FDA-filed SPL labeling · retrieved through openFDA

Atovaquone

Atovaquone is an antimicrobial oral suspension used to prevent and treat mild-to-moderate Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents who cannot tolerate the standard antibiotic TMP-SMX.

Brand name Mepron
Drug classes ⓘ Antimalarial
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 23 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMar 20, 2026
Clinical labels in scope ⓘ23
AvailabilityRx
Earliest approval/marketing year ⓘ1992
FDA-listed product records ⓘ71
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 17, 2026 🚨Class I recall on record
⭐ Atovaquone at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Atovaquone oral suspension is a well-established option for preventing and treating mild-to-moderate PCP in people who cannot tolerate the standard therapy TMP-SMX. The single most important thing to remember is to take it with food every dose — this is not optional, it is what makes the medicine work. Watch for signs of liver problems or a serious allergic reaction and contact your doctor immediately if either occurs.
How we write & review this content — our editorial policy →

📖 Atovaquone: Patient Information Guide

A plain-language walkthrough of Atovaquone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Atovaquone oral suspension is an antimicrobial used specifically against Pneumocystis jirovecii, the organism that causes PCP, a serious lung infection most often seen in people with weakened immune systems.

  • Prevention of PCP: Atovaquone oral suspension (including Mepron) is indicated to prevent PCP in adults and adolescents aged 13 and older who cannot tolerate TMP-SMX, the first-line preventive therapy.
  • Treatment of mild-to-moderate PCP: Atovaquone oral suspension (including Mepron) is indicated to treat active, mild-to-moderate PCP in adults and adolescents aged 13 and older who cannot tolerate TMP-SMX.
  • Not for severe PCP: Treatment of severe PCP with atovaquone has not been studied — it is not used in that setting.
  • Not for TMP-SMX treatment failures: Its effectiveness in people whose PCP is not responding to TMP-SMX has not been studied.
⚙️How it works▾

Atovaquone belongs to a class of medicines called quinone antimicrobials. It acts against Pneumocystis jirovecii by disrupting processes the organism needs to function and survive. Research has shown a clear link between the level of atovaquone in the blood and how well treatment works — the higher the blood level, the better the outcome — which is exactly why taking it with food to maximize absorption is so critical.

💊How it's taken▾

Atovaquone oral suspension is taken by mouth. The dose and frequency depend on whether you are using it to prevent or treat PCP — prevention uses a once-daily dose, while treatment uses a twice-daily dose for 21 days. It must be taken with food every time; taking it on an empty stomach can cut absorption in half and reduce its effectiveness.

  • Shake the bottle gently before each dose
  • Mepron foil pouches: squeeze the full contents of the pouch into your mouth, or into a spoon or cup first — use two pouches for a 10-mL dose
  • Do not adjust your dose or stop early without talking to your prescriber
  • If you miss a dose, follow your prescriber's guidance — do not double up without being told to
🤒Side effects — in detail▾

The most commonly reported side effects with atovaquone oral suspension include:

  • Diarrhea
  • Nausea
  • Rash (including maculopapular rash)
  • Vomiting
  • Headache
  • Fever
  • Insomnia
  • Sweating

More serious reactions to act on immediately include signs of liver damage (yellowing of skin or eyes, dark urine, severe fatigue), a severe allergic reaction (throat swelling, difficulty breathing, hives), severe skin reactions such as blistering or peeling (Stevens-Johnson syndrome has been reported after marketing), and bluish skin or lips that could signal a blood oxygen problem (methemoglobinemia).

