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Ambisome Side Effects summary
Total Ambisome reports: 308.Ambisome FDA safety alerts: No.
Reported deaths: 149 Reported hospitalizations: 96.
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Ambisome Side Effects: hypokalaemia, condition aggravated, aspartate aminotransferase increased, alanine aminotransferase increased, blood creatinine increased, blood urea increased, renal impairment, dyspnoea, convulsion, brain herniation, hepatic function abnormal,
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Ambisome Side Effects reported to FDA
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Ambisome Side Effects Report #5488823-1Physician from JAPAN reported AMBISOME problem on Oct 05, 2007. Male patient, child 10 years of age, was diagnosed with systemic candida and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: cerebral infarction, convulsion, malignant neoplasm progression, medulloblastoma recurrent, meningitis, mydriasis, partial seizures, pupillary reflex impaired. AMBISOME dosage: 2.5 MG/KG, UID/QD, IV NOS; 5 MG/KG, UID/QD, IV NOS. During the same period patient was treated with LORAZEPAM, ELEMENMIC, BAKTAR, ARTANE, SOLUTIONS PARENTERAL NUTRITION, RISUMIC, DECADRON. Patient was hospitalized. Patient died on 08/08/2007.
Ambisome Side Effects Report #5489446-0
AMBISOME problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 12, 2006. Male patient, 14 years of age, was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: venoocclusive liver disease. AMBISOME dosage: unknown. Patient recovered.
Ambisome Side Effects Report #5489449-6
Consumer or non-health professional from UNITED STATES reported AMBISOME problem on Feb 23, 2007. Male patient was diagnosed with sporotrichosis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood magnesium decreased, blood potassium decreased. AMBISOME dosage: 5 MG/KG, IV NOS. During the same period patient was treated with ZOFRAN, FENTANYL. Patient was hospitalized. Patient recovered.
Ambisome Side Effects Report #5489453-8
AMBISOME problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 20, 2006. Male patient was diagnosed with sporotrichosis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: asthenia, blood creatinine increased, lethargy, nausea, petechiae, vomiting. AMBISOME dosage: 5 MG/KG, IV NOS. During the same period patient was treated with ZOFRAN, FENTANYL. Patient was hospitalized. Patient recovered.

Ambisome Side Effects Report #5489477-0
Health Professional from UNITED STATES reported AMBISOME problem on May 15, 2007. Male patient, weighting 14.55 lb, was diagnosed with off label use, infection and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased. AMBISOME dosage: unknown. During the same period patient was treated with NOXAFIL, CYCLOSPORINE, ETOPOSIDE, DEXAMETHASONE. Patient recovered.
Ambisome Side Effects Report #5491410-2
AMBISOME problem was reported by a Health Professional from ITALY on Oct 02, 2007. Male patient, 55 years of age, was diagnosed with antifungal prophylaxis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, infusion related reaction, musculoskeletal chest pain, rash. AMBISOME dosage: 1 MG/KG, OTHER, IV NOS. During the same period patient was treated with ALLOPURINOL, TREOSULFAN, FLUDARABINE PHOSPHATE, RITUXIMAB, RAPAMYCIN, LEVOFLOXACIN, ACYCLOVIR. Patient recovered.
Ambisome Side Effects Report #5491414-X
Physician from JAPAN reported AMBISOME problem on Oct 02, 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 problems/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, liver disorder, lung infiltration. AMBISOME dosage: 140 MG, UID/QD, IV DRIP. During the same period patient was treated with VFEND, DECADRON, ERYTHROCIN, CELLCEPT, BAKTAR, LASIX, AMIKACIN SULPHATE, MAKIPIME. Patient died on 06/30/2007.
Ambisome Side Effects Report #5493864-4
AMBISOME problem was reported by a Pharmacist from UNITED STATES on Oct 05, 2007. Female patient, weighting 12.35 lb, was diagnosed with fungal infection and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: accidental overdose. AMBISOME dosage: 25 MG, UID/QD, IV NOS. During the same period patient was treated with NYSTATIN, URSODIOL. Patient recovered.
Ambisome Side Effects Report #5495501-1
Health Professional from ITALY reported AMBISOME problem on Oct 09, 2007. Female patient, 49 years of age, was diagnosed with off label use and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: dyspnoea, erythema, oxygen saturation decreased. AMBISOME dosage: 50 MG, TOTAL DOSE, IV NOS. During the same period patient was treated with AMIKACIN SULPHATE, PIPERACILLIN AND TAZOBACTAM. Patient recovered.

