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Leukeran (Chlorambucil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Leukeran (Chlorambucil) 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 (24)

Reports by Reaction Type

Mouth Ulceration (4)Squamous Cell Carcinoma of Skin (4)Pyrexia (3)Malaise (3)Dehydration (3)Hypophagia (3)Respiratory Tract Infection Viral (2)Ear Infection (2)Respiratory Tract Infection (2)Lymphadenopathy (1)Nasopharyngitis (1)Infection (1)

Possible Leukeran side effects in male

Reported by a physician from United Kingdom on 2012-08-22

Patient: male, weighing 83.0 kg (182.6 pounds)

Reactions: Extrasystoles

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2011-03-04
    End date: 2011-05-25

Ofatumumab
    Dosage: 2g weekly
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-07-05

Other drugs received by patient: Bisoprolol Fumarate



Possible Leukeran side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient:

Reactions: Colon Cancer

Drug(s) suspected as cause:
Leukeran

NO Treatment Received
    Indication: Renal Failure

Prednisolone



Possible Leukeran side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient:

Reactions: Squamous Cell Carcinoma

Drug(s) suspected as cause:
Leukeran

NO Treatment Received
    Indication: Renal Failure

Prednisolone



Possible Leukeran side effects in female

Reported by a physician from Sweden on 2012-08-10

Patient: female, weighing 63.0 kg (138.6 pounds)

Reactions: Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran



Possible Leukeran side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-02

Patient: 62 year old male

Reactions: Malaise, Intracranial Haematoma, Drug Administration Error, Headache, Hemiparesis, Intracranial Pressure Increased, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran

Other drugs received by patient: Ramipril; Humalog; Thiamine HCL; Simvastatin; Furosemide (Furosemide)



Possible Leukeran side effects in 60 year old female

Reported by a individual with unspecified qualification from Belgium on 2012-06-21

Patient: 60 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: (10 mg/m2,days 1-7 every 28 days) oral
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-09-21

Ofatumumab (Ofatumumab) (Unknown)
    Dosage: see image
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-09-21

Ofatumumab (Ofatumumab) (Unknown)
    Dosage: see image
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-09-28



Possible Leukeran side effects in 58 year old male

Reported by a individual with unspecified qualification from Poland on 2012-06-14

Patient: 58 year old male

Reactions: Lymphadenopathy, Pyrexia, Haematotoxicity, Fatigue, Vertigo, Haemolytic Anaemia, Splenomegaly, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran

Other drugs received by patient: Potassium Chloride; Electrolyte Fluids; Spironol; Metformin Hydrochloride; Hygroton; Allopurinol; Sulfamethoxazole and Trimethoprim; Polprazol



Possible Leukeran side effects in 62 year old male

Reported by a individual with unspecified qualification from United Kingdom on 2012-06-06

Patient: 62 year old male

Reactions: Pleural Effusion, Empyema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran



Possible Leukeran side effects in 76 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-31

Patient: 76 year old male

Reactions: Malaise, Pyrexia, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: 18 milligram (18 milligram, 1 in 1 days) , oral
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-03-23

Ofatumumab (Ofatumumab)(unknown)
    Dosage: (1000 milligram) intravenous (not otherwise specified)
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-03-22

Prednisolone
    Dosage: 20 milligram (20 milligram,l 1in 1 days) , oral
    Administration route: Oral
    Start date: 2012-04-23
    End date: 2012-04-25

Other drugs received by patient: Chlorpheniramine (Chlorpheniramine)(unknown); Ranitidine; Allopurinol; Bendamustine (Bendamustine)(unknown); Acetaminophen; Metoclopramide; Aciclovir (Aciclovir)(unknown); G-CSF (G-Csf)(unknown)



Possible Leukeran side effects in 78 year old female

Reported by a individual with unspecified qualification from Germany on 2012-05-17

Patient: 78 year old female

Reactions: Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran

Other drugs received by patient: Diuretic



Possible Leukeran side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-14

Patient: 63 year old male

Reactions: Hyperglycaemia, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran



Possible Leukeran side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-14

Patient: 63 year old male

Reactions: Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran



Possible Leukeran side effects in 63 year old male

Reported by a individual with unspecified qualification from United Kingdom on 2012-05-14

Patient: 63 year old male

Reactions: Respiratory Tract Infection

Drug(s) suspected as cause:
Leukeran



Possible Leukeran side effects in 81 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-14

Patient: 81 year old male

Reactions: Malaise, Nasopharyngitis, Neutropenic Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: 10 mg/m2days 1-7 every 28 days (10 mg/m2) oral
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-11-17

Ofatumumab (Ofatumumab)
    Dosage: 300mgat day 1, 1000mg at day 8 followed by 1000mg every 28 days intravenous(not otherwise specified)
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-11-17



Possible Leukeran side effects in 61 year old female

Reported by a individual with unspecified qualification from Ukraine on 2012-05-14

Patient: 61 year old female

Reactions: Ear Infection, Respiratory Tract Infection Viral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: (18 mg/m2) intravenous (not otherwise specified)
    Indication: Chronic Lymphocytic Leukaemia Refractory
    Start date: 2011-10-27

Ofatummab (Ofatummab)
    Dosage: intravenous (not otherwise specified)
    Indication: Chronic Lymphocytic Leukaemia Refractory
    Start date: 2011-12-21

Rituxan
    Dosage: (375 mg/m2) intravenous (not otherwise specified)
    Indication: Chronic Lymphocytic Leukaemia Refractory
    Start date: 2011-10-27



Possible Leukeran side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Ukraine on 2012-05-03

Patient: 61 year old female, weighing 74.0 kg (162.8 pounds)

Reactions: Ear Infection, Respiratory Tract Infection Viral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: (18 mg/m2)
    Indication: Chronic Lymphocytic Leukaemia Refractory
    Start date: 2011-10-27

Ofatumumab (Ofatumumab)
    Indication: Chronic Lymphocytic Leukaemia Refractory
    Start date: 2011-12-21

Rituxan
    Dosage: (375 mg/m2)
    Indication: Chronic Lymphocytic Leukaemia Refractory
    Start date: 2011-10-27



Possible Leukeran side effects in 80 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-05-02

Patient: 80 year old female

Reactions: Viral Upper Respiratory Tract Infection, Pneumonitis

Drug(s) suspected as cause:
Leukeran
    Dosage: 16 milligram, oral
    Administration route: Oral
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2011-01-10

Study Medication (Other)
    Dosage: 1000 milligram, 1 once, intravenous (not otherwise specified)
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2011-01-10
    End date: 2011-07-05

Other drugs received by patient: CO-Trimoxazole (Sulfamethoxazole and Trimethoprim); Albuterol Sulfate



Possible Leukeran side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-19

Patient: female

Reactions: Mouth Ulceration, Hypophagia, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-01

Matulane
    Dosage: 150 mg, unk
    Administration route: Oral
    Start date: 2012-01-06

Velcade
    Dosage: unk
    Start date: 2012-01-01



Possible Leukeran side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-02

Patient: female

Reactions: Dehydration, Hypophagia, Mouth Ulceration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-01

Matulane
    Dosage: 150 mg, unk
    Administration route: Oral
    Start date: 2012-01-06

Velcade
    Dosage: unk
    Start date: 2012-01-01



Possible Leukeran side effects in 62 year old female

Reported by a physician from United States on 2012-02-10

Patient: 62 year old female

Reactions: Hypophagia, Dehydration, Mouth Ulceration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leukeran
    Dosage: po
    Administration route: Oral
    Indication: Hodgkin's Disease
    Start date: 2012-01-01

Matulane
    Dosage: 150 mg;qd;po
    Administration route: Oral
    Indication: Hodgkin's Disease
    Start date: 2012-01-06

Velcade
    Dosage: iv
    Indication: Hodgkin's Disease
    Start date: 2012-01-01



Possible Leukeran side effects in 48 year old female

Reported by a individual with unspecified qualification from United States on 2011-12-22

