Pregnancy
Do not take Arthrotec during pregnancy. Misoprostol can cause uterine contractions, miscarriage, premature birth, uterine rupture, or birth defects. Diclofenac may also harm the developing baby, especially later in pregnancy.
People who can become pregnant should use effective birth control during treatment. Before starting Arthrotec, a healthcare provider may require a negative pregnancy test. Contact your healthcare provider immediately if you become pregnant or think you may be pregnant while taking this medication.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Diclofenac and substances produced from misoprostol may pass into breast milk. Your healthcare provider will consider the benefits of breastfeeding, your need for treatment, and the possible risks to the nursing baby before recommending Arthrotec.
Use in Children
The safety and effectiveness of Arthrotec have not been established in children. For this reason, it is generally prescribed only to adults unless a qualified healthcare provider determines otherwise.
Dizziness and Drowsiness
Arthrotec may cause dizziness, drowsiness, blurred vision, or tiredness in some people. These effects may reduce your ability to react quickly or concentrate.
Do not drive, operate machinery, or perform potentially dangerous activities until you know how the medication affects you. Alcohol may make dizziness or drowsiness worse and can also increase the risk of stomach bleeding.
Stomach and Intestinal Problems
Arthrotec contains misoprostol to help protect the digestive tract, but serious stomach or intestinal complications can still occur. These may include inflammation, ulcers, bleeding, or a hole in the stomach or intestine.
These problems can develop at any time and may occur without warning symptoms. The risk is greater in older adults and in people who:
- Have previously had a stomach ulcer or gastrointestinal bleeding
- Take high doses or use the medication for a long time
- Smoke or drink alcohol regularly
- Take blood thinners, corticosteroids, aspirin, or certain antidepressants
- Have poor general health or advanced liver disease
Tell your healthcare provider about any history of ulcers, gastrointestinal bleeding, inflammatory bowel disease, or other digestive conditions before starting treatment.
Seek immediate medical attention if you develop black or bloody stools, vomit that contains blood or looks like coffee grounds, severe stomach pain, fainting, or unusual weakness.
Heart and Circulation Risks
Diclofenac and other NSAIDs may increase the risk of a heart attack, stroke, blood clot, or other serious cardiovascular problem. These events can occur without warning and may be fatal. The risk may increase with higher doses, longer treatment, or an existing history of heart or blood vessel disease.
Tell your healthcare provider if you have heart disease, high blood pressure, high cholesterol, diabetes, circulation problems, or a history of heart attack or stroke. Arthrotec should not be used around the time of coronary artery bypass graft surgery.
Seek emergency care if you develop chest pain, shortness of breath, weakness on one side of the body, or difficulty speaking.
High Blood Pressure and Fluid Retention
Arthrotec may cause new or worsening high blood pressure. It may also cause the body to retain fluid, leading to swelling or worsening heart failure.
Your healthcare provider may check your blood pressure before and during treatment. Report swelling in your feet, ankles, legs, or hands, rapid weight gain, or difficulty breathing.
Kidney Problems
Diclofenac can reduce blood flow to the kidneys and may cause new or worsening kidney problems. The risk is higher in older adults and in people who have kidney disease, heart failure, liver disease, dehydration, or low blood volume.
Some blood pressure medicines and water pills can further increase this risk. Your healthcare provider may order blood tests to monitor your kidney function during treatment.
Contact your healthcare provider if you notice reduced urination, swelling, unexplained weight gain, unusual tiredness, or shortness of breath.
Liver Problems
Arthrotec may cause abnormal liver test results or, rarely, serious liver injury. Tell your healthcare provider if you have liver disease or regularly consume alcohol.
Your healthcare provider may monitor your liver function, especially during long-term treatment. Stop taking the medication and seek medical advice promptly if you develop yellowing of the skin or eyes, dark urine, persistent nausea, unusual tiredness, loss of appetite, itching, or pain in the upper-right abdomen.
Blood Disorders and Bleeding
Diclofenac can affect blood clotting and may increase the risk of bleeding. It may also contribute to anemia, particularly when long-term gastrointestinal blood loss occurs.
Tell your healthcare provider if you have a bleeding disorder, anemia, or take medication that affects blood clotting. Blood tests may be needed during long-term treatment.
Report unusual bruising, prolonged bleeding, pale skin, shortness of breath, weakness, or unexplained tiredness.
Allergic Reactions and Asthma
Do not take Arthrotec if you have had an allergic reaction to diclofenac, misoprostol, aspirin, or another NSAID. People who have experienced asthma attacks, hives, or other allergic reactions after taking aspirin or an NSAID may have a serious reaction to Arthrotec.
Seek emergency care if you develop swelling of the face, lips, tongue, or throat; difficulty breathing; wheezing; hives; or a severe rash.
Serious Skin Reactions
NSAIDs can rarely cause serious or life-threatening skin reactions. These may occur without warning, including during the first weeks of treatment.
Stop taking Arthrotec and seek medical attention immediately if you develop a spreading rash, blisters, peeling skin, fever, facial swelling, or sores in your mouth or around your eyes.
Medication Interactions
Arthrotec may interact with several prescription and non-prescription medications. Some combinations may increase the risk of bleeding, ulcers, kidney damage, or other serious complications.
Important interactions may include:
- Anticoagulants and antiplatelet medicines, such as warfarin or clopidogrel
- Aspirin and other NSAIDs, such as ibuprofen or naproxen
- Corticosteroids, such as prednisone
- Certain antidepressants, including SSRIs and SNRIs
- ACE inhibitors, angiotensin receptor blockers, beta-blockers, and diuretics
- Lithium
- Methotrexate
- Digoxin
- Cyclosporine or tacrolimus
- Certain antifungal medicines that affect the CYP2C9 enzyme
Corticosteroids and some antidepressants may further increase the risk of gastrointestinal bleeding. Blood pressure medicines and diuretics may become less effective or increase the risk of kidney problems when combined with Arthrotec.
Tell your healthcare provider about every prescription medication, over-the-counter product, vitamin, and supplement you use. Do not take aspirin, ibuprofen, naproxen, or another pain reliever with Arthrotec unless your healthcare provider approves the combination.
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