What the label lists and what reports show
Atovaquone side effects
Atovaquone's FDA label lists its adverse reactions in its own words. FAERS holds 8,003 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 pyrexia (442 reports).
- Generic listed
Check it at the source: the atovaquone FDA label on DailyMed (effective March 20, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following adverse reactions are discussed in another section of the labeling: • Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )]. • PCP Prevention: The most frequent adverse reactions (≥25% that required discontinuation) were diarrhea, rash, headache, nausea, and fever. ( 6.1 ) • PCP Treatment: The most frequent adverse reactions (≥14% that required discontinuation) were rash (including maculopapular), nausea, diarrhea, headache, vomiting, and fever. ( 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. …
Table 4. Percentage (≥10%) of Subjects with Selected Adverse Reactions in the Pentamidine Comparative PCP Treatment Trial (Primary Therapy Group)
| Adverse Reaction | MEPRON Tablets (n = 73) % | Pentamidine (n = 71) % |
|---|---|---|
| Fever | 40 | 25 |
| Nausea | 22 | 37 |
| Rash | 22 | 13 |
| Diarrhea | 21 | 31 |
| Insomnia | 19 | 14 |
| Headache | 18 | 28 |
| Vomiting | 14 | 17 |
| Cough | 14 | 1 |
| Sweat | 10 | 3 |
| Monilia, oral | 10 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, 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?
8,003 reports list atovaquone among the medicines taken, 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. Of the 20 reactions below, 6 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: 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