Remdesivir: adverse event reports filed with FDA

7,668

reports as suspect product

0% of all reports · about 1,012 a year

88

reports, 12 months to June 2026

249 in the 12 months before

79.6%

marked serious by the reporter

81.1% across the class

25.3%

record death among outcomes, as reported

1,941 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Remdesivir reports recording the termmedian drug in sars-cov-2 nucleotide analog rna polymerase inhibitor

1. Off label useused for a purpose or in a way not on the label13.1%1,007
2. Alanine aminotransferase increasedraised liver enzyme (ALT)12.2%935
3. Aspartate aminotransferase increasedraised liver enzyme (AST)7.9%609
4. Deaththe patient died; cause not stated by this term6.9%532
5. Acute kidney injurysudden loss of kidney function6.9%528
6. Bradycardiaslow heart rate5.8%445
7. Liver function test increased5.3%407
8. Drug ineffectivethe medicine did not work as expected5.3%406
9. Covid-19COVID-19 infection4.8%367
10. Blood creatinine increasedraised creatinine, a kidney test4.2%324
11. Respiratory failurethe lungs could not supply enough oxygen3.9%300
12. Condition aggravatedthe condition being treated got worse3.7%283
13. Hypotensionlow blood pressure2.8%214
14. Cardiac arrestthe heart stopped2.8%213
15. Drug ineffective for unapproved indication2.8%211
16. Hepatic enzyme increasedraised liver enzymes2.6%196
17. Therapy cessation2.5%193
18. COVID-19 pneumonia2.3%176
19. Hypoxialow oxygen2.2%171
20. Septic shockshock arising from infection2.2%170
21. Renal impairmentreduced kidney function2.1%159
22. Multiple organ dysfunction syndromeseveral organs failing1.9%144
23. Drug interactionan interaction between medicines1.8%136
24. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.8%135
25. Transaminases increased1.7%134
26. Pneumonialung infection1.6%123
27. Dyspnoeashortness of breath1.6%122
28. Acute respiratory distress syndrome1.5%115
29. Glomerular filtration rate decreasedreduced kidney filtering1.5%112
30. Renal failurekidney failure1.4%111

Top 30 of 815 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the sars-cov-2 nucleotide analog rna polymerase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 10,450 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 78.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 7,668 reports.

Drugs most often listed in the same reports

Other products listed in reports where Remdesivir is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the sars-cov-2 nucleotide analog rna polymerase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Remdesivir as a suspect or interacting product; reports listing it only as a concomitant medication (3,112) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.