82/100 · Critical
Manufactured by Actelion Pharmaceuticals US, Inc.
Macitentan Adverse Events: High Serious Reaction Rate and Pulmonary Arterial Hypertension Concerns
188,657 FDA adverse event reports analyzed
Last updated: 2026-05-12
MACITENTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actelion Pharmaceuticals US, Inc.. Based on analysis of 188,657 FDA adverse event reports, MACITENTAN has a safety score of 82 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 MACITENTAN include DYSPNOEA, HEADACHE, DEATH, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MACITENTAN.
Macitentan has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 188,657 adverse event reports for this medication, which is primarily manufactured by Actelion Pharmaceuticals Us, Inc..
The most commonly reported adverse events include Dyspnoea, Headache, Death. Of classified reports, 71.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Macitentan reports a high percentage of serious adverse events, particularly respiratory issues.
Pulmonary arterial hypertension and fluid retention are among the most frequently reported conditions. The drug is associated with a significant number of hospitalizations and deaths.
Patients taking Macitentan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Macitentan is contraindicated in patients with severe hepatic impairment and should be used with caution in patients with renal impairment. It may interact with other drugs that affect blood pressure, such as diuretics. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Macitentan received a safety concern score of 82/100 (high concern). This is based on a 71.6% serious event ratio across 66,727 classified reports. The score accounts for 188,657 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: 48,658, Male: 16,008, Unknown: 8. The most frequently reported age groups are age 69 (1,274 reports), age 70 (1,243 reports), age 65 (1,222 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 66,727 classified reports for MACITENTAN:
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.
Macitentan is contraindicated in patients with severe hepatic impairment and should be used with caution in patients with renal impairment. It may interact with other drugs that affect blood pressure, such as diuretics.
If you are taking Macitentan, here are important things to know. The most commonly reported side effects include dyspnoea, headache, death, diarrhoea, nausea. 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. Regular follow-up appointments are essential to monitor for potential side effects. 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 Macitentan due to its high risk of serious adverse events. Healthcare providers should regularly monitor patients for signs of pulmonary arterial hypertension and fluid retention.
The FDA has received approximately 188,657 adverse event reports associated with Macitentan. 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 Macitentan include Dyspnoea, Headache, Death, Diarrhoea, Nausea. By volume, the top reported reactions are: Dyspnoea (11,679 reports), Headache (8,041 reports), Death (7,277 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Macitentan.
Out of 66,727 classified reports, 47,757 (71.6%) were classified as serious and 18,970 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 Macitentan break down by patient sex as follows: Female: 48,658, Male: 16,008, Unknown: 8. 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 Macitentan adverse events are: age 69: 1,274 reports, age 70: 1,243 reports, age 65: 1,222 reports, age 73: 1,191 reports, age 75: 1,188 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 Macitentan 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 Macitentan include: Fatigue, Pneumonia, Dizziness, Hospitalisation, Fluid Retention. 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 Macitentan 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.
Macitentan has a safety concern score of 82 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. Macitentan reports a high percentage of serious adverse events, particularly respiratory issues.
Key safety signals identified in Macitentan's adverse event data include: Pulmonary arterial hypertension. Fluid retention. High serious reaction rate (71.6%). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Macitentan is contraindicated in patients with severe hepatic impairment and should be used with caution in patients with renal impairment. It may interact with other drugs that affect blood pressure, such as diuretics. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Macitentan.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular follow-up appointments are essential to monitor for potential side effects.
Macitentan has 188,657 adverse event reports on file with the FDA. Pulmonary arterial hypertension and fluid retention are among the most frequently reported conditions. The volume of reports for Macitentan reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Macitentan due to its high risk of serious adverse events. Healthcare providers should regularly monitor patients for signs of pulmonary arterial hypertension and fluid retention. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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