Common Side Effects of Remdesivir
Based on clinical trial data, several side effects are frequently observed in patients receiving remdesivir. The most common of these tend to be gastrointestinal issues and liver enzyme elevations.
Gastrointestinal Issues
- Nausea: This is one of the most commonly reported side effects of remdesivir.
- Diarrhea and Vomiting: These are also frequently reported gastrointestinal adverse events.
- Constipation: Some patients have reported constipation during treatment.
Liver Function Abnormalities
Increases in liver enzymes, specifically alanine aminotransferase (ALT) and aspartate aminotransferase (AST), are common in patients receiving remdesivir. In many cases, these elevations are mild to moderate and resolve after the medication is stopped. However, significant increases or accompanying signs of liver inflammation warrant consideration of treatment discontinuation.
Serious and Potentially Dangerous Side Effects
While less common, some side effects of remdesivir can be severe and require immediate medical attention. Healthcare providers closely monitor for these serious events during and after infusion.
Infusion-Related and Hypersensitivity Reactions
Because remdesivir is administered intravenously, infusion-related and hypersensitivity reactions can occur, often within an hour of administration. These can range from mild to life-threatening, including anaphylaxis. Symptoms can include:
- Changes in heart rate or blood pressure (hypotension, tachycardia, bradycardia)
- Shortness of breath, wheezing
- Fever, chills, shivering
- Nausea and sweating
- Swelling of the face, lips, tongue, or throat (angioedema)
- Rash, hives, itching
Acute Kidney Injury (AKI)
Concerns exist regarding the potential for remdesivir to cause or exacerbate kidney problems. The medication contains the excipient sulfobutylether beta-cyclodextrin sodium (SBECD), which is cleared by the kidneys. In patients with pre-existing renal impairment, SBECD can accumulate and potentially lead to toxicity. Several pharmacovigilance studies have detected a significant association between remdesivir and acute kidney injury. Therefore, baseline and daily monitoring of renal function is recommended, and the drug is generally not recommended for patients with severe renal impairment (eGFR < 30 mL/min).
Other Rare Adverse Events
Clinical trial data and post-marketing reports have noted other less frequent but serious adverse events, including:
- Seizures
- Cardiac arrest (very rare)
- Anemia and lymphopenia
- Hyperglycemia
- Psychiatric effects like delirium
Comparison of Adverse Events: Remdesivir vs. Placebo
Clinical trials often compare the frequency of adverse events in patients receiving remdesivir versus a placebo or standard of care. This helps distinguish side effects of the drug from complications of the underlying disease.
| Adverse Event | Remdesivir Group | Placebo/Standard of Care Group |
|---|---|---|
| Serious Adverse Events (SAEs) | Similar or lower rates reported in some trials, but overall rates can vary. For example, one trial reported SAEs in 24.6% of remdesivir patients vs. 31.6% in the placebo group. | Varied, often similar to or higher than remdesivir groups due to underlying COVID-19 severity. |
| Discontinuation due to AEs | Higher rate reported in some studies for remdesivir patients compared to placebo. | Lower rate reported in some studies compared to remdesivir. |
| Nausea | A very common side effect in remdesivir groups. | Also occurs but can be less frequent than in remdesivir-treated patients. |
| Transaminase Elevations | Can occur in a significant portion of remdesivir patients. | Can also occur in COVID-19 patients not on remdesivir, making attribution complex. |
| Acute Kidney Injury (AKI) | A reported concern, with some pharmacovigilance studies indicating a higher association with remdesivir use. | Also a known complication of severe COVID-19, complicating causality assessment. |
Precautions and Monitoring
Given the potential for both common and serious side effects, patient monitoring is a critical part of remdesivir therapy. Before starting treatment, healthcare providers should assess baseline renal and hepatic function. During treatment, continuous monitoring is necessary to check for adverse events. For patients with severe kidney impairment (eGFR < 30 mL/min), remdesivir is generally not recommended due to the risk of SBECD accumulation.
Drug Interactions
Remdesivir can interact with other medications. A notable interaction exists with chloroquine phosphate and hydroxychloroquine sulfate. Co-administration of these drugs is not recommended, as lab studies have shown they can reduce the antiviral activity of remdesivir. Other potential interactions, particularly with drugs metabolized by certain liver enzymes, should be considered.
Conclusion
As an antiviral treatment for COVID-19, remdesivir has demonstrated clinical benefits, particularly in reducing recovery time and disease progression in specific patient populations. However, as with any potent medication, it is associated with negative side effects that require careful management. The most frequently reported adverse effects include gastrointestinal distress and transient elevations in liver enzymes, while serious concerns revolve around hypersensitivity reactions and the potential for acute kidney injury, especially in patients with pre-existing renal impairment. The risk of side effects must always be balanced against the potential benefits of the therapy, with continuous monitoring by healthcare professionals being essential for patient safety. The safety data collected since its approval continues to inform prescribing practices and risk mitigation strategies.
Visit the FDA for important safety information on Veklury (remdesivir)
