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Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. Pletal (cilostazol) (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on Pletal (cilostazol) and 134 days for patients on placebo.
The only adverse event resulting in discontinuation of therapy in ≥ 3% of patients treated with Pletal (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 Pletal (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 Pletal (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, hypesthesia, paresthesia, dyspnea, rash, hematuria, urinary tract infection, flu syndrome, angina pectoris, arthritis, and bronchitis.
Most Commonly Reported AEs (Incidence ≥ 2%) in Patients on Pletal (cilostazol) (PLT) 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||PLT 50 mg b.i.d.
|PLT 100 mg b.i.d.
|BODY AS A WHOLE|
|METABOLIC & NUTRITIONAL|
Less frequent adverse events ( < 2%) that were experienced by patients exposed to Pletal (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 haemorrhage.
Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, haemorrhage, 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 haemorrhage, esophagitis, increased GGT, gastritis, gastroenteritis, gum haemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal haemorrhage, 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 haemorrhage, retinal haemorrhage, tinnitus.
Urogenital: Albuminuria, cystitis, urinary frequency, vaginal haemorrhage, vaginitis.
The following events have been reported spontaneously from worldwide post-marketing experience since the launch of Pletal (cilostazol) in the US.
- Blood and lymphatic system disorders:
- Cardiac disorders:
- 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. Cilostazol was used “off label” due to its positive chronotropic action)
- Gastrointestinal disorders:
- Gastrointestinal haemorrhage
- General disorders and administration site conditions:
- Pain, chest pain, hot flushes
- Hepatobiliary disorders:
- Hepatic dysfunction/abnormal liver function tests, jaundice
- Injury, poisoning and procedural complications:
- Extradural haematoma and subdural haematoma
- Nervous system disorders:
- Intracranial haemorrhage, cerebral haemorrhage, cerebrovascular accident
- Respiratory, thoracic and mediastinal disorders:
- Pulmonary haemorrhage, interstitial pneumonia
- Skin and subcutaneous tissue disorders:
- Haemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa)
- Vascular disorders:
- Subacute thrombosis (these cases of subacute thrombosis occurred in patients treated with aspirin and “off label” use of cilostazol for prevention of thrombotic complication after coronary stenting)
Read the Pletal (cilostazol) Side Effects Center for a complete guide to possible side effects
Since Pletal (cilostazol) is extensively metabolized by cytochrome P-450 isoenzymes, caution should be exercised when Pletal (cilostazol) is coadministered with inhibitors of CYP3A4 such as ketoconazole and erythromycin or inhibitors of CYP2C19 such as omeprazole. Pharmacokinetic studies have demonstrated that omeprazole and erythromycin significantly increased the systemic exposure of cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of cilostazol among patients concurrently treated with diltiazem, an inhibitor of CYP3A4 (see CLINICAL PHARMACOLOGY, Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions). Pletal (cilostazol) does not, however, appear to cause increased blood levels of drugs metabolized by CYP3A4, as it had no effect on lovastatin, a drug with metabolism very sensitive to CYP3A4 inhibition.
Use with other antiplatelet agents
Pletal (cilostazol) inhibits platelet aggregation but in a reversible manner. Caution is advised in patients at risk of bleeding from surgery or pathologic processes. Platelet aggregability returns to normal within 96 hours of stopping Pletal (cilostazol) . Caution is advised in patients receiving both Pletal (cilostazol) and any other antiplatelet agent, or in patients with thrombocytopenia.
Repeated oral administration of cilostazol to dogs (30 or more mg/kg/day for 52 weeks, 150 or more mg/kg/day for 13 weeks, and 450 mg/kg/day for 2 weeks), produced cardiovascular lesions that included endocardial haemorrhage, hemosiderin deposition and fibrosis in the left ventricle, haemorrhage in the right atrial wall, haemorrhage and necrosis of the smooth muscle in the wall of the coronary artery, intimal thickening of the coronary artery, and coronary arteritis and periarteritis. At the lowest dose associated with cardiovascular lesions in the 52-week study, systemic exposure (AUC) to unbound cilostazol was less than that seen in humans at the maximum recommended human dose (MRHD) of 100 mg b.i.d. Similar lesions have been reported in dogs following the administration of other positive inotropic agents (including PDE III inhibitors) and/or vasodilating agents. No cardiovascular lesions were seen in rats following 5 or 13 weeks of administration of cilostazol at doses up to 1500 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were only about 1.5 and 5 times (male and female rats, respectively) the exposure seen in humans at the MRHD. Cardiovascular lesions were also not seen in rats following 52 weeks of administration of cilostazol at doses up to 150 mg/kg/day. At this dose, systemic exposures (AUCs) to unbound cilostazol were about 0.5 and 5 times (male and female rats, respectively) the exposure in humans at the MRHD. In female rats, cilostazol AUCs were similar at 150 and 1500 mg/kg/day. Cardiovascular lesions were also not observed in monkeys after oral administration of cilostazol for 13 weeks at doses up to 1800 mg/kg/day. While this dose of cilostazol produced pharmacologic effects in monkeys, plasma cilostazol levels were less than those seen in humans given the MRHD, and those seen in dogs given doses associated with cardiovascular lesions.
Read the Pletal Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/19/2007
This monograph has been modified to include the generic and brand name in many instances.
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