Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.

Diclofenac and misoprostol is a combination medicine used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.

Diclofenac and misoprostol may also be used for purposes not listed in this medication guide.

Diclofenac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac and misoprostol, especially in older adults.

You should not use this medicine if you are allergic to diclofenac or misoprostol, or:

• if you have active bleeding in your stomach or intestines;
• if you are pregnant; or
• if you have a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• liver or kidney disease; or
• fluid retention.

Do not use this medicine if you are pregnant. Diclofenac and misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus. Use an effective form of birth control to prevent pregnancy while you are using this medicine. Tell your doctor right away if you become pregnant during treatment.

You will need to have a pregnancy test within 2 weeks before you start taking diclofenac and misoprostol. You may need to start taking this medicine only on the 2nd or 3rd day of a normal menstrual period.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Use Diclofenac And Misoprostol (Arthrotec) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using diclofenac and misoprostol and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• abnormal vaginal bleeding;
• heartburn, indigestion stomach pain, gas;
• nausea, vomiting;
• diarrhea, constipation; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb diclofenac and misoprostol.

Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to diclofenac (such as aspirin, ibuprofen, ketoprofen, or naproxen).