FDA
FDA expands indication for IV ibuprofen to include postoperative pain
FDA has approved an expanded indication for Caldolor (ibuprofen), adding management of postoperative pain to its prescribing information. Caldolor is now indicated in adults and pediatric patients ≥3 months of age for: management of mild to moderate pain (including postoperative pain), management of moderate to severe pain (including postoperative pain) as an adjunct to opioid analgesics, and reduction of fever.
Previously, Caldolor’s labeling focused on pain and fever management without explicit reference to postoperative use. The updated indication provides regulatory clarity for IV ibuprofen use in perioperative and acute care settings, where oral analgesics may be unavailable or inappropriate.
From a clinical standpoint, the expanded labeling supports the use of IV ibuprofen as part of multimodal analgesia strategies, either as a sole agent for less severe pain or in combination with opioids for more significant postoperative pain. This change may facilitate protocol development and more consistent use of non‑opioid options in surgical and inpatient care settings.
Source: Cumberland Pharmaceuticals News release. (2026, April 16). Cumberland Pharmaceuticals announces expanded indication for Caldolor (ibuprofen) Injection and launch of new brand website