Last reviewed · How we verify
Caldolor
At a glance
| Generic name | Caldolor |
|---|---|
| Also known as | IV Ibuprofen, Ibuprofen, Intravenous Ibuprofen |
| Sponsor | Cumberland Pharmaceuticals |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. ( 5.1 ) CALDOLOR is contraindicated in the set
Common side effects
- Nausea
- Vomiting
- Flatulence
- Headache
- Hemorrhage
- Dizziness
- Infusion site pain
- Anemia
- Abdominal pain
- Nasal congestion
Serious adverse events
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforation
- Hepatotoxicity
- Hypertension
- Heart Failure and Edema
- Renal Toxicity and Hyperkalemia
- Anaphylactic reactions
- Stevens-Johnson Syndrome (SJS)
- Toxic epidermal necrolysis (TEN)
- Hematologic Toxicity
Key clinical trials
- Immediate Restoration of a New Implant With High Primary Stability (NA)
- Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis (NA)
- Jaw Muscle Pain Post Wisdom Molar Surgery (PHASE2)
- Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement (PHASE2)
- Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD) (NA)
- ERAS (Enhanced Recovery After Surgery) and Multimodal Analgesia in Laparoscopic Cholecystectomy
- Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis (NA)
- A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) Versus Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |