Virazole

Name: VIRAZOLE () — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

63,912 adverse event reports submitted to the FDA (2003–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with Virazole in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.

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Fatigue 9,555 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
Anaemia 8,367 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →
Nausea 7,429 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →
Rash 5,362 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →
Headache 4,786 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Pruritus 4,643 reports
Itching of the skin.
Full definition in the glossary → See all drugs reporting this event →
Vomiting 3,806 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Diarrhoea 3,744 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →
Asthenia 3,612 reports
Physical weakness or lack of strength.
Full definition in the glossary →
Pyrexia 3,583 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →
White Blood Cell Count Decreased 3,444 reports
A blood test result showing a low level of white blood cells, which help fight infection.
Full definition in the glossary →
Insomnia 3,436 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →
Dyspnoea 3,328 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →
Decreased Appetite 3,271 reports
Reduced desire to eat.
Full definition in the glossary → See all drugs reporting this event →
Drug Ineffective 3,213 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →

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Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

View reporter sex data as a table

Virazole adverse event reports by reporter sex
Sex	Reports
Male	33,413
Female	24,733
Unknown	866

By Age Group

View age group data as a table

Virazole adverse event reports by reporter age group
Age group	Reports
0-17	373
18-34	2,160
35-49	8,424
50-64	22,216
65-74	4,640
75+	806

This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.

Reported Outcomes

Outcomes recorded in FAERS reports that included Virazole. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

View outcome data as a table

Virazole adverse event reports by reported outcome
Outcome	Reports
Other Serious	26,772
Non-Serious	25,971
Hospitalization	14,139
Death	3,401
Life-Threatening	1,506
Disability	693

Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.

Report Volume Over Time

Number of FAERS reports received per quarter for Virazole. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.

View report trend as a table

Virazole adverse event reports by year
Year	Reports
2003	5
2004	395
2005	623
2006	687
2007	921
2008	1,232
2009	1,196
2010	966
2011	1,404
2012	13,703
2013	9,244
2014	4,844
2015	13,690
2016	5,558
2017	2,872
2018	2,639
2019	1,486
2020	816
2021	504
2022	417
2023	236
2024	266
2025	176
2026 (partial)	32

The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →

Data last updated: June 2026