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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.

ARTEMETHER\LUMEFANTRINE: 291 Adverse Event Reports & Safety Profile

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291
Total FAERS Reports
14 (4.8%)
Deaths Reported
140
Hospitalizations
291
As Primary/Secondary Suspect
25
Life-Threatening
12
Disabilities

First Report: 2001 · Latest Report: 20241114

What Are the Most Common ARTEMETHER\LUMEFANTRINE Side Effects?

#1 Most Reported
Haemolytic anaemia
49 reports (16.8%)
#2 Most Reported
Pyrexia
28 reports (9.6%)
#3 Most Reported
Vomiting
18 reports (6.2%)

All ARTEMETHER\LUMEFANTRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Haemolytic anaemia 49 16.8% 0 40
Pyrexia 28 9.6% 2 17
Vomiting 18 6.2% 1 3
Asthenia 17 5.8% 1 11
Headache 16 5.5% 0 9
Haemolysis 15 5.2% 1 12
Malaria 15 5.2% 1 4
Drug ineffective 14 4.8% 2 7
Maternal exposure during pregnancy 12 4.1% 1 2
Product use in unapproved indication 11 3.8% 0 0
Nausea 10 3.4% 0 5
Anaemia 9 3.1% 2 5
Chills 9 3.1% 0 5
Dyspnoea 9 3.1% 1 5
Foetal exposure during pregnancy 9 3.1% 2 1
Plasmodium falciparum infection 9 3.1% 0 5
Decreased appetite 8 2.8% 1 4
Pruritus 8 2.8% 1 4
Condition aggravated 7 2.4% 0 2
Fatigue 7 2.4% 0 4

Who Reports ARTEMETHER\LUMEFANTRINE Side Effects? Age & Gender Data

Gender: 50.0% female, 50.0% male. Average age: 33.5 years. Most reports from: FR. View detailed demographics →

Is ARTEMETHER\LUMEFANTRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 1 1
2003 1 0 1
2007 1 0 0
2008 1 0 1
2009 1 0 0
2011 1 0 1
2014 23 2 12
2015 18 0 10
2016 15 1 13
2017 22 1 19
2018 17 1 11
2019 12 0 4
2020 9 0 3
2021 12 0 6
2022 12 0 10
2023 10 0 6
2024 10 0 8

View full timeline →

What Is ARTEMETHER\LUMEFANTRINE Used For?

IndicationReports
Malaria 147
Plasmodium falciparum infection 50
Product used for unknown indication 49
Hiv infection 7
Babesiosis 5
Foetal exposure during pregnancy 5

ARTEMETHER\LUMEFANTRINE vs Alternatives: Which Is Safer?

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

Official FDA Label for ARTEMETHER\LUMEFANTRINE

Official prescribing information from the FDA-approved drug label.