Patient: 48 year old female

Reactions: Squamous Cell Carcinoma of Skin

Drug(s) suspected as cause:
Arava
    Indication: Behcet's Syndrome
    Start date: 2007-06-01

Cellcept
    Indication: Behcet's Syndrome
    Start date: 2001-01-01
    End date: 2001-09-01

Colchicine
    Indication: Behcet's Syndrome
    Start date: 1999-10-01
    End date: 2002-12-01

Colchicine
    Start date: 2004-08-01

Cycloserine
    Indication: Behcet's Syndrome
    Start date: 2000-05-01
    End date: 2001-01-06

Cytoxan
    Start date: 2003-03-01
    End date: 2003-04-01

Cytoxan
    Start date: 2003-08-01
    End date: 2003-08-01

Cytoxan
    Start date: 2003-02-01
    End date: 2003-02-01

Cytoxan
    Start date: 2003-03-01
    End date: 2003-03-01

Cytoxan
    Start date: 2003-10-01
    End date: 2004-05-01

Cytoxan
    Indication: Behcet's Syndrome
    Start date: 2002-12-01
    End date: 2002-12-01

Cytoxan
    Start date: 2003-05-01
    End date: 2003-07-01

Cytoxan
    Start date: 2003-01-01
    End date: 2003-01-01

Cytoxan
    Start date: 2003-09-01
    End date: 2003-09-01

Dapsone
    Indication: Behcet's Syndrome
    Start date: 1999-09-01
    End date: 2000-05-01

Dapsone
    Start date: 2003-06-01
    End date: 2005-09-01

Enbrel
    Indication: Behcet's Syndrome
    Start date: 2004-09-01
    End date: 2005-02-01

Imuran
    Start date: 2007-01-01
    End date: 2007-03-01

Imuran
    Indication: Behcet's Syndrome
    Start date: 2005-02-01
    End date: 2005-04-01

Leukeran
    Indication: Behcet's Syndrome
    Start date: 2001-11-01
    End date: 2002-04-01

Leukeran
    Start date: 2002-06-01
    End date: 2002-09-01

Leukeran
    Start date: 2002-04-01
    End date: 2002-06-01

Methotrexate
    Indication: Behcet's Syndrome
    Start date: 1998-10-01
    End date: 1999-07-01

Plaquenil
    Start date: 2002-06-01
    End date: 2004-08-01

Plaquenil
    Indication: Behcet's Syndrome
    Start date: 1999-07-01
    End date: 2002-05-01

Plaquenil
    Start date: 2004-08-01

Prednisone TAB
    Indication: Behcet's Syndrome

Remicade
    Indication: Behcet's Syndrome
    Start date: 2005-04-01
    End date: 2005-05-01

Remicade
    Start date: 2005-05-01
    End date: 2005-07-01

Remicade
    Start date: 2005-07-01
    End date: 2005-09-01

Remicade
    Start date: 2005-09-01
    End date: 2006-02-01

Rituxan
    Start date: 2006-07-05
    End date: 2006-07-05

Rituxan
    Indication: Behcet's Syndrome
    Start date: 2006-06-01
    End date: 2006-06-01

Other drugs received by patient: Sertraline Hydrochloride; Terbutaline Sulfate; Pregabalin; Acyclovir; Theophylline; Erythromycin; Esomeprazole Magnesium; Pentoxifylline; Fentanyl-100; Imiquimod; Fluticasone Propionate / Salmeterol; Folic Acid; Ipratropium Bromide and Albuterol Sulfate; Furosemide; Immune Globulin NOS; Imiquimod



Possible Leukeran side effects in 48 year old female

Reported by a physician from United States on 2011-12-13

Patient: 48 year old female

Reactions: Squamous Cell Carcinoma of Skin

Drug(s) suspected as cause:
Arava
    Dosage: 20 mg, daily
    Start date: 2007-06-01

Cellcept
    Dosage: 1000 mg, 2x/day
    Indication: Behcet's Syndrome
    Start date: 2001-01-01
    End date: 2001-09-01

