This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nipent (Pentostatin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (13)
Death (3)
Life Threatening Events (3)
Disability (1)
Reports by Reaction Type
Fall (4),
Dyspnoea (4),
Ascites (4),
Dehydration (4),
Atelectasis (3),
Confusional State (3),
Nuchal Rigidity (3),
Cardiomegaly (3),
Pericardial Effusion (3),
Fatigue (3),
Musculoskeletal Stiffness (3),
Cardiac Failure Congestive (3)
Possible Nipent side effects in female
Reported by a physician from Italy on 2012-08-27
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Vomiting, Hypotension, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 600mgm2 cyclic
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-07-19
Losazid
Dosage: 50mg twice per day
Administration route: Oral
Indication: Hypertension
Start date: 2009-03-29
End date: 2012-07-25
Nipent
Dosage: 2mgm2 cyclic
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-07-19
Arzerra
Dosage: 300mg cyclic
Indication: Chronic Lymphocytic Leukaemia
Start date: 2012-07-20
Other drugs received by patient: Allopurinol; Sulfamethoxazole and Trimethoprim
Possible Nipent side effects in 23 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-20
Patient: 23 year old male
Reactions: Weight Decreased, Diarrhoea, Clostridium Difficile Colitis, Hepatitis Fulminant, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nipent
Dosage: (df intravenous (not otherwise specifed))
Indication: Product Used FOR Unknown Indication
Start date: 2012-02-06
End date: 2012-02-06
Flagyl
Dosage: (df oral)
Administration route: Oral
Indication: Clostridium Difficile Colitis
Start date: 2012-01-31
End date: 2012-02-16
Rocephin
Dosage: (df)
Indication: Product Used FOR Unknown Indication
Start date: 2012-02-01
Other drugs received by patient: Prednisolone
Possible Nipent side effects in 23 year old male
Reported by a physician from France on 2012-06-14
Patient: 23 year old male
Reactions: Cytolytic Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nipent
Indication: Product Used FOR Unknown Indication
Start date: 2012-02-06
End date: 2012-02-06
Flagyl
Administration route: Oral
Indication: Clostridium Difficile Colitis
Start date: 2012-01-31
End date: 2012-02-16
Rocephin
Indication: Product Used FOR Unknown Indication
Start date: 2012-02-01
Possible Nipent side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-05
Patient: 54 year old male, weighing 119.0 kg (261.8 pounds)
Reactions: Nasopharyngitis, Dyspnoea, Oropharyngeal Pain, Pyrexia, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acyclovir Sodium
Dosage: 100 mg mwf cycle 1, then 878 d1 cycle 2-6
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-03-14
End date: 2011-08-02
Cytoxan
Dosage: 1404 mg on d1 c1-6, wks 1, 5, 9, 13, 17 and 21, intravenous (not otherwise specified)
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-03-14
End date: 2011-08-02
Campath
Dosage: 30 mg, tiw x 4 weeks, subcutaneous
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-10-31
End date: 2011-11-25
Nipent
Dosage: 9.36 mg on day 1 c1-6, intravenous (not otherwise specified)
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-03-14
End date: 2011-08-02
Other drugs received by patient: Bactrim DS; Acyclovir
Possible Nipent side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-02
Patient: female, weighing 77.4 kg (170.3 pounds)
Reactions: Metastatic Neoplasm, Refusal of Treatment by Patient, Chronic Lymphocytic Leukaemia, Lymphadenopathy, Lymph Node Pain, Anaemia Haemolytic Autoimmune, Ascites
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
(Rituximab)
Dosage: 375 mg/m2 over 4 hr/on one day on weeks 1,5, 9, 13,17 and 21 intravenous (not otherwise specified)
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-06-16
End date: 2008-11-17
Nipent
Dosage: 4 mg/m2 x 1 day weeks 1, 5, 9, 13, 17 and 21 intravenous (not otherwise specified)
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-06-16
End date: 2008-11-17
Cyclophosphamide
Dosage: 600 mg/m2 on weeks 1,5,9, 13, 17 and 21 intravenous (not otherwise specified)
Indication: Chronic Lymphocytic Leukaemia
Start date: 2008-06-16
End date: 2008-11-17
Other drugs received by patient: Rituxan
Possible Nipent side effects in 70 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-17
Patient: 70 year old male, weighing 66.3 kg (145.9 pounds)
Reactions: Productive Cough, Rales, Pericardial Effusion, Cardiomegaly, Oedema Peripheral, Pneumothorax, Cardiac Failure Congestive, Bronchopulmonary Aspergillosis, Pulmonary Necrosis, Cytomegalovirus Test Positive, Anaemia, Hypotension, Pancytopenia, Rhonchi, Dehydration, non-Small Cell Lung Cancer, Atelectasis, Confusional State, Nuchal Rigidity, Fall, Fatigue, Pleural Effusion, Musculoskeletal Stiffness, Sinusitis, Thrombocytopenia, Lethargy, Candidiasis, Decreased Appetite, Dyspnoea, Lung Neoplasm, Jugular Vein Distension, Cerebral Atrophy, Ascites, Hypophagia, Bradycardia, Bronchitis, Gait Disturbance, Asthenia, Blood Pressure Fluctuation, Face Injury
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 1212mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Nipent
Dosage: 8 mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Alemtuzumab
Dosage: 60 mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-10-31
End date: 2011-11-02
Rituximab
Dosage: 758 mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Possible Nipent side effects in male
Reported by a physician from France on 2012-01-06
Patient: male
Reactions: Thrombotic Microangiopathy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Amitriptyline HCL
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-02-22
