Ambisome and hepatic function abnormal Patient Reports February 12, 2012

Ambisome Side Effects Report #5903386-1
Ambisome side effect was reported by a Physician from JAPAN on Sept 18, 2008. Male patient, 75 years of age, was diagnosed with systemic candida and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood urea increased, hepatic function abnormal, jaundice . Ambisome dosage: 150 MG, UID/QD, IV NOS. During the same period patient was treated with MEROPEN, CIPROFLOXACIN, CLINDAMYCIN, ITRACONAZOLE. Patient died on 04/01/2008.

Ambisome Side Effects Report #5927261-1
Ambisome side effect was reported by a Physician from JAPAN on Oct 07, 2008. Male patient, 75 years of age, was diagnosed with systemic candida and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood urea increased, hepatic function abnormal, jaundice , multi-organ failure. Ambisome dosage: 150 MG, UID/QD, IV NOS. During the same period patient was treated with MEROPEN, CIPROFLOXACIN, CLINDAMYCIN, ITRACONAZOLE. Patient died on 04/01/2008.

Ambisome Side Effects Report #5527621-7
Ambisome side effect was reported by a Health Professional from JAPAN on Nov 16, 2007. Female patient, 72 years of age, was diagnosed with systemic candida and was treated with Ambisome. After drug was administered, patient experienced the following side effects: anaemia, hepatic function abnormal, renal failure. Ambisome dosage: 250 MG, UID/QD, IV DRIP. During the same period patient was treated with PREDONINE, BENAMBAX, MAXIPIME, CEFTRIAXONE. Patient died on 08/03/2007.

Ambisome Side Effects Report #5572342-8
Ambisome side effect was reported by a Physician from JAPAN on Dec 06, 2007. Female patient, 72 years of age, was diagnosed with systemic candida and was treated with Ambisome. After drug was administered, patient experienced the following side effects: anaemia, condition aggravated, hepatic function abnormal, juvenile arthritis, liver disorder, renal disorder, renal failure. Ambisome dosage: 250 MG, UID/QD, IV DRIP. During the same period patient was treated with PREDONINE, BENAMBAX, MAXIPIME, CEFTRIAXONE. Patient died on 08/03/2007.


Ambisome Side Effects Report #5809593-0
Ambisome side effect was reported by a Health Professional from JAPAN on June 24, 2008. Female patient, 72 years of age, was diagnosed with systemic candida and was treated with Ambisome. After drug was administered, patient experienced the following side effects: anaemia, condition aggravated, hepatic function abnormal, renal failure. Ambisome dosage: 250 MG, UID/QD, IV DRIP. During the same period patient was treated with PREDONINE, BENAMBAX, MAXIPIME, CEFTRIAXONE, HUMULIN R, LANSOPRAZOLE, SIGMART, LASIX. Patient died on 08/03/2007.

Ambisome Side Effects Report #4846891-1
Ambisome side effect was reported by a Health Professional from SPAIN on Sept 13, 2005. Male patient, 35 years of age, was diagnosed with mucormycosis, fungal infection , depression , pyrexia and was treated with Ambisome. After drug was administered, patient experienced the following side effects: hepatic function abnormal, hepatitis toxic, mitral valve incompetence, mucormycosis, pleural effusion, prothrombin time abnormal, viral infection . Ambisome dosage: 6.00 MG/KG, UID/QD. During the same period patient was treated with POSACONAZOLE, TRAZODONE, FLUOXETINE, PARACETAMOL, GLEEVEC, OMEPRAZOLE, VORICONAZOLE, CASPOFUNGIN. Patient recovered.

Ambisome Side Effects Report #5401408-8
Ambisome side effect was reported by a Health Professional from JAPAN on July 11, 2007. Female patient, 83 years of age, was diagnosed with meningitis cryptococcal, meningitis tuberculous and was treated with Ambisome. After drug was administered, patient experienced the following side effects: aspartate aminotransferase increased, bacteraemia, blood albumin decreased, cholestasis, encephalitis fungal, fungal sepsis, hepatic function abnormal, multi-organ failure, renal impairment. Ambisome dosage: 200 MG, UID/QD, IV NOS. During the same period patient was treated with ISONIAZID, NEO MINOPHAGEN C, METILON, LASIX, INTEBAN SP, ETHAMBUTOL DIHYDROCHLORIDE, PYRAZINAMIDE, PYDOXAL. Patient died on 04/26/2007.

