CALDOLOR® is an ethical pharmaceutical that has been approved and is regulated by the US Food and Drug Administration (FDA). CALDOLOR can be obtained only by prescription from a licensed healthcare provider after diligent disclosure by the healthcare provider.
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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.
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.
Please see full Prescribing Information, including Boxed Warning.