AMLODIPINE BESYLATE 10 mg

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
AMLODIPINE BESYLATE 10 mg
Generic name
AMLODIPINE BESYLATE
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
47e494d2-8971-3f8f-e063-6394a90adb20
SPL ID
47e48dff-09df-2ea2-e063-6394a90a8e41
Version
1
Effective date
2026-01-08
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:13:07
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 4 matching rows.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. 5.3 Patients with Hepatic Failure Because amlodipine besylate tablets are extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.

warnings and cautions

5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

warnings and cautions

5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease.

warnings and cautions

5.3 Patients with Hepatic Failure Because amlodipine besylate tablets are extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.

Adverse reactions cross-check#

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Adverse reactions sections page 2 of 2 · 5 matching rows.

adverse reactions table

<table ID="SPLSERV-2a5df20c-cba1-4439-a5ff-cc1d33a881cb" width="621px"><caption/><col align="left"/><col align="center"/><col align="center"/><col align="center"/><col align="center"/><tbody><tr><td align="left"> </td><td align="center" colspan="2">Amlodipine besylate tablets </td><td align="center" colspan="2">Placebo </td></tr><tr><td align="left"> </td><td align="center">Male=% (N=1218) </td><td align="center">Female=% (N=512) </td><td align="center">Male=% (N=914) </td><td align="center">Female=% (N=336) </td></tr><tr><td align="left"> Edema</td><td align="center">5.6</td><td align="center">14.6</td><td align="center">1.4</td><td align="center">5.1</td></tr><tr><td align="left"> Flushing</td><td align="center">1.5</td><td align="center">4.5</td><td align="center">0.3</td><td align="center">0.9</td></tr><tr><td align="left"> Palpitations</td><td align="center">1.4</td><td align="center">3.3</td><td align="center">0.9</td><td align="center">0.9</td></tr><tr><td align="left"> Somnolence</td><td align="center">1.3</td><td align="center">1.6</td><td align="center">0.8</td><td align="center">0.3</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.