This is a summary of the most important information about naproxen (Aleve). For
details, talk to your healthcare provider.
FDA Alert [12/23/04]: Based on emerging
information, the risk of cardiovascular and
cerebrovascular events may increase among
patients taking naproxen. FDA recommends
patients not exceed the recommended dose.
For more information about these risks, refer
to the FDA Alert for Healthcare Providers.

Naproxen is a non-steroidal anti-inflammatory drug (NSAID)
used as a pain reliever/fever reducer.
It is available over the counter for:
âEUR¢ Headache
âEUR¢ Minor pain of arthritis
âEUR¢ Backaches
âEUR¢ Menstrual cramps
âEUR¢ Muscular aches
âEUR¢ Toothaches
âEUR¢ The common cold
âEUR¢ Temporary reducing fever
And by prescription for:
âEUR¢ Relief of symptoms of osteoarthritis (the arthritis caused by
age-related wear and tear on bones and joints), rheumatoid
arthritis in adults, and juvenile arthritis
âEUR¢ Relief of signs and symptoms of ankylosing spondylitis
âEUR¢ Reducing swelling and relieving pain caused by gout
âEUR¢ Relieving the signs and symptoms of tendonitis and bursitis

Who Should Not Take Naproxen?
Do not take naproxen if you:
âEUR¢ Ever had asthma, rhinitis, or nasal polyps after taking aspirin
or other NSAID medicines. Aspirin-sensitive patients should
not take naproxen as reactions have the potential of causing
âEUR¢ Have advanced kidney disease
âEUR¢ Are pregnant, especially your last 3 months.

What Should I Do Before Taking Naproxen?
Ask a doctor or pharmacist before using naproxen if you:
âEUR¢ Are trying to get pregnant, are pregnant, or are breast-feeding
âEUR¢ Have or had angina (chest pain), heart attack, or blocked
artery in your heart
âEUR¢ Have kidney problems
âEUR¢ Have liver problems
âEUR¢ Have heart failure
âEUR¢ Have high blood pressure
âEUR¢ Retain fluids (hold extra body water and swell)
âEUR¢ Had an allergic reaction to aspirin or other NSAID medicines
âEUR¢ Had a serious stomach problem in the past
âEUR¢ Have or had any other medical problems or allergies
Does Naproxen Interact with other Drugs or Food?
Tell your healthcare provider about all the medicines you take,
including prescription and non-prescription medicines, vitamins,
and herbal supplements. Your healthcare provider may have to
adjust your dose or watch you more closely if you take any of the
following medications:
âEUR¢ Certain blood pressure medicines called ACE inhibitors
âEUR¢ Furosemide (Lasix)
âEUR¢ Lithium
âEUR¢ Methotrexate
âEUR¢ Warfarin (coumadin)
âEUR¢ Aspirin
âEUR¢ Other NSAIDs

Are There Other Risks?
Naproxen can cause stomach ulcers that bleed. The chance of
this serious problem increases the longer you take naproxen and
with higher doses of naproxen. Stomach bleeding can also
happen suddenly while you take naproxen. Stop taking naproxen
and call your healthcare provider right away if you get:
âEUR¢ A burning stomach pain
âEUR¢ Black bowel movements that look like tar
âEUR¢ Vomit that looks like blood or coffee grounds

Allergic reactions: Naproxen can cause serious allergic
reactions, including asthma-like symptoms (problems breathing,
swallowing, and wheezing) and rash.
Liver damage: Stop taking naproxen and tell your doctor right
away if you have nausea, vomiting, tiredness, loss of appetite,
itching, yellow coloring of skin or eyes, flu-like symptoms, and
dark urine.
Kidney problems: Naproxen can cause serious kidney problems,
including sudden kidney failure or worsening of kidney problems
that you already have.
Fluid retention: Naproxen can cause fluid retention (holding of
water in your body) and swelling. Fluid retention can be a serious
problem if you have high blood pressure or heart failure.
Pregnancy: Do not take naproxen during your last 3 months of
pregnancy because it may cause problems in the unborn child or
complications during delivery. Tell your doctor if you are
pregnant or planning to become pregnant
Breast-feeding: Tell your doctor if you are breast-feeding.

How Do I Take Naproxen?
When taking an over-the-counter naproxen product, 1 tablet (220
mg) should be taken every 8 to 12 hours while symptoms last.
You may take 2 tablets within the first hour of symptoms for the
first dose. However, you should not exceed 2 tablets (440 mg) in
any 8 to 12 hour period or 3 tablets (660 mg) in a 24-hour period.
If your healthcare provider has prescribed naproxen to you, you
should take it according to their directions.

FDA Naproxen Approval: 1976