⚠️Warnings & precautions▾
  • Take with food — always. Atovaquone is poorly absorbed without food. Skipping food with each dose can result in blood levels too low to prevent or treat PCP. If stomach or gut problems limit your ability to eat or absorb medicines, your doctor may need to reconsider this treatment.
  • Liver toxicity is a real risk. Cases of hepatitis (liver inflammation), elevated liver enzymes, and fatal liver failure have been reported. People with severe liver impairment need close monitoring. Tell your doctor immediately if you notice yellowing of the skin or eyes, very dark urine, or unusual fatigue.
  • Serious allergic reactions have occurred. Angioedema (severe swelling), bronchospasm (airway tightening), throat tightness, and hives have been reported. Do not take atovaquone if you have had a serious allergic reaction to it before.
  • Serious skin reactions including erythema multiforme and Stevens-Johnson syndrome have been identified in post-marketing reports — seek care immediately if you develop widespread blistering or peeling of the skin.
🔀What it interacts with▾

Several medicines can lower atovaquone levels in the blood or be affected by atovaquone — tell your doctor and pharmacist about everything you take:

  • Rifampin or rifabutin (TB antibiotics): cut atovaquone blood levels by roughly half — this combination is not recommended
  • Tetracycline (an antibiotic): can reduce atovaquone levels — if you must use both, watch for signs the atovaquone is not working
  • Metoclopramide (used for nausea or stomach motility): reduces atovaquone absorption — use only when no other anti-nausea medicine is an option
  • Indinavir (an HIV medicine): atovaquone lowers indinavir trough levels, which could reduce indinavir's effectiveness — use together with caution and monitoring

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • History of serious allergic reaction to atovaquone: Do not take this medicine — it is contraindicated.
  • Liver disease: Serious liver problems including fatal liver failure have occurred — patients with severe hepatic impairment need close monitoring.
  • Stomach or intestinal disorders: Conditions that impair oral absorption may prevent atovaquone from reaching effective levels — discuss alternatives with your doctor.
  • Pregnancy: There are not enough human data to fully assess risk. Pregnant women with HIV who develop PCP face serious risks from the infection itself. Discuss the risks and benefits carefully with your doctor.
  • Breastfeeding: Mothers with HIV-1 should not breastfeed regardless of atovaquone use, to prevent passing the virus to the infant. Atovaquone may also pass into breast milk.
  • Children aged 12 and younger: Safety and effectiveness have not been established in this age group.
  • Adults aged 65 and older: Not enough older adults were studied to know if they respond differently — use with appropriate monitoring.
🚑If you take too much▾

Overdoses of up to very large amounts of atovaquone have been reported. Reported effects include rash and, in one case where another medicine was also taken, methemoglobinemia (a condition where the blood cannot carry oxygen normally, causing bluish skin or lips). There is no known antidote for atovaquone, and it is not known whether dialysis can remove it from the body. If you suspect an overdose, contact Poison Control or go to an emergency room immediately.

📡Pharmacodynamics — effects in the body▾

Studies in people with HIV/AIDS showed a strong relationship between atovaquone blood levels and successful treatment of PCP — patients with higher steady-state blood concentrations had much better outcomes. This is why maximizing absorption through food intake is so important clinically. The effect of atovaquone oral suspension on the heart's electrical activity (specifically the QT interval) has not been established in humans.

🔬Pharmacokinetics — how your body processes it▾

Atovaquone is a highly fat-soluble compound that is poorly absorbed when taken without food — eating a meal can increase the total amount absorbed by about 2.5-fold. Once in the body, it binds very tightly to plasma proteins (about 99.9%) and has a long half-life of roughly 2.5 to 3 days, meaning it stays in the body for an extended time. It is excreted mostly unchanged in the feces, with more than 94% recovered that way; its metabolism is not fully understood. The pharmacokinetics of atovaquone have not been formally studied in people with liver or kidney impairment.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Do not freeze.

