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.

Diclofenac sodium is approved by the FDA and is safe and effective when used according to the Drug Facts label. You should never take more diclofenac sodium or for a longer period of time than the label instructs unless your doctor or other healthcare professional tells you to. Certain health risks such as heart attack, stroke, liver damage, or stomach bleeding may increase if you use more than directed or for longer than directed.

Ask a healthcare professional before use if:

• You have problems or serious side effects from taking pain relievers or fever reducers.
• You are currently using another medicine containing an NSAID (e.g., aspirin, magnesium salicylate, naproxen sodium, ibuprofen, or ketoprofen).
• You are over the age of 60.
• You are taking a blood thinner (anticoagulant), steroid drug, or diuretic.
• You have or have a history of having stomach ulcers, bleeding problems, heartburn, or other stomach problems.
• You drink three or more alcoholic drinks per day.
• You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke.
• You are pregnant or breastfeeding. Women in the last three months of pregnancy are specifically told to not use diclofenac sodium or any NSAID unless directed to do so by a doctor.
• You are under age 18 years.

Do not use if:

• You have ever had an allergic reaction to any other pain reliever or fever reducer.
• You are preparing to have heart surgery or if you just had heart surgery.
• You are treating strains, sprains, bruises, or sports injuries – diclofenac sodium has not been shown to work for these types of injuries.
• You are treating more than two body areas at the same time.
• Tamper-evident packaging features such as seals, locks, and films are not clear or seem broken.

Stop use and ask a doctor if:

• An allergic reaction occurs. Seek medical help right away.
• Your pain gets worse or lasts more than 21 days.
• Redness or swelling is present in the painful area.
• Fever, skin irritation, or any new symptoms occur.
• You have signs of stomach bleeding, such as if you feel faint, vomit blood, have stomach pain or upset that lasts or does not get better, or have bloody or black stools.
• You have symptoms of heart problems or stroke, such as chest pain, trouble breathing, leg swelling, weakness in one part or side of body, or slurred speech.
• You take too much. Immediately contact a healthcare professional or the Poison Control national helpline at 800.222.1222.

What are the side effects of diclofenac sodium?

• Diclofenac sodium, like all NSAIDs, may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters.
• 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)