Prescription medicine
Atovaquone Brand names: Mepron
Atovaquone (Mepron) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.767 per mL (Atovaquone 750 mg/5 mL suspension) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the atovaquone FDA label on DailyMed (effective March 20, 2026); the NDA 20259 record on Drugs@FDA; every atovaquone label on DailyMed.
Highlights of the record
FDA label of March 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMEPRON 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).
Forms and strengths
- 750 mg/5ml
Suspension.
On the market
- Earliest approval on file
- November 25, 1992 Mepron, Glaxosmithkline Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first March 18, 2014; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 20 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.767 per mL Atovaquone 750 mg/5 mL suspension
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2021 4 Class I among all firms' recalls; latest September 17, 2024
- FAERS reports
- 8,003 through July 30, 2026
What is atovaquone used for?
From the label: indications and usageMEPRON 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). ( 1.1 )
Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. ( 1.2 ) Limitations of Use ( 1.3 ):
Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO 2 ] >45 mm Hg) with MEPRON has not been studied. […]
FDA pharmacologic class: Antimalarial and Antiprotozoal.
Source: FDA drug label (MEPRON), GlaxoSmithKline LLC, effective March 20, 2026 (SPL set b426b6bf-f07e-4580-97ae-dfca1ddf5b8f), via openFDA; the full label on DailyMed
Is there a generic for atovaquone (Mepron)?
The FDA approved the first generic atovaquone on March 18, 2014. 9 generic applications are approved; 7 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 from 20 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.
- 1992 earliest approval on file
- 2014 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for atovaquone (Mepron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.767 per mL (Atovaquone 750 mg/5 mL suspension), down 12% from $0.877 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 750 mg/5 mL suspension (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Atovaquone 750 mg/5 mL suspension | Generic | $0.767 per mL | n/a | -12% |
| Atovaquone 750 mg/5 mL suspension cup | Generic | $0.767 per mL | n/a | -12% |
| Atovaquone 750 mg/5 mL suspension cup | Generic | $0.767 per mL | n/a | -12% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has atovaquone been recalled?
The FDA's Enforcement Report lists 4 recalls naming atovaquone since 2021: 4 Class I (the most serious), 0 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 17, 2024 | Class I | Bionpharma Inc. | Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. |
| March 28, 2024 | Class I | AvKARE | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. |
| March 13, 2023 | Class I | Camber Pharmaceuticals Inc. | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product. |
| July 2, 2021 | Class I | KVK-Tech, Inc. | Temperature abuse: the firm received customer complaints of unusual grittiness in the product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the atovaquone label say about other medicines?
The atovaquone label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name atovaquone. 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 | Concomitant administration with metoclopramide reduces atovaquone concentrations; administer concomitantly only if other antiemetics are not available. |
| Rifabutin | drug interactions | Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with MEPRON oral suspension is not recommended. |
| Rifampin | drug interactions | Concomitant administration of rifampin or rifabutin reduces atovaquone concentrations; concomitant use with MEPRON oral suspension is not recommended. |
| Tetracycline | drug interactions | Concomitant administration of tetracycline reduces atovaquone concentrations; use caution when coadministering. |
Other labels that name atovaquone
Source: FDA drug label (MEPRON), GlaxoSmithKline LLC, effective March 20, 2026 (SPL set b426b6bf-f07e-4580-97ae-dfca1ddf5b8f), via openFDA; the full label on DailyMed
What do FAERS reports show for atovaquone?
The FDA Adverse Event Reporting System holds 8,003 reports that list atovaquone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,348 are coded as a death and 4,055 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 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other