Indication1: 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.
IMPORTANT SAFETY INFORMATION1
Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen and in patients who have experienced asthma, urticarial, or allergic-type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS1
WARNINGS AND PRECAUTIONS1
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.
PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING BOXED WARING
1. Prescribing Information for Caldolor, Cumberland Pharmaceuticals Inc. Nashville, TN.