J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website https://jocmr.elmerjournals.com

Original Article

Volume 17, Number 8, August 2025, pages 437-444

Safety of Molnupiravir in Hospitalized Patients With Coronavirus Disease 2019: A Retrospective, Single-Center, Cohort Study

↓ Figure 2. Distribution of adverse events among patients receiving molnupiravir (n = 27). The number and percentage of patients are indicated in each category. Patients with missing AE data were excluded from this analysis. “Others” include CPK increase with anemia (n = 1), CPK increase with AST and/or ALT increase (n = 1), CPK increase with AST and/or ALT increase and WBC decrease (n = 1), CPK increase with anemia and platelet count decrease (n = 1), anemia with WBC decrease (n = 1), anemia with AST and/or ALT increase (n = 1), AST and/or ALT increase with rash (n = 1), creatinine increase (n = 1), and one rash (n = 1). ALT: alanine aminotransferase; AST: aspartate aminotransferase; CPK: creatine phosphokinase; WBC: white blood cell count.

↓ **Table 1.** Incidence and Severity of Adverse Events
Adverse events	Total, n (%)	Grade 1, n (%)	Grade 2, n (%)	Grade 3, n (%)	Actual value^a	Grade 4, n (%)	Actual value^a
^aFor grade 3/4 adverse events, actual values (e.g., maximum CPK, lowest Hb) are provided. For grade 1/2 events, only the number of cases is reported. ALT: alanine aminotransferase; AST: aspartate aminotransferase; CPK: creatine phosphokinase; Cr: serum creatinine; Hb: hemoglobin; PLT: platelet; WBC: white blood cell count.
CPK increase	11 (14.1)	5 (6.4)	5 (6.4)	0 (0)	-	1 (1.3)	3,964 U/L
Anemia	11 (14.1)	0 (0.0)	10 (12.8)	1 (1.3)	7.9 g/dL	0 (0.0)	-
AST and/or ALT increase	9 (11.5)	8 (10.3)	1 (1.3)	0 (0.0)	-	0 (0.0)	-
WBC decrease	6 (7.7)	3 (3.8)	3 (3.8)	0 (0.0)	-	0 (0.0)	-
Rash	2 (2.6)	2 (2.6)	0 (0.0)	0 (0.0)	-	0 (0.0)	-
Cr increase	1 (1.3)	1 (1.3)	0 (0.0)	0 (0.0)	-	0 (0.0)	-
PLT decrease	1 (1.3)	1 (1.3)	0 (0.0)	0 (0.0)	-	0 (0.0)	-

↓ Table 1. Incidence and Severity of Adverse Events

Adverse events

Total, n (%)

Grade 1, n (%)

Grade 2, n (%)

Grade 3, n (%)

Actual value^a

Grade 4, n (%)

Actual value^a

^aFor grade 3/4 adverse events, actual values (e.g., maximum CPK, lowest Hb) are provided. For grade 1/2 events, only the number of cases is reported. ALT: alanine aminotransferase; AST: aspartate aminotransferase; CPK: creatine phosphokinase; Cr: serum creatinine; Hb: hemoglobin; PLT: platelet; WBC: white blood cell count.

CPK increase

11 (14.1)

5 (6.4)

0 (0)

1 (1.3)

3,964 U/L

Anemia

11 (14.1)

0 (0.0)

10 (12.8)

1 (1.3)

7.9 g/dL

0 (0.0)

AST and/or ALT increase

9 (11.5)

8 (10.3)

1 (1.3)

0 (0.0)

WBC decrease

6 (7.7)

3 (3.8)

0 (0.0)

Rash

2 (2.6)

0 (0.0)

Cr increase

1 (1.3)

0 (0.0)

PLT decrease

1 (1.3)

0 (0.0)

