Does Remdesivir Cause Kidney Failure? Unpacking the Evidence

October 10, 2025 •

3 min read

Initial pharmacovigilance reports from databases like the WHO's VigiBase and the FDA's FAERS showed a statistically significant signal of acute kidney injury (AKI) potentially associated with remdesivir treatment. This triggered widespread discussion and re-evaluation of the antiviral's kidney safety profile, prompting the question: does remdesivir cause kidney failure?.

Quick Summary

This article examines the evidence regarding remdesivir and kidney failure, discussing initial safety signals, the role of the SBECD carrier, and the findings of clinical trials. It explores the reasons behind changing regulatory guidance and clarifies the current understanding of remdesivir's safety for patients with renal impairment.

Key Points

Initial Pharmacovigilance Signals: Early analysis of spontaneous adverse event reports suggested a statistically higher incidence of acute kidney injury (AKI) associated with remdesivir.
SBECD Excipient Concerns: Concern over the excipient sulfobutylether beta-cyclodextrin (SBECD) accumulating in patients with pre-existing severe kidney impairment drove early caution against its use in this population.
Randomized Controlled Trial Data: Meta-analyses of more rigorous RCTs found no significant increased risk of AKI in remdesivir patients compared to control groups.
Official FDA Update: In July 2023, the FDA revised its prescribing information, approving remdesivir for use in patients with any degree of renal impairment, including those on dialysis, based on updated safety data.
COVID-19 as a Confounding Factor: Severe COVID-19 itself is a significant cause of AKI due to factors like multi-organ failure and inflammation, confounding early pharmacovigilance data.
Safety in Renal Impairment: Current clinical evidence and regulatory approval support the safe use of remdesivir in patients with impaired kidney function without requiring dosage adjustments.
Monitoring is Still Key: Despite updated guidance, monitoring kidney function remains a prudent part of patient care, especially for those with pre-existing conditions or those receiving intensive care.

Conflicting Evidence: Initial Concerns and Post-Marketing Data

When remdesivir (Veklury) was approved for use during the COVID-19 pandemic, early data from spontaneous adverse event reporting systems suggested potential renal safety issues. Analysis of databases such as the FDA's Adverse Event Reporting System (FAERS) and the WHO's VigiBase indicated a disproportionate number of reports linking remdesivir to acute kidney injury (AKI). One study in 2021 noted a significantly increased reporting risk of acute renal failure with remdesivir compared to other COVID-19 medications. These initial findings led to caution among healthcare providers, particularly since severe COVID-19 is known to cause kidney injury.

The Role of SBECD Accumulation

A component of the remdesivir formulation is sulfobutylether beta-cyclodextrin (SBECD), which helps dissolve the drug. Early concerns focused on the possibility of SBECD building up in patients with severe kidney problems, potentially causing toxicity in the kidneys and liver. While healthy kidneys eliminate SBECD efficiently, impaired kidneys retain it, increasing its concentration and the risk of dose-related side effects. Consequently, the FDA initially advised against using remdesivir in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min.

The Shift in Scientific Consensus and Regulatory Guidance

As more comprehensive clinical trial data emerged, the understanding of remdesivir's impact on kidney function evolved. Later meta-analyses of randomized controlled trials (RCTs) indicated no significant difference in the risk of AKI between patients treated with remdesivir and those in control groups. Furthermore, large observational studies involving hospitalized COVID-19 patients with reduced kidney function (eGFR 15–60 mL/min/1.73m²) did not show an increased risk of negative kidney outcomes when compared to patients who did not receive remdesivir.

This led to updated regulatory recommendations. On July 14, 2023, the FDA updated the prescribing information for Veklury, removing the previous restriction based on eGFR. This decision was based on extensive safety and pharmacokinetic data, which confirmed that dosage adjustments are not needed for patients with any level of kidney impairment, including those undergoing dialysis. The revised guidance indicates confidence that the benefits of remdesivir outweigh potential risks associated with its components, even in vulnerable patient populations.

Factors Influencing Kidney Function in COVID-19 Patients

Acute kidney injury during the pandemic was complex, influenced by comorbidities, disease severity, concomitant medications, and hydration.

Comparing Early vs. Current Understanding of Remdesivir Renal Risk


Feature	Early Pharmacovigilance Data (2020-2021)	Current Clinical and Regulatory View (Post-2023)
Primary Concern	High reporting odds ratios for acute kidney injury (AKI) in pharmacovigilance databases.	Risk of AKI appears comparable to untreated patients, especially when confounding factors are considered.
SBECD Excipient Risk	Concern over accumulation in patients with eGFR <30 mL/min, potentially causing kidney and liver toxicity.	New data shows remdesivir can be safely administered to patients with severe renal impairment, including those on dialysis.
RCT Findings	Early trials were limited and often excluded patients with severe renal impairment.	Later meta-analyses of RCTs and real-world studies found no significant increased risk of AKI.
FDA Guidance	Caution and non-recommendation for patients with eGFR <30 mL/min.	No dosage adjustment needed for any degree of renal impairment, reflecting updated safety data.

Conclusion: Navigating the Nuances of Renal Risk with Remdesivir

While early reports suggested a possible risk, more extensive studies have provided a clearer perspective. Updated guidance from the FDA now permits use in patients with severe kidney impairment, including those on dialysis, offering reassurance. Kidney injury in severely ill COVID-19 patients is likely due to the disease, pre-existing conditions, and other treatments, not solely remdesivir. Current evidence supports remdesivir as safe for eligible patients, regardless of kidney status.

For additional details, healthcare professionals can refer to the official FDA prescribing information.

Frequently Asked Questions

Yes, initial pharmacovigilance studies found a statistically significant signal suggesting an association between remdesivir and acute kidney injury, but this was later found to be influenced by confounding factors and reporting bias.

Yes. As of July 2023, the FDA approved remdesivir for use in patients with any degree of renal impairment, including those on dialysis, based on updated safety data.

SBECD (sulfobutylether beta-cyclodextrin) is an excipient used to make remdesivir soluble for intravenous administration. It was initially a concern because it could accumulate in patients with severe renal impairment, but subsequent data supported its safety even in this population.

The guidance changed due to a more complete understanding of remdesivir's safety profile based on newer, more comprehensive safety data and pharmacokinetic studies, which alleviated earlier concerns about the SBECD excipient.

Before initiating therapy, and as needed during treatment, healthcare professionals monitor patients' kidney function through blood tests measuring creatinine clearance and liver enzymes.

In some cases, yes. Severe COVID-19 infection is a significant risk factor for kidney injury, and distinguishing between injury caused by the disease versus the drug is complex. This confounding factor likely contributed to the initial pharmacovigilance signals.

Yes, many early clinical trials excluded patients with severe kidney impairment. This created a gap in knowledge that subsequent real-world and observational studies sought to address.