78/100 · Elevated
Manufactured by PFIZER LABORATORIES DIV PFIZER INC
Amodipine Besylate Adverse Events: High Serious Reaction Rate
281,512 FDA adverse event reports analyzed
Last updated: 2026-05-12
AMLODIPINE BESYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by PFIZER LABORATORIES DIV PFIZER INC. Based on analysis of 281,512 FDA adverse event reports, AMLODIPINE BESYLATE 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 AMLODIPINE BESYLATE include FATIGUE, NAUSEA, DIARRHOEA, DYSPNOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMLODIPINE BESYLATE.
Amlodipine Besylate 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 281,512 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 69.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and dizziness are the most common side effects.
Serious reactions, including pneumonia, renal failure, and death, are frequent. Drug interactions and hypotension are significant safety concerns.
Patients taking Amlodipine Besylate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Amodipine Besylate can cause hypotension and drug interactions, which may require careful monitoring and dose adjustment. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Amlodipine Besylate received a safety concern score of 78/100 (high concern). This is based on a 69.4% serious event ratio across 140,986 classified reports. The score accounts for 281,512 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: 75,659, Male: 57,024, Unknown: 247. The most frequently reported age groups are age 65 (3,179 reports), age 72 (2,707 reports), age 71 (2,700 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 140,986 classified reports for AMLODIPINE BESYLATE:
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 Besylate can cause hypotension and drug interactions, which may require careful monitoring and dose adjustment.
If you are taking Amlodipine Besylate, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, 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 for signs of hypotension and adjust dosage as needed. Be cautious of drug interactions, especially with other blood pressure 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 closely monitors Amodipine Besylate due to its high rate of serious adverse events, particularly in older adults.
The FDA has received approximately 281,512 adverse event reports associated with Amlodipine Besylate. 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 Besylate include Fatigue, Nausea, Diarrhoea, Dyspnoea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (9,349 reports), Nausea (8,077 reports), Diarrhoea (7,573 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 Besylate.
Out of 140,986 classified reports, 97,835 (69.4%) were classified as serious and 43,151 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 Besylate break down by patient sex as follows: Female: 75,659, Male: 57,024, Unknown: 247. 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 Besylate adverse events are: age 65: 3,179 reports, age 72: 2,707 reports, age 71: 2,700 reports, age 75: 2,686 reports, age 74: 2,653 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 Besylate adverse event reports is Pfizer Laboratories Div Pfizer 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 Besylate include: Pain, Dizziness, Headache, Asthenia, Fall. 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 Besylate 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 Besylate 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. Fatigue, nausea, and dizziness are the most common side effects.
Key safety signals identified in Amlodipine Besylate's adverse event data include: Pneumonia and renal failure are among the most serious reactions.. Hypotension and drug interactions are common, indicating potential risks.. Death reports are notable, suggesting severe adverse effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Amodipine Besylate can cause hypotension and drug interactions, which may require careful monitoring and dose adjustment. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Amlodipine Besylate.
Monitor for signs of hypotension and adjust dosage as needed. Be cautious of drug interactions, especially with other blood pressure medications.
Amlodipine Besylate has 281,512 adverse event reports on file with the FDA. Serious reactions, including pneumonia, renal failure, and death, are frequent. The volume of reports for Amlodipine Besylate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Amodipine Besylate due to its high rate of serious adverse events, particularly in older adults. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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