Molnupiravir side effects
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Molnupiravir Side Effects: A Comprehensive Overview
Common Side Effects of Molnupiravir
Molnupiravir, an antiviral drug used to treat COVID-19, has been generally well tolerated in clinical trials. The most frequently reported side effects include headache, diarrhea, nausea, vomiting, dizziness, and rash1 2 5. In a Phase I study, headache was observed in 12.5% of participants receiving molnupiravir compared to 18.8% in the placebo group, while diarrhea was reported equally in both groups at 7.1%1.
Serious Adverse Events
While serious adverse events are relatively rare, they have been documented. In a Phase II study, serious adverse events included cerebrovascular accidents and acute respiratory failure in a small number of participants1. Additionally, in a Phase III study, serious adverse events were reported in 30.4% of the molnupiravir group compared to 33.0% in the placebo group, indicating a similar safety profile between the drug and placebo3.
Rare and Uncommon Side Effects
Some less common side effects have also been reported. For instance, tremors were observed in three patients during molnupiravir treatment, suggesting that this could be a rare side effect2. Additionally, a study involving kidney transplant recipients and hemodialysis patients noted acute kidney injury in five participants, although no serious side effects or interactions with immunosuppressive medications were observed4.
Safety in Special Populations
Molnupiravir has been tested in various populations, including those with comorbidities and immunocompromised individuals. In a study involving kidney transplant recipients and hemodialysis patients, molnupiravir was found to be safe and effective, with no serious adverse events reported4. Another study confirmed that molnupiravir was well tolerated across different doses, with no severe adverse events noted5.
Conclusion
Overall, molnupiravir appears to be a safe and well-tolerated antiviral treatment for COVID-19, with common side effects such as headache, diarrhea, and nausea. Serious adverse events are rare, and the drug has shown a similar safety profile to placebo in clinical trials. However, rare side effects like tremors and acute kidney injury have been reported, warranting further investigation. Molnupiravir's safety in special populations, including those with comorbidities, has also been demonstrated, making it a viable option for treating COVID-19 in diverse patient groups.
Sources and full results
Most relevant research papers on this topic
The use of a new oral antiviral drug molnupiravir in the treatment of COVID-19 from a safety perspective
Molnupiravir is a well-tolerated and safe oral antiviral drug for treating mild to moderate COVID-19, reducing hospitalizations and deaths when used within 5 days of symptom onset.
RCTCan Tremor Be a Rare Side Effect Related to Molnupiravir?
Tremor may be a rare side effect of molnupiravir, a well-tolerated antiviral for COVID-19 treatment, but common side effects include diarrhea, nausea, vomiting, headache, dizziness, and rash.
Case ReportMolnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
Early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19.
RCT
Large Human Trial
Rigorous Journal
Highly CitedMolnupiravir When Used Alone Seems to Be Safe and Effective as Outpatient COVID-19 Therapy for Hemodialyzed Patients and Kidney Transplant Recipients
Molnupiravir therapy alone appears to be safe and effective for treating COVID-19 in kidney transplant recipients and hemodialysis patients, with symptoms improving rapidly within 24 to 48 hours of starting treatment.
Observational StudyOptimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study
Molnupiravir is a safe and well-tolerated treatment for early SARS-CoV-2 infection, with a recommended dose of 800 mg twice daily for 5 days for Phase II evaluation.
RCTHighly CitedHuman Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity against SARS-CoV-2
Molnupiravir is a well-tolerated oral antiviral agent with activity against SARS-CoV-2 and other RNA viruses, with no serious adverse events observed in this study.
RCTHighly CitedEfficacy and safety of molnupiravir for the treatment of SARS-CoV-2 infection: a systematic review and meta-analysis
Molnupiravir does not reduce mortality or hospitalization risk in COVID-19 outpatients, and its effects on symptom resolution are uncertain.
Meta-AnalysisAntiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial
Molnupiravir significantly accelerates the clearance of SARS-CoV-2 Omicron RNA in patients with COVID-19, with a good safety profile and no serious adverse events reported.
RCTA phase 2a clinical trial of molnupiravir in patients with COVID-19 shows accelerated SARS-CoV-2 RNA clearance and elimination of infectious virus
Molnupiravir (800mg dose) accelerated SARS-CoV-2 RNA clearance and eliminated infectious virus in nasopharyngeal swabs in COVID-19 patients, offering a potential oral treatment for the pandemic.
RCTRigorous JournalHighly CitedRandomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19.
Molnupiravir effectively reduces Covid-19 symptoms in hospitalized patients, with no dose-limiting side effects or adverse events.
RCTHighly Cited