Section 02 · Monograph
Naproxen sodium
Reviewed Nov 2026FDA label
Anaprox DS / AleveNSAID
- Forms
- Tab: 220mg (OTC), 275, 550mg
- Dose
- 550mg at onset (max 1375mg/day)
- MOA
- COX inhibition
Black Box Warning
- Risk of serious cardiovascular thrombotic events; contraindicated in CABG surgery
- Risk of serious GI bleeding, ulceration and perforation, which can be fatal
Indications
- Mild to moderate pain, dysmenorrhea, tendinitis, bursitis, acute gout, arthritisFDA-labeled
Off-Label Uses
- Acute migraineOff-label
- Menstrual migraine mini-prophylaxisOff-label
Mechanism of Action
- Non-selective COX inhibitor with a relatively long half-life reducing prostaglandin-mediated pain and inflammation
Full Dosing
Adult / usual
- Acute pain/migraine: 550mg at onset; maximum 1375mg on the first day and 1100mg/day thereafter
- OTC 220mg tablets: 1-2 tablets with water; limit duration
- Take with food if GI upset
Contraindications
- Asthma, urticaria or allergic reaction to aspirin or NSAIDs
- Perioperative CABG pain
Drug Interactions
- Anticoagulants and aspirin: bleeding risk
- ACE inhibitors, ARBs and diuretics: reduced effect and renal risk
- Raises lithium and methotrexate levels
Adverse Effects
- GI upset, ulcer and bleeding
- Renal impairment, fluid retention, hypertension
- Cardiovascular thrombotic events
- Medication overuse headache
Monitoring Parameters
- Renal function and blood pressure with chronic use
- GI symptoms
- Headache frequency
Pregnancy & Lactation
- Avoid at 20 weeks gestation and later; avoid in the third trimester
- Present in milk; generally acceptable for short-term use