORMOTEROL ACLARUBICIN vs ACORAMIDIS ACLARUBICIN vs ACTEMRA ACLARUBICIN vs ACTIQ ACLARUBICIN vs ACTIVATED CHARCOAL ACLARUBICIN vs ACTONEL ACLARUBICIN vs ACYCLOVIR ACLARUBICIN vs AD26.COV2.S ACLARUBICIN vs ADAGRASIB

Official FDA Label for ACLARUBICIN

Official prescribing information from the FDA-approved drug label.