REMDESIVIR: 10,501 Adverse Event Reports & Safety Profile
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10,501
Total FAERS Reports
2,729 (26.0%)
Deaths Reported
2,556
Hospitalizations
10,501
As Primary/Secondary Suspect
883
Life-Threatening
127
Disabilities
Oct 22, 2020
FDA Approved
Gilead Sciences, Inc.
Manufacturer
Prescription
Status
Drug Class: SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor [EPC] · Route: INTRAVENOUS · Manufacturer: Gilead Sciences, Inc. · FDA Application: 214787 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
Patent Expires: Sep 6, 2029 · First Report: 19400901 · Latest Report: 20250803
What Are the Most Common REMDESIVIR Side Effects?
#1 Most Reported
Off label use
1,092 reports (10.4%)
#2 Most Reported
Alanine aminotransferase increased
1,047 reports (10.0%)
#3 Most Reported
Death
808 reports (7.7%)
All REMDESIVIR Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 1,092 | 10.4% | 201 | 515 |
| Alanine aminotransferase increased | 1,047 | 10.0% | 72 | 114 |
| Death | 808 | 7.7% | 803 | 100 |
| Aspartate aminotransferase increased | 713 | 6.8% | 55 | 102 |
| Bradycardia | 652 | 6.2% | 55 | 142 |
| Acute kidney injury | 605 | 5.8% | 231 | 177 |
| Covid-19 | 570 | 5.4% | 328 | 278 |
| Drug ineffective | 497 | 4.7% | 242 | 300 |
| Liver function test increased | 447 | 4.3% | 30 | 67 |
| Respiratory failure | 394 | 3.8% | 275 | 117 |
| Blood creatinine increased | 359 | 3.4% | 83 | 79 |
| Condition aggravated | 318 | 3.0% | 133 | 93 |
| Covid-19 pneumonia | 280 | 2.7% | 166 | 136 |
| Renal impairment | 258 | 2.5% | 85 | 84 |
| Hypotension | 254 | 2.4% | 102 | 40 |
| Cardiac arrest | 235 | 2.2% | 182 | 59 |
| Hepatic enzyme increased | 226 | 2.2% | 25 | 32 |
| Therapy cessation | 215 | 2.1% | 13 | 29 |
| Drug ineffective for unapproved indication | 212 | 2.0% | 61 | 181 |
| Pneumonia | 212 | 2.0% | 84 | 75 |
Who Reports REMDESIVIR Side Effects? Age & Gender Data
Gender: 39.8% female, 60.2% male. Average age: 61.7 years. Most reports from: US. View detailed demographics →