End date: 2011-12-06
Leucovorin Calcium
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-27
End date: 2011-12-06
Prograf
Dosage: 2mg twice per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-06-07
End date: 2011-12-06
Bactrim
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-27
End date: 2011-12-06
Nipent
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-27
End date: 2011-11-30
Prednisone TAB
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
End date: 2011-12-06
Valacyclovir Hydrochloride
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
End date: 2011-12-06
Other drugs received by patient: Neoral; Mycophenolate Mofetil (Cellcept)
Possible Nipent side effects in 70 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-19
Patient: 70 year old male, weighing 66.3 kg (145.9 pounds)
Reactions: Lung Infection, Pericardial Effusion, Cardiomegaly, Pneumothorax, Cardiac Failure Congestive, Cytomegalovirus Test Positive, Hypotension, Pancytopenia, Fungal Infection, Dehydration, Depressed Level of Consciousness, non-Small Cell Lung Cancer, Mobility Decreased, Confusional State, Atelectasis, Effusion, Nuchal Rigidity, Fall, Musculoskeletal Stiffness, Abdominal Distension, Sinusitis, Candidiasis, Jugular Vein Distension, Lung Neoplasm, Cerebral Atrophy, Ascites, Disease Recurrence, Aspergillosis, Bronchitis, Bradycardia, Blood Pressure Fluctuation, Face Injury
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 1212 mg,
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Nipent
Dosage: 8 mg
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
(Alemtuzumab)
Dosage: 60 mg,
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-10-31
End date: 2011-11-02
(Rituximab)
Dosage: 758 mg
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Possible Nipent side effects in 70 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-12
Patient: 70 year old male, weighing 61.0 kg (134.3 pounds)
Reactions: Confusional State, Atelectasis, Lung Infection, Nuchal Rigidity, Fall, Cardiomegaly, Pericardial Effusion, Fatigue, Oedema Peripheral, Musculoskeletal Stiffness, Pleural Effusion, Thrombocytopenia, Candidiasis, Lethargy, Cardiac Failure Congestive, Dyspnoea, Cytomegalovirus Test Positive, Anaemia, Cerebral Atrophy, Pancytopenia, Ascites, Fungal Infection, Dehydration, non-Small Cell Lung Cancer, Bronchitis, Face Injury, Mobility Decreased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Nipent
Dosage: 8 mg,
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Cyclophosphamide
Dosage: 1212 mg,
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
(Alemtuzumab)
Dosage: 60 mg,
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-10-31
End date: 2011-11-02
(Rituximab)
Dosage: 758 mg
Indication: Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Possible Nipent side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-01
Patient: male, weighing 127.4 kg (280.3 pounds)
Reactions: Dysphagia, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Muscular Weakness, Polymyositis, Connective Tissue Disorder, Musculoskeletal Disorder, Aspartate Aminotransferase Increased, Blood Uric Acid Increased, Mastication Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Nipent
Dosage: 10 mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-09-01
End date: 2011-09-01
(Rituximab)
Dosage: 945 mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-09-01
End date: 2011-09-01
Cyclophosphamide
Dosage: 1512 mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-09-01
End date: 2011-09-01
Possible Nipent side effects in 43 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-29
Patient: 43 year old male
Reactions: Vomiting, Diarrhoea, Nausea, Epstein-Barr Virus Associated Lymphoproliferative Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Busulfan
Dosage: not reported, not reported, unknown, (unknown)
Indication: Stem Cell Transplant
Nipent
Dosage: not reported, not reported, unknown, (unknown)
Indication: Stem Cell Transplant
Other drugs received by patient: Rituxan
Possible Nipent side effects in 70 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-27
Patient: 70 year old male, weighing 67.9 kg (149.4 pounds)
Reactions: Dyspnoea, Anaemia, Muscular Weakness, Hypoaesthesia, Fall, Paraesthesia, Fatigue, Dehydration, Platelet Count Decreased, Cytomegalovirus Infection, Blood Pressure Decreased, Immobile, Infestation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Campath
Dosage: 30 mg, tiw x 18 weeks, subcutaneous
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-07-29
End date: 2011-09-14
Nipent
Dosage: 8 mg
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
(Rituximab)
Dosage: 758 mg, not reported
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Cyclophosphamide
Dosage: 1212 mg
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-12-27
End date: 2011-05-18
Possible Nipent side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-18
Patient: 47 year old male, weighing 130.9 kg (288.0 pounds)
Reactions: Lymphopenia
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 600 mg/m2 (1506 mg total dose), day 1 of weeks 1,5,9.,14,17,21
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-08-04
End date: 2011-08-04
Nipent
Dosage: 4 mg/m2 (10 mg total dose) on weeks 1,5,9,13,17,21
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-08-04
End date: 2011-08-04
Rituxan
Dosage: 375 mg.m2 (941 mg total dose), on weeks 1,5,9,13,17,21; week 1,3 days/week; weeks 5-21; 1 day/week
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-08-04
End date: 2011-08-04
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