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Drug side effects

molnupiravir Side Effects

The reactions most often reported to the FDA for molnupiravir (also sold as Lagevrio), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

5,119
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2018 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of molnupiravir come from 5,119 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 5,119 reports to the FDA Adverse Event Reporting System (FAERS) for molnupiravir (Lagevrio): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

5,119

Reports Mentioning Death

472

9.2% of reports — not proof the medicine caused the death

Hospitalizations

933

18.2% of reports

Top Indication

Covid-19 Treatment

Most Reported Adverse Reactions

COVID-19
476
DIARRHOEA
268
PRODUCT USE COMPLAINT
212
RASH
210
ACCIDENTAL UNDERDOSE
207
NAUSEA
191
UNDERDOSE
184
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
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
COVID-19 PNEUMONIA 67
PNEUMONIA 58
DIARRHOEA 53
ADVERSE EVENT 46
VOMITING 40
CONDITION AGGRAVATED 34
NAUSEA 34
OXYGEN SATURATION DECREASED 32
PYREXIA 31
DECREASED APPETITE 30
PNEUMONIA ASPIRATION 30
DYSPHAGIA 24
HOSPITALISATION 22
DEHYDRATION 20
ANAEMIA 19
DYSPNOEA 19

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 covid-19 with 476 submissions, followed by diarrhoea and product use complaint.

How to read these numbers

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.