78/100 · Elevated
Manufactured by Gilead Sciences, Inc.
Ambrisentan Adverse Events: High Serious Event Rate and Pulmonary Hypertension Concerns
240,584 FDA adverse event reports analyzed
Last updated: 2026-05-12
AMBRISENTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc.. Based on analysis of 240,584 FDA adverse event reports, AMBRISENTAN 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 AMBRISENTAN include DYSPNOEA, DEATH, HEADACHE, PNEUMONIA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMBRISENTAN.
Ambrisentan 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 240,584 adverse event reports for this medication, which is primarily manufactured by Gilead Sciences, Inc..
The most commonly reported adverse events include Dyspnoea, Death, Headache. Of classified reports, 64.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ambrisentan reports a high serious event rate, particularly for respiratory and cardiovascular issues.
Pulmonary arterial hypertension and fluid retention are among the most frequently reported adverse reactions. The majority of adverse events are related to respiratory and cardiovascular systems, indicating a significant safety concern.
Patients taking Ambrisentan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ambrisentan 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 ACE inhibitors and diuretics. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ambrisentan received a safety concern score of 78/100 (high concern). This is based on a 64.8% serious event ratio across 122,607 classified reports. The score accounts for 240,584 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: 91,271, Male: 29,252, Unknown: 172. The most frequently reported age groups are age 70 (2,350 reports), age 64 (2,256 reports), age 66 (2,236 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 122,607 classified reports for AMBRISENTAN:
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.
Ambrisentan 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 ACE inhibitors and diuretics.
If you are taking Ambrisentan, here are important things to know. The most commonly reported side effects include dyspnoea, death, headache, pneumonia, 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 symptoms of respiratory distress or cardiovascular issues to their healthcare provider immediately. Avoid driving or operating heavy machinery if experiencing dizziness or fatigue. 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 ambrisentan due to the risk of pulmonary arterial hypertension and other serious cardiovascular events. Regular monitoring of blood pressure and pulmonary function is recommended.
The FDA has received approximately 240,584 adverse event reports associated with Ambrisentan. 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 Ambrisentan include Dyspnoea, Death, Headache, Pneumonia, Diarrhoea. By volume, the top reported reactions are: Dyspnoea (18,953 reports), Death (11,263 reports), Headache (10,594 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ambrisentan.
Out of 122,607 classified reports, 79,490 (64.8%) were classified as serious and 43,117 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 Ambrisentan break down by patient sex as follows: Female: 91,271, Male: 29,252, Unknown: 172. 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 Ambrisentan adverse events are: age 70: 2,350 reports, age 64: 2,256 reports, age 66: 2,236 reports, age 69: 2,213 reports, age 65: 2,192 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 Ambrisentan adverse event reports is Gilead Sciences, 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 Ambrisentan include: Fatigue, Dizziness, Nausea, Fluid Retention, Malaise. 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 Ambrisentan 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.
Ambrisentan 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. Ambrisentan reports a high serious event rate, particularly for respiratory and cardiovascular issues.
Key safety signals identified in Ambrisentan's adverse event data include: High rate of serious events (64.8%). Frequent reports of pulmonary arterial hypertension. Common occurrence of fluid retention and dyspnea. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ambrisentan 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 ACE inhibitors and diuretics. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ambrisentan.
Patients should report any symptoms of respiratory distress or cardiovascular issues to their healthcare provider immediately. Avoid driving or operating heavy machinery if experiencing dizziness or fatigue.
Ambrisentan has 240,584 adverse event reports on file with the FDA. Pulmonary arterial hypertension and fluid retention are among the most frequently reported adverse reactions. The volume of reports for Ambrisentan reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued a black box warning for ambrisentan due to the risk of pulmonary arterial hypertension and other serious cardiovascular events. Regular monitoring of blood pressure and pulmonary function is recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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