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Arthrotec Consumer (continued)
Diarrhea and upset stomach may occur within a few weeks after you start taking this medication, and usually last for about 1 week. See How to Use for ways to reduce diarrhea.
Nausea, heartburn, gas, stomach pain, constipation, headache, drowsiness, and dizziness may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Rarely, diarrhea can become so severe and persistent that it may lead to a large loss of your body's water and minerals (dehydration). Be sure to drink plenty of fluids and get enough minerals/electrolytes to prevent dehydration. Tell your doctor right away if you develop any of the following signs: severe/persistent diarrhea, stomach cramps, severe dizziness, decreased amount of urine, muscle weakness.
Tell your doctor right away if you have any serious side effects, including: difficult/painful swallowing, swelling of the hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes (e.g., depression), fast/pounding heartbeat, persistent/severe headache, fainting, unusual/heavy vaginal bleeding, menstrual problems/irregular periods, unusual tiredness, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), change in the amount of urine, unexplained stiff neck.
This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking diclofenac/misoprostol and tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Arthrotec (diclofenac sodium, misoprostol) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking diclofenac/misoprostol, tell your doctor or pharmacist if you are allergic to either of these drugs; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, inflammatory bowel disease), heart disease (e.g., history of heart attack), high blood pressure, stroke, swelling (edema, fluid retention), blood disorders (e.g., anemia), bleeding or clotting problems, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), growths in the nose (nasal polyps).
Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.
Before having surgery, tell your doctor or dentist that you are using this medication.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
Diclofenac may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding, kidney problems, and worsening heart problems.
This medication must not be used during pregnancy. It can harm the unborn baby and mother. Use reliable forms of birth control to prevent pregnancy while taking this medication. If you become pregnant or think you may be pregnant, inform your doctor immediately. See Warning section.
This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
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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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