Ambisome Side Effects Report #5421610-9
Ambisome side effect was reported by a Health Professional from JAPAN on Aug 03, 2007. Female patient, 83 years of age, was diagnosed with meningitis cryptococcal and was treated with Ambisome. After drug was administered, patient experienced the following side effects: bacteraemia, blood albumin decreased, cholestasis, condition aggravated, hepatic function abnormal, meningioma, meningitis fungal, multi-organ failure, renal impairment. Ambisome dosage: 20 MG, UID/QD, IV NOS. During the same period patient was treated with ISONIAZID, NEO MINOPHAGEN C, METILON, LASIX, INTEBAN SP, ETHAMBUTOL DIHYDROCHLORIDE, PYRAZINAMIDE, PYDOXAL. Patient died on 04/26/2007.

Ambisome Side Effects Report #5383170-0
Ambisome side effect was reported by a Health Professional from JAPAN on June 18, 2007. Female patient, 83 years of age, was diagnosed with meningism, meningitis tuberculous and was treated with Ambisome. After drug was administered, patient experienced the following side effects: bacteraemia, cholestasis, hepatic function abnormal, renal impairment. Ambisome dosage: 200 MG, UID/QD, IV NOS. During the same period patient was treated with ISONIAZID, NEO MINOPHAGEN C, METILON, LASIX, INTEBAN SP, ETHAMBUTOL DIHYDROCHLORIDE, PYRAZINAMIDE, PYDOXAL. Patient recovered.


Ambisome Side Effects Report #5724499-3
Ambisome side effect was reported by a Physician from JAPAN on Feb 05, 2008. Male patient, 76 years of age, weighting 132.3 lb, was diagnosed with fungal infection  and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, condition aggravated, hepatic function abnormal. Ambisome dosage: 200 MG, UID/QD, ORAL. During the same period patient was treated with ITRACONAZOLE, AVELOX, CARBENIN, DOPAMINE HYDROCHLORIDE, PLATELETS, PREDONINE, GASTER D. Patient recovered.

Ambisome Side Effects Report #5741383-X
Ambisome side effect was reported by a Health Professional from JAPAN on Apr 30, 2008. Male patient, 76 years of age, weighting 132.3 lb, was diagnosed with fungal infection  and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, hepatic function abnormal. Ambisome dosage: 200 MG, UID/QD, ORAL. During the same period patient was treated with ITRACONAZOLE, AVELOX, CARBENIN, DOPAMINE HYDROCHLORIDE, PLATELETS, PREDONINE, GASTER D. Patient recovered.

Ambisome Side Effects Report #5500147-2
Ambisome side effect was reported by a Physician from JAPAN on Oct 10, 2007. Female patient, 24 years of age, was diagnosed with fungal infection , cellulitis  and was treated with Ambisome. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, blood bilirubin increased, blood potassium decreased, condition aggravated, haemoglobin decreased, hepatic function abnormal, jaundice , pneumonitis, renal impairment. Ambisome dosage: 100 MG. During the same period patient was treated with VANCOMYCIN HYDROCHLORIDE, PAZUCROSS, NEUPOGEN, LASIX, IDAMYCIN, CYTARABINE. Patient died on 06/25/2007.

Ambisome Side Effects Report #5647053-0
Ambisome side effect was reported by a Health Professional from JAPAN on Feb 14, 2008. Female patient, 77 years of age, was diagnosed with candidiasis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, hepatic function abnormal, lung adenocarcinoma. Ambisome dosage: 100 MG, UID/QD, IV NOS. During the same period patient was treated with POTASSIUM CHLORIDE, NEOPHAGEN, INTEBAN, VITAJECT. Patient died on 11/14/2007.

Ambisome Side Effects Report #5822367-X
Ambisome side effect was reported by a Physician from JAPAN on July 09, 2008. Male patient, 77 years of age, weighting 142.6 lb, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, antithrombin iii deficiency, aspartate aminotransferase increased, blood bilirubin increased, bronchopulmonary aspergillosis, condition aggravated, haemodialysis, hepatic function abnormal, hyperkalaemia. Ambisome dosage: 3.9 MG/KG, UID/QD, IV NOS, 200 MG, UID/QD, IV NOS. During the same period patient was treated with DECADRON, DIFLUCAN, FUNGUARD, MAXIPIME, VFEND, GANCICLOVIR, POLYGLOBIN. Patient was hospitalized. Patient died on 10/14/2007.