📄 Written from Atovaquone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Atovaquone

17 supplements and herbal products have documented interactions with Atovaquone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate TRAGACANTH Moderate +9 more
Every supplement checked against Atovaquone — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Atovaquone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Atovaquone — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to take this medicine with food? Is it really that important? ▾
Yes, it really matters — this is one of the most important things to know about atovaquone. Without food, your body absorbs roughly half as much of the medicine, which can mean blood levels too low to actually prevent or treat PCP. You don't need a huge meal, but eating something when you take each dose is essential. Think of food as part of the dose itself.
What is PCP, and why am I being prescribed this instead of a more common antibiotic? ▾
PCP (Pneumocystis jirovecii pneumonia) is a serious lung infection caused by a fungal organism. It mainly affects people with weakened immune systems, such as those with HIV/AIDS. The usual first-choice medicine for PCP is called TMP-SMX, but some people can't tolerate it due to allergies or side effects. Atovaquone is a well-established alternative for people in that situation — it targets the same organism but through a different mechanism.
What side effects should I expect, and when should I actually call my doctor? ▾
The most common side effects are diarrhea, nausea, rash, vomiting, headache, and fever — these are unpleasant but often manageable. What you do need to call your doctor about right away are signs of a liver problem (yellowing of your skin or eyes, dark urine, severe tiredness), a serious allergic reaction (swelling of your throat, trouble breathing, hives), or severe skin blistering or peeling. Those are rare but serious and need prompt attention.
Are there any other medicines I should avoid while taking atovaquone? ▾
Yes, a few important ones. Rifampin and rifabutin — antibiotics sometimes used for TB — can cut your atovaquone levels dramatically and should not be taken with it. Tetracycline antibiotics and metoclopramide (a nausea medicine) can also lower your atovaquone levels. If you take the HIV medicine indinavir, atovaquone can affect how much indinavir stays active in your body. Always tell your pharmacist and doctor about everything you're taking so they can check for these interactions.
I'm pregnant — is it safe to take atovaquone? ▾
There isn't enough human data to say for certain. Animal studies did not show birth defects at the doses studied, but that doesn't guarantee safety in humans. Here's the important thing: PCP during pregnancy can be very serious for both you and your baby, so the risk of the infection may outweigh the uncertainty about the medicine. This is a conversation to have directly with your doctor, who can help weigh what's safest for your specific situation.
Can I breastfeed while taking atovaquone? ▾
If you have HIV-1, the guidance is not to breastfeed — not because of atovaquone specifically, but because breastfeeding can pass the HIV virus to your infant. Since atovaquone is used in people with HIV, breastfeeding is not recommended while taking it. Talk to your doctor about safe feeding options for your baby.
Is Atovaquone available over the counter? ▾
Atovaquone is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Atovaquone first available? ▾
Atovaquone has been available in the United States since at least 1992, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Atovaquone? ▾
Atovaquone is supplied by 37 manufacturers listed in the FDA NDC Directory, including GlaxoSmithKline LLC, Glenmark Pharmaceuticals Inc., USA, PAI Holdings, LLC.

💬 Answers drafted from Atovaquone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Atovaquone supplement interactions17 checked — ranked by severity 🌿Drug & Supplement CheckerAtovaquone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Atovaquone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Atovaquone comes

Atovaquone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Oral suspension

By mouth
Brands Mepron
How this form is used
What it may be used for
  • Atovaquone oral suspension is approved to prevent PCP in adults and adolescents aged 13 and older who cannot tolerate TMP-SMX
  • Atovaquone oral suspension is approved to treat mild-to-moderate PCP in adults and adolescents aged 13 and older who cannot tolerate TMP-SMX
  • Mepron oral suspension is approved for the same prevention and mild-to-moderate treatment uses in the same age group
  • Not studied for severe PCP or for PCP that is not responding to TMP-SMX — not used in those situations
Important instructions
  • Always take atovaquone oral suspension with food — food significantly increases how much the body absorbs
  • Shake the bottle gently before measuring and taking each dose
  • Mepron foil pouches: for a 5-mL dose, open one pouch and take the full contents by mouth or pour into a dosing spoon or cup; for a 10-mL dose, use two pouches
  • Follow your prescriber's directions for how often to take it — dosing frequency differs between prevention and treatment use
Available strengths 2 strengths
750 mg/5 mL 1500 mg/10 mL
59 FDA-listed product records ⓘ

