What the label lists and what reports show
Atovaquone and proguanil side effects
Atovaquone and proguanil's FDA label: “The most common treatment‑emergent adverse events with MALARONE were abdominal pain (13%), headache (13%), and cough (10%).” FAERS holds 2,119 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (189 reports).
- Generic listed
Check it at the source: the atovaquone and proguanil FDA label on DailyMed (effective June 10, 2026, GlaxoSmithKline LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common treatment‑emergent adverse events with MALARONE were abdominal pain (13%), headache (13%), and cough (10%).
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in another section of the labeling: • Vomiting and Diarrhea [see Warnings and Precautions ( 5.1 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.3 )]. • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )]. • Prophylaxis: Common adverse reactions (≥4%) in adults were diarrhea, dreams, oral ulcers, and headache; these events occurred in a similar or lower proportion of subjects receiving MALARONE than an active comparator. Common adverse reactions (≥5%) in pediatric patients included abdominal pain, headache, cough, and vomiting. ( 6.1 ) • Treatment: Common adverse reactions (≥5%) in adolescents and adults were abdominal pain, nausea, vomiting, headache, diarrhea, asthenia, anorexia, and dizziness. Common adverse reactions (≥6%) in pediatric patients included vomiting, pruritus, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, 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?
2,119 reports list atovaquone and proguanil among the medicines taken, 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. Of the 22 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Atovaquone and proguanil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions