72/100 · Elevated
Manufactured by ANI Pharmaceuticals, Inc.
Hydrochlorothiazide Adverse Events: High Fatigue and Nausea Reports
308,024 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCHLOROTHIAZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 308,024 FDA adverse event reports, HYDROCHLOROTHIAZIDE 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 HYDROCHLOROTHIAZIDE include FATIGUE, NAUSEA, DRUG INEFFECTIVE, DIARRHOEA, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROCHLOROTHIAZIDE.
Hydrochlorothiazide 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 308,024 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 67.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and nausea are the most frequently reported adverse events.
Serious adverse events, such as acute kidney injury and death, are also common. Drug interactions and hypotension are important safety concerns.
Patients taking Hydrochlorothiazide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrochlorothiazide can cause hypotension and drug interactions, so it is important to monitor blood pressure and avoid concurrent use with other diuretics or vasodilators. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydrochlorothiazide received a safety concern score of 72/100 (elevated concern). This is based on a 67.4% serious event ratio across 140,421 classified reports. The score accounts for 308,024 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: 83,528, Male: 47,675, Unknown: 179. The most frequently reported age groups are age 65 (3,175 reports), age 71 (2,791 reports), age 67 (2,744 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 140,421 classified reports for HYDROCHLOROTHIAZIDE:
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.
Hydrochlorothiazide can cause hypotension and drug interactions, so it is important to monitor blood pressure and avoid concurrent use with other diuretics or vasodilators.
If you are taking Hydrochlorothiazide, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, diarrhoea, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of hypotension and adjust dosing accordingly. Be aware of potential drug interactions and avoid concurrent use with other diuretics or vasodilators. 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 Hydrochlorothiazide, and updates will be provided as necessary.
The FDA has received approximately 308,024 adverse event reports associated with Hydrochlorothiazide. 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 Hydrochlorothiazide include Fatigue, Nausea, Drug Ineffective, Diarrhoea, Pain. By volume, the top reported reactions are: Fatigue (10,016 reports), Nausea (9,703 reports), Drug Ineffective (9,355 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hydrochlorothiazide.
Out of 140,421 classified reports, 94,610 (67.4%) were classified as serious and 45,811 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 Hydrochlorothiazide break down by patient sex as follows: Female: 83,528, Male: 47,675, Unknown: 179. 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 Hydrochlorothiazide adverse events are: age 65: 3,175 reports, age 71: 2,791 reports, age 67: 2,744 reports, age 64: 2,723 reports, age 68: 2,687 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 Hydrochlorothiazide adverse event reports is Ani 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 Hydrochlorothiazide include: Dyspnoea, Headache, Dizziness, Arthralgia, Off Label Use. 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 Hydrochlorothiazide 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.
Hydrochlorothiazide 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. Fatigue and nausea are the most frequently reported adverse events.
Key safety signals identified in Hydrochlorothiazide's adverse event data include: Acute kidney injury and death are serious adverse events.. Hypotension and drug interactions are key safety signals.. Hypokalemia and hyponatremia are also notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrochlorothiazide can cause hypotension and drug interactions, so it is important to monitor blood pressure and avoid concurrent use with other diuretics or vasodilators. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydrochlorothiazide.
Monitor for signs of hypotension and adjust dosing accordingly. Be aware of potential drug interactions and avoid concurrent use with other diuretics or vasodilators.
Hydrochlorothiazide has 308,024 adverse event reports on file with the FDA. Serious adverse events, such as acute kidney injury and death, are also common. The volume of reports for Hydrochlorothiazide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Hydrochlorothiazide, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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