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Review Anidulafungin Safety Reports submitted to FDA

Total Anidulafungin reports: 11.
Anidulafungin FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 3.
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FDA Reported Anidulafungin Side Effects: pancreatitis, thrombocytopenia, rash, incorrect dose administered.
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Anidulafungin Side Effects Report #5685377-1
Consumer or non-health professional from MEXICO reported ANIDULAFUNGIN problem on Mar 18, 2008. Female patient, 25 years of age, weighting 148.8 lb, was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: ventricular tachycardia. ANIDULAFUNGIN dosage: unknown. During the same period patient was treated with OMEPRAZOLE, METAMIZOLE, FUROSEMIDE, KETOROLAC, COMBIVENT, PULMICORT, METHYLPREDNISOLONE. Patient recovered.

Anidulafungin Side Effects Report #5626733-7
ANIDULAFUNGIN problem was reported by a Pharmacist from NETHERLANDS on Feb 04, 2008. Female patient, child 12 years of age, was diagnosed with cerebral aspergillosis and was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: brain injury. ANIDULAFUNGIN dosage: unknown. During the same period patient was treated with AMPHOTERICIN B. Patient died.

Anidulafungin Side Effects Report #5632611-X
Physician from AUSTRIA reported ANIDULAFUNGIN problem on Feb 08, 2008. Male patient, weighting 220.5 lb, was diagnosed with candidiasis, hyperlipidaemia and was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, myoglobin blood increased, rhabdomyolysis. ANIDULAFUNGIN dosage: DAILY DOSE:100MG. During the same period patient was treated with SORTIS, OPTINEM. Patient was hospitalized. Patient recovered.

Anidulafungin Side Effects Report #5486071-2
ANIDULAFUNGIN problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 03, 2007. Female patient, 60 years of age, was diagnosed with pneumonia and was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis. ANIDULAFUNGIN dosage: unknown. Patient recovered.

Anidulafungin Side Effects Report #5486137-7
Consumer or non-health professional from UNITED STATES reported ANIDULAFUNGIN problem on Oct 03, 2007. Male patient, 69 years of age, was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis. ANIDULAFUNGIN dosage: unknown. Patient recovered.

Anidulafungin Side Effects Report #5454969-7
ANIDULAFUNGIN problem was reported by a Pharmacist from on Sept 05, 2007. Female patient, weighting 31.09 lb, was diagnosed with antifungal prophylaxis and was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: pancreatitis. ANIDULAFUNGIN dosage: DAILY DOSE:50MG. During the same period patient was treated with PREDNISONE, LANSOPRAZOLE, PREDNISOLONE, AMLODIPINE, PENICILLIN VK, ONDANSETRON, ACETAMINOPHEN, CIPROFLOXACIN. Patient recovered.

Anidulafungin Side Effects Report #5433631-0
Pharmacist from UNITED STATES reported ANIDULAFUNGIN problem on Aug 28, 2007. Male patient, 74 years of age, was diagnosed with fungaemia and was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: rash, thrombocytopenia. ANIDULAFUNGIN dosage: MG EVERY DAY IV. Patient was hospitalized. Patient recovered.

Anidulafungin Side Effects Report #5706104-5
ANIDULAFUNGIN problem was reported by a Consumer or non-health professional from MEXICO on Apr 04, 2008. Female patient, weighting 148.8 lb, was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: ventricular tachycardia. ANIDULAFUNGIN dosage: unknown. During the same period patient was treated with OMEPRAZOLE, METAMIZOLE, DIPHENYLHYDANTOIN, FUROSEMIDE, KETOROLAC TROMETHAMINE, COMBIVENT, PULMICORT, METHYLPREDNISOLONE. Patient recovered.

Anidulafungin Side Effects Report #5707598-1
Consumer or non-health professional from MEXICO reported ANIDULAFUNGIN problem on Apr 11, 2008. Female patient, weighting 148.8 lb, was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. ANIDULAFUNGIN dosage: unknown. During the same period patient was treated with OMEPRAZOLE, METAMIZOLE, DIPHENYLHYDANTOIN, FUROSEMIDE, KETOROLAC TROMETHAMINE, COMBIVENT, PULMICORT, METHYLPREDNISOLONE. Patient recovered.

Anidulafungin Side Effects Report #5713379-5
ANIDULAFUNGIN problem was reported by a Consumer or non-health professional from MEXICO on Apr 11, 2008. Female patient, weighting 149.9 lb, was diagnosed with systemic candida and was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, peripheral ischaemia, supraventricular tachycardia. ANIDULAFUNGIN dosage: unknown. During the same period patient was treated with OMEPRAZOLE, METAMIZOLE, DIPHENYLHYDANTOIN, FUROSEMIDE, KETOROLAC TROMETHAMINE, COMBIVENT, PULMICORT, METHYLPREDNISOLONE. Patient recovered.

Anidulafungin Side Effects Report #5376721-3
Pharmacist from UNITED STATES reported ANIDULAFUNGIN problem on June 29, 2007. Female patient, weighting 31.09 lb, was diagnosed with antifungal prophylaxis and was treated with ANIDULAFUNGIN. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered, pancreatitis. ANIDULAFUNGIN dosage: 50 MG DAILY IV. During the same period patient was treated with LANSOPRAZOLE, PREDNISOLONE, AMLODIPINE, PENICILLIN VK, ONDANSETRON, ACETAMINOPHEN, CIPROFLOXACIN, ANTITHYMOCYTE IMMUNOGLOBULIN. Patient recovered.


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ventricular tachycardia, brain injury, blood creatine phosphokinase increased, myoglobin blood increased, rhabdomyolysis, , was diagnosed with cerebral aspergillosis and was diagnosed with candidiasis, hyperlipidaemia and was diagnosed with pneumonia and