Medications and Drugs
Brand Names: Arthrotec
Generic Name: diclofenac and misoprostol (Pronunciation: dye KLOE fen ak and mye so PROST ole)
What is diclofenac and misoprostol (Arthrotec)?
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.
Diclofenac and misoprostol may also be used for purposes not listed in this medication guide.
Arthrotec 50 mg
round, white, imprinted with SEARLE 1411, AAAA 50
Arthrotec 75 mg
round, white, imprinted with SEARLE 1421, AAAA 75
What are the possible side effects of diclofenac and misoprostol (Arthrotec)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using diclofenac and misoprostol and call your doctor at once if you have a serious side effect such as:
Less serious side effects may include:
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.
What is the most important information I should know about diclofenac and misoprostol (Arthrotec)?
Misoprostol can cause birth defects, miscarriage, premature labor, or rupture of the uterus if the medication is taken during pregnancy. Diclofenac can cause birth defects if it is taken during the last 3 months of pregnancy.
Do not use diclofenac and misoprostol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.
This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use diclofenac and misoprostol just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac and misoprostol, especially in older adults.
Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by diclofenac.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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