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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.

SEMUSTINE: 156 Adverse Event Reports & Safety Profile

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156
Total FAERS Reports
51 (32.7%)
Deaths Reported
18
Hospitalizations
156
As Primary/Secondary Suspect
5
Life-Threatening

First Report: 2010 · Latest Report: 20240814

What Are the Most Common SEMUSTINE Side Effects?

#1 Most Reported
Pneumonia
25 reports (16.0%)
#2 Most Reported
Febrile neutropenia
21 reports (13.5%)
#3 Most Reported
Product use in unapproved indication
16 reports (10.3%)

All SEMUSTINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pneumonia 25 16.0% 7 4
Febrile neutropenia 21 13.5% 0 6
Product use in unapproved indication 16 10.3% 9 0
Cystitis haemorrhagic 14 9.0% 3 2
Drug ineffective 14 9.0% 4 2
Off label use 13 8.3% 5 2
Complications of bone marrow transplant 12 7.7% 9 0
Infection 12 7.7% 12 0
Post transplant lymphoproliferative disorder 12 7.7% 7 0
Pulmonary alveolar haemorrhage 12 7.7% 9 0
Gastrointestinal disorder 11 7.1% 0 0
Epstein-barr viraemia 10 6.4% 6 0
Haematotoxicity 9 5.8% 0 0
Cytomegalovirus infection 8 5.1% 3 2
Thrombocytopenia 8 5.1% 2 4
Cytomegalovirus viraemia 7 4.5% 5 0
Bacterial infection 6 3.9% 2 0
Fungal infection 6 3.9% 3 0
Graft versus host disease 6 3.9% 5 0
Product administered to patient of inappropriate age 6 3.9% 1 0

Who Reports SEMUSTINE Side Effects? Age & Gender Data

Gender: 44.8% female, 55.2% male. Average age: 26.6 years. Most reports from: CN. View detailed demographics →

Is SEMUSTINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 0
2013 1 0 0
2014 1 0 0
2018 1 0 0
2022 1 0 1
2024 5 0 2

View full timeline →

What Is SEMUSTINE Used For?

IndicationReports
Bone marrow conditioning regimen 96
Stem cell transplant 44
Allogenic stem cell transplantation 15
Acute myeloid leukaemia 11
Prophylaxis against transplant rejection 10
Acute lymphocytic leukaemia 8
Prophylaxis against graft versus host disease 6

SEMUSTINE vs Alternatives: Which Is Safer?

SEMUSTINE vs SENNA LEAF SEMUSTINE vs SENNA LEAF\SENNOSIDES\SENNOSIDES A AND B SEMUSTINE vs SENNOSIDES SEMUSTINE vs SENNOSIDES A AND B SEMUSTINE vs SENSIPAR SEMUSTINE vs SERETIDE SEMUSTINE vs SEROQUEL SEMUSTINE vs SERTRALINE SEMUSTINE vs SETMELANOTIDE SEMUSTINE vs SEVELAMER

Official FDA Label for SEMUSTINE

Official prescribing information from the FDA-approved drug label.