78/100 · Elevated
Manufactured by Bausch Health US LLC
Diltiazem Hydrochloride Adverse Events: High Serious Reaction Rate
97,371 FDA adverse event reports analyzed
Last updated: 2026-05-12
DILTIAZEM HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US LLC. Based on analysis of 97,371 FDA adverse event reports, DILTIAZEM HYDROCHLORIDE 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 DILTIAZEM HYDROCHLORIDE include DYSPNOEA, FATIGUE, NAUSEA, PAIN, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DILTIAZEM HYDROCHLORIDE.
Diltiazem Hydrochloride 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 97,371 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us Llc.
The most commonly reported adverse events include Dyspnoea, Fatigue, Nausea. Of classified reports, 74.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Diltiazem Hydrochloride reports include a high number of serious adverse events, particularly respiratory and cardiovascular issues.
The most common reactions are dyspnea, fatigue, and nausea, indicating a broad range of potential side effects. Reports show a significant number of cardiovascular events, including atrial fibrillation and congestive heart failure.
Patients taking Diltiazem Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Diltiazem Hydrochloride can interact with other drugs, leading to hypotension and other cardiovascular side effects. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Diltiazem Hydrochloride received a safety concern score of 78/100 (high concern). This is based on a 74.1% serious event ratio across 33,608 classified reports. The score accounts for 97,371 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: 20,123, Male: 11,319, Unknown: 59. The most frequently reported age groups are age 77 (1,068 reports), age 69 (743 reports), age 75 (740 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 33,608 classified reports for DILTIAZEM 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.
Diltiazem Hydrochloride can interact with other drugs, leading to hypotension and other cardiovascular side effects. Patients should inform their healthcare provider of all medications they are taking.
If you are taking Diltiazem Hydrochloride, here are important things to know. The most commonly reported side effects include dyspnoea, fatigue, nausea, pain, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any pre-existing conditions, especially cardiovascular issues, before starting Diltiazem Hydrochloride. Monitor for signs of serious adverse events such as respiratory distress, chest pain, and cardiovascular symptoms. 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 Diltiazem Hydrochloride for safety. Healthcare providers should be vigilant in monitoring patients for serious adverse events and adjust dosages as necessary.
The FDA has received approximately 97,371 adverse event reports associated with Diltiazem 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 Diltiazem Hydrochloride include Dyspnoea, Fatigue, Nausea, Pain, Dizziness. By volume, the top reported reactions are: Dyspnoea (3,199 reports), Fatigue (2,638 reports), Nausea (2,368 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Diltiazem Hydrochloride.
Out of 33,608 classified reports, 24,907 (74.1%) were classified as serious and 8,701 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 Diltiazem Hydrochloride break down by patient sex as follows: Female: 20,123, Male: 11,319, Unknown: 59. 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 Diltiazem Hydrochloride adverse events are: age 77: 1,068 reports, age 69: 743 reports, age 75: 740 reports, age 72: 730 reports, age 74: 705 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 Diltiazem Hydrochloride adverse event reports is Bausch Health 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 Diltiazem Hydrochloride include: Diarrhoea, Drug Ineffective, Fall, Headache, Atrial Fibrillation. 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 Diltiazem 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.
Diltiazem Hydrochloride 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. Diltiazem Hydrochloride reports include a high number of serious adverse events, particularly respiratory and cardiovascular issues.
Key safety signals identified in Diltiazem Hydrochloride's adverse event data include: Atrial fibrillation and congestive heart failure are key safety signals, indicating potential cardiovascular risks.. Respiratory issues such as pneumonia and wheezing are also notable, suggesting potential pulmonary side effects.. Serious reactions account for 74.1% of all reported outcomes, highlighting the severity of adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Diltiazem Hydrochloride can interact with other drugs, leading to hypotension and other cardiovascular side effects. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Diltiazem Hydrochloride.
Inform your healthcare provider about any pre-existing conditions, especially cardiovascular issues, before starting Diltiazem Hydrochloride. Monitor for signs of serious adverse events such as respiratory distress, chest pain, and cardiovascular symptoms.
Diltiazem Hydrochloride has 97,371 adverse event reports on file with the FDA. The most common reactions are dyspnea, fatigue, and nausea, indicating a broad range of potential side effects. The volume of reports for Diltiazem Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Diltiazem Hydrochloride for safety. Healthcare providers should be vigilant in monitoring patients for serious adverse events and adjust dosages as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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