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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.

ARTESUNATE: 161 Adverse Event Reports & Safety Profile

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161
Total FAERS Reports
27 (16.8%)
Deaths Reported
95
Hospitalizations
161
As Primary/Secondary Suspect
11
Life-Threatening
1
Disabilities
May 26, 2020
FDA Approved
Prescription
Status

FDA Application: 213036 ·

Patent Expires: Feb 16, 2044 · First Report: 200805 · Latest Report: 20250408

What Are the Most Common ARTESUNATE Side Effects?

#1 Most Reported
Haemolytic anaemia
48 reports (29.8%)
#2 Most Reported
Drug ineffective
17 reports (10.6%)
#3 Most Reported
Haemolysis
12 reports (7.5%)

All ARTESUNATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemolytic anaemia 48 29.8% 0 44
Drug ineffective 17 10.6% 8 8
Haemolysis 12 7.5% 0 7
Condition aggravated 11 6.8% 5 7
Maternal exposure during pregnancy 11 6.8% 2 3
Off label use 11 6.8% 5 4
Acute kidney injury 7 4.4% 0 3
Agranulocytosis 7 4.4% 0 7
Drug interaction 7 4.4% 0 1
Exposure during pregnancy 7 4.4% 2 2
Hepatotoxicity 7 4.4% 0 0
Premature delivery 7 4.4% 3 2
Coombs positive haemolytic anaemia 5 3.1% 0 5
Drug-induced liver injury 5 3.1% 0 0
Foetal exposure during pregnancy 5 3.1% 0 2
Low birth weight baby 5 3.1% 0 2
Myelosuppression 5 3.1% 1 0
Premature baby 5 3.1% 0 2

Who Reports ARTESUNATE Side Effects? Age & Gender Data

Gender: 55.2% female, 44.8% male. Average age: 35.9 years. Most reports from: FR. View detailed demographics →

Is ARTESUNATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 0 1
2011 2 1 1
2014 10 0 9
2015 8 1 4
2016 2 0 2
2017 6 0 6
2018 18 0 18
2019 10 3 5
2020 2 0 2
2021 10 0 10
2022 3 1 1
2023 8 0 5
2024 2 1 1
2025 1 0 1

View full timeline →

What Is ARTESUNATE Used For?

IndicationReports
Malaria 81
Plasmodium falciparum infection 29
Product used for unknown indication 14
Cytomegalovirus infection 5

ARTESUNATE vs Alternatives: Which Is Safer?

ARTESUNATE vs ARTICAINE\EPINEPHRINE ARTESUNATE vs ASCIMINIB ARTESUNATE vs ASCORBIC ACID ARTESUNATE vs ASCORBIC ACID\FERROUS ARTESUNATE vs ASCORBIC ACID\FERROUS\FOLIC ACID ARTESUNATE vs ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM ARTESUNATE vs ASENAPINE ARTESUNATE vs ASFOTASE ALFA ARTESUNATE vs ASIAN GINSENG ARTESUNATE vs ASMANEX TWISTHALER

Official FDA Label for ARTESUNATE

Official prescribing information from the FDA-approved drug label.