78/100 · Elevated
Manufactured by United Therapeutics Corporation
Tadalafil Adverse Events: High Serious Reaction Rate, Primarily Respiratory and Gastrointestinal Issues
207,750 FDA adverse event reports analyzed
Last updated: 2026-05-12
TADALAFIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by United Therapeutics Corporation. Based on analysis of 207,750 FDA adverse event reports, TADALAFIL 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 TADALAFIL include DYSPNOEA, HEADACHE, DIARRHOEA, NAUSEA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TADALAFIL.
Tadalafil 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 207,750 adverse event reports for this medication, which is primarily manufactured by United Therapeutics Corporation.
The most commonly reported adverse events include Dyspnoea, Headache, Diarrhoea. Of classified reports, 62.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are dyspnea, headache, and diarrhea, with a significant proportion of serious adverse events.
Respiratory and gastrointestinal issues are the leading causes of serious adverse events. Drug ineffectiveness and death are also reported, though less frequently.
Patients taking Tadalafil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tadalafil may interact with drugs that affect blood pressure, leading to hypotension. It is contraindicated with nitrates. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tadalafil received a safety concern score of 78/100 (high concern). This is based on a 62.7% serious event ratio across 96,530 classified reports. The score accounts for 207,750 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: 48,955, Male: 43,692, Unknown: 52. The most frequently reported age groups are age 65 (1,820 reports), age 60 (1,802 reports), age 70 (1,738 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 96,530 classified reports for TADALAFIL:
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.
Tadalafil may interact with drugs that affect blood pressure, leading to hypotension. It is contraindicated with nitrates.
If you are taking Tadalafil, here are important things to know. The most commonly reported side effects include dyspnoea, headache, diarrhoea, nausea, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for respiratory and gastrointestinal symptoms, especially in elderly patients. Follow prescribed dosing instructions and report any serious adverse events immediately. 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 serious respiratory and cardiovascular events.
The FDA has received approximately 207,750 adverse event reports associated with Tadalafil. 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 Tadalafil include Dyspnoea, Headache, Diarrhoea, Nausea, Death. By volume, the top reported reactions are: Dyspnoea (11,665 reports), Headache (10,690 reports), Diarrhoea (7,799 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tadalafil.
Out of 96,530 classified reports, 60,485 (62.7%) were classified as serious and 36,045 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 Tadalafil break down by patient sex as follows: Female: 48,955, Male: 43,692, Unknown: 52. 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 Tadalafil adverse events are: age 65: 1,820 reports, age 60: 1,802 reports, age 70: 1,738 reports, age 66: 1,686 reports, age 64: 1,656 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 Tadalafil adverse event reports is United Therapeutics Corporation. 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 Tadalafil include: Fatigue, Drug Ineffective, Dizziness, Pneumonia, Cough. 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 Tadalafil 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.
Tadalafil 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. The most common reactions are dyspnea, headache, and diarrhea, with a significant proportion of serious adverse events.
Key safety signals identified in Tadalafil's adverse event data include: High rate of serious adverse events (62.7%). Common reactions include dyspnea and headache. Significant number of reports of pneumonia and pulmonary arterial hypertension. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tadalafil may interact with drugs that affect blood pressure, leading to hypotension. It is contraindicated with nitrates. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tadalafil.
Monitor for respiratory and gastrointestinal symptoms, especially in elderly patients. Follow prescribed dosing instructions and report any serious adverse events immediately.
Tadalafil has 207,750 adverse event reports on file with the FDA. Respiratory and gastrointestinal issues are the leading causes of serious adverse events. The volume of reports for Tadalafil reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious respiratory and cardiovascular events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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