Atovaquone
Other Agents Against Amoebiasis and Other Protozoal Diseases
Sold as MEPRON · MALARONE · MALARONE PEDIATRIC
- Drug class
- Other Agents Against Amoebiasis and Other Protozoal Diseases
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 35
- FDA reports (12 mo)
- 762
Overview
Plain-language summary, compiled from the cited regulatory records
Atovaquone is an antimicrobial drug belonging to the drug class of other agents against amoebiasis and other protozoal diseases [1]. It is approved for the prevention and treatment of mild-to-moderate *Pneumocystis jirovecii* pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX) [1]. The drug is not indicated for the treatment of severe PCP [1].
In the past 12 months, there have been 762 adverse event reports associated with atovaquone [2]. The most frequent reactions reported include off-label use, nausea, pneumonia, condition aggravated, and drug ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 22 | May 29, 2026 |
| CA Canada | Health Canada | 10 | April 15, 2026 |
| US United States | FDA | 3 | December 11, 2025 |
GBUnited Kingdom· MHRA
22 products
Uses
Malarone paediatric tablets contain a fixed dose combination of atovaquone and proguanil hydrochloride, which acts as a blood schizontocide and also has activity against hepatic schizonts of Plasmodium falciparum.
They are indicated for:
Prophylaxis of P. falciparum malaria in individuals weighing 11-40 kg. Treatment of acute, uncomplicated P. falciparum malaria in children weighing ≥5 kg and <11 kg. For treatment of acute, uncomplicated P. falciparum malaria in individuals weighing 11-40 kg please refer to the Summary of Product Characteristics for Malarone tablets.
Malarone may be active against P. falciparum that are resistant to one or more other antimalarial agents. Therefore, Malarone may be particularly suitable for prophylaxis and treatment against P. falciparum infections in areas where this species is known to be commonly resistant to one or more other antimalarial agents and also for treatment of patients infected with P.
CACanada· Health Canada
10 products
How to take
Each ATOVAQUONE PROGUANIL (atovaquone and proguanil hydrochloride) Tablet contains 250 mg of atovaquone and 100 mg proguanil hydrochloride. The daily dose should be taken with food or a milky drink (to ensure maximum absorption) at the same time each day (see PRECAUTIONS, General).
In the event of vomiting within 1 hour of dosing a repeat dose should be taken. Should vomiting continue, alternative therapy should be considered or the patient’s parasitemia should be monitored. ATOVAQUONE PROGUANIL Tablets (adult strength) should preferably be swallowed whole.
Either tablet may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing tablets. ). Prophylaxis should be continued daily throughout the stay and for 7 additional days after leaving the area of concern.
Dosage in Adults One ATOVAQUONE PROGUANIL Tablet (adult strength = 250 mg atovaquone and 100 mg proguanil hydrochloride) daily. Dosage in Children (see PRECAUTIONS, Use in Children, and CLINICAL PHARMACOLOGY, Special Populations, Pediatrics) The dosage for prevention of malaria in children is based upon body weight.
USUnited States· FDA
3 products
Uses
1 INDICATIONS AND USAGE Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1 ) treatment of acute, uncomplicated P.
falciparum malaria. 1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 2 Treatment of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P.
falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
Drug interactions
Known interactions involving Atovaquone. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL109490363 · revised January 30, 2026
- [2]Health Canada (DPD) · 02421429 · revised March 22, 2025
- [3]FDA DailyMed · 152433eb-1341-9c… · revised December 11, 2025 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.