BlackBoxRX
 
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Amlodipine/Celecoxib

Risk of Serious Cardiovascular and Gastrointestinal Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. 
  • CONSENSI is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. 
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. 

FDA and Industry Communications

Index to FDA Safety Information

Patient Counseling Information

CONSENSI

Medication Guides

Patient Medication Guide - CONSENSI

Package Inserts

Amlodipine/Celecoxib

Updated June 2018