85/100 · Critical
Manufactured by Bayer HealthCare Pharmaceuticals Inc.
High Safety Concerns with RIOCIGUAT, Particularly for Serious Adverse Events
100,865 FDA adverse event reports analyzed
Last updated: 2026-05-12
RIOCIGUAT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare Pharmaceuticals Inc.. Based on analysis of 100,865 FDA adverse event reports, RIOCIGUAT has a safety score of 85 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 RIOCIGUAT include DYSPNOEA, DEATH, HEADACHE, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RIOCIGUAT.
Riociguat has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 100,865 adverse event reports for this medication, which is primarily manufactured by Bayer Healthcare Pharmaceuticals Inc..
The most commonly reported adverse events include Dyspnoea, Death, Headache. Of classified reports, 77.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Riociguat is associated with a high number of serious adverse events, including death and hospitalization.
The most common reactions include dyspnea, headache, and nausea, indicating potential respiratory and gastrointestinal side effects. There is a significant risk of fluid retention and peripheral swelling, which could be life-threatening in severe cases.
Patients taking Riociguat should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Riociguat is contraindicated in patients with severe liver or kidney impairment. It should be used with caution in patients with a history of cardiovascular disease, as it may exacerbate symptoms. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Riociguat received a safety concern score of 85/100 (high concern). This is based on a 77.1% serious event ratio across 31,382 classified reports. The score accounts for 100,865 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: Female: 22,327, Male: 8,346, Unknown: 9. The most frequently reported age groups are age 71 (693 reports), age 74 (677 reports), age 72 (662 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,382 classified reports for RIOCIGUAT:
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.
Riociguat is contraindicated in patients with severe liver or kidney impairment. It should be used with caution in patients with a history of cardiovascular disease, as it may exacerbate symptoms.
If you are taking Riociguat, here are important things to know. The most commonly reported side effects include dyspnoea, death, headache, nausea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow all dosing instructions carefully and do not alter the dose without consulting a healthcare professional. 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.
The FDA has issued a black box warning for riociguat due to the high risk of serious adverse events. Healthcare providers should closely monitor patients for signs of respiratory and cardiovascular issues.
The FDA has received approximately 100,865 adverse event reports associated with Riociguat. 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 Riociguat include Dyspnoea, Death, Headache, Nausea, Diarrhoea. By volume, the top reported reactions are: Dyspnoea (5,572 reports), Death (5,347 reports), Headache (4,397 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Riociguat.
Out of 31,382 classified reports, 24,201 (77.1%) were classified as serious and 7,181 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 Riociguat break down by patient sex as follows: Female: 22,327, Male: 8,346, Unknown: 9. 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 Riociguat adverse events are: age 71: 693 reports, age 74: 677 reports, age 72: 662 reports, age 69: 629 reports, age 77: 621 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 Riociguat adverse event reports is Bayer Healthcare Pharmaceuticals Inc.. 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 Riociguat include: Dizziness, Hypotension, Fatigue, Hospitalisation, Vomiting. 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 Riociguat 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.
Riociguat has a safety concern score of 85 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. Riociguat is associated with a high number of serious adverse events, including death and hospitalization.
Key safety signals identified in Riociguat's adverse event data include: High percentage of serious adverse events (77.1%). Multiple reports of respiratory issues such as pneumonia and pulmonary arterial hypertension. Significant number of cardiovascular events including chest pain and heart failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Riociguat is contraindicated in patients with severe liver or kidney impairment. It should be used with caution in patients with a history of cardiovascular disease, as it may exacerbate symptoms. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Riociguat.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow all dosing instructions carefully and do not alter the dose without consulting a healthcare professional.
Riociguat has 100,865 adverse event reports on file with the FDA. The most common reactions include dyspnea, headache, and nausea, indicating potential respiratory and gastrointestinal side effects. The volume of reports for Riociguat reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued a black box warning for riociguat due to the high risk of serious adverse events. Healthcare providers should closely monitor patients for signs of respiratory and cardiovascular issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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