drugs information

Clinoril Black Box Warning

Market Name: Clinoril

Generic Name: Sulindac

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

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

Black Box Warning Date: January 2006

FDA Link: Clinoril

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