AMLODIPINE BESYLATE

According to the FDA label: Amlodipine besylate tablet, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension (1.1) o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

65,672 adverse event reports submitted to the FDA (2003–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about FAERS.

Top Reported Adverse Events

The most frequently reported events in association with AMLODIPINE BESYLATE in the FAERS database. These are events reported by patients taking this medication — not necessarily caused by it. A single report may include multiple events.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

By Age Group

Reported Outcomes

Outcomes recorded in FAERS reports that included AMLODIPINE BESYLATE. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

Number of FAERS reports received per quarter for AMLODIPINE BESYLATE. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior — not changes in the medication's safety profile.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA Adverse Event Reporting System (FAERS) via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →