Arthrotec

Arthrotec Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Arthrotec (diclofenac sodium/misoprostol) is used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), and misoprostol is a prostaglandin that protects the stomach from irritating effects of NSAIDs. This medication is available in generic form. Common side effects include diarrhea and upset stomach within a few weeks after you start taking this medication, and usually last for about 1 week.

For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose of Arthrotec is 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol. Arthrotec may interact with blood thinners, cyclosporine, digoxin, diuretics (water pills), insulin or oral diabetes medicine, lithium, methotrexate, phenobarbital, steroids, aspirin or other NSAIDs, or ACE inhibitors. Tell your doctor all medications you use. Arthrotec must not be used during pregnancy. It can harm the fetus and mother. Use birth control while taking this medication. This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Our Arthrotec (diclofenac sodium/misoprostol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Arthrotec in Detail - Patient Information: Side Effects

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:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild stomach pain, nausea, diarrhea, bloating, gas;
  • dizziness, drowsiness, headache;
  • blurred vision, ringing in your ears; or
  • unusual vaginal bleeding.

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.

Read the entire detailed patient monograph for Arthrotec (Diclofenac Sodium, Misoprostol) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Arthrotec Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

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 immediately if you develop any of the following signs: severe/persistent diarrhea, stomach cramps, severe dizziness, decreased amount of urine, muscle weakness.

Tell your doctor immediately if any of these unlikely but serious side effects occur: 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.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, seizures.

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 immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 entire patient information overview for Arthrotec (Diclofenac Sodium, Misoprostol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Arthrotec FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions associated with ARTHROTEC

Adverse reaction information for ARTHROTEC is derived from Phase III multinational controlled clinical trials in over 2,000 patients receiving ARTHROTEC 50 or ARTHROTEC 75, as well as from blinded, controlled trials of Voltaren® Delayed-Release tablets (diclofenac) and Cytotec® tablets (misoprostol).

Gastrointestinal

GI disorders had the highest reported incidence of adverse events for patients receiving ARTHROTEC. These events were generally minor, but led to discontinuation of therapy in 9% of patients on ARTHROTEC and 5% of patients on diclofenac. For GI ulcer rates, see Clinical Studies-Upper gastrointestinal safety.

GI disorder ARTHROTEC Diclofenac
Abdominal pain 21% 15%
Diarrhea 19% 11%
Dyspepsia 14% 11%
Nausea 11% 6%
Flatulence 9% 4%

ARTHROTEC can cause more abdominal pain, diarrhea, and other GI symptoms than diclofenac alone.

Diarrhea and abdominal pain developed early in the course of therapy, and were usually self-limited (resolved after 2 to 7 days). Rare instances of profound diarrhea leading to severe dehydration have been reported in patients receiving misoprostol. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if ARTHROTEC is prescribed. The incidence of diarrhea can be minimized by administering ARTHROTEC with food and by avoiding coadministration with magnesium-containing antacids.

Gynecological

Gynecological disorders previously reported with misoprostol use have also been reported for women receiving ARTHROTEC (see below). Postmenopausal vaginal bleeding may be related to administration of ARTHROTEC. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology (see BOXED CONTRAINDICATIONS AND WARNINGS).

Elderly

Overall, there were no significant differences in the safety profile of ARTHROTEC in over 500 patients 65 years of age or older compared with younger patients.

Other adverse experiences reported occasionally or rarely with ARTHROTEC, diclofenac or other NSAIDs, or misoprostol are:

Body as a whole: Asthenia, death, fatigue, fever, infection, malaise, sepsis, chills.

Cardiovascular system: Arrhythmia, atrial fibrillation, congestive heart failure, hypertension, hypotension, increased CPK, increased LDH, myocardial infarction, palpitations, phlebitis, premature ventricular contractions, syncope, tachycardia, vasculitis.

Central and peripheral nervous system: Coma, convulsions, dizziness, drowsiness, headache, hyperesthesia, hypertonia, hypoesthesia, insomnia, meningitis, migraine, neuralgia, paresthesia, somnolence, stroke, tremor, vertigo.

Digestive: Anorexia, appetite changes, constipation, dry mouth, dysphagia, enteritis, esophageal ulceration, esophagitis, eructation, gastritis, gastroesophageal reflux, GI bleeding, GI neoplasm benign, glossitis, heartburn, hematemesis, hemorrhoids, intestinal perforation, peptic ulcer, stomatitis and ulcerative stomatitis, tenesmus, vomiting.

Female reproductive disorders: Breast pain, dysmenorrhea, intermenstrual bleeding, leukorrhea, menstrual disorder, menorrhagia, vaginal hemorrhage.

Hemic and lymphatic system: Agranulocytosis, anemia, aplastic anemia, coagulation time increased, ecchymosis, eosinophilia, epistaxis, hemolytic anemia, leukocytosis, leukopenia, lymphadenopathy, melena, pancytopenia, pulmonary embolism, purpura, rectal bleeding, thrombocythemia, thrombocytopenia.

Hypersensitivity: Angioedema, laryngeal/pharyngeal edema, urticaria.

Liver and biliary system: Abnormal hepatic function, bilirubinemia, hepatitis, jaundice, liver failure, pancreatitis.

Male reproductive disorders: Impotence, perineal pain.

Metabolic and nutritional: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, BUN increased, dehydration, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperuricemia, hypoglycemia, hyponatremia, periorbital edema, porphyria, weight changes.

Musculoskeletal system: Arthralgia, myalgia.

Psychiatric: Anxiety, concentration impaired, confusion, depression, disorientation, dream abnormalities, hallucinations, irritability, nervousness, paranoia, psychotic reaction.

Respiratory system: Asthma, coughing, dyspnea, hyperventilation, pneumonia, respiratory depression.

Skin and appendages: Acne, alopecia, bruising, eczema, erythema multiforme, exfoliative dermatitis, pemphigoid reaction, photosensitivity, pruritus, pruritus ani, rash, skin ulceration, Stevens-Johnson syndrome, sweating increased, toxic epidermal necrolysis.

Special senses: Hearing impairment, taste loss, taste perversion, tinnitus.

Urinary system: Cystitis, dysuria, hematuria, interstitial nephritis, micturition frequency, nocturia, nephrotic syndrome, oliguria/polyuria, papillary necrosis, proteinuria, renal failure, urinary tract infection.

Vision: Amblyopia, blurred vision, conjunctivitis, diplopia, glaucoma, iritis, lacrimation abnormal, night blindness, vision abnormal.

Read the entire FDA prescribing information for Arthrotec (Diclofenac Sodium, Misoprostol) »

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Arthrotec - User Reviews

Arthrotec User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Arthrotec sorted by most helpful. Patient Discussions FAQs

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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