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adverse reactions
ADVERSE REACTIONS Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. cilostazol tablets (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on cilostazol and 134 days for patients on placebo. The only adverse event resulting in discontinuation of therapy in ≥ 3% of patients treated with cilostazol 50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with cilostazol 50 mg b.i.d., 100 mg b.i.d. or placebo, respectively. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1% for placebo. The most commonly reported adverse events, occurring in ≥ 2% of patients treated with cilostazol 50 or 100 mg b.i.d., are shown in the table below. Other events seen with an incidence of ≥ 2%, but occurring in the placebo group at least as frequently as in the 100 mg b.i.d. group were: asthenia, hypertension, vomiting, leg cramps, hyperesthesia, paresthesia, dyspnea, rash, hematuria, urinary tract infection, flu syndrome, angina pectoris, arthritis, and bronchitis. Most Commonly Reported AEs (Incidence ≥2%) in Patients on Cilostazol 50 mg b.i.d. or 100 mg b.i.d. and Occurring at a Rate in the 100 mg b.i.d. Group Higher Than in Patients on Placebo Adverse Events (AEs) by Body System Cilostazol 50 mg b.i.d. (N=303) % Cilostazol 100 mg b.i.d. (N=998) % Placebo (N=973) % BODY AS A WHOLE Abdominal pain 4 5 3 Back pain 6 7 6 Headache 27 34 14 Infection 14 10 8 CARDIOVASCULAR Palpitation 5 10 1 Tachycardia 4 4 1 DIGESTIVE Abnormal stools 12 15 4 Diarrhea 12 19 7 Dyspepsia 6 6 4 Flatulence 2 3 2 Nausea 6 7 6 METABOLIC & NUTRITIONAL Peripheral edema 9 7 4 MUSCULO-SKELETAL Myalgia 2 3 2 NERVOUS Dizziness 9 10 6 Vertigo 3 1 1 RESPIRATORY Cough increased 3 4 3 Pharyngitis 7 10 7 Rhinitis 12 7 5 Less frequent adverse events (< 2%) that were experienced by patients exposed to cilostazol 50 mg b.i.d. or 100 mg b.i.d. in the eight controlled clinical trials and that occurred at a frequency in the 100 mg b.i.d. group greater than in the placebo group, regardless of suspected drug relationship, are listed below. Body As a Whole: Chills, face edema, fever, generalized edema, malaise, neck rigidity, pelvic pain, retroperitoneal hemorrhage. Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, hemorrhage, hypotension, myocardial infarction, myocardial ischemia, nodal arrhythmia, postural hypotension, supraventricular tachycardia, syncope, varicose vein, vasodilation, ventricular extrasystoles, ventricular tachycardia. Digestive: Anorexia, cholelithiasis, colitis, duodenal ulcer, duodenitis, esophageal hemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum hemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal hemorrhage, stomach ulcer, tongue edema. Endocrine: Diabetes mellitus. Hemic and Lymphatic: Anemia, ecchymosis, iron deficiency anemia, polycythemia, purpura. Metabolic and Nutritional: : Increased creatinine, gout, hyperlipemia, hyperuricemia. Musculoskeletal: Arthralgia, bone pain, bursitis. Nervous: Anxiety, insomnia, neuralgia. Respiratory: Asthma, epistaxis, hemoptysis, pneumonia, sinusitis. Skin and Appendages: Dry skin, furunculosis, skin hypertrophy, urticaria. Special Senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye hemorrhage, retinal hemorrhage, tinnitus. Urogenital: Albuminuria, cystitis, urinary frequency, vaginal hemorrhage, vaginitis.