Dacogen and off label use Patient Reports February 11, 2012

Dacogen Side Effects Report #5255617-1
Dacogen side effect was reported by a Physician from UNITED STATES on Sept 19, 2006. Female patient, 67 years of age, was diagnosed with refractory anaemia with an excess of blasts and was treated with Dacogen. After drug was administered, patient experienced the following side effects: off label use, pancytopenia. Dacogen dosage: 20 MG/M**2; QD; IV. Patient recovered.

Dacogen Side Effects Report #5763449-0
Dacogen side effect was reported by a Health Professional from UNITED STATES on Apr 29, 2008. Female patient, 67 years of age, was diagnosed with pancreatic carcinoma and was treated with Dacogen. After drug was administered, patient experienced the following side effects: chest pain , constipation , off label use, vomiting. Dacogen dosage: 10 MG/M2, INTRAVENOUS ; 10 MG/M2, INTRAVENOUS. Patient was hospitalized. Patient recovered.

Dacogen Side Effects Report #5763503-3
Dacogen side effect was reported by a Health Professional from UNITED STATES on Apr 29, 2008. Female patient, 67 years of age, was diagnosed with neoplasm malignant and was treated with Dacogen. After drug was administered, patient experienced the following side effects: chest pain , constipation , off label use, vomiting. Dacogen dosage: 10 MG/M2, INTRAVENOUS ; 10 MG/M2, INTRAVENOUS. Patient was hospitalized. Patient recovered.

Dacogen Side Effects Report #5336098-6
Dacogen side effect was reported by a Health Professional from UNITED STATES on Jan 09, 2007. Male patient, 86 years of age, weighting 140.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: febrile neutropenia, off label use. Dacogen dosage: unknown. During the same period patient was treated with ASPIRIN, COZAAR, ISOSORBIDE, NEXIUM, NASAL SPRAY, VITAMIN, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.


Dacogen Side Effects Report #5336032-9
Dacogen side effect was reported by a Consumer or non-health professional from UNITED STATES on Nov 13, 2006. Male patient, 80 years of age, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: arthralgia, gingival pain, haemoglobin decreased, off label use, pain in jaw, platelet count decreased, toothache, white blood cell count decreased. Dacogen dosage: unknown. During the same period patient was treated with ZOFRAN, DECADRON, PROCRIT, THALIDOMID, VIDAZA. Patient recovered.

Dacogen Side Effects Report #5140878-X
Dacogen side effect was reported by a Physician from UNITED STATES on July 17, 2006. Female patient, 80 years of age, weighting 181.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: off label use, pancytopenia. Dacogen dosage: 20 MG/M**2;QD;IV. Patient was hospitalized. Patient recovered.

Dacogen Side Effects Report #5255620-1
Dacogen side effect was reported by a Health Professional from UNITED STATES on Oct 06, 2006. Male patient, 79 years of age, weighting 199.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: off label use, platelet count decreased. Dacogen dosage: 20 MG/M**2; QD; IV. During the same period patient was treated with PREDNISONE, NEUPOGEN. Patient recovered.

Dacogen Side Effects Report #5255621-3
Dacogen side effect was reported by a Consumer or non-health professional from UNITED STATES on Oct 20, 2006. Male patient, 79 years of age, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: bone marrow failure, off label use. Dacogen dosage: unknown. During the same period patient was treated with NEULASTA, TOPROL, LEVOTHYROXINE, ARANESP. Patient recovered.

Dacogen Side Effects Report #5358482-7
Dacogen side effect was reported by a Health Professional from UNITED STATES on Feb 13, 2007. Male patient, 79 years of age, weighting 199.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: neutrophil count decreased, off label use, platelet count decreased. Dacogen dosage: unknown. During the same period patient was treated with PREDNISONE, NEUPOGEN, ARANESP, LORAZEPAM, LEVAQUIN. Patient recovered.


Dacogen Side Effects Report #5140879-1
Dacogen side effect was reported by a Consumer or non-health professional from UNITED STATES on July 20, 2006. Female patient, 78 years of age, weighting 125.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: anaemia, neutropenia, off label use, stomatitis. Dacogen dosage: 32.5 MG;QD;IV. During the same period patient was treated with PRILOSEC, AMBIEN. Patient was hospitalized. Patient recovered.

