72/100 · Elevated
Manufactured by Actavis Pharma, Inc.
Clonidine Adverse Events: Common and Serious Reactions
108,277 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLONIDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 108,277 FDA adverse event reports, CLONIDINE has a safety score of 72 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 CLONIDINE include DRUG INEFFECTIVE, PAIN, FATIGUE, NAUSEA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLONIDINE.
Clonidine has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 108,277 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 70.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Clonidine reports include a high volume of serious adverse events, particularly related to cardiovascular issues and renal dysfunction.
The most common reactions are pain, fatigue, and nausea, indicating a broad spectrum of side effects. Death and chronic kidney disease are among the more severe outcomes reported, highlighting significant safety concerns.
Patients taking Clonidine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clonidine can cause significant cardiovascular and renal side effects, and patients should be monitored closely for signs of these issues. Drug interactions, particularly with other antihypertensive agents, should be avoided. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clonidine received a safety concern score of 72/100 (elevated concern). This is based on a 70.0% serious event ratio across 49,330 classified reports. The score accounts for 108,277 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: 26,805, Male: 18,487, Unknown: 122. The most frequently reported age groups are age 58 (844 reports), age 61 (713 reports), age 62 (709 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 49,330 classified reports for CLONIDINE:
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.
Clonidine can cause significant cardiovascular and renal side effects, and patients should be monitored closely for signs of these issues. Drug interactions, particularly with other antihypertensive agents, should be avoided.
If you are taking Clonidine, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, nausea, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of cardiovascular and renal issues, especially in elderly patients. Be aware of potential drug interactions, particularly with other antihypertensive medications. 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 clonidine for safety, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should not stop taking clonidine without consulting their healthcare provider.
The FDA has received approximately 108,277 adverse event reports associated with Clonidine. 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 Clonidine include Drug Ineffective, Pain, Fatigue, Nausea, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (3,867 reports), Pain (3,037 reports), Fatigue (2,925 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Clonidine.
Out of 49,330 classified reports, 34,539 (70.0%) were classified as serious and 14,791 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 Clonidine break down by patient sex as follows: Female: 26,805, Male: 18,487, Unknown: 122. 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 Clonidine adverse events are: age 58: 844 reports, age 61: 713 reports, age 62: 709 reports, age 63: 691 reports, age 66: 679 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 Clonidine adverse event reports is Actavis Pharma, 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 Clonidine include: Headache, Hypertension, Dyspnoea, Diarrhoea, Chronic Kidney Disease. 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 Clonidine 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.
Clonidine has a safety concern score of 72 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. Clonidine reports include a high volume of serious adverse events, particularly related to cardiovascular issues and renal dysfunction.
Key safety signals identified in Clonidine's adverse event data include: High number of serious adverse events (34,539 out of 49,330 outcomes, 70%). Cardiovascular issues (hypertension, hypotension, heart rate increased) and renal problems (renal failure, chronic kidney disease) are frequent. Overdose and drug withdrawal syndrome are notable safety signals. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clonidine can cause significant cardiovascular and renal side effects, and patients should be monitored closely for signs of these issues. Drug interactions, particularly with other antihypertensive agents, should be avoided. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clonidine.
Monitor patients closely for signs of cardiovascular and renal issues, especially in elderly patients. Be aware of potential drug interactions, particularly with other antihypertensive medications.
Clonidine has 108,277 adverse event reports on file with the FDA. The most common reactions are pain, fatigue, and nausea, indicating a broad spectrum of side effects. The volume of reports for Clonidine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor clonidine for safety, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should not stop taking clonidine without consulting their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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