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Hydroxyurea (Hydroxyurea) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Hydroxyurea 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 (162)
Death (50)
Life Threatening Events (10)
Disability (4)

Reports by Reaction Type

Neoplasm Malignant (29)Death (15)Pneumonia (12)Skin Ulcer (8)Acute Myeloid Leukaemia (8)Respiratory Failure (8)Cardiac Failure (8)Maternal Exposure During Pregnancy (7)Platelet Count Increased (6)Drug Withdrawal Syndrome Neonatal (6)Pericardial Effusion (6)Thrombocytopenia (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Hydroxyurea. For a complete list or a specific selection of reports, please use the links above.

Possible Hydroxyurea side effects in 82 year old female

Reported by a consumer/non-health professional from Russian Federation on 2012-08-24

Patient: 82 year old female

Reactions: Product Counterfeit, Drug Ineffective

Drug(s) suspected as cause:
Hydroxyurea



Possible Hydroxyurea side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 100.7 kg (221.5 pounds)

Reactions: Nausea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Blinded NO Treatment Received
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-01
    End date: 2012-07-06

Fluorouracil
    Dosage: unk
    Start date: 2012-07-29

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Start date: 2012-07-15
    End date: 2012-07-20

Hydroxyurea
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-29

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Start date: 2012-07-15
    End date: 2012-07-20

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-01
    End date: 2012-07-06

Paclitaxel
    Dosage: 228 mg qwk
    Start date: 2012-07-15
    End date: 2012-07-20

Paclitaxel
    Dosage: unk
    Start date: 2012-07-29

Paclitaxel
    Dosage: 228 mg qwk
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-02

Placebo
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Other drugs received by patient: Fentanyl; Neosporin (Neomycin Sulfate / Polymyxin B Sulfate); Senna; Bacitracin; Filgrastim; Morphine; Famotidine; Fluconazole; Eucerin; Prochlorperazine; Esomeprazole Sodium; Guaifenesin; Enoxaparin; Amoxicillin and Clavulanate Potassium; Miralax; Lidocaine; Escitalopram; Ondansetron; Rosuvastatin; Docusate; Aquaphor; Hydromorphone Hydrochloride; Nystatin



Possible Hydroxyurea side effects in

Reported by a consumer/non-health professional from Germany on 2012-08-16

Patient:

Reactions: Blood Folate Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydroxyurea



Possible Hydroxyurea side effects in

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

Patient:

Reactions: Death, Peripheral Sensorimotor Neuropathy, Multiple Myeloma

Adverse event resulted in: death

Drug(s) suspected as cause:
Bortezomib
    Dosage: 1 mg, / day

Bortezomib
    Dosage: 1.3 mg/m2 days:1,4,8,11
    Indication: Multiple Myeloma

Dexamethasone
    Dosage: unk, unknown
    Indication: Multiple Myeloma

Hydroxyurea
    Dosage: unk, unknown
    Indication: Essential Thrombocythaemia
    Start date: 2000-09-01

Thalidomide
    Dosage: unk, unknown
    Indication: Multiple Myeloma

Other drugs received by patient: Thyroid Replacement Therapy



Possible Hydroxyurea side effects in

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

Patient:

Reactions: Death, Peripheral Sensorimotor Neuropathy, Multiple Myeloma

Adverse event resulted in: death

Drug(s) suspected as cause:
Bortezomib
    Dosage: 1 mg, / day

Bortezomib
    Dosage: 1.3 mg/m2 days:1,4,8,11
    Indication: Multiple Myeloma

Dexamethasone
    Dosage: unk, unknown
    Indication: Multiple Myeloma

Hydroxyurea
    Dosage: unk, unknown
    Indication: Essential Thrombocythaemia
    Start date: 2000-09-01

Thalidomide
    Dosage: unk, unknown
    Indication: Multiple Myeloma

Other drugs received by patient: Thyroid Replacement Therapy



Possible Hydroxyurea side effects in 50 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-06

Patient: 50 year old male

Reactions: Amnesia

Drug(s) suspected as cause:
Gabapentin

Hydroxyurea
    Start date: 2011-01-05

Infumorph
    Dosage: caps

Naproxen

Oramorph SR
    Dosage: strength:oramorph10mg/5ml
    Administration route: Oral

Tramadol HCL

Other drugs received by patient: Acetaminophen



Possible Hydroxyurea side effects in male

Reported by a physician from United States on 2012-08-03

Patient: male, weighing 100.7 kg (221.5 pounds)

