Prescription medicine
Atovaquone and proguanil Brand names: Malarone; first approved as Malarone Pediatric
Atovaquone and proguanil (Malarone) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $1.49 per atovaquone-proguanil 250-100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the atovaquone and proguanil FDA label on DailyMed (effective June 10, 2026, GlaxoSmithKline LLC); the NDA 21078 record on Drugs@FDA; every atovaquone and proguanil label on DailyMed.
Highlights of the record
FDA label of June 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMALARONE is an antimalarial indicated for:
prophylaxis of Plasmodium falciparum (P.
Forms and strengths
- 62.5 mg / 25 mg
- 250 mg / 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 14, 2000 Malarone Pediatric, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first January 12, 2011; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 6 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.49 per tablet Atovaquone-proguanil 250-100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,119 through July 30, 2026
What is atovaquone and proguanil used for?
From the label: indications and usageMALARONE is an antimalarial indicated for:
prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. ( 1.1 )
treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria MALARONE is indicated for the prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria MALARONE is indicated for the treatment of acute, uncomplicated P. falciparum malaria. […]
FDA pharmacologic class: Antimalarial and Antiprotozoal.
Source: FDA drug label (MALARONE), GlaxoSmithKline LLC, effective June 10, 2026 (SPL set fc22e8d8-3bfb-4f70-a599-dd81262a4887), via openFDA; the full label on DailyMed
Is there a generic for atovaquone and proguanil (Malarone)?
The FDA approved the first generic atovaquone and proguanil on January 12, 2011. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists atovaquone and proguanil from 6 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2011 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for atovaquone and proguanil (Malarone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.49 per Atovaquone-proguanil 250-100 mg tablet, down 13% from $1.70 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Atovaquone-proguanil 250-100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Atovaquone-proguanil 250-100 mg tablet | Generic | $1.49 per tablet | $44.58 | -13% |
| Atovaquone-proguanil 62.5-25 | Generic | $0.927 per unit | n/a | -29% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the atovaquone and proguanil label say about other medicines?
The atovaquone and proguanil label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name atovaquone and proguanil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Metoclopramide | drug interactions | 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 )]. |
| Rifabutin | drug interactions | Administration with rifampin or rifabutin is known to reduce atovaquone concentrations; concomitant use with MALARONE is not recommended. |
| Rifampin | drug interactions | Administration with rifampin or rifabutin is known to reduce atovaquone concentrations; concomitant use with MALARONE is not recommended. |
| Tetracycline | drug interactions | Tetracycline may reduce atovaquone concentrations; parasitemia should be closely monitored. |
| Warfarin | drug interactions | Proguanil may potentiate anticoagulant effect of warfarin and other coumarin-based anticoagulants. |
Source: FDA drug label (MALARONE), GlaxoSmithKline LLC, effective June 10, 2026 (SPL set fc22e8d8-3bfb-4f70-a599-dd81262a4887), via openFDA; the full label on DailyMed
What do FAERS reports show for atovaquone and proguanil?
The FDA Adverse Event Reporting System holds 2,119 reports that list atovaquone and proguanil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 33 are coded as a death and 513 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antimalarials
- the pharmacologic class, with prices and generics
- Atovaquone and proguanil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other