Dacogen Side Effects Report #5358425-6
Dacogen side effect was reported by a Pharmacist from UNITED STATES on Mar 07, 2007. Male patient, 77 years of age, weighting 230.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: off label use, vision blurred. Dacogen dosage: 40 MG;QD;IV. During the same period patient was treated with DIFLUCAN, ALBUTEROL. Patient recovered.

Dacogen Side Effects Report #5358436-0
Dacogen side effect was reported by a Health Professional from UNITED STATES on Mar 19, 2007. Female patient, 77 years of age, weighting 145.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: blood count abnormal, off label use, urticaria. Dacogen dosage: unknown. During the same period patient was treated with PRILOSEC, ZOLOFT, CALCIUM CHLORIDE, MOVE FREE. Patient recovered.

Dacogen Side Effects Report #5255475-5
Dacogen side effect was reported by a Physician from UNITED STATES on Sept 25, 2006. Male patient, 75 years of age, weighting 207.2 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: escherichia sepsis, off label use, pancytopenia, thrombocytopenia. Dacogen dosage: 20 MG/M**2; QD; IV. During the same period patient was treated with NEULASTA. Patient was hospitalized. Patient recovered.

Dacogen Side Effects Report #5140873-0
Dacogen side effect was reported by a Health Professional from UNITED STATES on June 14, 2006. Male patient, 75 years of age, weighting 217.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: feeling cold, off label use. Dacogen dosage: 20 MG/M**2;QD;IV. Patient recovered.


Dacogen Side Effects Report #5255615-8
Dacogen side effect was reported by a Physician from UNITED STATES on Sept 13, 2006. Male patient, 74 years of age, weighting 208.1 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: constipation , fluid retention, off label use. Dacogen dosage: 20 MG/M**2; QD; IV. During the same period patient was treated with KYTRIL, INDERAL, MYSOLINE, FLOMAX. Patient recovered.

Dacogen Side Effects Report #5255619-5
Dacogen side effect was reported by a Physician from UNITED STATES on Oct 10, 2006. Male patient, 74 years of age, weighting 176.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: infusion site extravasation, injection site irritation, off label use. Dacogen dosage: 40 MG/M**2/QD/ IV. Patient recovered.

Dacogen Side Effects Report #5355068-5
Dacogen side effect was reported by a Physician from UNITED STATES on Mar 19, 2007. Male patient, 72 years of age, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: asthenia, off label use. Dacogen dosage: unknown. Patient was hospitalized. Patient recovered.

Dacogen Side Effects Report #5358439-6
Dacogen side effect was reported by a Health Professional from UNITED STATES on Mar 21, 2007. Male patient, 72 years of age, weighting 184.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: blood blister, off label use, rash . Dacogen dosage: 40 MG;QD;IV. During the same period patient was treated with HYDROXYUREA, ALLOPURINOL, EFFEXOR, CLONAZEPAM, LISINOPRIL. Patient recovered.

Dacogen Side Effects Report #5336034-2
Dacogen side effect was reported by a Health Professional from UNITED STATES on Dec 13, 2006. Male patient, 70 years of age, weighting 134.5 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: off label use, pyrexia, white blood cell count decreased. Dacogen dosage: 40 MG; QD; IV. Patient recovered.


Dacogen Side Effects Report #5255623-7
Dacogen side effect was reported by a Physician from UNITED STATES on Oct 27, 2006. Male patient, 62 years of age, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: neutrophil count decreased, off label use, platelet count decreased, white blood cell count decreased. Dacogen dosage: 20 MG/M**2; QD; IV. During the same period patient was treated with TOPROL, ZOCOR. Patient recovered.

Dacogen Side Effects Report #5336038-X
Dacogen side effect was reported by a Pharmacist from UNITED STATES on Jan 30, 2007. Male patient, 62 years of age, weighting 167.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: infusion site extravasation, off label use. Dacogen dosage: 20 MG; QD; IV. During the same period patient was treated with ANZEMET. Patient recovered.

