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.
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
Gynecological: Gynecological disorders previously reported with misoprostol
use have also been reported for women receiving ARTHROTEC. Postmenopausal
vaginal bleeding may be related to ARTHROTEC administration. If it occurs,
diagnostic workup should be undertaken to rule out gynecological pathology.
There have been reports in which intravaginal administration of misoprostol
in pregnant women resulted in rupture of the uterus and death of the infant.
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,
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,
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,
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.