65/100 · Elevated
Manufactured by SOLCO HEALTHCARE US, LLC
Moderate Safety Concerns with Ropinirole Hydrochloride
7,752 FDA adverse event reports analyzed
Last updated: 2026-05-12
ROPINIROLE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by SOLCO HEALTHCARE US, LLC. Based on analysis of 7,752 FDA adverse event reports, ROPINIROLE HYDROCHLORIDE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ROPINIROLE HYDROCHLORIDE include NAUSEA, FATIGUE, DRUG INEFFECTIVE, FALL, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROPINIROLE HYDROCHLORIDE.
Ropinirole Hydrochloride has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 7,752 adverse event reports for this medication, which is primarily manufactured by Solco Healthcare Us, Llc.
The most commonly reported adverse events include Nausea, Fatigue, Drug Ineffective. Of classified reports, 60.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and fatigue are the most common side effects.
Serious adverse events, such as falls and pneumonia, are reported. Drug interactions and misuse are significant safety signals. Weight changes and respiratory issues are notable concerns.
Patients taking Ropinirole Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and misuse are common, and patients should be advised to avoid driving or operating heavy machinery due to potential dizziness and fatigue. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ropinirole Hydrochloride received a safety concern score of 65/100 (elevated concern). This is based on a 60.1% serious event ratio across 3,286 classified reports. The score accounts for 7,752 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 2,007, Male: 959, Unknown: 2. The most frequently reported age groups are age 76 (135 reports), age 77 (61 reports), age 69 (60 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 3,286 classified reports for ROPINIROLE HYDROCHLORIDE:
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.
Drug interactions and misuse are common, and patients should be advised to avoid driving or operating heavy machinery due to potential dizziness and fatigue.
If you are taking Ropinirole Hydrochloride, here are important things to know. The most commonly reported side effects include nausea, fatigue, drug ineffective, fall, dyspnoea. 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 adverse events to their healthcare provider immediately. Follow the prescribed dosage and schedule to avoid potential misuse. 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 continues to monitor the safety of Ropinirole Hydrochloride, and updates will be provided as necessary.
The FDA has received approximately 7,752 adverse event reports associated with Ropinirole Hydrochloride. 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 Ropinirole Hydrochloride include Nausea, Fatigue, Drug Ineffective, Fall, Dyspnoea. By volume, the top reported reactions are: Nausea (240 reports), Fatigue (235 reports), Drug Ineffective (223 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ropinirole Hydrochloride.
Out of 3,286 classified reports, 1,975 (60.1%) were classified as serious and 1,311 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 Ropinirole Hydrochloride break down by patient sex as follows: Female: 2,007, Male: 959, Unknown: 2. 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 Ropinirole Hydrochloride adverse events are: age 76: 135 reports, age 77: 61 reports, age 69: 60 reports, age 72: 60 reports, age 62: 58 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 Ropinirole Hydrochloride adverse event reports is Solco Healthcare Us, 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 Ropinirole Hydrochloride include: Asthenia, Dizziness, Headache, Asthma, Pain. 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 Ropinirole Hydrochloride 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.
Ropinirole Hydrochloride has a safety concern score of 65 out of 100 (elevated 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. Nausea and fatigue are the most common side effects.
Key safety signals identified in Ropinirole Hydrochloride's adverse event data include: Falls and pneumonia are serious adverse events.. Drug interactions and misuse are common.. Weight changes and respiratory issues are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and misuse are common, and patients should be advised to avoid driving or operating heavy machinery due to potential dizziness and fatigue. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ropinirole Hydrochloride.
Patients should report any serious adverse events to their healthcare provider immediately. Follow the prescribed dosage and schedule to avoid potential misuse.
Ropinirole Hydrochloride has 7,752 adverse event reports on file with the FDA. Serious adverse events, such as falls and pneumonia, are reported. The volume of reports for Ropinirole Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Ropinirole Hydrochloride, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with ROPINIROLE HYDROCHLORIDE:
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