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If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It is often used to relieve pain from headaches, menstrual cramps, muscle aches, and dental pain. It also reduces pain, swelling, and joint stiffness caused by arthritis and gout attacks.
While a healthcare provider can prescribe naproxen, people can also purchase lower strengths of the drug over the counter. In the United States, prescription naproxen is known under popular brand names such as Anaprox or Naprosyn. Over-the-counter (OTC) naproxen is often sold as Aleve, All Day Pain Relief, or All Day Relief.
Naproxen works by blocking certain enzymes (cyclooxygenase-1 and 2), which decreases inflammation. Inflammation means that the body reacts to an irritant with an immune response.
Naproxen is FDA approved for the treatment of (FDA, 2017):
- mild to moderate pain
- signs and symptoms of gout, ankylosing spondylitis, bursitis, polyarticular juvenile idiopathic arthritis, osteoarthritis, rheumatoid arthritis, and tendinopathy
- treatment of dysmenorrhea (pain with your period or menstrual cramps)
Naproxen can also be used “off-label” to treat other conditions. When a drug is used off-label, it means that FDA didn’t explicitly approve it for a particular use. A healthcare provider can prescribe medications for an unapproved use if they decide that it’s the proper treatment for their patient.
Off-label uses of naproxen include the treatment of acute migraines and migraine prophylaxis. However, NSAIDs like naproxen are not preferred for the acute management of migraines during pregnancy because of concerns that there might be a link between NSAIDs and certain birth defects.
Naproxen side effects
The most common side effects of naproxen and other NSAIDs are stomach upset, heartburn, and nausea (FDA, 2017). If the medicine upsets your stomach, you can try taking it with food. If that doesn’t help and the stomach issues persist, talk with your healthcare provider to make sure it’s not a more serious problem.
Sometimes, naproxen may make you dizzy or drowsy.
In rare cases, it can also cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, including:
- yellowing eyes/skin
- dark urine
- nausea/vomiting that doesn’t stop
- loss of appetite
You can take naproxen by mouth, in both fast-acting and extended-release (long-acting) tablets or suspension forms (drugs mixed with a liquid), as well as topical gels. Naproxen is typically taken two or three times a day with a full glass of water. Some healthcare providers recommend taking this medication with food, milk, or an antacid to prevent stomach upset.
The recommended dose of naproxen will depend on age, symptoms, medical condition, and response to treatment. Follow your healthcare provider’s orders or the directions on the label. It’s recommended to use the lowest effective dose for the shortest duration of time.
The following information includes only the average doses of this medicine.
Dysmenorrhea (period cramps)
- 500 mg orally initially, then 250 mg orally every 6-8 hours or 500 mg orally every 12 hours (long-acting formula)
Migraine, acute (off-label use):
- 500 to 750 mg once orally (immediate-release)
Mild to moderate arthritis:
- 220 to 550 mg orally every 12 hours, maximum dose: 1.5 g/day.
- 200 to 400 mg orally initially, then 200 mg every 8 to 12 hours as needed; maximum dose: 400 mg in any 8- to 12-hour period or 600 mg in a 24-hour period.
Children ≥12 years and Adolescents:
- Fever: 200 mg orally every 8 to 12 hours; if needed may take 400 mg for the initial dose; maximum daily dose: 600 mg/day
Naproxen has two black box warnings (FDA, 2017). One is for cardiovascular events and one is for gastrointestinal bleeding. Black box warnings are the most serious warnings from the Food and Drug Administration (FDA), alerting healthcare providers and patients about drug effects that may be dangerous.
Cardiovascular events (black box warning):
NSAIDs like naproxen can increase your risk of heart attack and other serious cardiovascular events like stroke, which can be fatal.
Serious gastrointestinal bleeding, ulceration, and perforation (black box warning):
NSAIDs increase the risk of serious gastrointestinal (GI) bleeding, ulceration, and perforation of the stomach or intestines. This can lead to sudden blood loss and is potentially fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Severe allergic reaction:
Serious allergic reactions to this drug are rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing
People with a history of asthma or allergic-type reactions after taking aspirin or other NSAIDs shouldn’t take naproxen and should consult their healthcare provider.
Drug interactions have the potential to change how your medications work and can increase your risk for serious side effects.
Naproxen may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include (FDA, 2017):
- anti-platelet drugs such as clopidogrel
- “blood thinners” such as dabigatran/enoxaparin/warfarin
When taken with other NSAIDs like celecoxib, ibuprofen, and aspirin, the risk of side effects from naproxen and these other NSAIDs increases.
Other drugs that may interact with naproxen are:
- ACE inhibitors (such as captopril, lisinopril)
- Diuretics such as furosemide (“water pills”)
- Angiotensin II receptor blockers (such as losartan, valsartan)
- Corticosteroids (such as prednisone)
- Lithium (a mood stabilizer)
As with all medications, it’s crucial that you follow your healthcare provider’s instructions and complete the full course you’ve been prescribed. Should you have any side effects or concerns, speak with your provider to determine the best approach for you.
- U.S. Food and Drug Administration (FDA) (2017). NAPROXEN. Retrieved April 26, 2021 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf
Dr. Steve Silvestro is a board-certified pediatrician and Senior Manager, Medical Content & Education at Ro.