Colchicine Adverse Event Report 2018

$19.99

This report includes data from the FDA’s Adverse Events Reports for 2018.  We removed reports where the subject of the report was taking only this drug. This report provides the following fields:

  • ID
  • Patient Summary
  • Patient Gender
  • Patient Age
  • Drug Products
  • Drug Reactions

Description

Colchicine affects the way the body responds to uric acid crystals, which reduces swelling and pain. Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA. The Colcrys brand of colchicine is FDA-approved to treat or prevent gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old. The Mitigare brand of colchicine is FDA-approved to prevent gout flares in adults. Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain). Colchicine is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing. Colchicine should not be used as a routine pain medication for other conditions. Colchicine may also be used for purposes not listed in this medication guide.https://www.drugs.com/mtm/colchicine.html

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What is an Adverse Event Report?

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA.