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
Atovaquone Glenmark 750 mg/5 ml oral suspension is indicated for:
Acute treatment of mild to moderate Pneumocystis pneumonia (PCP, caused by Pneumocystis jiroveci, formerly classified as P. 4).
How to take
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 oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
1 ) Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. 3 ): Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] >45 mm Hg) with atovaquone oral suspension has not been studied.
The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied. 1 Prevention of Pneumocystis jirovecii Pneumonia Atovaquone oral suspension is indicated for the prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
2 Treatment of Mild-to-Moderate Pneumocystis jirovecii Pneumonia Atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
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) · PL252580235 · revised January 16, 2026
- [2]Health Canada (DPD) · 02421429 · revised March 22, 2025
- [3]FDA DailyMed · 03ddcc33-729c-4d… · revised June 1, 2021 [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.