Last reviewed · How we verify
Aleve (naproxen)
Reversibly inhibits COX-1 and COX-2 with a long half-life, providing sustained anti-inflammatory, analgesic, and antipyretic effects.
Naproxen is a long-acting NSAID first approved in 1976, now available OTC as Aleve and generically worldwide. Its 12-17 hour half-life allows convenient twice-daily dosing and it has the most favorable cardiovascular safety profile among NSAIDs.
At a glance
| Generic name | naproxen |
|---|---|
| Also known as | Naprosyn, Anaprox, Aleve |
| Sponsor | Generic (originally Syntex) |
| Drug class | NSAID |
| Target | Aldo-keto reductase family 1 member C2, Aldo-keto reductase family 1 member C3, Prostaglandin G/H synthase 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1976-01-01 (United States) |
Mechanism of action
Naproxen is a long-acting NSAID with a half-life of 12-17 hours, allowing twice-daily dosing. It inhibits both cyclooxygenase isoforms, reducing prostaglandin production. Among NSAIDs, naproxen has shown the most favorable cardiovascular safety profile in large meta-analyses, making it a preferred choice for patients with cardiovascular risk factors who require anti-inflammatory therapy.
Approved indications
- Ankylosing spondylitis
- Bursitis
- Dysmenorrhea
- Fever
- Gout
- Headache disorder
- Joint pain
- Juvenile rheumatoid arthritis
- Migraine
- Muscle pain
- Nasal discharge
- Osteoarthritis
- Pain
- Rheumatoid arthritis
- Sinus headache
- Tendinitis
- Toothache
Common side effects
- Dyspepsia
- Abdominal pain
- Nausea
- Headache
- Heartburn
- Rash
- Ecchymosis
- Edema
- Dizziness
- Drowsiness
- Pruritus
- Skin eruptions
Serious adverse events
- Gross bleeding/perforation
- GI ulcers
- Pancreatitis
- Jaundice
- Melena
- Thrombocytopenia
- Agranulocytosis
- Vomiting
- Abnormal renal function
- Anemia
Key clinical trials
- A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis (Phase 4)
- A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of SJP-001 in Comparison With Fexofenadine and Naproxen Administered (Phase 1)
- Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain (Phase 4)
- A Double-Blind, Randomized, Active Comparator Study of LT-NS001 Versus Naprosyn for Seven Days in Healthy Subjects With Endoscopic Evaluation (Phase 1)
- A Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (Phase 1)
- Comparison of Treximet and Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache. (N/A)
- NCT00442208 (Phase 1)
- A Randomized Trial of CT-guided Perineural Injection With a Corticosteroid Plus a Long Acting Local Anesthetic Versus Standard Medical Management in Patients With Acute Lumbar Radiculopathy and a Corr (Phase 4)
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 |