Colchicine
    Dosage: 6 mg, 2x/day
    Indication: Behcet's Syndrome
    Start date: 1999-10-01
    End date: 2002-12-01

Colchicine
    Dosage: 6 mg, 2x/day
    Start date: 2004-08-01

Cyclosporine
    Dosage: unk
    Indication: Behcet's Syndrome
    Start date: 2000-05-01
    End date: 2001-01-06

Cytoxan
    Dosage: 500 mg, unk
    Start date: 2003-01-01

Cytoxan
    Dosage: 1250 mg, unk
    Start date: 2003-03-01

Cytoxan
    Dosage: 500 mg, unk
    Start date: 2003-05-01

Cytoxan
    Dosage: 1000 mg, unk
    Start date: 2003-09-01

Cytoxan
    Dosage: 750 mg, unk
    Start date: 2003-08-01

Cytoxan
    Dosage: 250 mg, unk
    Start date: 2002-12-01

Cytoxan
    Dosage: 500 mg, unk
    End date: 2004-05-01

Cytoxan
    Dosage: 750 mg, unk
    Start date: 2003-02-01

Cytoxan
    Dosage: 1000 mg, unk
    Start date: 2003-03-01

Cytoxan
    Dosage: 500 mg, unk
    Start date: 2003-07-01

Cytoxan
    Dosage: 1250 mg, unk
    Start date: 2003-04-01

Dapsone
    Dosage: 50 mg, daily
    Start date: 2003-06-01
    End date: 2005-09-01

Dapsone
    Dosage: 100 mg, 2x/day
    Indication: Behcet's Syndrome
    Start date: 1999-09-01
    End date: 2000-05-01

Enbrel
    Dosage: 25 mg, 2x/week
    Indication: Ankylosing Spondylitis
    Start date: 2004-09-01
    End date: 2005-02-01

Imuran
    Dosage: 150 mg, daily
    Indication: Behcet's Syndrome
    Start date: 2005-02-01
    End date: 2005-04-01

Imuran
    Dosage: 150 mg, daily
    Start date: 2007-01-01
    End date: 2007-03-01

Leukeran
    Dosage: 2 mg, unk
    Start date: 2002-06-01
    End date: 2002-09-01

Leukeran
    Dosage: 4 mg, daily
    Indication: Behcet's Syndrome
    Start date: 2001-11-01

Leukeran
    Dosage: 3 mg, unk
    Start date: 2002-04-01

Methotrexate
    Dosage: titrated from 7.5 mg up to 20 mg weekly
    Indication: Behcet's Syndrome
    Start date: 1998-10-01
    End date: 1999-07-01

Plaquenil
    Dosage: 300 mg, qd
    Indication: Behcet's Syndrome
    Start date: 1999-07-01
    End date: 2002-01-01

Plaquenil
    Dosage: 200 mg, 2x/day
    Start date: 2004-08-01

Plaquenil
    Dosage: 200 mg, daily
    Start date: 2002-06-01

Prednisone TAB
    Dosage: 10 mg, daily, occasional pulses
    Indication: Behcet's Syndrome

Remicade
    Dosage: 400 mg, unk
    Start date: 2005-05-01

Remicade
    Dosage: 300 mg, unk
    Start date: 2005-07-01

Remicade
    Dosage: 400 mg, unk
    Start date: 2005-11-01

Remicade
    Dosage: 400 mg, unk
    Start date: 2006-01-01
    End date: 2006-02-01

Remicade
    Dosage: 200 mg, unk
    Indication: Behcet's Syndrome
    Start date: 2005-04-01

Remicade
    Dosage: 400 mg, unk
    Start date: 2005-09-01

Rituxan
    Dosage: 1000 mg, unk
    Indication: Behcet's Syndrome
    Start date: 2006-06-01

Rituxan
    Dosage: 1000 mg, unk
    Start date: 2006-07-05

Other drugs received by patient: Fentanyl; Galenic / Fluticasone / Salmeterol /; Acyclovir; Folic Acid; Terbutaline Sulfate; Albuterol Sulfate and Ipratropium Bromide; Theophylline; Erythromycin; Esomeprazole Magnesium; Sertraline Hydrochloride; Furosemide; Pentoxifylline; Pregabalin



Possible Leukeran side effects in 48 year old female

Reported by a physician from United States on 2011-10-28

Patient: 48 year old female

Reactions: Renal Failure, Nausea, Mouth Ulceration, Anaemia, Squamous Cell Carcinoma of Skin, Neutropenia, Rash, Accidental Exposure

Drug(s) suspected as cause:
Arava
    Dosage: 20 mg daily
    Indication: Behcet's Syndrome

Cellcept
    Dosage: 1000 mg twice daily
    Indication: Behcet's Syndrome

Colchicine
    Dosage: 6 mg twice daily, 6 mg twice daily
    Indication: Behcet's Syndrome

Cyclosporine
    Indication: Behcet's Syndrome
    End date: 2001-01-06

Cytoxan
    Dosage: 250 mg, 250 mg, 500 mg, 750 mg, 1000 mg, 1250 mg, intravenous
    Indication: Behcet's Syndrome

Dapsone
    Dosage: titrated up to 100 mg twice daily, titrated up to 50 mg daily
    Indication: Behcet's Syndrome

Enbrel
    Dosage: 25 mg twice weekly
    Indication: Behcet's Syndrome

Imuran
    Dosage: titrated up to 150 mg daily
    Indication: Behcet's Syndrome

Leukeran
    Dosage: titrated up to 4 mg daily, 3 mg daily, 3 mg daily
    Indication: Behcet's Syndrome

Methotrexate
    Dosage: 7.5 mg per week, titrated up to 20 mg per week
    Indication: Behcet's Syndrome

Plaquenil
    Dosage: 300 mg daily, 200 mg daily, 200 mg twice daily, oral
    Administration route: Oral
    Indication: Behcet's Syndrome

Prednisone
    Dosage: 10 mg daily
    Indication: Behcet's Syndrome

Remicade
    Dosage: 200 mg, 300 mg, 400 mg, intravenous
    Indication: Behcet's Syndrome

Rituxan
    Dosage: 1000 mg, 1000 mg, intravenous
    Indication: Behcet's Syndrome
    End date: 2006-07-05

Other drugs received by patient: Terbutaline Sulfate; (Esomeprazole); Pregabalin; Acyclovir; (Fentanyl); Erythromycin; Sertraline Hydrochloride; Theophylline; Pentoxifylline; Furosemide; Folic Acid; Fluticasone Propionate / Salmeterol; Ipratropium Bromide and Albuterol Sulfate



Possible Leukeran side effects in 48 year old female

Reported by a physician from United States on 2011-10-19

Patient: 48 year old female

Reactions: Squamous Cell Carcinoma of Skin

Drug(s) suspected as cause:
Arava
    Indication: Behcet's Syndrome

Colchicine
    Indication: Behcet's Syndrome

Cyclosporine
    Indication: Behcet's Syndrome

Cytoxan
    Indication: Behcet's Syndrome

Dapsone
    Indication: Behcet's Syndrome

Enbrel
    Indication: Behcet's Syndrome

Imuran
    Indication: Behcet's Syndrome

Leukeran
    Indication: Behcet's Syndrome

Methotrexate
    Indication: Behcet's Syndrome

Mycophenolate Mofetil (Cellcept)
    Indication: Behcet's Syndrome

Plaquenil
    Indication: Behcet's Syndrome

Prednisone
    Indication: Behcet's Syndrome

Remicade
    Indication: Behcet's Syndrome

Rituxan
    Indication: Behcet's Syndrome

Other drugs received by patient: Pregabalin; Acyclovir; Folic Acid; Furosemide; Terbutaline Sulfate; Erythromycin; Esomeprazole Sodium; Pentoxifylline; Theophylline; Fentanyl-100; Fluticasone Propionate / Salmeterol; Sertraline Hydrochloride

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