Market Name: Voltaren

Generic Name: Diclofenac sodium

Voltaren is a non-steroidal anti-inflammatory drug indicated for the short-term relief of moderate to severe pain. Serious gastrointestinal side effects have occurred with Voltaren including peptic ulcers, bleeding and perforation of the stomach/intestines. In addition, serious cardiovascular events including stroke and heart attack were observed. Voltaren also increases the risk of kidney problems, bleeding, and fetal problems during pregnancy and delivery.

A black box warning was added to Voltaren’s prescribing information by the FDA in January of 2006.

Black Box Warning Date: January 2006

FDA Link: Voltaren