Reactions: Nausea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: no treatment received
    Indication: Squamous Cell Carcinoma

Blinded NO Treatment Received
    Dosage: no treatment received
    Indication: Squamous Cell Carcinoma

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Start date: 2012-07-15
    End date: 2012-07-20

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-15
    End date: 2012-07-06

Hydroxyurea
    Dosage: 500 mg, unk
    Administration route: Oral
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-01
    End date: 2012-07-06

Hydroxyurea
    Dosage: 500 mg, unk
    Administration route: Oral
    Start date: 2012-07-15
    End date: 2012-07-20

Paclitaxel
    Dosage: 228 mg qwk
    Start date: 2012-07-15
    End date: 2012-07-20

Paclitaxel
    Dosage: 228 mg qwk
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-02

Placebo
    Dosage: no treatment received
    Indication: Squamous Cell Carcinoma

Other drugs received by patient: Bacitracin; Fentanyl Citrate; Miralax; Escitalopram; Senna-Mint WAF; Famotidine; Filgrastim; Fluconazole; Eucerin; Aquaphor; Prochlorperazine; Ondansetron; Lidocaine; Morphine Sulfate; Amoxicillin and Clavulanate Potassium; Neosporin (Neomycin Sulfate / Polymyxin B Sulfate); Rosuvastatin



Possible Hydroxyurea side effects in 48 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-02

Patient: 48 year old female

Reactions: Multiple Myeloma

Adverse event resulted in: death

Drug(s) suspected as cause:
Hydroxyurea



Possible Hydroxyurea side effects in

Reported by a physician from Italy on 2012-08-01

Patient:

Reactions: Atrial Fibrillation, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydroxyurea
    Dosage: 17.5 mg, monthly
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 1994-10-17
    End date: 2002-03-01

Interferon
    Dosage: 3 miu, three times per week
    Indication: Essential Thrombocythaemia
    Start date: 2002-05-20
    End date: 2003-03-13

Other drugs received by patient possibly interacting with the suspect drug:
Anagrelide HCL
    Dosage: .5 mg, 2x/day:bid
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2007-06-04
    End date: 2009-10-07

Ticlopidine Hydrochloride
    Dosage: 250 mg, 1x/day:qd
    Administration route: Oral
    Indication: Thrombocytosis
    Start date: 1994-10-17



Possible Hydroxyurea side effects in 85 year old female

Reported by a consumer/non-health professional from Japan on 2012-07-31

Patient: 85 year old female

Reactions: Impaired Healing, Skin Ulcer, Pseudomonas Infection

Drug(s) suspected as cause:
Hydroxyurea



Possible Hydroxyurea side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: 72 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Left Ventricular Dysfunction, Dyspnoea, Conduction Disorder, Pulmonary Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemtuzumab
    Dosage: 3 milligram/sq. meter
    Start date: 2012-03-12
    End date: 2012-03-19

Hydroxyurea
    Dosage: 1500 milligram
    Administration route: Oral
    Start date: 2012-03-12
    End date: 2012-03-22

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-03-12
    End date: 2012-03-18



Possible Hydroxyurea side effects in 55 year old male

Reported by a physician from Sweden on 2012-07-30

Patient: 55 year old male

Reactions: Torsade DE Pointes, Electrocardiogram QT Prolonged, Cardio-Respiratory Arrest, Respiratory Depression, Arrhythmia, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Acenocumarol
    Dosage: 3 mg, qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 1996-05-23

Anagrelide Hydrochloride
    Dosage: 1 mg, qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2005-10-10

Aspirin
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2006-05-05

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 1997-12-05
    End date: 2005-10-09

Other drugs received by patient: Atenolol; Candesartan; Gliclazide; Tamsulosin HCL



Possible Hydroxyurea side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 73 year old male, weighing 81.0 kg (178.1 pounds)

Reactions: Cardiac Failure, Cardiomyopathy, Pericardial Effusion, Generalised Oedema, Cardiomegaly

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid W / Dipyridamole
    Dosage: 1 df daily dose
    Start date: 2003-01-27
    End date: 2005-03-20

Acetylsalicylic Acid W / Dipyridamole
    Dosage: 2 df daily dose
    Indication: Essential Thrombocythaemia
    Start date: 2005-03-20
    End date: 2009-09-21

Anagrelide HCL
    Dosage: 2mg
    Administration route: Oral
    Start date: 2009-06-02
    End date: 2009-09-21

Anagrelide HCL
    Dosage: 1mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-11-09
    End date: 2009-11-17

Anagrelide HCL
    Dosage: dose of 1 mg and 3.5 mg
    Administration route: Oral
    Start date: 2000-06-28
    End date: 2009-03-02

Aspirin
    Dosage: 150mg
    Administration route: Oral
    Start date: 2003-01-27
    End date: 2003-03-20

Aspirin
    Dosage: 75mg
    Administration route: Oral
    Start date: 2009-12-30
    End date: 2010-07-08

Aspirin
    Dosage: 150mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2000-06-28
    End date: 2003-01-25

Hydroxyurea
    Dosage: 500mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-09-21
    End date: 2009-09-22

Hydroxyurea
    Dosage: 500mg
    Administration route: Oral
    Start date: 2009-10-12
    End date: 2009-11-02

Other drugs received by patient: Citalopram Hydrobromide



Possible Hydroxyurea side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-26

Patient: 55 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Hypovolaemic Shock, Myocardial Ischaemia, Anaphylactic Reaction, Encephalitis, Loss of Consciousness, Haemodynamic Instability, Tachyarrhythmia, Hypotension, Hyperglycaemia, Delirium, Anaphylactoid Shock, Areflexia, Septic Shock, Arteritis, Respiratory Depression, Neuropathy Peripheral, Cardio-Respiratory Arrest, Ventricular Tachyarrhythmia, Brain Oedema, Dizziness, Myocardial Infarction, Oxygen Saturation Decreased, Guillain-Barre Syndrome, Mydriasis, Hyponatraemia, Arrhythmia, Torsade DE Pointes, Vestibular Disorder, Ventricular Fibrillation, Embolism Arterial, Meningitis Noninfective, Neurogenic Shock, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Acenocoumarol
    Dosage: 3 mg, qd
    Start date: 1996-05-23

Anagrelide HCL
    Dosage: 5 mg, unk
    Start date: 2006-02-08
    End date: 2006-04-10

Anagrelide HCL
    Dosage: 5 mg, unk
    Start date: 2005-10-10
    End date: 2005-12-12

Anagrelide HCL
    Dosage: 1.5 mg, unk
    Start date: 2007-02-27
    End date: 2007-06-25

Anagrelide HCL
    Dosage: 1.5 mg, unk
    Start date: 2006-04-11
    End date: 2006-07-28

Anagrelide HCL
    Dosage: 1.5 mg, unk
    Start date: 2005-12-13
    End date: 2006-02-07

Anagrelide HCL
    Dosage: 1 mg, unk
    Start date: 2009-10-28

Anagrelide HCL
    Dosage: 1 mg, unk
    Start date: 2006-07-29
    End date: 2007-02-26

Anagrelide HCL
    Dosage: 1.5 mg, unk
    Start date: 2008-07-15
    End date: 2008-10-27

Anagrelide HCL
    Dosage: 1 mg, unk
    Start date: 2007-06-26
    End date: 2008-07-14

Aspirin
    Dosage: 100 mg, unk
    Start date: 2006-05-05

Atenolol
    Dosage: 100 mg, unk
    Indication: Hypertension
    Start date: 2008-01-01

Candesartan
    Dosage: 8 mg, qd
    Indication: Hypertension
    Start date: 2008-01-01

Gliclazide
    Dosage: 30 mg, unk
    Indication: Diabetes Mellitus
    Start date: 2008-01-01

Hydroxyurea
    Dosage: 500 mg, unk
    Start date: 1997-12-05
    End date: 2005-10-09

Tamsulosin Hydrochloride
    Dosage: 4 mg, unk
    Indication: Prostatic Disorder
    Start date: 2008-01-01



Possible Hydroxyurea side effects in 86 year old male

Reported by a physician from Germany on 2012-07-24

Patient: 86 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydroxyurea

Other drugs received by patient: Aspirin; Allopurinol; Torsemide; ACC 200; Cotrim



Possible Hydroxyurea side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-13

Patient:

