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molnupiravir Side Effects

Also known as: Lagevrio

Analysis of 5,119 adverse event reports submitted to the FDA from 2018 to 2025.

Total Reports

5,119

Death-Related

472

9.2% of reports

Hospitalizations

933

18.2% of reports

Top Indication

Covid-19 Treatment

Most Reported Adverse Reactions

PRODUCT USE ISSUE
709
NO ADVERSE EVENT
623
COVID-19
476
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
390
PRODUCT USE IN UNAPPROVED INDICATION
308
DIARRHOEA
268
PRODUCT USE COMPLAINT
212
RASH
210
ACCIDENTAL UNDERDOSE
207
NAUSEA
191
UNDERDOSE
184
DRUG INEFFECTIVE
181
ACCIDENTAL OVERDOSE
152
VOMITING
144
DIZZINESS
138
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
137
OVERDOSE
117
PRODUCT PRESCRIBING ISSUE
113
COVID-19 PNEUMONIA
105
DEATH
103

Who Reports Side Effects

Gender Distribution

Female 2,577 (55%)
Male 2,124 (45%)
Unknown 8

Age Distribution

0-17 375 (9%)
18-44 302 (7%)
45-64 838 (20%)
65-74 873 (21%)
75+ 1,840 (44%)

Reporting Trend by Year

18
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 472 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
COVID-19 131
DEATH 103
PNEUMONIA ASPIRATION 39
PNEUMONIA 34
RESPIRATORY FAILURE 29
COVID-19 PNEUMONIA 28
DECREASED APPETITE 25
DRUG INEFFECTIVE 24
PRODUCT USE ISSUE 22
MULTIPLE ORGAN DYSFUNCTION SYNDROME 20
HAEMATEMESIS 18
NAUSEA 18
CARDIAC FAILURE 16
CARDIAC ARREST 14
DIARRHOEA 14
DYSPHAGIA 14
ABDOMINAL DISCOMFORT 13
CONDITION AGGRAVATED 11
MARASMUS 11
SEPSIS 11

Reactions in Hospitalization Reports

Top reactions in 933 reports where hospitalization was an outcome.

Reaction Reports
COVID-19 258
DRUG INEFFECTIVE 69
COVID-19 PNEUMONIA 67
PNEUMONIA 58
DIARRHOEA 53
ADVERSE EVENT 46
PRODUCT USE ISSUE 42
VOMITING 40
CONDITION AGGRAVATED 34
NAUSEA 34
OXYGEN SATURATION DECREASED 32
PYREXIA 31
DECREASED APPETITE 30
PNEUMONIA ASPIRATION 30
OFF LABEL USE 27
DYSPHAGIA 24
HOSPITALISATION 22
DEHYDRATION 20
ANAEMIA 19
DYSPNOEA 19

Nearby — Related Medications

Compare molnupiravir vs acyclovir →

What the FAERS Data Reveals About molnupiravir Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 5,119 voluntary reports linked to molnupiravir and its brand equivalents (Lagevrio), spanning 2018 through 2025. Of those, 472 (9.2%) listed death as an outcome and 933 (18.2%) involved hospitalization. The most common indication reported alongside adverse events was Covid-19 Treatment.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 55% were female and 45% male; age distribution skews toward 75+, with 1,840 reports in that bracket. The single most reported reaction is product use issue with 709 submissions, followed by no adverse event and covid-19.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.