Drug · FAERS side-effect profile with label screen
Remdesivir side effects: what 13,249 FDA adverse event reports show
Drug class
SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor
FDA label (Established Pharmacologic Class)
Brand names
Veklury
openFDA label
Who reports
13,249 reports · 84% serious · 3,287 with death outcome · 40% female
openFDA FAERS counts, all years, deduplication not applied
Used for
VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are : Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
FDA label, Indications and Usage
What it is
VEKLURY contains remdesivir, a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 1Likely indication confounding 3Reporting / coding artifact 1Not in label — unassessed 35
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 958 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Clinical trial participant | 21 | 910.5 531.7–1,559.1ROR 911.9 · χ² 11,481 / p <1e-300 | 377.2 EB05 260.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=17 · 100% clinician | no trial data cached |
| Covid-19 treatment | 21 | 697.4 417.0–1,166.2ROR 698.5 · χ² 9,618 / p <1e-300 | 335.0 EB05 231.1 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=19 · 100% clinician | no trial data cached |
| Sars-cov-2 viraemia | 12 | 407.2 215.8–768.4ROR 407.5 · χ² 3,541 / p <1e-300 | 213.7 EB05 130.3 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Sars-cov-2 rna increased | 11 | 301.2 158.0–574.2ROR 301.5 · χ² 2,513 / p <1e-300 | 176.1 EB05 104.9 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=11 | no trial data cached |
| Rhinocerebral mucormycosis | 39 | 203.6 145.9–284.1ROR 204.2 · χ² 6,777 / p <1e-300 | 165.7 EB05 126.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=39 · 100% clinician | no trial data cached |
| Cryptococcal meningoencephalitis | 13 | 174.9 98.6–310.2ROR 175.1 · χ² 1,868 / p <1e-300 | 128.2 EB05 79.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Cutaneous mucormycosis | 15 | 145.4 85.7–246.8ROR 145.6 · χ² 1,838 / p <1e-300 | 114.2 EB05 73.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Bronchopleural fistula | 29 | 131.2 89.9–191.6ROR 131.5 · χ² 3,337 / p <1e-300 | 112.3 EB05 82.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 15% (drug 40%) | no trial data cached |
| Pulmonary mucormycosis | 36 | 118.8 84.7–166.6ROR 119.1 · χ² 3,799 / p <1e-300 | 104.5 EB05 78.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=36 · 100% clinician | no trial data cached |
| Humoral immune defect | 16 | 71.1 43.1–117.4ROR 71.2 · χ² 992 / p 4e-218 | 63.2 EB05 41.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Covid-19 pneumonia | 502 | 69.8 63.9–76.2ROR 72.5 · χ² 32,522 / p <1e-300 | 66.7 EB05 61.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 46.0 · 92% clinician | no trial data cached |
| Herpes simplex reactivation | 15 | 66.0 39.4–110.5ROR 66.0 · χ² 859 / p 3e-189 | 58.8 EB05 37.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Disseminated aspergillosis | 18 | 63.1 39.4–101.1ROR 63.2 · χ² 999 / p 1e-219 | 57.2 EB05 38.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Pneumomediastinum | 68 | 62.7 49.2–79.8ROR 63.0 · χ² 3,910 / p <1e-300 | 59.4 EB05 48.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=67 · 97% clinician | no trial data cached |
| Pulmonary necrosis | 12 | 57.8 32.5–102.8ROR 57.9 · χ² 592 / p 4e-131 | 51.5 EB05 31.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Diverticulitis intestinal perforated | 11 | 55.0 30.2–100.4ROR 55.1 · χ² 513 / p 8e-114 | 49.0 EB05 29.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Subcutaneous emphysema | 33 | 55.0 38.9–77.8ROR 55.1 · χ² 1,637 / p <1e-300 | 51.6 EB05 38.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=33 · 100% clinician | no trial data cached |
| Mucormycosis | 84 | 53.4 43.0–66.3ROR 53.7 · χ² 4,123 / p <1e-300 | 51.1 EB05 42.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=84 · 100% clinician | no trial data cached |
| Pneumonia cryptococcal | 30 | 52.5 36.5–75.5ROR 52.6 · χ² 1,417 / p <1e-300 | 49.3 EB05 36.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | no trial data cached |
| Disseminated mucormycosis | 12 | 50.5 28.4–89.7ROR 50.5 · χ² 517 / p 1e-114 | 45.6 EB05 27.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Disseminated cryptococcosis | 22 | 48.8 31.9–74.5ROR 48.9 · χ² 953 / p 2e-209 | 45.6 EB05 31.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Myopathy toxic | 17 | 46.4 28.6–75.1ROR 46.4 · χ² 690 / p 3e-152 | 43.1 EB05 28.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Bronchopulmonary aspergillosis | 204 | 42.9 37.4–49.3ROR 43.6 · χ² 8,091 / p <1e-300 | 41.6 EB05 37.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 · 97% clinician | no trial data cached |
| Superinfection bacterial | 20 | 41.0 26.3–63.9ROR 41.1 · χ² 722 / p 2e-159 | 38.6 EB05 26.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Ischaemic hepatitis | 32 | 38.3 27.0–54.4ROR 38.4 · χ² 1,099 / p 2e-241 | 36.7 EB05 27.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Infection reactivation | 27 | 38.2 26.1–55.9ROR 38.3 · χ² 919 / p 4e-202 | 36.4 EB05 26.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 15% (drug 40%) · 100% clinician | no trial data cached |
| Cytokine storm | 16 | 38.1 23.2–62.5ROR 38.1 · χ² 528 / p 4e-117 | 35.7 EB05 23.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Post-acute covid-19 syndrome | 28 | 36.7 25.2–53.3ROR 36.7 · χ² 915 / p 3e-201 | 35.1 EB05 25.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Infusion site extravasation | 136 | 35.4 29.9–41.9ROR 35.7 · χ² 4,408 / p <1e-300 | 34.4 EB05 29.9 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=34 · 98% clinician | no trial data cached |
| Recalled product | 37 | 34.4 24.8–47.6ROR 34.5 · χ² 1,141 / p 2e-250 | 33.1 EB05 25.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pulmonary cavitation | 18 | 33.6 21.1–53.7ROR 33.7 · χ² 527 / p 8e-117 | 32.0 EB05 21.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Pneumothorax spontaneous | 14 | 33.2 19.6–56.4ROR 33.2 · χ² 397 / p 1e-88 | 31.3 EB05 19.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cryptococcosis | 33 | 33.1 23.4–46.7ROR 33.2 · χ² 974 / p 4e-214 | 31.9 EB05 23.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 12% (drug 40%) · 100% clinician | no trial data cached |
| Diffuse alveolar damage | 23 | 32.2 21.3–48.6ROR 32.2 · χ² 650 / p 9e-144 | 30.8 EB05 21.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 14% (drug 40%) · 100% clinician | no trial data cached |
| Pneumonia staphylococcal | 39 | 31.9 23.3–43.8ROR 32.0 · χ² 1,115 / p 8e-245 | 30.9 EB05 23.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=39 · 97% clinician | no trial data cached |
| Liver function test increased | 421 | 31.9 29.0–35.0ROR 32.9 · χ² 12,314 / p <1e-300 | 31.2 EB05 28.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 · 98% clinician | no trial data cached |
| Vaccination failure | 32 | 30.9 21.8–43.8ROR 31.0 · χ² 878 / p 2e-193 | 29.8 EB05 22.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=32 · 100% clinician | no trial data cached |
| Stenotrophomonas infection | 25 | 30.1 20.3–44.7ROR 30.1 · χ² 661 / p 4e-146 | 29.0 EB05 20.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=25 | no trial data cached |
| Pulmonary nocardiosis | 15 | 29.6 17.7–49.3ROR 29.6 · χ² 379 / p 1e-84 | 28.1 EB05 18.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Fungaemia | 28 | 28.8 19.8–41.9ROR 28.9 · χ² 711 / p 5e-157 | 27.8 EB05 20.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 2,239 | 4.1 3.9–4.2ROR 4.7 · χ² 5,438 / p <1e-300 | 4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 98% clinician | no trial data cached |
