Prescription medication · Antimalarial Combination

atovaquone/proguanil

Also sold as Malarone. Malarone is used to prevent malaria, especially in areas where the malaria parasite is resistant to chloroquine.

Data updated 2026-05-15

3,187
FDA reports
4
InteractionsFew interactions
$6.61
Brand price (NADAC)

What the data shows

atovaquone/proguanil (Malarone) is a prescription Antimalarial Combination, with 3,187 FDA adverse-event reports on file, with 4 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

atovaquone/proguanil (Malarone) is a prescription Antimalarial Combination. Malarone is used to prevent malaria, especially in areas where the malaria parasite is resistant to chloroquine.

Malarone is a drug used to prevent and treat malaria. It contains two medicines, atovaquone and proguanil, that work together to kill the malaria parasite.

Drug Pricing (NADAC)

Brand Price

$6.61/unit

Generic Available

No

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What it does

Malarone is used to prevent malaria, especially in areas where the malaria parasite is resistant to chloroquine.

Common side effects

Abdominal pain, Headache, Cough

Key warnings

Elevated liver tests, hepatitis, and liver failure have been reported with Malarone.

The sections below are summarized in plain English from atovaquone/proguanil's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Malarone contains two active ingredients: atovaquone and proguanil. Atovaquone stops the malaria parasite's energy production. Proguanil disrupts the parasite's ability to multiply. Together, they kill the parasite and treat or prevent malaria.

Side Effects (from patient reports)

Based on 3,187 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for atovaquone/proguanil, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Elevated liver tests, hepatitis, and liver failure have been reported with Malarone. If you have severe kidney problems, do not use Malarone to prevent malaria. Malarone has not been tested for treating severe malaria affecting the brain, lungs, or kidneys.

Known Drug Interactions

moderate rifampin

7 DRUG INTERACTIONS • Administration with rifampin or rifabutin is known to reduce atovaquone concentrations; concomitant use with MALARONE is not recommended. ( 7.3 ) 7.1 Rifampin/Rifabutin Concomitant administration of rifampin or rifabutin is known to reduce atovaquone concentrations [see Clinical Pharmacology ( 12.3 )] . The concomitant administration of MALARONE and rifampin or rifabutin is not recommended.

Mechanism: Rifampin lowers the amount of atovaquone in your blood, which can make the medicine less effective at fighting infection.

( 7.1 ) • Proguanil may potentiate anticoagulant effect of warfarin and other coumarin-based anticoagulants. 7.2 Anticoagulants Proguanil may potentiate the anticoagulant effect of warfarin and other coumarin-based anticoagulants.

Mechanism: Proguanil can increase the blood-thinning effects of warfarin, which may make you bleed more easily.

( 7.2 ) • Tetracycline may reduce atovaquone concentrations; parasitemia should be closely monitored. 7.3 Tetracycline Concomitant treatment with tetracycline has been associated with a reduction in plasma concentrations of atovaquone [see Clinical Pharmacology ( 12.3 )] . Parasitemia should be closely monitored in patients receiving tetracycline.

Mechanism: Tetracycline can lower the amount of atovaquone in your body, making it harder for the drug to fight off the infection.

7.4 Metoclopramide While antiemetics may be indicated for patients receiving MALARONE, metoclopramide may reduce the bioavailability of atovaquone and should be used only if other antiemetics are not available [see Clinical Pharmacology ( 12.3 )] .

Mechanism: Metoclopramide speeds up the digestive system, which can lower the total amount of atovaquone that gets into your blood.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take Malarone if I have kidney problems?
If you have severe kidney problems, you should not use Malarone to prevent malaria. Talk to your doctor about other options.
What should I do if I vomit after taking Malarone?
If you vomit within 1 hour of taking Malarone, take another dose right away.
Can I crush the Malarone tablet?
Yes, you can crush the tablet and mix it with condensed milk if you have trouble swallowing it.
How long should I take Malarone for malaria prevention?
Start taking Malarone 1 or 2 days before entering a malaria area, continue daily while you're there, and for 7 days after you leave.
What are the common side effects of Malarone?
Common side effects include abdominal pain, headache, cough, vomiting, diarrhea, and nausea.
Can Malarone be used to treat severe malaria?
No, Malarone has not been tested for treating severe malaria affecting the brain, lungs, or kidneys.
Is Malarone safe to take during pregnancy?
It is not known if Malarone can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
What drugs should I avoid while taking Malarone?
Avoid taking Malarone with rifampin or rifabutin. Be careful when taking Malarone with warfarin or tetracycline.
What should I do if I miss a dose of Malarone?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose.
How should I store Malarone?
Store Malarone at room temperature, away from heat and moisture.
What are the common side effects of atovaquone/proguanil?
The registry lists Abdominal pain, Headache, Cough, Vomiting, Diarrhea among the most-reported FAERS reaction terms for atovaquone/proguanil. The compiled record contains 3,187 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does atovaquone/proguanil interact with other medications?
The registry has 4 documented interaction rows for atovaquone/proguanil. Notable source-record pairings include rifampin, warfarin, tetracycline. These rows are not a complete medication review.
What drug class is atovaquone/proguanil?
atovaquone/proguanil belongs to the Antimalarial Combination drug class. It requires a prescription (Rx). Malarone is used to prevent malaria, especially in areas where the malaria parasite is resistant to chloroquine.
What pregnancy or breastfeeding source fields are listed for atovaquone/proguanil?
The FDA label for atovaquone/proguanil contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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What the FDA Data Shows for atovaquone/proguanil

The FDA label for atovaquone/proguanil (sold under brand names such as Malarone) classifies it as a prescription-only medication in the Antimalarial Combination class. Malarone is used to prevent malaria, especially in areas where the malaria parasite is resistant to chloroquine. Official labeling lists 12 commonly reported side effects, including Abdominal pain, Headache, Cough.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,187 voluntary reports. The database also lists 4 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: November 14, 2023

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page