drugs information
Indocin Black Box Warning
Market Name: Indocin
Generic Name: Indomethacin
Indocin 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 Indocin including peptic ulcers, bleeding and perforation of the stomach/intestines. In addition, serious cardiovascular events including stroke and heart attack were observed. Indocin also increases the risk of kidney problems, bleeding, and fetal problems during pregnancy and delivery.
A black box warning was added to Indocin’s prescribing information by the FDA in January of 2006.
Black Box Warning Date: January 2006
FDA Link: Indocin