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Veklury Side Effects

Generic Name: remdesivir

Note: This document contains side effect information about remdesivir. Some of the dosage forms listed on this page may not apply to the brand name Veklury.

For the Consumer

Applies to remdesivir: parenteral powder for injection for iv infusion, parenteral solution concentrate for injection for iv infusion

Side effects include:

Adverse effects reported in ≥5% of patients receiving remdesivir (the active ingredient contained in Veklury) include nausea and increased ALT and AST concentrations.

Phase 3, adaptive, randomized, placebo-controlled trial in hospitalized adults with mild/moderate or severe COVID-19 (NCT04280705; ACTT-1): Serious adverse events reported in 51% of patients in remdesivir group and 57% in placebo group. Adverse events leading to discontinuance of treatment reportedly occurred in 2% of patients receiving remdesivir (seizure, infusion-related reactions, increased aminotransferase concentrations, decreased GFR, acute kidney injury) and 3% of those receiving placebo.

Phase 3, randomized, open-label trial in hospitalized adults with severe COVID-19 (NCT04292899; GS-US-540-5773; SIMPLE-Severe): Adverse events reported in 70 or 74% of patients who received a 5- or 10-day remdesivir regimen, respectively; serious adverse events (e.g., respiratory distress or failure, septic shock) reported in 21 or 35%, respectively, and grade 3 or greater adverse events reported in 30 or 43%, respectively. Drug discontinued because of adverse events in 4% of patients in 5-day group and 10% of patients in 10-day group. Most common adverse events overall were nausea (10 or 9%), acute respiratory failure (6 or 11%), increased ALT concentrations (6 or 8%), and constipation (7% in both groups),

Phase 3, randomized, open-label trial in hospitalized adults with moderate COVID-19 (NCT04292730; GS-US-540-5774; SIMPLE-Moderate): Adverse events reported in 51 or 59% of patients who received a 5- or 10-day remdesivir regimen, respectively; serious adverse events reported in 5% of patients in both treatment groups, and grade 3 or greater adverse events reported in 11 or 12% of patients receiving 5- or 10-day regimen, respectively. Most common adverse events in patients receiving these respective regimens were nausea (10 or 9%), diarrhea (6 or 5%), hypokalemia (5 or7%), and headache (5% in both treatment groups). Four patients (2%) in 5-day group and 8 patients (4%) in 10-day group discontinued remdesivir due to an adverse event.

For Healthcare Professionals

Applies to remdesivir: intravenous powder for injection, intravenous solution

General

The most common side effect in healthy subjects was increased transaminases. The most common side effects in patients with coronavirus disease 2019 (COVID-19) were nausea, increased AST, and increased ALT.[Ref]

Hepatic

In studies in healthy subjects, increases in ALT, AST, or both in those who received this drug were grade 1 (10%) or grade 2 (4%). In a clinical study of patients with COVID-19, the incidence of at least grade 3 nonserious side effects of increased aminotransferase levels (including ALT, AST, or both) was 4% with this drug compared to 6% with placebo. In a clinical trial in hospitalized patients with severe COVID-19 receiving this drug for 5 or 10 days, any grade (at least 1.25 times the upper limit of normal [1.25 x ULN]) laboratory abnormalities of increased AST and increased ALT were reported in 40% and 42% of patients, respectively; at least grade 3 (at least 5 x ULN) laboratory abnormalities of increased AST and increased ALT were both reported in 7% of patients. In a clinical trial in hospitalized patients with moderate COVID-19 receiving this drug for 5 or 10 days compared to standard of care, any grade laboratory abnormalities of increased AST and increased ALT occurred in 32% and 33% of patients, respectively, receiving this drug and 33% and 39% of patients, respectively, receiving standard of care; at least grade 3 laboratory abnormalities of increased AST and increased ALT occurred in 2% and 3% of patients, respectively, receiving this drug and 6% and 7%, respectively, receiving standard of care.[Ref]

Very common (10% or more): Increased transaminases, increased ALT, increased AST

Common (1% to 10%): Increased aminotransferase levels (including ALT, AST, or both), increased bilirubin

Uncommon (0.1% to 1%): Increased hepatic enzyme, hypertransaminasemia, increased liver function tests[Ref]

Renal

Very common (10% or more): Decreased CrCl (based on Cockcroft-Gault formula; up to 19%), decreased estimated glomerular filtration rate (eGFR; up to 18%), increased creatinine (up to 15%)

Uncommon (0.1% to 1%): Decreased GFR, acute kidney injury[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 15%), decreased lymphocytes (up to 11%)

Common (1% to 10%): Increased prothrombin time[Ref]

Metabolic

Very common (10% or more): Increased glucose (up to 12%)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Seizure

Frequency not reported: Generalized seizure[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Angioedema[Ref]

Other

Uncommon (0.1% to 1%): Infusion-related reactions, increased blood alkaline phosphatase[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Decreased heart rate[Ref]

Local

Uncommon (0.1% to 1%): Injection site erythema

Frequency not reported: Administration site extravasation[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity

Frequency not reported: Anaphylaxis[Ref]

References

1. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Veklury (remdesivir)." Gilead Sciences, Foster City, CA.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.