Reactions: Adverse Drug Reaction

Drug(s) suspected as cause:
Hydroxyurea



Possible Hydroxyurea side effects in 41 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06

Patient: 41 year old male

Reactions: Acute Myeloid Leukaemia, Myelodysplastic Syndrome, Pancytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Hydroxyurea



Possible Hydroxyurea side effects in male

Reported by a physician from United States on 2012-07-05

Patient: male, weighing 103.2 kg (227.0 pounds)

Reactions: Pneumonia Aspiration, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: no treatment
    Indication: Head and Neck Cancer

Blinded NO Treatment Received
    Dosage: no treatment
    Indication: Head and Neck Cancer

Comparator Cetuximab
    Dosage: 576 mg, qw
    Start date: 2011-03-14

Comparator Cetuximab
    Indication: Head and Neck Cancer

Fluorouracil
    Indication: Head and Neck Cancer

Fluorouracil
    Dosage: 1400 mg / day civ for 120 hours
    Start date: 2011-03-13
    End date: 2011-03-18

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Start date: 2011-03-13
    End date: 2011-03-18

Hydroxyurea
    Administration route: Oral
    Indication: Head and Neck Cancer

Placebo
    Dosage: no treatment
    Indication: Head and Neck Cancer

Other drugs received by patient: Senna-Mint WAF; Dulcolax; Percocet; Fentanyl; Lorazepam; Remeron; Acetaminophen; Neurontin; Claritin; Nexium; Lantus; Nasal Saline; Benadryl; M.v.i.; Lidocaine HCL Viscous; Insulin; Lidoderm; Ondansetron; Guaifenesin



Possible Hydroxyurea side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: male, weighing 52.8 kg (116.2 pounds)

Reactions: Large Intestine Perforation, Cellulitis, Respiratory Failure, Radiation Skin Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Blinded NO Treatment Received
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Cisplatin
    Dosage: unk
    Indication: Head and Neck Cancer

Cisplatin
    Dosage: 120 mg, q21d
    Start date: 2011-05-24

Comparator Cetuximab
    Dosage: 400 mg, qw
    Start date: 2011-07-13

Comparator Cetuximab
    Dosage: 400 mg, qw
    Start date: 2011-08-08
    End date: 2011-08-12

Comparator Cetuximab
    Dosage: 400 mg, qw
    Indication: Head and Neck Cancer
    Start date: 2011-06-07

Fluorouracil
    Dosage: 950 mg/d over 120 hours
    Start date: 2011-08-07
    End date: 2011-08-12

Fluorouracil
    Dosage: 975 mg/d over 120 hours
    Indication: Head and Neck Cancer
    Start date: 2011-07-04
    End date: 2011-07-09

Hydroxyurea
    Dosage: 500 mg, bid per gt
    Administration route: Oral
    Indication: Head and Neck Cancer
    Start date: 2011-07-04
    End date: 2011-07-09

Hydroxyurea
    Dosage: 500 mg, bid per gt
    Start date: 2011-08-07
    End date: 2011-08-12

Paclitaxel
    Dosage: 299.3 mg, q21 d
    Indication: Head and Neck Cancer
    Start date: 2012-05-24

Placebo
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Other drugs received by patient: Elixir Paregorique Lipha; Nexium; Enalapril Maleate; Labetalol HCL; Lexapro; Neosporin (Neomycin Sulfate / Polymyxin B Sulfate); Dexamethasone Sodium Phosphate; Morphine; Colace; Nystatin; Ondansetron; Esomeprazole; Lorazepam; Prochlorperazine; Ciprofloxacin HCL; Oxycodone HCL; Oxycontin; Oramorph SR; Enoxaparin; Docusate



Possible Hydroxyurea side effects in male

Reported by a physician from United States on 2012-07-03

Patient: male, weighing 65.6 kg (144.3 pounds)

Reactions: Renal Injury, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Indication: Squamous Cell Carcinoma

Blinded NO Treatment Received
    Dosage: unk
    Indication: Squamous Cell Carcinoma

Comparator Cetuximab
    Dosage: 482 mg, qw
    Indication: Tongue Cancer Metastatic
    Start date: 2011-06-20
    End date: 2011-06-24

Decadron

Fluorouracil
    Dosage: 950 mg, qd
    Indication: Tongue Cancer Metastatic
    Start date: 2011-06-19
    End date: 2011-06-24

