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Diclofenac/misoprostol (By mouth)

Diclofenac Sodium (dye-KLOE-fen-ak SOE-dee-um), Misoprostol (mye-soe-PROST-ol)

Treats arthritis pain. This medicine is a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a prostaglandin (to protect against ulcers of the stomach and intestines).

Brand Name(s):

Arthrotec, Arthrotec 75

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you are pregnant, or have had an allergic reaction (including an asthma attack) to diclofenac, misoprostol, or similar medicines. Some other NSAID medicines are aspirin, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Voltaren®. Some other prostaglandin medicines are alprostadil, iloprost, latanoprost, Caverject®, Muse®, Prostin®, Ventavis®, and Xalatan®. Do not use this medicine right before or right after you have coronary artery bypass graft (CABG) surgery .

How to Use This Medicine:

Tablet, Coated Tablet

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • It is best to take this medicine with food to prevent diarrhea and stomach upset.
  • Swallow the tablet whole with a full glass of water. Do not crush, break, or chew it.
  • You might also be given another pill that contains only diclofenac or misoprostol, if this combination tablet does not have enough of one of the medicines. Take all medicines that are prescribed.

If a dose is missed:

  • Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are also using aspirin, cyclosporine (Gengraf®, Neoral®, Sandimmune®), digoxin (Lanoxin®), lithium (Eskalith®, Lithobid®), methotrexate (Rheumatrex®, Trexall®), phenobarbital, rifampin (Rifadin®, Rimactane®), voriconazole (Vfend®), insulin or diabetes medicine that you take by mouth (such as glimepiride, glyburide, metformin, Actos®, Janumet®, Januvia®), a steroid medicine (such as dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, Medrol®), medicine to lower blood pressure (such as benazepril, enalapril, lisinopril, Lotrel®, Vasotec®, Zestoretic®, Zestril®), a diuretic (water pill, such as furosemide, hydrochlorothiazide (HCTZ), spironolactone, torsemide, triamterene, Aldactone®, Demadex®, Lasix®), or a blood thinner (such as warfarin, Coumadin®, Jantoven®).
  • Do not use any other NSAID medicine unless your doctor tells you to. Other NSAIDs may include aspirin, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Voltaren®.
  • Do not use an antacid that contains magnesium, such as Gaviscon®, Maalox®, Milk of Magnesia, Mylanta®, Pepcid® Complete, Rolaids®. Ask your doctor or pharmacist if you are not sure which antacid you can use.
  • Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Continue to use birth control for at least 1 month after you stop using this medicine. You will need to have a negative pregnancy test before you start using this medicine.
  • Make sure your doctor knows if you are breastfeeding or have kidney or liver disease, anemia, asthma, bleeding problems, diabetes, porphyria, high blood pressure, congestive heart failure (CHF), or other heart problems. Tell your doctor if you have a digestion problem (such as inflammatory bowel disease), lupus, or a similar connective tissue disease.
  • This medicine may raise your risk for a heart attack or stroke. This is more likely in people who already have heart disease, or who use this medicine for a long time.
  • This medicine may cause bleeding in your stomach or intestines. This is more likely if you have had a stomach or intestinal ulcer or bleeding, you smoke or drink alcohol regularly, you are over 60 years of age, you have poor health, or you use other medicines (such as steroids or blood thinners). These problems can happen without warning signs and may be life threatening.
  • Stop using this medicine and tell your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, nausea, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • Serious skin reactions can occur with this medicine. Stop taking this medicine and tell your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
  • Make sure any doctor or dentist who treats you knows that you are using this medicine.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Blistering, peeling, or red skin rash
  • Bloody or black, tarry stools, vomiting blood or material that looks like coffee grounds, severe stomach pain, severe or ongoing diarrhea
  • Change in how much or how often you urinate
  • Chest pain that may spread to your arms, jaw, back, or neck, or faint
  • Chest pain, trouble breathing, coughing up blood
  • Cold sweat, bluish-colored skin, rapid weight gain, swelling in your hands, ankles, or feet
  • Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
  • Fever, chills, cough, sore throat, and body aches
  • Numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, problems with vision, speech, or walking
  • Pain in your lower leg (calf)
  • Severe neck pain and stiffness, sensitivity to light
  • Unusual bleeding or bruising, including heavy vaginal bleeding

If you notice these less serious side effects, talk with your doctor:

  • Mild nausea or stomach pain, constipation, diarrhea, gas, upset stomach that lasts longer than 7 days
  • Ringing in your ears

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 9/4/2014


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