📊 Atovaquone across the U.S. market

How Atovaquone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
37
Manufacturers
3
Brand names
71
FDA-listed product records ⓘ
1992
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

GlaxoSmithKline LLC11%
Glenmark Pharmaceuticals Inc., USA4%
PAI Holdings, LLC4%
American Health Packaging4%
Amneal Pharmaceuticals LLC4%
Golden State Medical Supply, Inc.4%
Other makers68%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Atovaquone is used

A general measure of how commonly Atovaquone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Atovaquone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

24,509
Medicaid prescriptions filled (Q1–Q4 2025)
$6.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Atovaquone prescribed? Of the 1,596 medications we measure, Atovaquone ranks #771 by Medicaid prescriptions — more than 52% of them.

Where Atovaquone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #771 of 1,596
#766 Ibandronate 25,078 Rx #767 Daratumumab and Hyalur... 24,846 Rx #768 Fesoterodine 24,735 Rx #769 Netarsudil Ophthalmic 24,727 Rx #770 Dapsone Topical 24,570 Rx #771 Atovaquone 24,509 Rx #772 Spironolactone and Hyd... 24,202 Rx #773 Metaxalone 23,917 Rx #774 Felbamate 23,708 Rx #775 Mercaptopurine 23,610 Rx #776 Nivolumab Injection 23,499 Rx

Utilization by Atovaquone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

atovaquone 150 MG/ML Oral Suspension

24,509 Medicaid prescriptions (Q1–Q4 2025) 100% of Atovaquone prescriptions shown $6.1M gross reimbursement (before rebates) ≈ $249 per prescription (gross)

Summed across the 10 of 71 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308429

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Atovaquone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 10 of 71 listed Atovaquone NDCs with Medicaid activity.

🔍 Compare Atovaquone products

A representative set of FDA-listed product records for Atovaquone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 71 of 71 products — FDA National Drug Code Directory. See every product, package size and price: browse all 71 Atovaquone NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Atovaquone RxCUI 60212 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Suspension RxCUI 370622 In current FDA listings
    Clinical drug / strength (SCD) 150 MG/ML RxCUI 308429

Look up RxCUI 60212 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Mepron

🏭 Manufacturers & labelers

GlaxoSmithKline LLC 8 Glenmark Pharmaceuticals Inc., USA 3 PAI Holdings, LLC 3 American Health Packaging 3 Amneal Pharmaceuticals LLC 3 Golden State Medical Supply, Inc. 3 AvPAK 3 Bionpharma Inc. 3 Lupin Pharmaceuticals, Inc. 2 Hetero Drugs Limited 2 KVK-Tech, Inc. 2 Lohxa 2 Abon Pharmaceuticals, LLC 2 Major Pharmaceuticals 2 Northstar Rx LLC 2 PAI Holdings, LLC dba PAI Pharma 2 Pharmaceutical Associates, Inc. 2 Chartwell RX, LLC 2 Atlantic Biologicals Corp. 2 Camber Pharmaceuticals, Inc. 2 Divi's Laboratories Limited 2 NorthStar RxLLC 1 Zydus Lifesciences Limited 1 VistaPharm, LLC 1

…and 13 more on the FDA NDC directory.

RxNorm drug class

Atovaquone belongs to the Antimalarial class.

Pharmacologic class Antimalarial, Antiprotozoal
Drug family (ATC) Biguanides, Other agents against amoebiasis and other protozoal diseases

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 20, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Atovaquone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Atovaquone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
23
NDC products indexed
71
Distinct labelers/manufacturers represented
37
Linked representative label ⓘ
GlaxoSmithKline LLC
Linked label effective
Mar 20, 2026
Composite sections available
22
Linked SPL Set ID
b426b6bf-f07e-4580-97ae-dfca1ddf5b8f
Linked SPL Document ID
568047d4-1669-4c16-bbd0-d242a6b91507
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 23 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. GlaxoSmithKline LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.