ADVERSE REACTIONS
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.
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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REPORTS OF SUSPECTED ARTHROTEC SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Arthrotec. The information is not vetted and should not be considered as verified clinical evidence.
Possible Arthrotec side effects / adverse reactions in 80 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-09-30
Patient: 80 year old female
Reactions: Bone Marrow Failure
Adverse event resulted in: hospitalization
Suspect drug(s):
Enalapril Maleate
Dosage: 20 mg daily
Administration route: Oral
Indication: Hypertension
Start date: 2004-01-01
End date: 2011-09-09
Arthrotec
Dosage: unk
Administration route: Oral
Indication: Arthralgia
Start date: 2004-01-01
End date: 2011-09-06
Acetaminophen
Dosage: unk
Administration route: Oral
Indication: Pain
Start date: 2004-01-01
End date: 2011-09-07
Possible Arthrotec side effects / adverse reactions in 64 year old male
Reported by a physician from Sweden on 2011-10-04
Patient: 64 year old male
Reactions: Cardiac Failure
Adverse event resulted in: hospitalization
Suspect drug(s):
Byetta
Dosage: 20 mg daily
Start date: 2008-10-31
Arthrotec
Dosage: 50 mg daily
Administration route: Oral
Start date: 2008-05-15
End date: 2011-08-09
Other drugs received by patient: Felodipine; Metformin; Tenormin
Possible Arthrotec side effects / adverse reactions in 80 year old male
Reported by a physician from Norway on 2011-10-25
Patient: 80 year old male
Reactions: Muscle Haemorrhage, Drug Interaction, Haemorrhagic Anaemia, Myocardial Infarction, Fall, Haemorrhage Subcutaneous
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Fragmin
Dosage: 7500 iu, 2x/day, subcutaneous
Indication: Atrial Fibrillation
Start date: 2008-12-09
End date: 2008-12-22
Warfarin Sodium
Dosage: as per schedule
Indication: Atrial Fibrillation
Start date: 2008-12-20
End date: 2008-12-23
Cordarone
Dosage: 300 mg, iv bolus
Indication: Atrial Fibrillation
Start date: 2008-12-11
End date: 2008-12-11
Cordarone
Dosage: gradually reduced doses, oral
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2008-12-15
End date: 2008-12-26
Cordarone
Dosage: 1500 mg, intravenous
Indication: Atrial Fibrillation
Start date: 2008-12-12
End date: 2008-12-14
Arthrotec
Dosage: oral
Administration route: Oral
Start date: 2008-12-24
End date: 2008-12-26
Warfarin Sodium
Dosage: as per schedule, oral
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2008-12-10
End date: 2008-12-13
Other drugs received by patient: Bumetanide; Amaryl; Allopurinol; Metoprolol Succinate; Metformin HCL; Monoket OD (Isosorbide Mononitrate); Potassium Chloride; Prednisolone; Apocillin (Phenoxymethylpenicillin Potassium)
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