What the label lists and what reports show
Remdesivir side effects
Remdesivir's FDA label: “The most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased.” FAERS holds 13,249 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is alanine aminotransferase increased (935 reports).
- No generic listed
Check it at the source: the remdesivir FDA label on DailyMed (effective July 29, 2026, Gilead Sciences, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VEKLURY?VEKLURY may cause serious side effects, including: Allergic reactions. Allergic reactions can happen during or after infusion with VEKLURY. Your healthcare provider will monitor you for signs and symptoms of allergic reactions during your infusion and for at least 1 hour after your infusion. Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction: changes in your heart rate fever shortness of breath, wheezing swelling of the lips, face, or throat rash nausea sweating shivering Increase in liver enzymes. Increases in liver enzymes are common in people who have received VEKLURY and may be a sign of liver injury. Your healthcare provider will do blood tests to check your liver enzymes before and during treatment with VEKLURY as needed. Your healthcare provider may stop treatment with VEKLURY if you develop liver problems. […]
Source: FDA drug label, Gilead Sciences, Inc., effective July 29, 2026 (SPL set c0978fa8-53ff-4ca2-82a7-567fd3e958ca), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased.
Table 11 Laboratory Abnormalities (Grades 3–4) Reported in ≥3% of Hospitalized Subjects in Trial 5912
| Reaction | VEKLURY 5 Days N=163 | Placebo N=80 |
|---|---|---|
| Lymphocytes decreased | 27% | 27% |
| Hemoglobin decreased | 25% | 25% |
| Glucose increased | 15% | 19% |
| Uric acid increased | 11% | 4% |
| Creatinine increased | 12% | 14% |
| Albumin decreased | 12% | 10% |
| Lipase increased | 12% | 7% |
| Prothrombin time increased | 11% | 4% |
| Prothrombin INR increased | 7% | 4% |
| AST increased | 6% | 4% |
| Thromboplastin time increased | 5% | 4% |
| ALT increased | 5% | 6% |
| Sodium increased | 3% | 3% |
| Calcium increased | 3% | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in other sections of the labeling: Hypersensitivity Including Infusion-related and Anaphylactic Reactions [see Warnings and Precautions (5.1) ] Increased Risk of Transaminase Elevations [see Warnings and Precautions (5.2) ] The most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Adult Subjects The safety of VEKLURY is based on data from four Phase 3 studies in 1,476 hospitalized adult subjects with COVID-19, one Phase 3 study in 279 non-hospitalized adult and pediatric subjects (12 years of age and older weighing at least 40 kg) with mild-to-moderate COVID-19, four Phase 1 studies in 131 healthy adults, and from patients with COVID-19 who received VEKLURY under the Emergency Use Authorization or in a compassionate use program.
Source: FDA drug label, Gilead Sciences, Inc., effective July 29, 2026 (SPL set c0978fa8-53ff-4ca2-82a7-567fd3e958ca), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,249 reports list remdesivir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,287 are coded as a death and 4,512 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (4,479, against a median of 536 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 16 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Remdesivir: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions