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Ibuprofen/acetaminophen
Ibuprofen/acetaminophen is a Analgesic/antipyretic combination (NSAID + non-NSAID analgesic) Small molecule drug developed by Montefiore Medical Center. It is currently FDA-approved for Mild to moderate pain, Fever reduction, Headache. Also known as: Ibuprofen/paracetamol (lower dose).
Ibuprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, while acetaminophen inhibits prostaglandin synthesis and modulates pain perception centrally.
Ibuprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, while acetaminophen inhibits prostaglandin synthesis and modulates pain perception centrally. Used for Mild to moderate pain, Fever reduction, Headache.
At a glance
| Generic name | Ibuprofen/acetaminophen |
|---|---|
| Also known as | Ibuprofen/paracetamol (lower dose) |
| Sponsor | Montefiore Medical Center |
| Drug class | Analgesic/antipyretic combination (NSAID + non-NSAID analgesic) |
| Target | Cyclooxygenase (COX-1, COX-2) for ibuprofen; prostaglandin synthesis and central pain pathways for acetaminophen |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that blocks COX-1 and COX-2 enzymes, reducing production of inflammatory prostaglandins and providing analgesic, antipyretic, and anti-inflammatory effects. Acetaminophen (paracetamol) works primarily through central inhibition of prostaglandin synthesis and modulation of pain and temperature regulation pathways. The combination provides complementary analgesic and antipyretic effects with potentially improved efficacy over either agent alone.
Approved indications
- Mild to moderate pain
- Fever reduction
- Headache
- Musculoskeletal pain
Common side effects
- Gastrointestinal upset
- Nausea
- Dyspepsia
- Hepatotoxicity (acetaminophen component at high doses)
- Renal impairment (ibuprofen component)
Key clinical trials
- Jaw Muscle Pain Post Wisdom Molar Surgery (PHASE2)
- Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD) (NA)
- Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis (NA)
- Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain (NA)
- Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial (PHASE4)
- Selected Exercise Program on Upper Cross Syndrome Post-unilateral Mastectomy (NA)
- Phase 2 Herniorrhaphy Study for Opioid Elimination (PHASE2)
- Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ibuprofen/acetaminophen CI brief — competitive landscape report
- Ibuprofen/acetaminophen updates RSS · CI watch RSS
- Montefiore Medical Center portfolio CI
Frequently asked questions about Ibuprofen/acetaminophen
What is Ibuprofen/acetaminophen?
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Is Ibuprofen/acetaminophen also known as anything else?
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Related
- Drug class: All Analgesic/antipyretic combination (NSAID + non-NSAID analgesic) drugs
- Target: All drugs targeting Cyclooxygenase (COX-1, COX-2) for ibuprofen; prostaglandin synthesis and central pain pathways for acetaminophen
- Manufacturer: Montefiore Medical Center — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Mild to moderate pain
- Indication: Drugs for Fever reduction
- Indication: Drugs for Headache
- Also known as: Ibuprofen/paracetamol (lower dose)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing