Last reviewed 2026-04-20 · How we verify

Advil (ibuprofen)

Ibuprofen inhibits prostaglandin synthetase, reducing pain, fever, and inflammation.

Ibuprofen is one of the most widely used NSAIDs globally, first approved in the UK in 1969 and available OTC since 1983. Developed by Boots Group, it is now off-patent and manufactured by hundreds of generic companies. Available in oral, topical, and IV formulations, it is a first-line treatment for mild-to-moderate pain, fever, and inflammation.

At a glance

Mechanism of action

Ibuprofen's analgesic and antipyretic activities are related to inhibition of prostaglandin synthetase, though the complete mechanism is not fully understood. It reduces prostaglandin synthesis and activity, which decreases pain signaling, fever, and inflammatory responses. In dysmenorrhea, it reduces elevated prostaglandin levels in menstrual fluid and decreases intrauterine pressure and uterine contractions.

Approved indications

• Acute postoperative pain
• Dysmenorrhea
• Fever
• Headache disorder
• Influenza-like symptoms
• Juvenile rheumatoid arthritis
• Osteoarthritis
• Pain
• Patent ductus arteriosus
• Rheumatoid arthritis
• Severe pain
• Sinus headache

Common side effects

• Gastrointestinal complaints (general)
• Nausea
• Epigastric pain
• Heartburn
• Diarrhea
• Abdominal distress
• Nausea and vomiting
• Indigestion
• Constipation
• Abdominal cramps or pain
• Bloating or flatulence
• Dizziness

Serious adverse events

• Gastric or duodenal ulcer with bleeding and/or perforation
• Gastrointestinal hemorrhage
• Stevens-Johnson Syndrome (SJS)
• Toxic epidermal necrolysis (TEN)
• Aseptic meningitis with fever and coma
• Aplastic anemia
• Agranulocytosis
• Congestive heart failure
• Hepatitis
• Pancreatitis

Key clinical trials

• Double-blind, Randomized, Placebo-controlled, Single-center, Exploratory Clinical Trial to Investigate Safety and Efficacy of COMBOPROFEN for Treatment of Muscular Pain Associated With DOMS. (Phase 2)
• Prescription Antipyretics to Decrease Unscheduled Return Visits In A Pediatric Emergency Department (NA)
• Effect of Preoperative Oral Administration of Ibuprofen and Acetaminophen on the Anesthetic Efficacy of Buccal Infiltration During Vital Pulpotomy of Mandibular Primary Molars: A Prospective, Double-b (NA)
• An Open-label, Randomised Study Comparing the Uptake of rIL-2 in HIV-1 Infected Individuals Receiving Different Combinations of Antiemetics and Analgesic Agents During rIL-2 Dosing in ESPRIT: Toxicity (Phase 3)
• Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children (Phase 3)
• Assessing Perceived Quality of Care With Differing Pain Management Protocols After Outpatient Otolaryngology Procedures (N/A)
• Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries (Phase 2)
• A Study to Assess Efficacy Over Placebo and Speed of Onset of Pain Relief of New Paracetamol and Caffeine Tablets as Compared to Ibuprofen in Episodic Tension Type Headache (Phase 3)

Patents

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:

• Advil CI brief — competitive landscape report
• Advil updates RSS · CI watch RSS
• Generic (originally Boots Group) portfolio CI