| Alanine aminotransferase increased | 935 | 24.4 23.0–26.0ROR 26.2 · χ² 20,742 / p <1e-300 | 24.1 EB05 22.8 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.9 · 99% clinician | no trial data cached |
| Covid-19 | 914 | 8.2 7.7–8.7ROR 8.7 · χ² 5,802 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.6 · 91% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 766 | 0.9 0.9–1.0ROR 0.9 · χ² 5 / p 0.010 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.8 · 95% clinician | no trial data cached |
| Death | 759 | 1.4 1.3–1.5ROR 1.4 · χ² 88 / p 3e-21 | 1.4 EB05 1.3 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| Bradycardia (slow heart rate) | 652 | 19.7 18.2–21.2ROR 20.6 · χ² 11,410 / p <1e-300 | 19.4 EB05 18.2 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.3 · 99% clinician | no trial data cached |
| Aspartate aminotransferase increased | 629 | 19.0 17.6–20.5ROR 19.9 · χ² 10,584 / p <1e-300 | 18.7 EB05 17.5 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.1 · 99% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 626 | 6.5 6.0–7.0ROR 6.8 · χ² 2,934 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 97% clinician | no trial data cached |
| Respiratory failure | 536 | 11.7 10.8–12.7ROR 12.2 · χ² 5,215 / p <1e-300 | 11.6 EB05 10.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 95% clinician | no trial data cached |
| Covid-19 pneumonia | 502 | 69.8 63.9–76.2ROR 72.5 · χ² 32,522 / p <1e-300 | 66.7 EB05 61.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 46.0 · 92% clinician | no trial data cached |
| Liver function test increased | 421 | 31.9 29.0–35.0ROR 32.9 · χ² 12,314 / p <1e-300 | 31.2 EB05 28.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 · 98% clinician | no trial data cached |
| Condition aggravated | 384 | 2.0 1.8–2.2ROR 2.0 · χ² 198 / p 3e-45 | 2.0 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.0 · 96% clinician | no trial data cached |
| Pneumonia (lung infection) | 330 | 1.6 1.5–1.8ROR 1.6 · χ² 78 / p 5e-19 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 1.1 · 95% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 327 | 9.3 8.4–10.4ROR 9.5 · χ² 2,417 / p <1e-300 | 9.2 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 · 100% clinician | no trial data cached |
| Blood creatinine increased | 323 | 7.8 7.0–8.7ROR 8.0 · χ² 1,920 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · 98% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Clinical trial participant — n=21, PRR 910.5
- Rhinocerebral mucormycosis — n=39, PRR 203.6
- Bronchopleural fistula — n=29, PRR 131.2
- Pulmonary mucormycosis — n=36, PRR 118.8
- Covid-19 pneumonia — n=502, PRR 69.8
- Pneumomediastinum — n=68, PRR 62.7
- Subcutaneous emphysema — n=33, PRR 55.0
- Mucormycosis — n=84, PRR 53.4
- Pneumonia cryptococcal — n=30, PRR 52.5
- Disseminated cryptococcosis — n=22, PRR 48.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Remdesivir?
In FDA FAERS, the most frequently co-reported reaction terms for Remdesivir are alanine aminotransferase increased, covid-19, bradycardia, aspartate aminotransferase increased, acute kidney injury, respiratory failure. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Remdesivir have an FDA boxed warning?
No. The FDA label retrieved for Remdesivir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Remdesivir causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID c0978fa8-53ff-4ca2-82a7-567fd3e958ca, effective 20260729; matched on
openfda.generic_name.exact:"REMDESIVIR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 998 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.