↓ **Table 2.** Factors Associated With CPK Elevation in Patients Receiving Molnupiravir
Factor	No CPK elevation (n = 67)	CPK elevation (n = 11)	Univariate	Multivariate
AEs: adverse events; aOR: adjusted odds ratio; CCI: Charlson Comorbidity Index; COVID-19: coronavirus disease 2019; CPK: creatine phosphokinase; IQR: interquartile range; OR: odds ratio; 95% CI: 95% confidence interval.
Age, median (IQR)	82 (74 - 89)	80 (73 - 85)	0.99	0.94 - 1.05	0.54	-	-	-
Male, n (%)	37 (55.2%)	7 (63.6%)	1.41	0.37 - 5.30	0.74	-	-	-
History of AEs or allergies, n (%)	13 (19.4%)	3 (27.3%)	1.55	0.36 - 6.69	0.68	-	-	-
CCI, median (IQR)	2 (1 - 4)	2 (1 - 3)	0.85	0.59 - 1.10	0.74	-	-	-
CCI ≥ 3, n (%)	28 (41.8%)	5 (45.5%)	1.16	0.32 - 4.18	0.81	-	-	-
History of heart disease, n (%)	15 (22.4%)	3 (27.3%)	1.30	0.30 - 5.51	0.70	-	-	-
Bacterial coinfection cases, n (%)	10 (14.9%)	4 (36.4%)	3.25	1.00 - 10.50	0.10	3.3	0.75 - 13.32	0.10
Concomitant medications
Lipid-lowering agent, n (%)	20 (29.9%)	4 (36.4%)	1.34	0.35 - 5.10	0.72	1.39	0.32 - 5.37	0.63
Use of steroids, n (%)	2 (3.0%)	1 (9.1%)	3.25	0.26 - 39.24	0.37	-	-	-
Antiparkinsonian agents, n (%)	2 (3.0%)	0 (0%)	-	-	1.0	-	-	-
COVID-19 severity
Mild, n (%)	49 (73.1%)	8 (72.7%)	1 (Ref)	-	-	-	-	-
Moderate I, n (%)	11 (16.4%)	3 (27.3%)	1.67	0.32 - 6.90	0.50	-	-	-
Moderate II, n (%)	7 (10.4%)	0 (0%)	-	-	-	-	-	-
Oxygen therapy, n (%)	13 (19.4%)	3 (27.3%)	1.55	0.36 - 6.69	0.68	-	-	-

↓ Table 2. Factors Associated With CPK Elevation in Patients Receiving Molnupiravir

Factor

No CPK elevation (n = 67)

CPK elevation (n = 11)

Univariate

Multivariate

95% CI

P-value

aOR

95% CI

P-value

AEs: adverse events; aOR: adjusted odds ratio; CCI: Charlson Comorbidity Index; COVID-19: coronavirus disease 2019; CPK: creatine phosphokinase; IQR: interquartile range; OR: odds ratio; 95% CI: 95% confidence interval.

Age, median (IQR)

82 (74 - 89)

80 (73 - 85)

0.99

0.94 - 1.05

0.54

Male, n (%)

37 (55.2%)

7 (63.6%)

1.41

0.37 - 5.30

0.74

History of AEs or allergies, n (%)

13 (19.4%)

3 (27.3%)

1.55

0.36 - 6.69

0.68

CCI, median (IQR)

2 (1 - 4)

2 (1 - 3)

0.85

0.59 - 1.10

0.74

CCI ≥ 3, n (%)

28 (41.8%)

5 (45.5%)

1.16

0.32 - 4.18

0.81

History of heart disease, n (%)

15 (22.4%)

3 (27.3%)

1.30

0.30 - 5.51

0.70

Bacterial coinfection cases, n (%)

10 (14.9%)

4 (36.4%)

3.25

1.00 - 10.50

0.10

3.3

0.75 - 13.32

0.10

Concomitant medications

Lipid-lowering agent, n (%)

20 (29.9%)

4 (36.4%)

1.34

0.35 - 5.10

0.72

1.39

0.32 - 5.37

0.63

Use of steroids, n (%)

2 (3.0%)

1 (9.1%)

3.25

0.26 - 39.24

0.37

Antiparkinsonian agents, n (%)

2 (3.0%)

0 (0%)

1.0

COVID-19 severity

Mild, n (%)

49 (73.1%)

8 (72.7%)

1 (Ref)

Moderate I, n (%)

