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METABOLIC & NUTRITIONAL
Peripheral edema 9 7 4 MUSCULO-SKELETAL
Myalgia 2 3 2 NERVOUS
Dizziness 9 10 6
Vertigo 3 1 1 Text Continues Below
RESPIRATORY
Cough increased 3 4 3
Pharyngitis 7 10 7
Rhinitis 12 7 5
Post-Marketing Experience
The following adverse drug reactions (ADRs) to PLETAL have been reported worldwide since launch of PLETAL in the US. Although the exact rate cannot be calculated, the frequency of these ADRs can be estimated as: very rare (<1/10,000: <0.01%) Blood and lymphatic system disorders Very rare: agranulocytosis, granulocytopenia, thrombocytopenia, leukopenia, bleeding tendency Cardiac disorders Very rare: Torsades de pointes, QTc prolongation (Very rare cases of 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 Very rare: gastrointestinal haemorrhage General disorders and administration site conditions Very rare: pain, chest pain, hot flushes Hepatobiliary disorders Very rare: hepatic dysfunction/abnormal liver function tests, jaundice Injury, poisoning and procedural complications Very rare: extradural haematoma and subdural haematoma Investigations Very rare: blood glucose increased, blood uric acid increased, platelet count decreased, white blood cell count decreased, increase in BUN (blood urea increased) Nervous system disorders Very rare: intracranial haemorrhage, cerebral haemorrhage, cerebrovascular accident Respiratory, thoracic and mediastinal disorders Very rare: pulmonary haemorrhage, interstitial pneumonia Skin and subcutaneous tissue disorders Very rare: haemorrhage subcutaneous, pruritus, skin eruptions including Stevens Johnson syndrome, skin drug eruption (dermatitis medicamentosa) Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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