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Review Denosine Safety Reports submitted to FDA

Total Denosine reports: 15.
Denosine FDA safety alerts: No.
Reported deaths: 7    Reported hospitalizations: 10.
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FDA Reported Denosine Side Effects: bone marrow failure, white blood cell count decreased, rash, neutropenia, herpes zoster, cerebral toxoplasmosis, pancytopenia, renal impairment, kaposi's sarcoma, hypertriglyceridaemia, renal disorder.
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Denosine Side Effects Report #5684877-8
Physician from JAPAN reported DENOSINE problem on Jan 26, 1996. Male patient, 28 years of age, was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, convulsion, pneumonia cytomegaloviral. DENOSINE dosage: unknown. During the same period patient was treated with TIENAM. Patient was hospitalized. Patient died on 10/28/1995.

Denosine Side Effects Report #5685042-0
DENOSINE problem was reported by a Physician from JAPAN on Aug 19, 1998. Male patient, 74 years of age, was diagnosed with pneumonia cytomegaloviral and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: leukopenia, red blood cell count decreased, thrombocytopenia. DENOSINE dosage: unknown. During the same period patient was treated with MODACIN, CARBENIN. Patient died on 12/16/1997.

Denosine Side Effects Report #5643132-2
Consumer or non-health professional from JAPAN reported DENOSINE problem on Feb 07, 2008. Female patient, 81 years of age, was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, coma, renal impairment. DENOSINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, BISPHOSPHONATE, ETOPOSIDE, VINCRISTINE SULPHATE, DOXORUBICIN HYDROCHLORIDE. Patient was hospitalized. Patient died.

Denosine Side Effects Report #5520994-0
DENOSINE problem was reported by a Physician from JAPAN on Nov 09, 2007. Female patient, 59 years of age, was diagnosed with encephalitis cytomegalovirus and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: nephrogenic diabetes insipidus. DENOSINE dosage: unknown. During the same period patient was treated with ACYCLOVIR, ANTITUBERCULOUS AGENT NOS, ANTIBIOTIC NOS. Patient recovered.

Denosine Side Effects Report #5492180-4
Physician from JAPAN reported DENOSINE problem on Oct 09, 2007. Male patient was diagnosed with cytomegalovirus infection and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: respiratory failure, staphylococcal sepsis, thrombocytopenia. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, DENOSINE IV, ASVERIN, ERYTHROCIN LACTOBIONATE, MUCODYNE, NEOPHYLLIN, VENOGLOBULIN. Patient was hospitalized. Patient died on 08/21/2004.

Denosine Side Effects Report #5499773-9
DENOSINE problem was reported by a Physician from JAPAN on Oct 17, 2007. Female patient, 78 years of age, weighting 90.39 lb, was diagnosed with cytomegalovirus enterocolitis, nephritis and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: pancytopenia, pulmonary haemorrhage. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, DENOSINE IV, DENOSINE IV, DENOSINE IV, PREDONINE, BREDININ. Patient died on 04/21/2007.

Denosine Side Effects Report #5442023-X
Physician from JAPAN reported DENOSINE problem on Aug 24, 2007. Female patient, 78 years of age, weighting 90.39 lb, was diagnosed with cytomegalovirus enterocolitis and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: pancytopenia, pulmonary haemorrhage. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, DENOSINE IV, DENOSINE IV, DENOSINE IV, STEROID NOS, MIZORIBINE. Patient died on 04/21/2007.

Denosine Side Effects Report #5447308-9
DENOSINE problem was reported by a Health Professional from JAPAN on Aug 29, 2007. Male patient, 55 years of age, was diagnosed with cytomegalovirus viraemia, diarrhoea, graft versus host disease, sepsis, deep vein thrombosis and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, renal disorder, white blood cell count decreased. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, DENOSINE IV, ARICEPT, NEORAL, MEROPEN, TARGOCID, VFEND, FRAGMIN. Patient was hospitalized. Patient recovered.

Denosine Side Effects Report #5419537-1
Physician from JAPAN reported DENOSINE problem on Aug 07, 2007. Male patient, 18 years of age, was diagnosed with pneumonia cytomegaloviral and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, renal impairment. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, BACTRIM, VENOGLOBULIN, IMMUNE GLOBULIN INTRAVENOUS, IMMUNE GLOBULIN INTRAVENOUS, IMMUNE GLOBULIN INTRAVENOUS. Patient was hospitalized. Patient recovered.

Denosine Side Effects Report #5736545-1
DENOSINE problem was reported by a Consumer or non-health professional from JAPAN on Apr 28, 2008. Female patient was diagnosed with cytomegalovirus enterocolitis and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: liver disorder. DENOSINE dosage: unknown. During the same period patient was treated with MAXIPIME, PREDONINE, ANAFRANIL, LASIX, HICALIQ. Patient died.

Denosine Side Effects Report #5355885-1
Physician from JAPAN reported DENOSINE problem on June 01, 2007. Male patient, 18 years of age, was diagnosed with pneumonia cytomegaloviral and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, renal impairment. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, BACTRIM, VENOGLOBULIN, IMMUNE GLOBULIN INTRAVENOUS, ANTIFUNGAL AGENT NOS, CMV IMMUNE GLOBULIN. Patient was hospitalized. Patient recovered.

Denosine Side Effects Report #5360691-8
DENOSINE problem was reported by a Physician from JAPAN on June 08, 2007. Male patient, 37 years of age, was diagnosed with cytomegalovirus enterocolitis, hiv infection and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: cerebral toxoplasmosis, herpes zoster, neutropenia, rash. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, VALIXA, BAKTAR, EPIVIR, ZERIT. Patient was hospitalized. Patient recovered.

Denosine Side Effects Report #5332304-2
Physician from JAPAN reported DENOSINE problem on May 11, 2007. Male patient, 64 years of age, was diagnosed with cytomegalovirus oesophagitis, hiv infection and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: hypertriglyceridaemia, kaposi's sarcoma, white blood cell count decreased. DENOSINE dosage: unknown. During the same period patient was treated with VALIXA, ZERIT, BAKTAR, EPIVIR, KALETRA, FILGRASTIM, DOXORUBICIN HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Denosine Side Effects Report #5288277-4
DENOSINE problem was reported by a Physician from JAPAN on Mar 28, 2007. Male patient, 37 years of age, was diagnosed with cytomegalovirus enterocolitis, hiv infection and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: cerebral toxoplasmosis, herpes zoster, neutropenia, rash. DENOSINE dosage: unknown. During the same period patient was treated with DENOSINE IV, VALIXA, BAKTAR, EPIVIR, ZERIT. Patient was hospitalized. Patient recovered.

Denosine Side Effects Report #5299260-7
Physician from JAPAN reported DENOSINE problem on Apr 05, 2007. Male patient, 64 years of age, was diagnosed with cytomegalovirus oesophagitis, hiv infection and was treated with DENOSINE. After drug was administered, patient experienced the following problems/side effects: hypertriglyceridaemia, kaposi's sarcoma, white blood cell count decreased. DENOSINE dosage: unknown. During the same period patient was treated with VALIXA, ZERIT, BAKTAR, EPIVIR, KALETRA, FILGRASTIM, DOXORUBICIN HYDROCHLORIDE. Patient was hospitalized. Patient recovered.


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altered state of consciousness, convulsion, pneumonia cytomegaloviral, leukopenia, red blood cell count decreased, thrombocytopenia, , was diagnosed with pneumonia cytomegaloviral and was diagnosed with encephalitis cytomegalovirus and