Pharmacologic class (EPC) · 2 drug pages

SARS-CoV-2 nucleotide analog RNA polymerase inhibitor: adverse event reports filed with FDA

10,450 reports list a drug in this class as a suspect or interacting product, 2018–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

10,450
reports across the class: 0.1% of all reports; 148
reports, 12 months to June 2026: 506 in the 12 months before; 81.1%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

SARS-CoV-2 nucleotide analog RNA polymerase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 10,450 adverse event reports received by FDA, 0.1% of the database, from December 2018 to June 2026.

148 reports arrived in the 12 months to June 2026, down 71% from 506 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 81.1% of the class's reports are marked serious, 25.9% record death among the outcomes and 25.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (10.8%), alanine aminotransferase increased (9.5%) and death (7.7%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Remdesivir	generic	7,668	88	79.6%	Off label use
VekluryRemdesivir	brand	2,782	60	85.2%	Death

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Off label useused for a purpose or in a way not on the label10.8%1,125
Alanine aminotransferase increasedraised liver enzyme (ALT)9.5%993
Deaththe patient died; cause not stated by this term7.7%802
Aspartate aminotransferase increasedraised liver enzyme (AST)6.3%662
Bradycardiaslow heart rate6.1%635
Covid-19COVID-19 infection5.6%588
Acute kidney injurysudden loss of kidney function5.6%586
Drug ineffectivethe medicine did not work as expected4.9%509
Liver function test increased4%422
Respiratory failurethe lungs could not supply enough oxygen3.6%381
Blood creatinine increasedraised creatinine, a kidney test3.2%337
Condition aggravatedthe condition being treated got worse3%313
COVID-19 pneumonia2.7%287
Renal impairmentreduced kidney function2.5%262
Hypotensionlow blood pressure2.3%240
Cardiac arrestthe heart stopped2.2%232
Hepatic enzyme increasedraised liver enzymes2.1%218
Pneumonialung infection2%212
Drug ineffective for unapproved indication2%211
Therapy cessation1.9%199
Hypoxialow oxygen1.9%194
Septic shockshock arising from infection1.8%185
Multiple organ dysfunction syndromeseveral organs failing1.7%178
Dyspnoeashortness of breath1.7%177
Maternal exposure during pregnancythe mother took the medicine during pregnancy1.7%173

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death25.9%2,702

Life-threatening8.6%898

Hospitalisation (initial or prolonged)25.2%2,637

Disability1.2%127

Congenital anomaly0.1%15

Other serious57.7%6,029

Not serious18.9%1,972

Patient age

Under 20.7%75

2 to 111%102

12 to 171%109

18 to 4413.9%1,453

45 to 6427%2,823

65 to 7419.5%2,040

75 and over23.8%2,488

Age not given13%1,360

Who reported

Physician22.4%2,341

Pharmacist46.9%4,900

Other health professional22.4%2,345

Lawyer0.1%12

Consumer or non-health professional5.9%621

Not given2.2%231

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about SARS-CoV-2 nucleotide analog RNA polymerase inhibitor reports

Which drugs are in the SARS-CoV-2 nucleotide analog RNA polymerase inhibitor class on this site?

Remdesivir and Veklury. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

10,450 reports through June 2026, 148 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

off label use (10.8%), alanine aminotransferase increased (9.5%), death (7.7%), aspartate aminotransferase increased (6.3%) and bradycardia (6.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.