Arthrotec Side Effects

Please note - some side effects for Arthrotec may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Arthrotec - for the consumer

Arthrotec

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Arthrotec:

Diarrhea; dizziness; drowsiness; gas; headache; indigestion; nausea; stomach pain; swelling; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding and ulcers in the stomach and intestines; dark urine; fever; heart failure; increase in asthma attacks; increased liver injury; loss of appetite; severe diarrhea; sore throat; trouble breathing; unusual bleeding or bruising; vaginal bleeding after menopause; vision or hearing problems; vomit that looks like coffee grounds; weight loss; yellowing of the skin or eyes.

For the professional

Arthrotec

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.

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. Postmenopausal vaginal bleeding may be related to administration of Arthrotec. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology.

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.

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, 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: Alkaline phosphatase 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.

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