Aleve (naproxen) is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Aleve is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Aleve may also be used for other purposes not listed in this medication guide.

Important information about Aleve

Aleve can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Aleve. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Aleve can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking Aleve. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Aleve (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen.

Do not drink alcohol while taking Aleve. Alcohol can increase the risk of stomach bleeding caused by Aleve. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result.

Before taking Aleve

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use Aleve just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to Aleve, or if you have a history of allergic reaction to aspirin or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Aleve:

• a history of heart attack, stroke, or blood clot;

• heart disease, congestive heart failure, high blood pressure;

• a history of stomach ulcers or bleeding;

• liver or kidney disease;

• asthma;

• polyps in your nose;

• a bleeding or blood clotting disorder; or

• if you smoke.

FDA pregnancy category C. Before using Aleve, tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Aleve during the last 3 months of pregnancy may result in birth defects. Do not take Aleve during pregnancy unless your doctor has told you to. Aleve can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

Naproxen Pregnancy and Breastfeeding Warnings

Naproxen is also known as: Aflaxen, Aleve, Anaprox, Anaprox-DS, Comfort Pac with Naproxen, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan, Naprosyn, Naproxen Sodium DS

Naproxen Pregnancy Warnings

Naproxen cord blood levels were obtained from two twins delivered at 30 weeks gestation of a mother treated for premature labor with naproxen 250 mg every eight hours, beginning 30 hours prior to delivery. The last dose was administered five hours before delivery. Naproxen concentrations were 59.5 mcg/mL in the first twin and 68 mcg/mL in the second twin. Both infants suffered from pulmonary hypertension and required assisted ventilation. One infant died. The pulmonary hypertension was presumed to be the result of intrauterine closure of the ductus arteriosus mediated by the naproxen-induced inhibition of fetal prostaglandin synthesis.

Naproxen has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of decreased fetal body weight, an increase in embryofetal death, and an increase in the total incidences of fetal abnormalities. These fetal abnormalities included increasing incidences of specific malformations (cardiac interventricular septal defect, fused caudal vertebrae, and variations (absent intermediate lobe of the lung, irregular ossification of the skull, and incompletely ossified sternal centra). There are no controlled data in human pregnancy. Use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Naproxen should be avoided in the third trimester. Naproxen is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Naproxen Breastfeeding Warnings

Naproxen is excreted into human milk in very small amounts. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants (prostaglandin-inhibiting effect on neonates), the use in nursing women should be avoided.

The excretion of naproxen into breast milk was evaluated in a 23-year-old female following chronic administration of naproxen 250 mg twice a day. Milk concentrations peaked at 4 hours post-dose and ranged from 1.14 to 1.25 ng/mL. Following a regimen of naproxen 375 mg twice a day, maximum milk concentrations averaged 2.37 ng/mL. Maternal and infant plasma samples were not obtained during the study. However, urine was collected from both mother and infant. The infant eliminated 0.47 mg naproxen and conjugates in the urine over a 12-hour post-dose period.