Pletaal Adverse Reactions

Treatment of ischemic symptoms, including ulceration, pain, and coldness of the extremities, in chronic arterial occlusion: Clinical Trials in Japan: Of 1,035 patients included in safety evaluations, 90 patients (8.7%) had adverse drug reactions, including abnormal laboratory values. The most common adverse reactions were headache/dull headache (3.2%), tachycardia (1.0%), abdominal pain (0.8%), nausea/vomiting (0.8%), and dizziness (0.7%) (at time of approval of PLETAAL Tablets).
Drug-use results surveys: Of 3,335 patients included in safety evaluations, 209 patients (6.3%) had adverse drug reactions, including abnormal laboratory values. The most common adverse drug reactions were headache/dull headache (3.4%), palpitation (0.7%), dizziness (0.5%), diarrhoea (0.3%), and nausea/vomiting (0.3%) (at time of completion of reexamination for PLETAAL Tablets).
Prevention of recurrence of cerebral infarction (excluding cardiogenic cerebral embolism): Clinical trials in Japan: Of 520 patients included in safety evaluations, 137 patients (26.3%) had adverse drug reactions, including abnormal laboratory values. The most common adverse drug reactions were headache/dull headache (12.9%), palpitation (5.2%), nausea/vomiting (2.7%), dizziness (1.7%), and rash (1.3%) (at time of approval of additional indication for PLETAAL Tablets).
Long-term special surveys: Of 1,075 patients included in safety evaluation, 239 patients (22.2%) had adverse drug reactions, including abnormal laboratory values. The most common adverse drug reactions were headache/dull headache (4.6%), hepatic dysfunction (as indicated by elevated AST [GOT], ALT [GPT], A1-P, or LDH) (3.6%), palpitation (2.9%), tachycardia (2.2%), anemia (1.1%), and leukopenia (1.1%) (at time of completion of reexamination for PLETAAL Tablets).
Post-marketing clinical trials: Of 1,337 patients included in safety evaluations, 702 patients (52.5%) had adverse drug reactions, including abnormal laboratory values. The most common adverse drug reactions headache/dull headache (17.7%), palpitation (10.5%), tachycardia (9.5%), arrhythmias (including atrial fibrillation, supraventricular tachycardia, supraventricular extrasystoles, and ventricular extrasystoles) (3.7%), and abdominal pain (3.0%) (at time of completion of reexamination for PLETAAL Tablets).
The incidences listed as follows under Clinically significant adverse reactions and Other adverse reactions are based on data reported at the time of initial approval and additional indication approval for cilostazol and from drug-use results surveys, long-term special surveys, and post-marketing clinical trials.
Adverse reactions reported after market launch for which the incidence could not be calculated are also included after the drug was placed on the market.
Clinically significant adverse reactions: Congestive heart failure, myocardial infarction, angina pectoris (0.1% to less than 5% for each), and ventricular tachycardia (incidence unknown*): Congestive heart failure, myocardial infarction, angina pectoris, and ventricular tachycardia may occur. If any signs of these adverse reactions are observed, the drug should be discontinued and appropriate measures should be taken.
Hemorrhage: Intracranial hemorrhage, such as cerebral hemorrhage (0.1% to less than 5%): Intracranial hemorrhage, such as cerebral hemorrhage (Early symptoms of intracranial hemorrhage include headache, nuasea, vomiting, consciousness disturbance, and hemiplegia) may occur. If any such symptoms occur, the drug should be discontinued and appropriate measures should be taken.
Pulmonary hemorrhage (less than 0.1%), hemorrhage in the digestive tract, epistaxis, and bleeding in the ocular fundus (0.1% to less than 5% for each): Pulmonary hemorrhage, hemorrhage in the digestive tract, epistaxis, and bleeding in the ocular fundus may occur. If any such symptoms occur, the drug should be discontinued and appropriate measures should be taken.
Gastric or duodenal ulcers (0.1% to less than 5%): Gastric or duodenal ulcers with hemorrhage may occur. Patients should be closely monitored. If any signs of these adverse reactions are observed, the drug should be discontinued and appropriate measures should be taken.
Pancytopenia, agranulocytosis (both incidence unknown*), and thrombocytopenia (0.1% to less than 5%): Pancytopenia, agranulocytosis, and thrombocytopenia may occur. Patients should be closely monitored. If any signs of these adverse reactions are observed, the drug should be discontinued and appropriate measures should be taken.
Interstitial pneumonia (less than 0.1%): Interstitial pneumonia accompanied by fever, cough dyspnoea, abnormal chest X-rays, and eosinophilia may occur. If any signs of interstitial pneumonia are noted, the drug should be discontinued and appropriate measures, including adrenocorticotropic hormone administration, should be taken.
Hepatic dysfunction (0.1% to less than 5%) and jaundice (incidence unknown*): Hepatic dysfunction, as indicated by elevated AST (GOT), ALT (GPT), A1-P, or LDH, and jaundice may occur. Patients should be closely monitored. If signs of hepatic dysfunction are observed, the drug should be discontinued and appropriate measures should be taken.
Acute renal failure (less than 0.1%): Acute renal failure may occur. Patients should be closely monitored, such as by renal function testing. If signs of renal failure are observed, the drug should be discontinued and appropriate measures should be taken.
*Information concerning incidence was not obtained because adverse reactions were voluntarily reported or occurred outside Japan.
Other adverse reactions: See Table 3.


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