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remdesivir Side Effects

Also known as: Veklury

Analysis of 13,113 adverse event reports submitted to the FDA from 2018 to 2025.

Total Reports

13,113

Death-Related

3,250

24.8% of reports

Hospitalizations

4,426

33.8% of reports

Top Indication

Covid-19

Most Reported Adverse Reactions

OFF LABEL USE
2,208
ALANINE AMINOTRANSFERASE INCREASED
933
COVID-19
896
DRUG INEFFECTIVE
762
DEATH
751
BRADYCARDIA
651
ASPARTATE AMINOTRANSFERASE INCREASED
627
ACUTE KIDNEY INJURY
622
RESPIRATORY FAILURE
526
COVID-19 PNEUMONIA
480
LIVER FUNCTION TEST INCREASED
420
CONDITION AGGRAVATED
378
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
328
PNEUMONIA
325
BLOOD CREATININE INCREASED
320
CARDIAC ARREST
286
RENAL IMPAIRMENT
279
HYPOTENSION
278
SEPTIC SHOCK
272
DYSPNOEA
257

Who Reports Side Effects

Gender Distribution

Female 4,881 (40%)
Male 7,235 (60%)
Unknown 2

Age Distribution

0-17 657 (6%)
18-44 1,877 (17%)
45-64 3,630 (32%)
65-74 2,485 (22%)
75+ 2,673 (24%)

Reporting Trend by Year

18
19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 3,250 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 747
COVID-19 397
OFF LABEL USE 384
DRUG INEFFECTIVE 359
RESPIRATORY FAILURE 334
ACUTE KIDNEY INJURY 253
CARDIAC ARREST 220
MULTIPLE ORGAN DYSFUNCTION SYNDROME 214
COVID-19 PNEUMONIA 203
SEPTIC SHOCK 194
HYPOXIA 158
CONDITION AGGRAVATED 150
HYPOTENSION 114
ACUTE RESPIRATORY DISTRESS SYNDROME 111
PNEUMONIA 111
SEPSIS 111
RENAL FAILURE 110
ACUTE RESPIRATORY FAILURE 107
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 102
GENERAL PHYSICAL HEALTH DETERIORATION 86

Reactions in Hospitalization Reports

Top reactions in 4,426 reports where hospitalization was an outcome.

Reaction Reports
OFF LABEL USE 1,163
COVID-19 557
DRUG INEFFECTIVE 488
COVID-19 PNEUMONIA 314
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 283
RESPIRATORY FAILURE 241
ACUTE KIDNEY INJURY 228
PNEUMONIA 175
BRADYCARDIA 164
SEPTIC SHOCK 148
DRUG INTERACTION 145
CONDITION AGGRAVATED 142
BRONCHOPULMONARY ASPERGILLOSIS 124
DYSPNOEA 118
DEATH 117
MULTIPLE ORGAN DYSFUNCTION SYNDROME 111
ALANINE AMINOTRANSFERASE INCREASED 110
RENAL IMPAIRMENT 105
CARDIAC ARREST 104
ASPARTATE AMINOTRANSFERASE INCREASED 101

Nearby — Related Medications

Compare remdesivir vs acyclovir →

What the FAERS Data Reveals About remdesivir Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 13,113 voluntary reports linked to remdesivir and its brand equivalents (Veklury), spanning 2018 through 2025. Of those, 3,250 (24.8%) listed death as an outcome and 4,426 (33.8%) involved hospitalization. The most common indication reported alongside adverse events was Covid-19.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 40% were female and 60% male; age distribution skews toward 45-64, with 3,630 reports in that bracket. The single most reported reaction is off label use with 2,208 submissions, followed by alanine aminotransferase increased 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.