The U.S. Food and Drug Administration (FDA) is warning that use of nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby.

Naproxen sodium is approved by FDA and is safe and effective when used according to the Drug Facts label. You should not take more medicine or for a longer period of time than the label says unless instructed by a healthcare provider.

Ask a healthcare provider before use if:

• You are currently using another medicine containing an NSAID (e.g., aspirin, magnesium salicylate, naproxen, ibuprofen, or ketoprofen).
• You are taking a blood thinner (anticoagulant), steroid, diuretic, or any other drug.
• You are pregnant or breastfeeding. Women in the last three months of pregnancy are specifically told not to use naproxen sodium or any NSAID without a healthcare provider’s permission.
• You are over the age of 60.
• You have had stomach ulcers or bleeding problems.
• You drink three or more alcoholic drinks every day.
• You are under a healthcare provider’s care for any serious condition.

Do not use if:

• You are preparing to have heart surgery or if you just had heart surgery.
• You have ever had an allergic reaction to any other pain reliever or fever reducer.
• You are a woman in the last three months of pregnancy unless your healthcare provider specifically tells you to. Problems in the unborn child or complications during delivery could occur.
• Tamper-evident packaging features such as seals, locks, and films are not clear or seem broken.
• Do not give an OTC medicine containing naproxen sodium to children under the age of 12 unless advised by a healthcare provider.

Stop use and ask a doctor if:

• An allergic reaction occurs. Seek medical help right away.
• Your fever gets worse or lasts more than three days, or if your pain gets worse and lasts more than 10 days.
• You have signs of stomach bleeding, such as you feel faint, vomit blood, have stomach pain or upset that lasts or does not get better, or have bloody or black stools.
• Redness or swelling is present in the painful area or if any new symptoms appear.
• You have difficulty swallowing or if it feels like the pill is stuck in your throat.
• You develop heartburn.
• You take too much. Immediately contact a healthcare provider or the poison control national helpline at 800.222.1222.

What are the side effects of naproxen sodium?

• Naproxen sodium, like other NSAIDs, may cause a severe allergic reaction, especially in people who are allergic to aspirin. If you experience serious symptoms such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, stop using the medicine and seek immediate medical attention.
• Severe stomach bleeding may occur. The chance is higher if you are age 60 or older; have had stomach ulcers or bleeding problems; or if you are taking a blood thinner (anticoagulant), steroid drug, or other medicines containing NSAIDs (e.g., aspirin, magnesium salicylate, naproxen sodium, ibuprofen, or ketoprofen).
• Long-term continuous use may increase the risk of heart attack or stroke.
• If upset stomach occurs, you may take the medicine with milk or food.