Artesunate

In a randomized cross‑over trial in 18 healthy adults given oral artesunate 300 mg daily for two days, all adverse events were mild but significant decreases in hemoglobin and marked reductions in reticulocyte counts were observed about 5–7 days after dosing, indicating transient bone marrow suppression.

Regulatory review summarizing artesunate safety reports reversible reticulocytopenia, mild anemia, and transient neutropenia and eosinophilia in healthy subjects receiving single or multiple doses, with most events mild and short‑lived. Hypersensitivity reactions, including rare severe events, are noted as potential risks.

This review summarizes preclinical and clinical pharmacology data for artesunate, including healthy volunteer studies showing reversible reticulocytopenia, mild anemia, and transient changes in neutrophil and eosinophil counts, generally resolving without intervention. The authors conclude that artesunate has a favorable short‑term safety profile but can transiently suppress bone marrow.

Pooled analysis of phase 1 studies in healthy subjects receiving single and multiple intravenous doses of artesunate found the most common adverse events were dysgeusia, dizziness, headache, nausea, vomiting, fatigue, myalgia, and anemia, all generally mild and resolving without treatment. One case of urticaria was reported at higher dosing.

In healthy volunteers receiving daily intravenous artesunate up to 8 mg/kg for three days, treatment was well tolerated with no serious adverse events. Transient, dose‑related decreases in reticulocyte counts and mild, reversible side effects such as altered taste were observed, without clinically significant ECG or hemodynamic changes.

Regulatory review summarizing artesunate safety reports reversible reticulocytopenia, mild anemia, and transient neutropenia and eosinophilia in healthy subjects receiving single or multiple doses, with most events mild and short‑lived. Hypersensitivity reactions, including rare severe events, are noted as potential risks.

Pooled analysis of phase 1 studies in healthy subjects receiving single and multiple intravenous doses of artesunate found the most common adverse events were dysgeusia, dizziness, headache, nausea, vomiting, fatigue, myalgia, and anemia, all generally mild and resolving without treatment. One case of urticaria was reported at higher dosing.

In healthy volunteers receiving daily intravenous artesunate up to 8 mg/kg for three days, treatment was well tolerated with no serious adverse events. Transient, dose‑related decreases in reticulocyte counts and mild, reversible side effects such as altered taste were observed, without clinically significant ECG or hemodynamic changes.

Pooled analysis of phase 1 studies in healthy subjects receiving single and multiple intravenous doses of artesunate found the most common adverse events were dysgeusia, dizziness, headache, nausea, vomiting, fatigue, myalgia, and anemia, all generally mild and resolving without treatment. One case of urticaria was reported at higher dosing.

In a randomized cross‑over trial in 18 healthy adults given oral artesunate 300 mg daily for two days, all adverse events were mild but significant decreases in hemoglobin and marked reductions in reticulocyte counts were observed about 5–7 days after dosing, indicating transient bone marrow suppression.

This review summarizes preclinical and clinical pharmacology data for artesunate, including healthy volunteer studies showing reversible reticulocytopenia, mild anemia, and transient changes in neutrophil and eosinophil counts, generally resolving without intervention. The authors conclude that artesunate has a favorable short‑term safety profile but can transiently suppress bone marrow.

Pooled analysis of phase 1 studies in healthy subjects receiving single and multiple intravenous doses of artesunate found the most common adverse events were dysgeusia, dizziness, headache, nausea, vomiting, fatigue, myalgia, and anemia, all generally mild and resolving without treatment. One case of urticaria was reported at higher dosing.

Pooled analysis of phase 1 studies in healthy subjects receiving single and multiple intravenous doses of artesunate found the most common adverse events were dysgeusia, dizziness, headache, nausea, vomiting, fatigue, myalgia, and anemia, all generally mild and resolving without treatment. One case of urticaria was reported at higher dosing.