Malaria: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

Side effects people report

337 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Pyrexia20 reports
  2. 2Autoimmune hepatitis17 reports
  3. 3Headache15 reports
  4. 4Haemolytic anaemia14 reports
  5. 5Nausea12 reports
  6. 6Rash papular12 reports
  7. 7Diarrhoea11 reports
  8. 8Skin exfoliation11 reports
  9. 9Anaemia10 reports
  10. 10Anxiety10 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on malaria

Countries side by side on public measures for this topic.

All benchmarks

Acuitas market sizes and forecasts are only in our full reports. How we use public data.