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Tongue Cancer Metastatic
    Start date: 2011-06-19
    End date: 2011-06-24

Placebo
    Dosage: unk
    Indication: Squamous Cell Carcinoma

Other drugs received by patient: Prilosec; Senna-S (Docusate Sodium / Senna Alexandrina); Lorazepam; Morphine; Mupirocin; Ondansetron; Silvadene; Oramorph SR; Fluconazole; Lidocaine; Miralax; Esomeprazole; Peri-Colace; Guaifenesin; Fentanyl; Ibuprofen; Mylanta



Possible Hydroxyurea side effects in 73 year old male

Reported by a physician from Denmark on 2012-07-02

Patient: 73 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Anaemia, General Physical Health Deterioration, Cerebrovascular Accident, Cardiomyopathy, Generalised Oedema, Cardiomegaly, Pericardial Effusion, Cardiac Failure, Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Anagrelide HCL
    Dosage: .5 mg, bid
    Administration route: Oral
    Start date: 2009-11-09
    End date: 2009-11-17

Anagrelide HCL
    Dosage: alternating between a daily dose of 1 mg and 3.5 mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2000-06-28
    End date: 2009-06-02

Anagrelide HCL
    Dosage: .5 mg, qid
    Administration route: Oral
    Start date: 2009-06-02
    End date: 2009-09-21

Aspirin
    Dosage: 150 mg, qd
    Administration route: Oral
    Start date: 2003-01-27
    End date: 2003-03-01

Aspirin
    Dosage: 150 mg, qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2000-06-28
    End date: 2003-01-25

Aspirin
    Dosage: 75 mg, qd
    Administration route: Oral
    Start date: 2009-12-30
    End date: 2010-07-08

Aspirin and Dipyridamole
    Dosage: 1 df, bid
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2003-01-27
    End date: 2005-03-01

Aspirin and Dipyridamole
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2005-03-01
    End date: 2009-09-21

Hydroxyurea
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-09-21
    End date: 2009-09-22

Hydroxyurea
    Dosage: 500 mg, qd
    Administration route: Oral
    Start date: 2009-10-12
    End date: 2009-11-02

Other drugs received by patient: Danazol; Citalopram Hydrobromide



Possible Hydroxyurea side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 73 year old male, weighing 81.0 kg (178.1 pounds)

Reactions: Cardiac Failure, Cardiomyopathy, Generalised Oedema, Cardiomegaly, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid W / Dipyridamole
    Dosage: 2 df daily dose
    Indication: Essential Thrombocythaemia
    Start date: 2005-03-20
    End date: 2009-09-21

Acetylsalicylic Acid W / Dipyridamole
    Dosage: 1 df daily dose
    Start date: 2003-01-27
    End date: 2005-03-20

Anagrelide HCL
    Dosage: 1mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-11-09
    End date: 2009-11-17

Anagrelide HCL
    Dosage: dose of 1 mg and 3.5 mg
    Administration route: Oral
    Start date: 2000-06-28
    End date: 2009-03-02

Anagrelide HCL
    Dosage: 2mg
    Administration route: Oral
    Start date: 2009-06-02
    End date: 2009-09-21

Aspirin
    Dosage: 150mg
    Administration route: Oral
    Start date: 2003-01-27
    End date: 2003-03-20

Aspirin
    Dosage: 150mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2000-06-28
    End date: 2003-01-25

Aspirin
    Dosage: 75mg
    Administration route: Oral
    Start date: 2009-12-30
    End date: 2010-07-08

Hydroxyurea
    Dosage: 500mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-09-21
    End date: 2009-09-22

Hydroxyurea
    Dosage: 500mg
    Administration route: Oral
    Start date: 2009-10-12
    End date: 2009-11-02

Other drugs received by patient: Citalopram Hydrobromide



Possible Hydroxyurea side effects in 85 year old male

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 85 year old male, weighing 79.4 kg (174.6 pounds)

Reactions: Basosquamous Carcinoma

Drug(s) suspected as cause:
Hydroxyurea



Possible Hydroxyurea side effects in male

Reported by a physician from Denmark on 2012-06-29

Patient: male, weighing 81.0 kg (178.2 pounds)

Reactions: Cardiomegaly, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anagrelide HCL
    Dosage: alternating between a daily dose of 1 mg and 3.5 mg
    Administration route: Oral
    Start date: 2000-06-28
    End date: 2009-03-02

