Remdesivir Side Effects
Applies to remdesivir: parenteral powder for injection for iv infusion, parenteral solution concentrate for injection for iv infusion
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that Remdesivir is not an approved treatment for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) for the treatment of severe COVID-19 in hospitalized patients. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information contained in the accompanying monograph, and specifically disclaims all such warranties. Readers of this information are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information contained in the monograph in any and all practice settings. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Side effects include:
Randomized, open-label clinical trial (Study GS-US-540-5773) in adults with severe COVID-19 treated with remdesivir for 5 or 10 days: Adverse events reported in 71 or 74%, serious adverse events reported in 21 or 35%, and grade 3 or greater adverse events reported in 31 or 43% of patients in the 5- or 10-day treatment group, respectively. Drug discontinued because of adverse events in 5% of patients receiving the 5-day regimen and 10% of patients receiving the 10-day regimen. All-cause mortality at day 28 was 10 or 13% in the 5- or 10-day treatment group, respectively.
Randomized, double-blind, placebo-controlled trial in hospitalized adults with severe COVID-19 in China: Adverse events (e.g., constipation, hypoalbuminemia, hypokalemia, anemia, thrombocytopenia, increased total bilirubin) reported in 66 or 64% of patients who received remdesivir or placebo, respectively. Serious adverse effects reported in 18% of patients who received remdesivir; drug discontinued because of adverse effects in 12% of patients.
Cohort of 53 hospitalized patients in manufacturer's compassionate-use program: Adverse effects (e.g., increased hepatic enzymes, diarrhea, rash, renal impairment, hypotension) reported in 60% of patients; serious adverse effects (e.g., multiple organ dysfunction syndrome, septic shock, acute kidney injury, hypotension) reported in 23%; drug discontinued because of adverse effects in 8% of patients.
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Some side effects may not be reported. You may report them to the FDA.