78/100 · Elevated
Manufactured by Amneal Pharmaceuticals NY LLC
CABERGOLINE Adverse Events: High Serious Reaction Rate and Diverse Safety Profile
10,212 FDA adverse event reports analyzed
Last updated: 2026-05-12
CABERGOLINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 10,212 FDA adverse event reports, CABERGOLINE 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 CABERGOLINE include DRUG INEFFECTIVE, OFF LABEL USE, HEADACHE, FATIGUE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CABERGOLINE.
Cabergoline 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 10,212 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Headache. Of classified reports, 81.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (81.9%) indicates significant safety concerns.
Diverse range of reactions suggests potential for multiple side effects. Common reactions include headache, fatigue, and nausea, with some reports of serious cardiovascular and respiratory issues.
Patients taking Cabergoline should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. CABERGOLINE has warnings for drug interactions and misuse, including potential for increased blood pressure and respiratory issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cabergoline received a safety concern score of 78/100 (high concern). This is based on a 81.9% serious event ratio across 4,669 classified reports. The score accounts for 10,212 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: 2,447, Male: 1,693, Unknown: 32. The most frequently reported age groups are age 56 (115 reports), age 68 (99 reports), age 65 (79 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 4,669 classified reports for CABERGOLINE:
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.
CABERGOLINE has warnings for drug interactions and misuse, including potential for increased blood pressure and respiratory issues.
If you are taking Cabergoline, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, headache, fatigue, 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 serious side effects to their healthcare provider immediately. Follow prescribed dosing instructions and avoid misuse or overdose. 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 CABERGOLINE for serious adverse events, particularly in patients with pre-existing cardiovascular or respiratory conditions.
The FDA has received approximately 10,212 adverse event reports associated with Cabergoline. 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 Cabergoline include Drug Ineffective, Off Label Use, Headache, Fatigue, Nausea. By volume, the top reported reactions are: Drug Ineffective (390 reports), Off Label Use (351 reports), Headache (319 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cabergoline.
Out of 4,669 classified reports, 3,822 (81.9%) were classified as serious and 847 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 Cabergoline break down by patient sex as follows: Female: 2,447, Male: 1,693, Unknown: 32. 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 Cabergoline adverse events are: age 56: 115 reports, age 68: 99 reports, age 65: 79 reports, age 38: 74 reports, age 34: 72 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 Cabergoline adverse event reports is Amneal Pharmaceuticals Ny Llc. 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 Cabergoline include: Dizziness, Malaise, Pain, Diarrhoea, Condition Aggravated. 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 Cabergoline 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.
Cabergoline 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. High percentage of serious adverse events (81.9%) indicates significant safety concerns.
Key safety signals identified in Cabergoline's adverse event data include: High number of serious adverse events (3822 out of 4669, 81.9%). Multiple cardiovascular and respiratory issues reported, including hypertension, dyspnea, and pneumonia. Significant drug interactions and misuse reported, with 142 cases of drug interaction and 104 cases of overdose. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
CABERGOLINE has warnings for drug interactions and misuse, including potential for increased blood pressure and respiratory issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cabergoline.
Patients should report any serious side effects to their healthcare provider immediately. Follow prescribed dosing instructions and avoid misuse or overdose.
Cabergoline has 10,212 adverse event reports on file with the FDA. Diverse range of reactions suggests potential for multiple side effects. The volume of reports for Cabergoline reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors CABERGOLINE for serious adverse events, particularly in patients with pre-existing cardiovascular or respiratory conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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