Last reviewed 2026-06-02 · How we verify

Acetaminophen/Ibuprofen

Acetaminophen/Ibuprofen is a Analgesic/Antipyretic combination (NSAID + non-NSAID) Small molecule drug developed by Seoul National University Hospital. It is currently FDA-approved for Mild to moderate pain, Fever reduction. Also known as: Acetaminophen/Ibuprofen #1, Acetaminophen/Ibuprofen #2, Tylenol/Advil, Acetaminophen/Tylenol.

This is a fixed-dose combination of two over-the-counter analgesics: acetaminophen (a non-selective cyclooxygenase inhibitor) and ibuprofen (a non-selective nonsteroidal anti-inflammatory drug) that work synergistically to reduce pain and fever.

Acetaminophen and ibuprofen are used to treat conditions such as fever, pain, postoperative pain, and osteoarthritis of the knee. They work by inhibiting cyclooxygenase, an enzyme involved in the production of prostaglandins, which contribute to pain and inflammation.

At a glance

Mechanism of action

Acetaminophen inhibits prostaglandin synthesis in the central nervous system to reduce pain perception and fever. Ibuprofen inhibits cyclooxygenase enzymes peripherally and centrally to reduce inflammation, pain, and fever. The combination provides enhanced analgesic efficacy compared to either agent alone at lower individual doses.

Approved indications

• Mild to moderate pain
• Fever reduction

Common side effects

• Gastrointestinal upset
• Nausea
• Dyspepsia
• Headache

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.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Acetaminophen/Ibuprofen CI brief — competitive landscape report
• Acetaminophen/Ibuprofen updates RSS · CI watch RSS
• Seoul National University Hospital portfolio CI

Frequently asked questions about Acetaminophen/Ibuprofen

Related

• Drug class: All Analgesic/Antipyretic combination (NSAID + non-NSAID) drugs
• Target: All drugs targeting Cyclooxygenase-1 (COX-1), Cyclooxygenase-2 (COX-2), prostaglandin synthesis pathways
• Manufacturer: Seoul National University Hospital — full pipeline
• Therapeutic area: All drugs in Pain Management
• Indication: Drugs for Mild to moderate pain
• Indication: Drugs for Fever reduction
• Also known as: Acetaminophen/Ibuprofen #1, Acetaminophen/Ibuprofen #2, Tylenol/Advil, Acetaminophen/Tylenol, Ibuprofen/Advil/Motrin

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing