DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Nipent (Pentostatin) - Side Effect Reports to FDA

 
 



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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014