Caldolor FDA Approval History

Last updated by Judith Stewart, BPharm on May 17, 2023.

FDA Approved: Yes (First approved June 11, 2009)
Brand name: Caldolor
Generic name: ibuprofen
Dosage form: Intravenous Injection
Company: Cumberland Pharmaceuticals Inc.
Treatment for: Pain, Fever

Caldolor (ibuprofen) is an intravenous formulation of the approved nonsteroidal anti-inflammatory drug ibuprofen for use in the treatment of pain and fever.

• Caldolor is indicated in adults and pediatric patients aged 3 months and older for the management of mild to moderate pain, the management of moderate to severe pain as an adjunct to opioid analgesics, and the reduction of fever.
• Caldolor is a nonsteroidal anti-inflammatory drug that is thought to work in the treatment of pain and fever through inhibition of cyclooxygenase (COX-1 and COX-2).
• Caldolor is administered by intravenous injection.
• The Caldolor product label carries a Boxed Warning for the increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke), and serious gastrointestinal (GI) adverse events (including bleeding, ulceration, and perforation of the stomach or intestines). Warnings and precautions associated with Caldolor include risk of hepatotoxicity, impaired response to antihypertensive medications, risk of worsening heart failure, risk of renal toxicity, anaphylactic reactions, exacerbation of asthma related to aspirin sensitivity, serious skin reactions, drug reaction with eosinophilia and systemic symptoms (DRESS), fetal toxicity, and hematologic toxicity.
• Common adverse reactions in adults include nausea, flatulence, vomiting, headache, hemorrhage and dizziness. Common adverse reactions in pediatric patients include infusion site pain, vomiting, nausea, anemia and headache.

Development timeline for Caldolor

Further information

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