Bestazol 50/Bestazol 100 Adverse Reactions

The only adverse reaction resulting in discontinuation of therapy in greater than or equal to 3% of patients treated with cilostazol 50 or 100 mg twice daily was headache, which occurred with an incidence of 1.3%, 3.5% and 0.3% in patients treated with cilostazol 50 mg twice daily, 100 mg twice daily, or placebo, respectively. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all dose) versus 0.1% for placebo. (See table.)

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Other adverse reactions: Other adverse reaction seen with an incidence of greater than or equal to 2%, but occurring in the placebo group at least as frequently as in the 100 mg twice daily group, were as follows: Cardiovascular: Angina pectoris, hypertension.
Central Nervous System: Hypesthesia, paresthesia.
Dermatologic: Rash.
Gastrointestinal: Vomiting.
Genitourinary: Hematuria, urinary tract infection.
Respiratory: Bronchitis, dyspnea.
Miscellaneous: Arthritis, asthenia, flu syndrome, leg cramps.
Less frequent adverse reactions (less than 2%) that were experienced by patients exposed to cilostazol 50 or 100 mg twice daily in the 8 controlled clinical trials and that occurred at a greater frequency in the 100 mg twice-daily group than in the placebo group, regardless of suspected drug relationship, were as follows: Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, hemorrhage, hypotension, myocardial infarction, myocardial ischemia, syncope, varicose vein, vasodilation, ventricular extrasystoles, ventricular tachycardia.
Central Nervous System: Anxiety, insomnia, malaise, neuralgia.
Dermatologic: Dry skin, furunculosis, skin hypertrophy, urticaria.
Endocrine: Diabetes mellitus.
Gastrointestinal: Anorexia, cholelithiasis, colitis, duodenal ulcer, duodenitis, esophageal hemorrhage, esophagitis, gastritis, gastroenteritis, gum hemorrhage, hematemesis, increased gamma-glutamyltransferase, melena, peptic ulcer, periodontal abscess, rectal hemorrhage, stomach ulcer, tongue edema.
Genitourinary: Albuminuria, cystitis, urinary frequency, vaginal hemorrhage, vaginitis.
Hematologic/Lymphatic: Anemia, ecchymosis, iron deficiency anemia, polycythemia, purpura.
Metabolic/Nutritional: Gout, hyperlipemia, hyperuricemia, increased creatinine.
Musculoskeletal: Arthralgia, bone pain, bursitis, neck rigidity.
Respiratory: Asthma, epistaxis, hemoptysis, pneumonia, sinusitis.
Special senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye hemorrhage, retinal hemorrhage, tinnitus.
Miscellaneous: Chills, face edema, fever, generalized edema, pelvic pain, retroperitoneal hemorrhage.
Postmarketing experience: The following events have been reported spontaneously from worldwide postmarketing experience since launch of cilostazol in the United States.
Hematologic/Lymphatic: Agranulocytosis, granulocytopenia, thrombocytopenia, leucopenia, bleeding tendency.
Cardiovascular: Torsades de pointes, QTc prolongation (Torsades de pointes and QTc prolongation occurred in patients with cardiac disorders e.g., complete atrioventricular block, cardiac failure and bradyarrythmia, when treated with cilostazol), subacute thrombosis (occurred in patients treated with aspirin and "off label" use of cilostazol for prevention of thrombotic complication after coronary stenting).
Gastrointestinal: Gastrointestinal hemorrhage.
General disorders and administration site conditions: Pain, chest pain, hot flushes.
Hepatobilliary disorders: Hepatic dysfunction/abnormal liver function tests, jaundice.
Injury, poisoning and procedural complications: Extradural hematoma and subdural hematoma.
Investigations: Blood glucose increased, blood uric acid increased, platelet count decreased, white blood cell count decreased, blood urea increased.
Central Nervous System: Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident.
Respiratory: Pulmonary hemorrhage, interstitial pneumonia.
Skin: Hemorrhage subcutaneous, pruritus, skin eruptions including Stevens Johnson syndrome, skin drug eruption (dermatitis medicamentosa).