Ambisome Side Effects Report #5500144-7
AMBISOME problem was reported by a Health Professional from ITALY on Oct 02, 2007. Male patient, 65 years of age, was diagnosed with antifungal prophylaxis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood culture positive, septic shock, staphylococcal infection. AMBISOME dosage: 3 MG/KG, Q3D, IV NOS, 7 MG/KG, WEEKLY. During the same period patient was treated with RAPAMYCIN, MYCOPHENOLATE MOFETIL, ACYCLOVIR, CEFTAZIDIME, OMEPRAZOLE, ACETAMINOPHEN. Patient recovered.
Ambisome Side Effects Report #5500145-9
Physician from FRANCE reported AMBISOME problem on Oct 10, 2007. Female patient, 34 years of age, was diagnosed with febrile bone marrow aplasia and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, oxygen saturation decreased. AMBISOME dosage: 70 MG, UID/QD, IV NOS. During the same period patient was treated with CLINOMEL, VALIUM, HEPARIN, OMEPRAZOLE, CYCLOSPORINE, ACUPAN, MORPHINE, CEFTAZIDIME PENTAHYDRATE. Patient was hospitalized. Patient recovered.
Ambisome Side Effects Report #5500146-0
AMBISOME problem was reported by a Physician from GREECE on Oct 10, 2007. Male patient, 36 years of age, was diagnosed with meningitis cryptococcal and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: convulsion, leukoencephalopathy. AMBISOME dosage: 300 MG, IV NOS. During the same period patient was treated with FLUOROCYTOSINE, FLUCONAZOLE. Patient recovered.
Ambisome Side Effects Report #5500147-2
Physician from JAPAN reported AMBISOME problem 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 problems/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 #5501372-7
AMBISOME problem was reported by a Health Professional from JAPAN on Oct 02, 2007. Male patient, 55 years of age, was diagnosed with systemic candida and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood potassium decreased, blood urine present, cytomegalovirus infection, haematocrit decreased, haemodialysis, haemoglobin decreased. AMBISOME dosage: 200 MG, UID/QD, IV DRIP. During the same period patient was treated with PROGRAF, MYCAMINE, VANCOMYCIN HYDROCHLORIDE, DENOSINE, TARGOCID, BACTRAMIN, NEUPOGEN, PREDNISONE. Patient died on 06/29/2007.

Ambisome Side Effects Report #5449318-4
Physician from JAPAN reported AMBISOME problem on Aug 22, 2007. Male patient, child 10 years of age, was diagnosed with systemic candida and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: cerebral infarction, convulsion, malignant neoplasm progression, medulloblastoma recurrent, meningitis, mydriasis, pupillary light reflex tests abnormal. AMBISOME dosage: 2.5 MG/KG, UID/QD, IV NOS, 5 MG/KG, UID/QD, IV NOS. During the same period patient was treated with LORAZEPAM, ELEMENMIC, BAKTAR, ARTANE, SOLUTIONS PARENTERAL NUTRITION, RISUMIC, DECADRON. Patient was hospitalized. Patient died on 08/08/2007.
Ambisome Side Effects Report #5449654-1
AMBISOME problem 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 problems/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.
Ambisome Side Effects Report #5449655-3
Consumer or non-health professional from UNITED KINGDOM reported AMBISOME problem on Aug 31, 2007. Male patient, 69 years of age, was diagnosed with systemic candida and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: leukopenia, proteus infection. AMBISOME dosage: 350 MG, BID, IV NOS. During the same period patient was treated with VANCOMYCIN HYDROCHLORIDE, IMIPENEM, HALOPERIDOL, INSULIN, CARVEDILOL, FUROSEMIDE, VITAMINS, CAPTOPRIL. Patient died on 08/25/2007.
Ambisome Side Effects Report #5452041-3
AMBISOME problem was reported by a Physician from UNITED STATES on July 16, 2007. Male patient, 74 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: haemoptysis, respiratory failure. AMBISOME dosage: unknown. Patient was hospitalized. Patient died.
Ambisome Side Effects Report #5453546-1
Health Professional from JAPAN reported AMBISOME problem on Aug 31, 2007. Male patient, 52 years of age, was diagnosed with febrile neutropenia and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: hypokalaemia, renal impairment. AMBISOME dosage: 150 MG, UID/QD, IV DRIP; 250 MG, UID/QD, IV NOS. During the same period patient was treated with KALETRA, ZERIT, EPIVIR, ITRACONAZOLE, ZYLORIC, ACYCLOVIR, VANCOMYCIN HYDROCHLORIDE. Patient recovered.

