85/100 · Critical
Manufactured by Nivagen Pharmaceuticals, Inc.
Hydralazine Hydrochloride Adverse Events Show High Risk of Renal and Cardiovascular Complications
59,065 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDRALAZINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Nivagen Pharmaceuticals, Inc.. Based on analysis of 59,065 FDA adverse event reports, HYDRALAZINE HYDROCHLORIDE has a safety score of 85 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 HYDRALAZINE HYDROCHLORIDE include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, RENAL FAILURE, END STAGE RENAL DISEASE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDRALAZINE HYDROCHLORIDE.
Hydralazine Hydrochloride has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 59,065 adverse event reports for this medication, which is primarily manufactured by Nivagen Pharmaceuticals, Inc..
The most commonly reported adverse events include Chronic Kidney Disease, Acute Kidney Injury, Renal Failure. Of classified reports, 77.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic kidney disease and acute kidney injury are the most frequent serious adverse reactions.
Cardiac failure and hypertension are also common, indicating potential cardiovascular risks. Renal impairment and failure are significant concerns, with a high number of reports.
Patients taking Hydralazine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydralazine Hydrochloride can cause severe renal and cardiovascular complications, and caution is advised when used in patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydralazine Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 77.1% serious event ratio across 28,486 classified reports. The score accounts for 59,065 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: 14,049, Male: 11,764, Unknown: 50. The most frequently reported age groups are age 74 (612 reports), age 75 (591 reports), age 68 (580 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,486 classified reports for HYDRALAZINE 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.
Hydralazine Hydrochloride can cause severe renal and cardiovascular complications, and caution is advised when used in patients with pre-existing conditions.
If you are taking Hydralazine Hydrochloride, here are important things to know. The most commonly reported side effects include chronic kidney disease, acute kidney injury, renal failure, end stage renal disease, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of renal and cardiovascular complications, especially in elderly patients. Follow prescribed dosages and do not alter the medication without consulting a healthcare provider. 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 the safety of Hydralazine Hydrochloride, and any unusual symptoms should be reported to healthcare providers immediately.
The FDA has received approximately 59,065 adverse event reports associated with Hydralazine 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 Hydralazine Hydrochloride include Chronic Kidney Disease, Acute Kidney Injury, Renal Failure, End Stage Renal Disease, Fatigue. By volume, the top reported reactions are: Chronic Kidney Disease (2,819 reports), Acute Kidney Injury (2,616 reports), Renal Failure (2,097 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hydralazine Hydrochloride.
Out of 28,486 classified reports, 21,953 (77.1%) were classified as serious and 6,533 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 Hydralazine Hydrochloride break down by patient sex as follows: Female: 14,049, Male: 11,764, Unknown: 50. 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 Hydralazine Hydrochloride adverse events are: age 74: 612 reports, age 75: 591 reports, age 68: 580 reports, age 69: 567 reports, age 78: 567 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 Hydralazine Hydrochloride adverse event reports is Nivagen Pharmaceuticals, 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 Hydralazine Hydrochloride include: Dyspnoea, Diarrhoea, Nausea, Drug Ineffective, Death. 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 Hydralazine 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.
Hydralazine Hydrochloride has a safety concern score of 85 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. Chronic kidney disease and acute kidney injury are the most frequent serious adverse reactions.
Key safety signals identified in Hydralazine Hydrochloride's adverse event data include: High frequency of chronic and acute kidney injuries. Multiple reports of cardiac failure and hypertension. Renal failure and end-stage renal disease are notable. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydralazine Hydrochloride can cause severe renal and cardiovascular complications, and caution is advised when used in patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydralazine Hydrochloride.
Monitor patients for signs of renal and cardiovascular complications, especially in elderly patients. Follow prescribed dosages and do not alter the medication without consulting a healthcare provider.
Hydralazine Hydrochloride has 59,065 adverse event reports on file with the FDA. Cardiac failure and hypertension are also common, indicating potential cardiovascular risks. The volume of reports for Hydralazine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors the safety of Hydralazine Hydrochloride, and any unusual symptoms should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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