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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.

AMIFOSTINE: 125 Adverse Event Reports & Safety Profile

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125
Total FAERS Reports
7 (5.6%)
Deaths Reported
35
Hospitalizations
125
As Primary/Secondary Suspect
10
Life-Threatening
1
Disabilities
Dec 8, 1995
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 020221 ·

First Report: 1996 · Latest Report: 20250515

What Are the Most Common AMIFOSTINE Side Effects?

#1 Most Reported
Thrombocytopenia
27 reports (21.6%)
#2 Most Reported
Mucosal inflammation
23 reports (18.4%)
#3 Most Reported
Nausea
20 reports (16.0%)

All AMIFOSTINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Thrombocytopenia 27 21.6% 1 18
Mucosal inflammation 23 18.4% 0 16
Nausea 20 16.0% 1 8
Anaemia 18 14.4% 0 16
Febrile neutropenia 18 14.4% 0 16
Pyrexia 13 10.4% 2 9
Vomiting 11 8.8% 0 3
Hypotension 10 8.0% 3 4
Rash 9 7.2% 0 3
Pulmonary toxicity 7 5.6% 0 0
Atrial fibrillation 6 4.8% 0 0
Malaise 6 4.8% 2 3
Injection site erythema 5 4.0% 0 1
Injection site reaction 5 4.0% 1 2
Neutropenia 5 4.0% 0 1
Pruritus 5 4.0% 1 1

Who Reports AMIFOSTINE Side Effects? Age & Gender Data

Gender: 45.4% female, 54.6% male. Average age: 53.3 years. Most reports from: US. View detailed demographics →

Is AMIFOSTINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 6 0 0
2001 3 0 0
2002 3 0 0
2003 8 0 2
2004 4 0 1
2005 2 0 2
2006 10 2 6
2007 1 0 0
2008 1 0 0
2011 2 1 1
2013 2 0 0
2014 1 0 0
2015 2 0 2
2018 3 0 0
2019 1 0 1
2022 2 0 1
2023 2 0 0
2024 2 0 2
2025 1 0 0

View full timeline →

What Is AMIFOSTINE Used For?

IndicationReports
Adverse drug reaction 28
Product used for unknown indication 24
Non-hodgkin's lymphoma 18
Radiotherapy 11
Prophylaxis 9
Chemotherapy 7
Drug toxicity prophylaxis 5

AMIFOSTINE vs Alternatives: Which Is Safer?

AMIFOSTINE vs AMIKACIN AMIFOSTINE vs AMILORIDE AMIFOSTINE vs AMILORIDE\HYDROCHLOROTHIAZIDE AMIFOSTINE vs AMINO ACIDS AMIFOSTINE vs AMINO ACIDS, SOURCE UNSPECIFIED AMIFOSTINE vs AMINO ACIDS\ANHYDROUS DEXTROSE\CALCIUM\MAGNESIUM HEPTAHYDRATE\POTASSIUM\SODIUM\SODIUM GLYCEROPHOSPHATE ANHYDROUS\SOYBEAN OIL AMIFOSTINE vs AMINO ACIDS\DEXTROSE\ELECTROLYTES NOS\SOYBEAN OIL AMIFOSTINE vs AMINO ACIDS\DEXTROSE\ELECTROLYTES NOS\SOYBEAN OIL\VITAMINS AMIFOSTINE vs AMINOBENZOIC ACID AMIFOSTINE vs AMINOCAPROIC ACID

Official FDA Label for AMIFOSTINE

Official prescribing information from the FDA-approved drug label.