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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.

ATOVAQUONE\PROGUANIL: 714 Adverse Event Reports & Safety Profile

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714
Total FAERS Reports
13 (1.8%)
Deaths Reported
190
Hospitalizations
714
As Primary/Secondary Suspect
29
Life-Threatening
39
Disabilities

Active Ingredient: ATOVAQUONE\PROGUANIL HYDROCHLORIDE ·

First Report: 2003 · Latest Report: 20250815

What Are the Most Common ATOVAQUONE\PROGUANIL Side Effects?

#1 Most Reported
Diarrhoea
63 reports (8.8%)
#2 Most Reported
Nausea
62 reports (8.7%)
#3 Most Reported
Drug ineffective
57 reports (8.0%)

All ATOVAQUONE\PROGUANIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 63 8.8% 0 22
Nausea 62 8.7% 0 20
Drug ineffective 57 8.0% 3 15
Headache 46 6.4% 0 8
Vomiting 44 6.2% 0 15
Malaria 40 5.6% 0 10
Pyrexia 40 5.6% 0 17
Fatigue 39 5.5% 0 15
Malaise 36 5.0% 0 15
Anxiety 30 4.2% 0 9
Decreased appetite 30 4.2% 0 13
Dizziness 30 4.2% 0 4
Asthenia 29 4.1% 0 13
Drug resistance 26 3.6% 3 15
Insomnia 26 3.6% 0 5
Off label use 24 3.4% 1 9
Dyspnoea 23 3.2% 0 10
Condition aggravated 21 2.9% 1 12
Rash 21 2.9% 0 5
Cough 20 2.8% 0 9

Who Reports ATOVAQUONE\PROGUANIL Side Effects? Age & Gender Data

Gender: 62.8% female, 37.2% male. Average age: 44.3 years. Most reports from: US. View detailed demographics →

Is ATOVAQUONE\PROGUANIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 1
2005 2 0 1
2006 2 0 0
2007 1 0 0
2008 2 0 0
2009 1 0 0
2010 3 0 0
2011 2 0 0
2012 6 0 0
2013 15 0 3
2014 54 0 17
2015 59 3 18
2016 51 0 13
2017 68 2 20
2018 39 0 14
2019 52 3 21
2020 15 0 2
2021 21 0 11
2022 14 0 2
2023 21 0 4
2024 19 0 2
2025 11 0 4

View full timeline →

What Is ATOVAQUONE\PROGUANIL Used For?

IndicationReports
Malaria prophylaxis 327
Product used for unknown indication 138
Prophylaxis 61
Malaria 57
Babesiosis 45
Plasmodium falciparum infection 18
Prophylactic chemotherapy 14
Lyme disease 11

ATOVAQUONE\PROGUANIL vs Alternatives: Which Is Safer?

ATOVAQUONE\PROGUANIL vs ATRACURIUM ATOVAQUONE\PROGUANIL vs ATRIPLA ATOVAQUONE\PROGUANIL vs ATROPINE ATOVAQUONE\PROGUANIL vs ATROPINE\ATROPINE ATOVAQUONE\PROGUANIL vs ATROPINE\DIPHENOXYLATE ATOVAQUONE\PROGUANIL vs AUBAGIO ATOVAQUONE\PROGUANIL vs AUGMENTIN ATOVAQUONE\PROGUANIL vs AUTOLOGOUS CULTURED CHONDROCYTES ATOVAQUONE\PROGUANIL vs AUTOLOGOUS CULTURED CHONDROCYTES\SUS SCROFA COLLAGEN ATOVAQUONE\PROGUANIL vs AVACINCAPTAD PEGOL

Official FDA Label for ATOVAQUONE\PROGUANIL

Official prescribing information from the FDA-approved drug label.