Ribavirin
According to the FDA label: Ribavirin for inhalation solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with ribavirin for inhalation solution, USP.
63,874 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Ribavirin 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 9,552 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 8,364 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 5,357 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 4,642 reports
Vomiting 3,808 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 3,745 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 3,581 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 3,442 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 3,329 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
Drug Ineffective 3,211 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 →
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
| Sex | Reports |
|---|---|
| Male | 33,384 |
| Female | 24,724 |
| Unknown | 866 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 369 |
| 18-34 | 2,152 |
| 35-49 | 8,419 |
| 50-64 | 22,205 |
| 65-74 | 4,639 |
| 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 Ribavirin. 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
| Outcome | Reports |
|---|---|
| Other Serious | 26,751 |
| Non-Serious | 25,965 |
| Hospitalization | 14,132 |
| Death | 3,397 |
| Life-Threatening | 1,502 |
| Disability | 692 |
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 Ribavirin. 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
| Year | Reports |
|---|---|
| 2003 | 5 |
| 2004 | 392 |
| 2005 | 621 |
| 2006 | 685 |
| 2007 | 920 |
| 2008 | 1,230 |
| 2009 | 1,195 |
| 2010 | 963 |
| 2011 | 1,403 |
| 2012 | 13,702 |
| 2013 | 9,239 |
| 2014 | 4,844 |
| 2015 | 13,685 |
| 2016 | 5,553 |
| 2017 | 2,869 |
| 2018 | 2,638 |
| 2019 | 1,485 |
| 2020 | 815 |
| 2021 | 504 |
| 2022 | 417 |
| 2023 | 236 |
| 2024 | 266 |
| 2025 | 175 |
| 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.
Medications commonly reported with Ribavirin
In FDA adverse event reports that mention Ribavirin, these medications appeared most often in the same report.
- Peginterferon Alfa-2a (28,299 reports)
- Sofosbuvir (8,068 reports)
- Omeprazole (1,529 reports)
- Ledipasvir And Sofosbuvir (1,187 reports)
- Tacrolimus (1,152 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
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