85/100 · Critical
Manufactured by Actelion Pharmaceuticals US, Inc.
High Serious Event Rate for BOSSENTAN
98,401 FDA adverse event reports analyzed
Last updated: 2026-05-12
BOSENTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actelion Pharmaceuticals US, Inc.. Based on analysis of 98,401 FDA adverse event reports, BOSENTAN 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 BOSENTAN include DEATH, DYSPNOEA, PNEUMONIA, PULMONARY ARTERIAL HYPERTENSION, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BOSENTAN.
Bosentan 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 98,401 adverse event reports for this medication, which is primarily manufactured by Actelion Pharmaceuticals Us, Inc..
The most commonly reported adverse events include Death, Dyspnoea, Pneumonia. Of classified reports, 84.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events reported are serious, with death being the most common reaction.
Pulmonary arterial hypertension and cardiac failure are significant safety concerns. Liver function abnormalities and increased liver enzymes are frequently reported.
Patients taking Bosentan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bosentan is contraindicated in patients with severe liver impairment and should be used with caution in patients with pre-existing liver disease. It may interact with drugs that affect liver enzymes. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Bosentan received a safety concern score of 85/100 (high concern). This is based on a 84.8% serious event ratio across 49,560 classified reports. The score accounts for 98,401 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: 27,925, Male: 10,115, Unknown: 170. The most frequently reported age groups are age 70 (783 reports), age 71 (737 reports), age 74 (735 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 49,560 classified reports for BOSENTAN:
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.
Bosentan is contraindicated in patients with severe liver impairment and should be used with caution in patients with pre-existing liver disease. It may interact with drugs that affect liver enzymes.
If you are taking Bosentan, here are important things to know. The most commonly reported side effects include death, dyspnoea, pneumonia, pulmonary arterial hypertension, fatigue. 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 symptoms of liver dysfunction or pulmonary hypertension to their healthcare provider immediately. Regular liver function tests are recommended for patients taking BOSSENTAN. 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 closely monitors BOSSENTAN due to its high serious event rate. Healthcare providers should regularly monitor patients for signs of liver dysfunction and pulmonary hypertension.
The FDA has received approximately 98,401 adverse event reports associated with Bosentan. 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 Bosentan include Death, Dyspnoea, Pneumonia, Pulmonary Arterial Hypertension, Fatigue. By volume, the top reported reactions are: Death (9,291 reports), Dyspnoea (5,974 reports), Pneumonia (2,684 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Bosentan.
Out of 49,560 classified reports, 42,031 (84.8%) were classified as serious and 7,529 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 Bosentan break down by patient sex as follows: Female: 27,925, Male: 10,115, Unknown: 170. 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 Bosentan adverse events are: age 70: 783 reports, age 71: 737 reports, age 74: 735 reports, age 67: 732 reports, age 76: 732 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 Bosentan adverse event reports is Actelion Pharmaceuticals Us, 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 Bosentan include: Headache, Nausea, Diarrhoea, Condition Aggravated, Dizziness. 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 Bosentan 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.
Bosentan 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. The majority of adverse events reported are serious, with death being the most common reaction.
Key safety signals identified in Bosentan's adverse event data include: High incidence of death and serious adverse events.. Significant reports of pulmonary hypertension and cardiac failure.. Frequent liver function abnormalities and increased liver enzymes.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Bosentan is contraindicated in patients with severe liver impairment and should be used with caution in patients with pre-existing liver disease. It may interact with drugs that affect liver enzymes. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bosentan.
Patients should report any symptoms of liver dysfunction or pulmonary hypertension to their healthcare provider immediately. Regular liver function tests are recommended for patients taking BOSSENTAN.
Bosentan has 98,401 adverse event reports on file with the FDA. Pulmonary arterial hypertension and cardiac failure are significant safety concerns. The volume of reports for Bosentan reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors BOSSENTAN due to its high serious event rate. Healthcare providers should regularly monitor patients for signs of liver dysfunction and pulmonary hypertension. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Actelion Pharmaceuticals US, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with BOSENTAN:
Drugs related to BOSENTAN based on therapeutic use, drug class, or shared indications: