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Review Isradipine Safety Reports submitted to FDA

Total Isradipine reports: 4.
Isradipine FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Isradipine Side Effects: pharyngitis, loss of consciousness, lactic acidosis, infection, hypoglycaemia, haemodialysis, gastric ulcer perforation, fluid intake reduced, decreased appetite, systemic lupus erythematosus, metaplasia.
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Isradipine Side Effects Report #5663428-8
Health Professional from CHILE reported ISRADIPINE problem on Mar 02, 2008. Male patient, 78 years of age, was diagnosed with hypertension and was treated with ISRADIPINE. After drug was administered, patient experienced the following problems/side effects: anaemia, blood folate decreased, blood immunoglobulin e increased, echography abnormal, hyperthyroidism, interstitial lung disease, pulmonary fibrosis, weight decreased. ISRADIPINE dosage: 5 MG;PO. During the same period patient was treated with AMIODARONE, HYTACAND, FLECAINIDE ACETATE, NEO MERCAZOLE, CARBIMAZOLE, PROPYLTHIOURACIL, ERTHROCYTE CONCENTRATE. Patient recovered.

Isradipine Side Effects Report #5601145-0
ISRADIPINE problem was reported by a Consumer or non-health professional from SWITZERLAND on Jan 10, 2008. Male patient, child 3 years of age, weighting 24.30 lb, was diagnosed with hypertension and was treated with ISRADIPINE. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, condition aggravated, cough, hypertension, left ventricular failure, post procedural complication. ISRADIPINE dosage: unknown. During the same period patient was treated with NICARDIPINE, CORGARD. Patient was hospitalized. Patient recovered.

Isradipine Side Effects Report #5605693-9
Consumer or non-health professional from SWITZERLAND reported ISRADIPINE problem on Jan 16, 2008. Female patient, 57 years of age, was diagnosed with liver transplant and was treated with ISRADIPINE. After drug was administered, patient experienced the following problems/side effects: hepatic fibrosis, hepatic steatosis. ISRADIPINE dosage: 2.5 MG; QD; PO. During the same period patient was treated with NEORAL, COPEGUS, PEGINTERFERON ALFA, OMEPRAZOLE, POTASSIUM CHLORIDE, COZAAR, FUROSEMIDE. Patient recovered.

Isradipine Side Effects Report #5491332-7
ISRADIPINE problem was reported by a Consumer or non-health professional from SWITZERLAND on Oct 11, 2007. Male patient was diagnosed with hypertension and was treated with ISRADIPINE. After drug was administered, patient experienced the following problems/side effects: bronchitis, dyspnoea, leukopenia, thrombocytopenia. ISRADIPINE dosage: unknown. During the same period patient was treated with HYZAAR, ATENOLOL, ATACAND, CARDENSIEL, AMLOR, TAHOR, ACARBOSE, GLIPIZIDE. Patient was hospitalized. Patient recovered.


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anaemia, blood folate decreased, blood immunoglobulin e increased, echography abnormal, hyperthyroidism, interstitial lung disease, pulmonary fibrosis, weight decreased, , was diagnosed with hypertension and was diagnosed with hypertension and was diagnosed with liver transplant and