Dacogen Side Effects Report #5255616-X
Dacogen side effect was reported by a Consumer or non-health professional from UNITED STATES on Sept 18, 2006. Male patient, 60 years of age, weighting 164.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: arthralgia, constipation , fatigue, off label use, platelet count decreased, pollakiuria, red blood cell count decreased, white blood cell count decreased. Dacogen dosage: unknown. During the same period patient was treated with FUROSEMIDE. Patient recovered.

Dacogen Side Effects Report #5336037-8
Dacogen side effect was reported by a Pharmacist from UNITED STATES on Jan 04, 2007. Female patient, 60 years of age, weighting 132.3 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, off label use. Dacogen dosage: unknown. During the same period patient was treated with ACYCLOVIR, AMICAR, AUGMENTIN, FLUCONAZOLE, DEXAMETHASONE. Patient recovered.

Dacogen Side Effects Report #5255618-3
Dacogen side effect was reported by a Health Professional from UNITED STATES on Sept 27, 2006. Male patient, 57 years of age, weighting 260.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, off label use. Dacogen dosage: 20 MG/M**2; QD; IV. During the same period patient was treated with EPOGEN. Patient recovered.


Dacogen Side Effects Report #5358423-2
Dacogen side effect was reported by a Health Professional from UNITED STATES on Feb 02, 2007. Male patient, weighting 195.0 lb, was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: infusion site extravasation, off label use. Dacogen dosage: 40 MG;QD;IV. Patient recovered.

Dacogen Side Effects Report #5358432-3
Dacogen side effect was reported by a Consumer or non-health professional from UNITED STATES on Mar 09, 2007. Male patient was diagnosed with myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: haemoglobin decreased, off label use, platelet count decreased, white blood cell count decreased. Dacogen dosage: unknown. During the same period patient was treated with NEUPOGEN. Patient recovered.

Dacogen Side Effects Report #5140875-4
Dacogen side effect was reported by a Consumer or non-health professional from UNITED STATES on July 05, 2006. Female patient, 63 years of age, weighting 104.0 lb, was diagnosed with acute myeloid leukaemia and was treated with Dacogen. After drug was administered, patient experienced the following side effects: diarrhoea, off label use. Dacogen dosage: unknown. During the same period patient was treated with CIPRO. Patient recovered.

Dacogen Side Effects Report #5140876-6
Dacogen side effect was reported by a Health Professional from UNITED STATES on July 11, 2006. Male patient, 53 years of age, weighting 233.0 lb, was diagnosed with acute myeloid leukaemia, myelodysplastic syndrome and was treated with Dacogen. After drug was administered, patient experienced the following side effects: off label use. Dacogen dosage: 40 MG;QD X5DQ28D;IV. During the same period patient was treated with LEVAQUIN, LASIX. Patient recovered.

Dacogen Side Effects Report #5336039-1
Dacogen side effect was reported by a Health Professional from UNITED STATES on Jan 31, 2007. Male patient, 66 years of age, weighting 251.0 lb, was treated with Dacogen. After drug was administered, patient experienced the following side effects: cellulitis , off label use. Dacogen dosage: unknown. During the same period patient was treated with ARANESP. Patient recovered.


Dacogen Side Effects Report #5336099-8
Dacogen side effect was reported by a Consumer or non-health professional from UNITED STATES on Jan 11, 2007. Male patient, 66 years of age, was treated with Dacogen. After drug was administered, patient experienced the following side effects: chills, haemoglobin decreased, off label use, pharyngolaryngeal pain, platelet count decreased, red blood cell count decreased, respiratory tract congestion, white blood cell count decreased. Dacogen dosage: 20 MG/M**2;QD;IV. Patient was hospitalized. Patient recovered.

Dacogen Side Effects Report #5336035-4
Dacogen side effect was reported by a Pharmacist from UNITED STATES on Dec 14, 2006. Female patient was treated with Dacogen. After drug was administered, patient experienced the following side effects: increased tendency to bruise, off label use, platelet count decreased, white blood cell count decreased. Dacogen dosage: 20 MG/M**2; QD; IV. Patient recovered.