Molcovir 200 Adverse Reactions

Adverse reactions observed in clinical studies: The following adverse reactions are adverse reactions found in clinical studies of molnupiravir to support emergency use. It can be directly compared with the incidence of adverse reactions in clinical trials of other drugs and may not reflect the incidence rates found in medical practice. Additional molnupiravir-associated adverse events may occur when the drug is widely used.
Overall, more than 900 subjects received molnupiravir at a dose of 800 mg twice daily in clinical studies. Initial evaluation of the safety of molnupiravir by monitoring and analysis subjects with COVID-19 and were not hospitalized over a 29-day period in the Phase 3 study (MOVe-OUT).
The safety of molnupiravir was assessed based on a randomized and double-blind trial, Phase 3 (MOVe-OUT) in 1,411 covid-19 and non-hospitalized subjects, randomized with 710 to receive molnupiravir or 701 to placebo for a period of up to 5 days, with adverse reactions similar to those reported during treatment up to 14 days after receiving the final dose from the completed/discontinued intervention study.
Intervention studies that ended due to adverse reactions found 1 percent in the group of subjects who received molnupiravir and 3 percent in the placebo group, while 7 percent of serious adverse reactions were found in the group of subjects who received molnupiravir and 10 percent in the placebo group, with the most common serious adverse reactions associated with COVID-19. Two death-causing adverse reactions (<1%) were observed in the subject group who received molnupiravir and 12 (2%) in the placebo group.
The most common adverse reactions among those receiving molnupiravir from the MOVe-OUT study are shown in Table 3, with the severity of these symptoms being grade 1 (mild symptoms) or Grade 2 (moderate symptoms). (See Table 3.)

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Abnormal laboratory results: Abnormal laboratory results in Grade 3 and 4 of biochemical parameter values (i.e., alanine aminotransferase, aspartate aminotransferase, creatinine, and lipase) and parameters from hematological examinations (including hemoglobin, platelets, and leukocytes) were all found at a rate of ≤2 percent and similar in both groups of the MOVe-OUT study.
Post-marketing Experience: The following adverse reactions occur during the use of molnupiravir after the drug is approved. These adverse reactions were reported voluntarily from an unknown population. Therefore, it cannot be estimated frequency, or it is not reliably conclude a causal relationship with drug exposure.
Immune system Disorders: Hypersensitivity, anaphylaxis, angioedema.
Skin and subcutaneous tissue disorders: Erythema, rash, urticaria.