Naproxen
ALEVE
Pronunciation: na-PROX-en
“Nap-rocks on a levee”
“The N said... NSAID”
What it isNonselective COX-1 and COX-2 inhibitor; pain and inflammation, notably gout and inflammatory arthritis.
Why this oneTwice-daily dosing from a long half-life, and the least cardiovascular signal among the traditional NSAIDs.
What limits itGI bleeding and kidney injury remain; it raises lithium exposure and can worsen hypertension or edema.
FDA-approved for
- pain/inflammation (1976)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis | Adults | 250, 375, or 500 mg BID | 250–500 mg BID | 1500 mg/day for limited periods (≤6 months) |
| Polyarticular juvenile idiopathic arthritis | Pediatric | ~10 mg/kg/day divided BID | ~10 mg/kg/day in 2 divided doses | Tablets not appropriate for children <50 kg |
| Pain, primary dysmenorrhea, acute tendonitis/bursitis | Adults | 500 mg once, then 250 mg every 6–8 h | 250 mg every 6–8 h PRN | 1250 mg/day |
| Acute gout | Adults | 750 mg once, then 250 mg every 8 h | 250 mg every 8 h until attack subsides |
Renal Not recommended in moderate-to-severe or severe renal impairment (CrCl <30 mL/min).
Hepatic Undefined (monitor; discontinue if liver disease develops).
Instructions
- Use lowest effective dose for shortest duration
- Do not use concomitantly with other naproxen products
Available strengths
- tab 220, 250, 375, 500 mg
- cap 200 mg
- DR tab 375, 500 mg
- ER tab 375, 500, 750 mg
- susp 25 mg/mL
Contraindications
- History of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs
- In the setting of coronary artery bypass graft (CABG) surgery
Cautions
- Cardiovascular thrombotic events
- GI bleeding/ulceration/perforation
- Hepatotoxicity
- Hypertension
- Heart failure/edema
- Renal toxicity/hyperkalemia
- Anaphylactic reactions
- Serious skin reactions
Adverse reactions
- Dyspepsia
- Abdominal pain
- Nausea
- Headache
- Rash
- Ecchymosis
- Edema
Pregnancy Avoid at ≥30 weeks (premature ductus arteriosus closure); limit use 20–30 weeks (oligohydramnios/neonatal renal impairment).
Lactation Undefined.
Cost
Generic entry1993
⚠ BOXED WARNINGS
- Cardiovascular thrombotic events
- Gastrointestinal bleeding, ulceration and perforation
Classes and tags
Clinical profile
Legacy pregnancy categoryMultiple / indication-, trimester- or formulation-dependent
Defining liabilityGI bleeding, kidney injury, hypertension and fluid retention; many agents increase lithium concentrations.
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