Important Safety Information
CALDOLOR should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots, and in those who have a history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. Ibuprofen has been associated with high blood pressure, serious skin reactions, and serious allergic reactions.
The most common adverse events reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.
Warning: Risk of Serious Cardiovascular and Gastrointestinal Events
Cardiovascular Risk
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use.
- CALDOLOR is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
- NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Events can occur at any time without warning symptoms. Elderly patients are at greater risk.
Indications for CALDOLOR
CALDOLOR is indicated in adults for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever.