Home FDA labels ea3d3b62-a7f0-4e5c-aa5d-e65eca0b33d2 FDA label ea3d3b62-a7f0-4e5c-aa5d-e65eca0b33d2 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID e079b043-09bd-44c2-b42d-f7b35f8a08e5
SPL ID ea3d3b62-a7f0-4e5c-aa5d-e65eca0b33d2
Version 8
Effective date 2026-02-27
Source export date 2026-10-12
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Failure to administer atovaquone oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Patients with gastrointestinal disorders may have limited absorption resulting in suboptimal atovaquone concentrations. ( 5.1 ) Hepatotoxicity: Elevated liver chemistry tests and cases of hepatitis and fatal liver failure have been reported. ( 5.2 ) 5.1 Risk of Limited Oral Absorption Absorption of orally administered atovaquone oral suspension is limited but can be significantly increased when the drug is taken with food. Failure to administer atovaquone oral suspension with food may result in lower plasma atovaquone concentrations and may limit response to therapy. Consider therapy with other agents in patients who have difficulty taking atovaquone oral suspension with food or in patients who have gastrointestinal disorders that may limit absorption of oral medications [see Clinical Pharmacology ( 12.3 ) ]. 5.2 Hepatotoxicity Cases of cholestatic hepatitis, elevated liver enzymes, and fatal liver failure have been reported in patients treated with atovaquone [see Adverse Reactions (6.2) ]. If treating patients with severe hepatic impairment, closely monitor patients following administration of atovaquone.
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adverse reactions table <table><col/><col/><col/><tbody><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Atovaquone Tablets </content><content styleCode="bold"> </content><content styleCode="bold">(n = 73)</content><content styleCode="bold"> </content><content styleCode="bold">%</content></td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule"><content styleCode="bold">Pentamidine </content><content styleCode="bold"> </content><content styleCode="bold">(n = 71)</content><content styleCode="bold"> </content><content styleCode="bold">%</content></td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Fever </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">40 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">25 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Nausea </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">22 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">37 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Rash </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">22 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">13 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Diarrhea </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">21 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">31 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Insomnia </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">19 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">14 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Headache </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">18 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">28 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Vomiting </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">14 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">17 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Cough </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">14 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">1 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Sweat </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">10 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">3 </td></tr><tr><td valign="top" styleCode=" Botrule Toprule Lrule Rrule">Monilia, oral </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">10 </td><td align="center" valign="top" styleCode=" Botrule Toprule Lrule Rrule">3 </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.