Last reviewed · How we verify
IBUPROFEN LYSINE
At a glance
| Generic name | IBUPROFEN LYSINE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2006 |
Approved indications
Common side effects
- Sepsis
- Anemia
- Total Bleeding
- Intraventricular Hemorrhage, All Grades
- Apnea
- Gastrointestinal Disorders
- Total Renal Events
- Respiratory Infection
- Skin Lesion/Irritation
- Intraventricular Hemorrhage, Grades 1/2
- Intraventricular Hemorrhage, Grades 3/4
- Hypoglycemia
Serious adverse events
- Gastrointestinal Perforation
- Necrotizing Enterocolitis
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Pulmonary Hypertension
- Cardiac Failure
- Renal Failure
- Convulsions
- Hypotension
- Cholestasis
- Ileus
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IBUPROFEN LYSINE CI brief — competitive landscape report
- IBUPROFEN LYSINE updates RSS · CI watch RSS