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| __NOTOC__
| | #REDIRECT [[Cilostazol#Adverse Reactions]] |
| {{Cilostazol}}
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| {{CMG}}; {{AE}} {{AZ}}
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| ==Adverse Reactions==
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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 (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on PLETAL and 134 days for patients on placebo.
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| The only adverse event resulting in discontinuation of therapy in ≥3% of patients treated with PLETAL 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 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.
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| The most commonly reported adverse events, occurring in ≥2% of patients treated with PLETAL 50 or 100 mg b.i.d., are shown in the table (below).
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| 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]].
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| [[File:AdverseCilostazol.JPG|700px]]
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| Less frequent adverse events (<2%) that were experienced by patients exposed to PLETAL 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.
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| '''Body as a whole:''' [[Chills]], face [[edema]], [[fever]], [[generalized edema]], [[malaise]], [[neck rigidity]], [[pelvic pain]], [[retroperitoneal haemorrhage]].
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| '''Cardiovascular:''' [[Atrial fibrillation]], [[atrial flutter]], cerebral [[infarct]],[[ cerebral ischemia]], [[congestive heart failure]], [[Cardiac arrest|heart arrest]],[[ haemorrhage]], [[hypotension]], [[myocardial infarction]], [[myocardial ischemia]], nodal arrhythmia, [[postural hypotension]], [[supraventricular tachycardia]], [[syncope]], [[varicose vein]], [[vasodilation]], [[ventricular extrasystoles]], [[ventricular tachycardia]].
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| '''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.
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| '''Endocrine:''' [[Diabetes mellitus]].
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| '''Hemic and Lymphatic:''' [[Anemia]], [[ecchymosis]],[[ iron deficiency anemia]], [[polycythemia]], [[purpura]].
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| '''Metabolic and Nutritional:''' Increased [[creatinine]], [[gout]], [[hyperlipemia]], [[hyperuricemia]].
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| '''Musculoskeletal:''' [[Arthralgia]], bone pain, [[bursitis]].
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| '''Nervous:''' [[Anxiety]], [[insomnia]], [[neuralgia]].
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| '''Respiratory:''' [[Asthma]], [[epistaxis]], [[hemoptysis]], [[pneumonia]], [[sinusitis]].
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| '''Skin and Appendages:''' Dry skin, [[furunculosis]], skin hypertrophy, [[urticaria]].
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| '''Special Senses:''' [[Amblyopia]], [[blindness]], [[conjunctivitis]], [[diplopia]], ear pain, eye haemorrhage, [[retinal haemorrhage]], [[tinnitus]].
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| '''Urogenital:''' [[Albuminuria]], [[cystitis]], [[urinary frequency]], vaginal haemorrhage, vaginitis.
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| ===Post-Marketing Experience===
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| The following events have been reported spontaneously from worldwide post-marketing experience since the launch of PLETAL in the US.
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| '''Blood and lymphatic system disorders:'''
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| -
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| [[Agranulocytosis]],[[ aplastic anemia]], [[granulocytopenia]], [[pancytopenia]], [[thrombocytopenia]], [[leukopenia]],
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| [[bleeding tendency]]
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| '''Cardiac disorders:'''
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| -
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| [[Torsades de pointes]], [[QT prolongation|QTc prolongation]] (torsades de pointes and QTc prolongation occurred in patients with cardiac disorders, e.g. [[complete atrioventricular block]], c[[ardiac failure ]]and [[bradyarrythmia]], when treated with cilostazol. Cilostazol was used "off label" due to its positive [[chronotropic]] action)
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| '''Gastrointestinal disorders:'''
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| Gastrointestinal haemorrhage
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| '''General disorders and administration site conditions''':
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| Pain, [[chest pain]],
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| [[hot flushes]]
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| '''Hepatobiliary disorders:'''
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| -
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| Hepatic dysfunction/abnormal liver function tests,
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| [[jaundice]]
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| '''Injury, poisoning and procedural complications:'''
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| -
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| Extradural [[haematoma ]]and subdural haematoma
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| '''Investigations:'''
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| [[Blood glucose]] increased, blood [[uric acid]] increased, [[platelet count]] decreased, [[white blood cell count]] decreased, increase in [[BUN]] (blood urea increased), blood pressure increase
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| '''Nervous system disorders:'''
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| -
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| [[Intracranial haemorrhage]], [[cerebral haemorrhage]],
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| [[cerebrovascular accident]]
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| '''Respiratory, thoracic and mediastinal disorders:'''
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| Pulmonary haemorrhage,
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| [[ interstitial pneumonia]]
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| '''Skin and subcutaneous tissue disorders:'''
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| Haemorrhage subcutaneous, [[pruritus]], skin eruptions including [[Stevens-Johnson syndrome]], skin drug eruption ([[dermatitis medicamentosa]])
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| '''Vascular disorders:'''
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| -
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| 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)<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PLETAL (CILOSTAZOL) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24d75b58-bafb-4440-b8d7-4f4079c08b0b | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Drugs]]
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