82/100 · Critical
Manufactured by Azurity Pharmaceuticals, Inc.
Amodipine Adverse Events: High Seriousness and Diverse Reactions
472,892 FDA adverse event reports analyzed
Last updated: 2026-05-12
AMLODIPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Azurity Pharmaceuticals, Inc.. Based on analysis of 472,892 FDA adverse event reports, AMLODIPINE has a safety score of 82 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 AMLODIPINE include FATIGUE, DIARRHOEA, NAUSEA, DYSPNOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMLODIPINE.
Amlodipine has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 472,892 adverse event reports for this medication, which is primarily manufactured by Azurity Pharmaceuticals, Inc..
The most commonly reported adverse events include Fatigue, Diarrhoea, Nausea. Of classified reports, 77.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Frequent serious reactions include acute kidney injury, fall, and death.
A wide range of reactions, from gastrointestinal issues to cardiovascular effects, are reported. Drug interactions and off-label use are common, warranting caution.
Patients taking Amlodipine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Amodipine can interact with other drugs, and its use in unapproved indications is reported, necessitating careful monitoring. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Amlodipine received a safety concern score of 82/100 (high concern). This is based on a 77.4% serious event ratio across 257,784 classified reports. The score accounts for 472,892 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: 125,199, Male: 111,134, Unknown: 335. The most frequently reported age groups are age 69 (5,697 reports), age 72 (5,576 reports), age 71 (5,534 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 257,784 classified reports for AMLODIPINE:
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.
Amodipine can interact with other drugs, and its use in unapproved indications is reported, necessitating careful monitoring.
If you are taking Amlodipine, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, nausea, dyspnoea, drug ineffective. 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 acute kidney injury, falls, and other serious reactions. Be cautious with drug interactions and ensure amodipine is used only for approved indications. 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 amodipine for safety, and healthcare providers should be vigilant about serious adverse events and drug interactions.
The FDA has received approximately 472,892 adverse event reports associated with Amlodipine. 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 Amlodipine include Fatigue, Diarrhoea, Nausea, Dyspnoea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (15,694 reports), Diarrhoea (14,039 reports), Nausea (13,423 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Amlodipine.
Out of 257,784 classified reports, 199,548 (77.4%) were classified as serious and 58,236 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 Amlodipine break down by patient sex as follows: Female: 125,199, Male: 111,134, Unknown: 335. 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 Amlodipine adverse events are: age 69: 5,697 reports, age 72: 5,576 reports, age 71: 5,534 reports, age 70: 5,529 reports, age 65: 5,520 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 Amlodipine adverse event reports is Azurity 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 Amlodipine include: Off Label Use, Dizziness, Headache, Acute Kidney Injury, 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 Amlodipine 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.
Amlodipine has a safety concern score of 82 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. Frequent serious reactions include acute kidney injury, fall, and death.
Key safety signals identified in Amlodipine's adverse event data include: Acute kidney injury is a significant serious adverse event.. Falls and death are reported with notable frequency.. A diverse range of reactions indicates potential for multiple side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Amodipine can interact with other drugs, and its use in unapproved indications is reported, necessitating careful monitoring. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Amlodipine.
Monitor patients for signs of acute kidney injury, falls, and other serious reactions. Be cautious with drug interactions and ensure amodipine is used only for approved indications.
Amlodipine has 472,892 adverse event reports on file with the FDA. A wide range of reactions, from gastrointestinal issues to cardiovascular effects, are reported. The volume of reports for Amlodipine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor amodipine for safety, and healthcare providers should be vigilant about serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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