78/100 · Elevated
Manufactured by Bausch Health US, LLC
Ribavirin Adverse Events: High Incidence of Serious Hematological and Gastrointestinal Reactions
157,291 FDA adverse event reports analyzed
Last updated: 2026-05-12
RIBAVIRIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US, LLC. Based on analysis of 157,291 FDA adverse event reports, RIBAVIRIN has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for RIBAVIRIN include FATIGUE, ANAEMIA, NAUSEA, RASH, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RIBAVIRIN.
Ribavirin has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 157,291 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us, Llc.
The most commonly reported adverse events include Fatigue, Anaemia, Nausea. Of classified reports, 59.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ribavirin is associated with a high incidence of serious hematological reactions such as anemia and leukopenia.
Gastrointestinal symptoms like nausea, vomiting, and diarrhea are commonly reported. The drug is linked to a range of serious reactions including hepatic failure and renal impairment.
Patients taking Ribavirin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ribavirin can cause significant hematological and renal side effects, and caution is advised when used with other drugs that may affect these systems. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ribavirin received a safety concern score of 78/100 (high concern). This is based on a 59.3% serious event ratio across 63,882 classified reports. The score accounts for 157,291 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 33,394, Female: 24,734, Unknown: 866. The most frequently reported age groups are age 57 (1,711 reports), age 54 (1,636 reports), age 59 (1,614 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,882 classified reports for RIBAVIRIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Ribavirin can cause significant hematological and renal side effects, and caution is advised when used with other drugs that may affect these systems.
If you are taking Ribavirin, here are important things to know. The most commonly reported side effects include fatigue, anaemia, nausea, rash, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor blood counts and liver function regularly during treatment with Ribavirin. Be cautious when combining Ribavirin with other drugs that may affect hematopoiesis or renal function. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on monitoring for serious adverse events, particularly hematological and renal issues.
The FDA has received approximately 157,291 adverse event reports associated with Ribavirin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Ribavirin include Fatigue, Anaemia, Nausea, Rash, Headache. By volume, the top reported reactions are: Fatigue (9,551 reports), Anaemia (8,365 reports), Nausea (7,421 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ribavirin.
Out of 63,882 classified reports, 37,913 (59.3%) were classified as serious and 25,969 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Ribavirin break down by patient sex as follows: Male: 33,394, Female: 24,734, Unknown: 866. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Ribavirin adverse events are: age 57: 1,711 reports, age 54: 1,636 reports, age 59: 1,614 reports, age 55: 1,612 reports, age 56: 1,605 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Ribavirin adverse event reports is Bausch Health Us, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Ribavirin include: Pruritus, Vomiting, Diarrhoea, Asthenia, Pyrexia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Ribavirin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Ribavirin has a safety concern score of 78 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Ribavirin is associated with a high incidence of serious hematological reactions such as anemia and leukopenia.
Key safety signals identified in Ribavirin's adverse event data include: High frequency of serious hematological reactions (anemia, leukopenia, thrombocytopenia). Common gastrointestinal symptoms (nausea, vomiting, diarrhea). Reports of serious hepatic and renal reactions. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ribavirin can cause significant hematological and renal side effects, and caution is advised when used with other drugs that may affect these systems. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ribavirin.
Monitor blood counts and liver function regularly during treatment with Ribavirin. Be cautious when combining Ribavirin with other drugs that may affect hematopoiesis or renal function.
Ribavirin has 157,291 adverse event reports on file with the FDA. Gastrointestinal symptoms like nausea, vomiting, and diarrhea are commonly reported. The volume of reports for Ribavirin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring for serious adverse events, particularly hematological and renal issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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