Ambisome Side Effects Report #5313512-3
Ambisome side effect was reported by a Physician from JAPAN on Apr 17, 2007. Female patient, 68 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: haemodialysis, hepatic failure, hepatic function abnormal, jaundice , pancytopenia. Ambisome dosage: 125 MG, UID/QD. During the same period patient was treated with OLMETEC, NORVASC, BACTRIM, LANSOPRAZOLE, HONKUNALIN, DIPRIVAN. Patient recovered.

Ambisome Side Effects Report #5510129-2
Ambisome side effect was reported by a Physician from JAPAN on Oct 24, 2007. Male patient, 33 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, cardio-respiratory arrest, condition aggravated, depressed level of consciousness, hepatic function abnormal, liver disorder. Ambisome dosage: 140 MG, UID/QD, IV DRIP. During the same period patient was treated with VFEND, DECADRON, ERYTHROCIN, CELLCEPT, BAKTAR, LASIX, AMIKACIN SULPHATE, MAXIPIME. Patient died on 06/30/2007.

Ambisome Side Effects Report #5165831-1
Ambisome side effect was reported by a Physician from JAPAN on Nov 14, 2006. Male patient was diagnosed with bronchopulmonary aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: adenocarcinoma, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood urea increased, disseminated intravascular coagulation, hepatic function abnormal, infection , renal impairment. Ambisome dosage: 100 MG, UID/QD, IV DRIP. During the same period patient was treated with HEPARIN, VFEND, CEFTRIAXONE, CEFTAZIDIME, CLINDAMYCIN, CIPROXAN, MINOCYCLINE, MEROPEN. Patient died.

Ambisome Side Effects Report #5832534-7
Ambisome side effect was reported by a Health Professional from JAPAN on July 23, 2008. Male patient, 33 years of age, weighting 113.5 lb, was diagnosed with aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: anaemia, disseminated intravascular coagulation, hepatic function abnormal, multi-organ failure. Ambisome dosage: 100 MG, UID/QD, IV NOS; 50 MG, IV NOS. Patient died on 04/17/2008.

Ambisome Side Effects Report #5869426-3
Ambisome side effect was reported by a Health Professional from JAPAN on Aug 21, 2008. Male patient, 33 years of age, weighting 113.5 lb, was diagnosed with aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: anaemia, disseminated intravascular coagulation, hepatic function abnormal, multi-organ failure. Ambisome dosage: 100 MG, UID/QD, IV NOS; 50 MG, IV NOS. Patient died on 04/17/2008.


Ambisome Side Effects Report #5891946-6
Ambisome side effect was reported by a Health Professional from JAPAN on Sept 09, 2008. Male patient, 33 years of age, weighting 113.5 lb, was diagnosed with aspergillosis and was treated with Ambisome. After drug was administered, patient experienced the following side effects: anaemia, disseminated intravascular coagulation, hepatic function abnormal, multi-organ failure. Ambisome dosage: 100 MG, UID/QD, IV NOS; 50 MG, IV NOS. Patient died on 04/16/2008.

Ambisome Side Effects Report #5421591-8
Ambisome side effect was reported by a Health Professional from AUSTRALIA on July 30, 2007. Male patient, 59 years of age, was diagnosed with acute myeloid leukaemia and was treated with Ambisome. After drug was administered, patient experienced the following side effects: biliary tract disorder, blood creatinine increased, hepatic encephalopathy, hepatic function abnormal, hepatitis , hepatitis acute, nephritis interstitial, pyrexia. Ambisome dosage: 30 MG, UID/QD, IV DRIP. During the same period patient was treated with IDARUBICIN, ETOPOSIDE, CYTARABINE, VANCOMYCIN HYDROCHLORIDE, MEROPENEM, AZITHROMYCIN. Patient was hospitalized. Patient recovered.

Ambisome Side Effects Report #5449654-1
Ambisome side effect was reported by a Health Professional from AUSTRALIA on Aug 27, 2007. Male patient, 59 years of age, weighting 260.1 lb, was diagnosed with acute myeloid leukaemia and was treated with Ambisome. After drug was administered, patient experienced the following side effects: biliary tract disorder, blood creatinine increased, hepatic encephalopathy, hepatic function abnormal, hepatitis acute, nephritis interstitial, pyrexia, renal impairment. Ambisome dosage: 30 MG, UID/QD, IV DRIP. During the same period patient was treated with IDARUBICIN, ETOPOSIDE, CYTARABINE, VANCOMYCIN HYDROCHLORIDE, MEROPENEM, AZITHROMYCIN. Patient was hospitalized. Patient recovered.