Anagrelide HCL
    Dosage: 1 mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-11-09
    End date: 2009-11-17

Anagrelide HCL
    Dosage: 2 mg
    Administration route: Oral
    Start date: 2009-06-02
    End date: 2009-09-21

Aspirin
    Dosage: 150 mg
    Administration route: Oral
    Start date: 2000-06-28
    End date: 2003-01-25

Aspirin
    Dosage: 150 mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2003-01-27
    End date: 2003-03-20

Aspirin
    Dosage: 75 mg
    Administration route: Oral
    Start date: 2009-12-30
    End date: 2010-07-08

Aspirin and Dipyridamole
    Dosage: 1 df
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2005-03-01
    End date: 2009-09-21

Aspirin and Dipyridamole
    Dosage: strength 1df. daily dose: 2df
    Administration route: Oral
    Start date: 2003-01-27
    End date: 2005-03-20

Hydroxyurea
    Dosage: 500 mg
    Administration route: Oral
    Start date: 2009-09-21
    End date: 2009-09-22

Hydroxyurea
    Dosage: 500 mg
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-10-12
    End date: 2009-11-02

Other drugs received by patient: Citalopram Hydrobromide



Possible Hydroxyurea side effects in male

Reported by a physician from Italy on 2012-06-26

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Cerebral Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Arsenic Trioxide
    Dosage: 10 milligram;
    Start date: 2012-06-12
    End date: 2012-06-16

Atracurium Besylate
    Dosage: 80 milligram;
    Start date: 2012-06-10
    End date: 2012-06-17

Hydroxyurea
    Dosage: 4 milligram;
    Start date: 2012-06-12
    End date: 2012-06-19

Other drugs received by patient: Methylprednisolone; Dexamethasone



Possible Hydroxyurea side effects in male

Reported by a physician from Germany on 2012-06-25

Patient: male, weighing 84.8 kg (186.6 pounds)

Reactions: Tumour Lysis Syndrome, Pneumonia, Coronary Artery Disease, Acute Myocardial Infarction, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Hydroxyurea

Inc424
    Dosage: 15 mg, bid
    Administration route: Oral
    Indication: Myelofibrosis
    Start date: 2012-02-28
    End date: 2012-04-22

Other drugs received by patient: Metoprolol Tartrate; Levothyroxine Sodium; Clopidogrel



Possible Hydroxyurea side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20

Patient: 77 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Troponin I Increased, Transfusion Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemtuzumab Ozogamicin
    Dosage: 3 milligram/sq. meter
    Start date: 2012-02-02
    End date: 2012-02-13

Hydroxyurea
    Dosage: 1500 milligram
    Administration route: Oral
    End date: 2012-02-05

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-02-02
    End date: 2012-02-10



Possible Hydroxyurea side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-06-19

Patient: female

Reactions: Complication of Pregnancy, Complication of Delivery, Maternal Exposure During Pregnancy, Abortion Induced, Abortion Spontaneous, Labour Complication

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: unk
    Indication: Migraine
    Start date: 2007-04-03
    End date: 2007-05-01

Anagrelide HCL
    Dosage: unk
    Start date: 2009-02-14

Anagrelide HCL
    Dosage: unk
    Start date: 2007-12-22

Anagrelide HCL
    Dosage: unk
    Start date: 2007-07-26
    End date: 2007-12-18

Anagrelide HCL
    Dosage: unk
    Start date: 2007-05-25
    End date: 2007-07-18

Anagrelide HCL
    Dosage: unk
    Start date: 2006-12-22
    End date: 2007-03-01

Anagrelide HCL
    Dosage: unk
    Indication: Essential Thrombocythaemia
    Start date: 2007-11-18
    End date: 2007-12-14

Anagrelide HCL
    Dosage: unk
    Start date: 2008-09-05
    End date: 2009-02-13

Aspirin
    Dosage: unk
    Indication: Essential Thrombocythaemia
    Start date: 2002-01-01
    End date: 2002-01-01

Enoxaparin
    Dosage: unk
    Indication: Prophylaxis
    Start date: 2007-04-27
    End date: 2007-06-17

Hydroxyurea
    Dosage: unk
    Indication: Essential Thrombocythaemia
    Start date: 1998-01-01
    End date: 2006-11-20