Ambisome Side Effects Report #5461121-8
AMBISOME problem was reported by a Physician from UNITED STATES on Sept 18, 2007. Female patient was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: device interaction, laboratory test interference. AMBISOME dosage: }5MG/KG. Patient recovered.
Ambisome Side Effects Report #5467181-2
Health Professional from SPAIN reported AMBISOME problem on Sept 04, 2007. Male patient, 64 years of age, was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: cerebral toxoplasmosis, hepatotoxicity. AMBISOME dosage: 300 MG. During the same period patient was treated with VORICONAZOLE. Patient died on 09/11/2005.
Ambisome Side Effects Report #5468150-9
AMBISOME problem was reported by a Health Professional from JAPAN on Sept 10, 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 problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, cardio-respiratory arrest, 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, MAXIPME. Patient died on 06/30/2007.
Ambisome Side Effects Report #5472512-3
Health Professional from JAPAN reported AMBISOME problem on Sept 10, 2007. Male patient, 70 years of age, was diagnosed with febrile neutropenia and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: condition aggravated, pneumonia. AMBISOME dosage: 150 MG, UID/QD, IV DRIP. During the same period patient was treated with MAXIPIME, IMMUNE GLOBULIN INTRAVENOUS, PLATELETS, RED BLOOD CELLS, OMEGACIN. Patient died on 04/20/2007.
Ambisome Side Effects Report #5472516-0
AMBISOME problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 10, 2007. Male patient, 69 years of age, was diagnosed with systemic candida and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: haemodynamic instability, leukopenia. AMBISOME dosage: 350 MG, BID, IV NOS. During the same period patient was treated with VANCOMYCIN HYDROCHLORIDE, IMIPENEM, HALOPERIDOL, INSULIN, CARVEDILOL, FUROSEMIDE, VITAMINS, CAPTOPRIL. Patient died on 08/25/2007.
Ambisome Side Effects Report #5473072-3
Health Professional from FRANCE reported AMBISOME problem on Sept 11, 2007. Male patient, 44 years of age, was diagnosed with visceral leishmaniasis, hiv infection and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: hypoacusis, renal tubular disorder. AMBISOME dosage: unknown. During the same period patient was treated with VIREAD, EPIVIR, SYMBICORT. Patient was hospitalized. Patient recovered.
Ambisome Side Effects Report #5410345-4
AMBISOME problem was reported by a Health Professional from JAPAN on July 23, 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 problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, bronchopulmonary aspergillosis, cardio-respiratory arrest, condition aggravated, lung infiltration. AMBISOME dosage: 140 MG, UID/QD, IV DRIP. During the same period patient was treated with VFEND, DECADRON, ERYTHROCIN, CELLCEPT, SULFAMETHOXAZOLE, LASIX, AMIKACIN SULPHATE, MAXIPIME. Patient died on 06/30/2007.
Ambisome Side Effects Report #5410360-0
Physician from JAPAN reported AMBISOME problem on July 24, 2007. Male patient was diagnosed with systemic mycosis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood amylase increased, blood glucose increased, blood lactate dehydrogenase increased, blood urea increased, blood uric acid increased, blood urine present, c-reactive protein increased. AMBISOME dosage: 19.6 MG, UID/QD, IV DRIP; 39.2 MG, UID/QD, IV DRIP. During the same period patient was treated with PROGRAF, SOLITA, HEPARIN, NICARDIPINE HYDROCHLORIDE, ZOVIRAX, CONIEL. Patient was hospitalized. Patient died on 01/20/2007.
Ambisome Side Effects Report #5421307-5
AMBISOME problem was reported by a Health Professional from JAPAN on Aug 02, 2007. Male patient, 55 years of age, was diagnosed with systemic candida and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood creatinine decreased, blood creatinine increased, blood urea increased, c-reactive protein increased, condition aggravated, haematocrit decreased. AMBISOME dosage: 200 MG, UID/QD, IV DRIP. During the same period patient was treated with PROGRAF, VANCOMYCIN HYDROCHLORIDE, NEUPOGEN, PREDNISOLONE, FRAGMIN, OMEPRAZOLE, FUNGUARD, VFEND. Patient recovered.
Ambisome Side Effects Report #5421591-8
Health Professional from AUSTRALIA reported AMBISOME problem 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 problems/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 #5421607-9
AMBISOME problem was reported by a Physician from DENMARK on Aug 03, 2007. Female patient, 42 years of age, was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: muscle contractions involuntary, neuropathy. AMBISOME dosage: 50 MG, TOTAL DOSE, IV NOS. During the same period patient was treated with ANCOTIL. Patient recovered.