11 (16.4%)

3 (27.3%)

1.67

0.32 - 6.90

0.50

Moderate II, n (%)

7 (10.4%)

0 (0%)

Oxygen therapy, n (%)

13 (19.4%)

3 (27.3%)

1.55

0.36 - 6.69

0.68

↓ **Table 3.** Factors Associated With Hb Decrease in Patients Receiving Molnupiravir
Factor	No Hb decrease (n = 67)	Hb decrease (n = 11)	Univariate	Multivariate
AEs: adverse events; aOR: adjusted odds ratio; CCI: Charlson Comorbidity Index; COVID-19: coronavirus disease 2019; Hb: hemoglobin; IQR: interquartile range; OR: odds ratio; 95% CI: 95% confidence interval.
Age, median (IQR)	82 (74 - 89)	84 (73 - 94)	1.03	0.97 - 1.11	0.29	-	-	-
Male, n (%)	39 (58.2%)	5 (45.5%)	0.59	0.16 - 2.15	0.42	-	-	-
History of AEs or allergies, n (%)	12 (17.9%)	4 (36.4%)	2.61	0.66 - 10.39	0.22	-	-	-
CCI, median (IQR)	2 (1 - 4)	2 (1 - 3)	0.89	0.63 - 1.13	0.40	-	-	-
CCI ≥ 3, n (%)	30 (44.8%)	3 (27.3%)	0.46	0.11 - 1.89	0.33	-	-	-
Bacterial coinfection cases, n (%)	9 (13.4%)	5 (45.5%)	5.37	1.35 - 21.32	0.010	5.40	1.27–23.69	0.022
COVID-19 severity
Mild, n (%)	51 (76.1%)	6 (54.6%)	1 (Ref)	-	-	1 (Ref)	-	-
Moderate I, n (%)	10 (14.9%)	4 (36.4%)	3.40	0.75 - 14.28	0.10	3.40	0.70–15.77	0.12
Moderate II, n (%)	6 (9.0%)	1 (9.1%)	1.41	0.06 - 10.51	0.77	1.08	0.04–9.16	0.94
Oxygen therapy, n (%)	14 (20.9%)	2 (18.2%)	0.84	0.16 - 4.34	1.00	-	-	-

↓ Table 3. Factors Associated With Hb Decrease in Patients Receiving Molnupiravir

Factor

No Hb decrease (n = 67)

Hb decrease (n = 11)

Univariate

Multivariate

95% CI

P-value

aOR

95% CI

P-value

AEs: adverse events; aOR: adjusted odds ratio; CCI: Charlson Comorbidity Index; COVID-19: coronavirus disease 2019; Hb: hemoglobin; IQR: interquartile range; OR: odds ratio; 95% CI: 95% confidence interval.

Age, median (IQR)

82 (74 - 89)

84 (73 - 94)

1.03

0.97 - 1.11

0.29

Male, n (%)

39 (58.2%)

5 (45.5%)

0.59

0.16 - 2.15

0.42

History of AEs or allergies, n (%)

12 (17.9%)

4 (36.4%)

2.61

0.66 - 10.39

0.22

CCI, median (IQR)

2 (1 - 4)

2 (1 - 3)

0.89

0.63 - 1.13

0.40

CCI ≥ 3, n (%)

30 (44.8%)

3 (27.3%)

0.46

0.11 - 1.89

0.33

Bacterial coinfection cases, n (%)

9 (13.4%)

5 (45.5%)

5.37

1.35 - 21.32

0.010

5.40

1.27–23.69

0.022

COVID-19 severity

Mild, n (%)

51 (76.1%)

6 (54.6%)

1 (Ref)

Moderate I, n (%)

10 (14.9%)

4 (36.4%)

3.40

0.75 - 14.28

0.10

3.40

0.70–15.77

0.12

Moderate II, n (%)

6 (9.0%)

1 (9.1%)

1.41

0.06 - 10.51

0.77

1.08

0.04–9.16

0.94

Oxygen therapy, n (%)

14 (20.9%)

2 (18.2%)

0.84

0.16 - 4.34

1.00