Peginterferon Alfa-2A
    Dosage: unk
    Start date: 2007-03-01
    End date: 2007-05-29

Peginterferon Alfa-2A
    Dosage: unk
    Start date: 2007-07-18
    End date: 2007-08-26

Peginterferon Alfa-2A
    Dosage: unk
    Start date: 2000-02-01
    End date: 2000-06-01

Peginterferon Alfa-2A
    Dosage: unk
    Start date: 2006-08-14
    End date: 2006-12-04

Peginterferon Alfa-2A
    Dosage: unk
    Indication: Essential Thrombocythaemia
    Start date: 2007-12-18
    End date: 2007-12-22

Tramadol HCL
    Dosage: unk
    Indication: Migraine
    Start date: 2007-05-25

Tramadol HCL
    Indication: Ear Pain



Possible Hydroxyurea side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: 85 year old female, weighing 154.3 kg (339.5 pounds)

Reactions: Overdose, Drug Abuse, Drug Dependence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anagrelide HCL
    Dosage: 5mg once a day
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2008-02-11
    End date: 2008-03-11

Anagrelide HCL
    Dosage: 2mg daily
    Administration route: Oral
    Start date: 2008-05-11
    End date: 2008-06-11

Anagrelide HCL
    Dosage: 1.5mg daily
    Administration route: Oral
    Start date: 2008-04-11
    End date: 2008-05-11

Anagrelide HCL
    Dosage: 1mg daily
    Administration route: Oral
    Start date: 2008-03-11
    End date: 2008-04-11

Anagrelide HCL
    Dosage: 2.5mg daily
    Administration route: Oral
    Start date: 2008-06-11
    End date: 2008-12-22

Anagrelide HCL
    Dosage: 2mg daily
    Administration route: Oral
    Start date: 2008-12-23
    End date: 2009-05-16

Aspirin
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 1999-06-27
    End date: 2009-05-20

Fluindione
    Dosage: 5mg once a day
    Start date: 2009-06-16

Fluindione
    Dosage: 10mg once a day
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-05-16
    End date: 2009-06-02

Hydroxyurea
    Dosage: 1000 or 1500mg daily
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 1996-06-20
    End date: 1998-06-18

Pipobroman
    Dosage: 400mg per week
    Administration route: Oral
    Start date: 2007-03-01
    End date: 2007-07-10

Pipobroman
    Dosage: 700mg per week
    Administration route: Oral
    Start date: 2007-11-16
    End date: 2008-05-26

Pipobroman
    Dosage: 525mg per week
    Administration route: Oral
    Start date: 2007-09-10
    End date: 2007-11-16

Pipobroman
    Dosage: 525 mg per week
    Start date: 2008-05-26
    End date: 2008-09-22

Pipobroman
    Dosage: 25 or 50mg daily
    Administration route: Oral
    Start date: 1998-08-03
    End date: 1999-02-01

Pipobroman
    Dosage: 25mg every two days
    Administration route: Oral
    Start date: 2009-07-03

Pipobroman
    Dosage: 325mg per week
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 1999-06-01
    End date: 2007-03-01

Pipobroman
    Dosage: 475mg per week
    Administration route: Oral
    Start date: 2007-07-10
    End date: 2007-09-10

Pipobroman
    Dosage: 175mg per week
    Administration route: Oral
    Start date: 2008-09-23
    End date: 2008-12-22

Pipobroman
    Dosage: 37,5mg every other day
    Administration route: Oral
    Start date: 2009-05-16
    End date: 2009-07-02

Other drugs received by patient: Flecainide Acetate; Anastrozole; Flecainide Acetate; Aranesp



Possible Hydroxyurea side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-06-19

Patient: 73 year old female

Reactions: Gastrointestinal Ulcer, Gastrointestinal Perforation, Gastrointestinal Haemorrhage, Large Intestinal Ulcer, Anaemia, Thrombocytosis, Pancytopenia, Erythropenia, Gastrointestinal Obstruction

Drug(s) suspected as cause:
Anagrelide HCL

Aspirin
    Dosage: 80 mg, unk

Calcium Carbonate

Cetirizine Hydrochloride

Epogen

Folic Acid

Furosemide

Hydroxyurea

Iron

Pravastatin

Sodium Bicarbonate

Vitamin B Complex CAP

Vitamin D

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