Ambisome Side Effects Report #5421610-9
Health Professional from JAPAN reported AMBISOME problem 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 problems/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 #5422229-6
AMBISOME problem was reported by a Pharmacist from UNITED STATES on Aug 20, 2007. Male patient, weighting 198.6 lb, was diagnosed with pneumonia and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: renal failure. AMBISOME dosage: 350 MG DAILY IV. Patient recovered.
Ambisome Side Effects Report #5422874-8
Pharmacist from SPAIN reported AMBISOME problem on Aug 02, 2007. Female patient was diagnosed with prophylaxis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: pulmonary fibrosis. AMBISOME dosage: 120 MG, UID/QD, IV DRIP. During the same period patient was treated with TEICOPLANIN, AZITHROMYCIN, CIPROFLOXACIN, NITRIC OXIDE. Patient was hospitalized. Patient died on 08/02/2007.
Ambisome Side Effects Report #5424442-0
AMBISOME problem was reported by a Consumer or non-health professional from BRAZIL on Aug 10, 2007. Female patient, child 5 years of age, was diagnosed with cutaneous leishmaniasis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, bronchopneumonia, malnutrition, nephropathy toxic, pseudomonas infection, sepsis. AMBISOME dosage: unknown. During the same period patient was treated with ANTIMONY. Patient died.
Ambisome Side Effects Report #5424527-9
Consumer or non-health professional from JAPAN reported AMBISOME problem on Aug 09, 2007. Male patient, 90 years of age, was diagnosed with meningitis cryptococcal and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: dehydration, hypoalbuminaemia, hypokalaemia, urine output increased. AMBISOME dosage: 150 MG, IV DRIP. During the same period patient was treated with UNASYN, FIRSTCIN, DIFLUCAN. Patient recovered.
Ambisome Side Effects Report #5424529-2
AMBISOME problem was reported by a Health Professional from JAPAN on Aug 08, 2007. Female patient, 68 years of age, was diagnosed with fungaemia and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, blood pressure increased, convulsion, depressed level of consciousness, nausea. AMBISOME dosage: 2.5 MG/KG, UID/QD, IV DRIP. During the same period patient was treated with CEFOTIAM HYDROCHLORIDE. Patient recovered.
Ambisome Side Effects Report #5427373-5
Health Professional from JAPAN reported AMBISOME problem on July 10, 2007. Female patient, 23 years of age, weighting 66.14 lb, was diagnosed with bronchopulmonary aspergillosis and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt prolonged. AMBISOME dosage: 80 MG, UID/QD, IV DRIP; 300 MG, IV DRIP. During the same period patient was treated with VFEND, PHYSIO, ANHYDROUS, LACTOBACILLUS BIFIDUS, AMOXICILLIN TRIHYDRATE, FLUMARIN, SOLUTIONS PARENTERAL NUTRITION. Patient recovered.
Ambisome Side Effects Report #5429298-8
AMBISOME problem was reported by a Health Professional from JAPAN on Aug 10, 2007. Male patient, 70 years of age, was diagnosed with febrile neutropenia and was treated with AMBISOME. AMBISOME dosage: 150 MG, UID/QD, IV DRIP. During the same period patient was treated with MAXIPIME, IMMUNE GLOBULIN INTRAVENOUS, PLATELETS, RED BLOOD CELLS, OMEGACIN. Patient died on 04/20/2007.
Ambisome Side Effects Report #5441529-7
Health Professional from JAPAN reported AMBISOME problem on Aug 16, 2007. Female patient, 68 years of age, was diagnosed with fungaemia and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, blood pressure increased, convulsion, depressed level of consciousness, nausea, suicidal ideation. AMBISOME dosage: 2.5 MG/KG, UID/QD, IV DRIP. During the same period patient was treated with CEFOTIAM HYDROCHLORIDE. Patient recovered.
Ambisome Side Effects Report #5441532-7
AMBISOME problem was reported by a Consumer or non-health professional from JAPAN on Aug 15, 2007. Male patient, 90 years of age, was diagnosed with meningitis cryptococcal and was treated with AMBISOME. After drug was administered, patient experienced the following problems/side effects: blood sodium decreased, dehydration, hypokalaemia, protein urine present, urine output increased, urobilin urine present. AMBISOME dosage: 150 MG, UID/QD, IV DRIP. During the same period patient was treated with UNASYN, PRODIF, FIRSTCIN, DIFLUCAN. Patient recovered.
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Ambisome Side Effects


