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Hydrea (Hydroxyurea) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Hydrea (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 (120)
Death (23)
Life Threatening Events (17)

Reports by Reaction Type

Pancytopenia (11)Renal Failure Acute (10)Dermatitis Bullous (8)Anaemia (7)Aplasia (7)Skin Ulcer (6)Thrombocytopenia (6)Haemorrhage (5)Drug Interaction (5)Platelet Count Increased (5)Laryngeal Oedema (5)Pyrexia (5)

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

Possible Hydrea side effects in

Reported by a pharmacist from Japan on 2012-08-24

Patient:

Reactions: Hyponatraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adalat

Hydrea



Possible Hydrea side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 48 year old female

Reactions: Central Nervous System Haemorrhage

Drug(s) suspected as cause:
Hydrea
    Indication: Chronic Myeloid Leukaemia

Sprycel
    Indication: Chronic Myeloid Leukaemia



Possible Hydrea side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17

Patient: 66 year old female

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lasix
    Start date: 2012-05-14
    End date: 2012-05-15

Hydrea
    Dosage: 500 mg daily every other days and 1000 mg daily every other day
    Administration route: Oral
    Indication: Deep Vein Thrombosis
    End date: 2012-05-01

Humalog
    Start date: 2012-05-12
    End date: 2012-05-17

Claforan
    Dosage: powder and solvant for injection solution
    Indication: Pneumonia Legionella
    Start date: 2012-05-12
    End date: 2012-05-14

Methotrexate Sodium

Other drugs received by patient: Actonel; Augmentin '500'; Propranolol; Augmentin '500'; Aspirin; Micardis; Clarithromycin; Clarithromycin; Prednisone TAB; Amitriptyline Hydrochloride; Terbinafine HCL; Aldactazine; Nexium; Xyzal; Atorvastatin; Lorazepam



Possible Hydrea side effects in 64 year old male

Reported by a consumer/non-health professional from Canada on 2012-08-10

Patient: 64 year old male

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea

Sprycel
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-07-01

Other drugs received by patient: Perindopril Erbumine; Metformin Hydrochloride; Lasix; Tiazac



Possible Hydrea side effects in 75 year old female

Reported by a consumer/non-health professional from Russian Federation on 2012-08-09

Patient: 75 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hydrea



Possible Hydrea side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Angina Unstable

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anagrelide Hydrochloride
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2011-07-14
    End date: 2012-02-13

Hydrea
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-09-14

Aspirin
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-09-14



Possible Hydrea side effects in 64 year old male

Reported by a consumer/non-health professional from Canada on 2012-08-03

Patient: 64 year old male

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea

Sprycel
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-07-01

Other drugs received by patient: Perindopril Erbumine; Lasix; Tiazac; Metformin Hydrochloride



Possible Hydrea side effects in 82 year old male

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

Patient: 82 year old male

Reactions: Pancytopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Hydrea

Other drugs received by patient: Aricept; Lovenox; Citalopram Hydrobromide



Possible Hydrea side effects in male

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

Patient: male

Reactions: Angina Unstable

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 75 mg, 1x/day:qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-09-14

Anagrelide Hydrochloride
    Dosage: 0.5 mg, 1x/day:qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2011-07-14
    End date: 2012-02-13

Hydrea
    Dosage: 500 mg, 1x/day:qd
    Administration route: Oral
    Indication: Essential Thrombocythaemia
    Start date: 2009-09-14



Possible Hydrea side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: 68 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Stomatitis, Neoplasm Malignant, Tongue Ulceration, Atrial Fibrillation, Gastroduodenitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Hydrea
    Administration route: Oral
    Indication: Leukocytosis

Cytarabine

Other drugs received by patient: Diflucan; Valtrex; Levaquin; Morphine Sulfate



Possible Hydrea side effects in 67 year old female

Reported by a consumer/non-health professional from Brazil on 2012-07-13

Patient: 67 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Product Counterfeit, Nail Discolouration, Anaemia, Platelet Count Increased

Drug(s) suspected as cause:
Hydrea



Possible Hydrea side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-12

Patient: 75 year old female

Reactions: Rash Pustular, Rash Erythematous

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-22
    End date: 2012-02-28

Tazobactam
    Dosage: 4 g, 3x/day
    Indication: Pyelonephritis
    Start date: 2012-02-22
    End date: 2012-02-25

Amoxicillin
    Dosage: 1 g, 4x/day
    Indication: Pyelonephritis
    Start date: 2012-02-26
    End date: 2012-02-27

Other drugs received by patient: Lovenox; Fenofibrate; Smecta ^pfizer^; Lercapress; Allopurinol



Possible Hydrea side effects in 76 year old female

Reported by a physician from France on 2012-07-12

Patient: 76 year old female

Reactions: Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-22
    End date: 2012-02-28

Amoxicillin
    Indication: Pyelonephritis
    Start date: 2012-02-26
    End date: 2012-02-27

Tazobactam
    Indication: Pyelonephritis
    Start date: 2012-02-22
    End date: 2012-02-25

Other drugs received by patient: Aluminum Hydroxide and Magnesium Trisilicate; Enalapril Maleate; Fenofibrate; Allopurinol; Lovenox



Possible Hydrea side effects in

Reported by a physician from Brazil on 2012-07-09

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Imatinib Mesylate
    Administration route: Oral

Nilotinib

Hydrea

Dasatinib



Possible Hydrea side effects in 78 year old male

Reported by a consumer/non-health professional from France on 2012-07-05

Patient: 78 year old male

Reactions: Arteritis Coronary

Drug(s) suspected as cause:
Hydrea
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication

Anagrelide Hydrochloride
    Dosage: 2 df, 1x/day:qd
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Cordarone



Possible Hydrea side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-04

Patient: male

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea
    Dosage: 1df:1 cap to begin with and then alternated betw taking 1 and 2 tab every 8 days
    Indication: White Blood Cell Count Increased
    End date: 2012-04-15

Hydrea
    Dosage: 1df:1 cap to begin with and then alternated betw taking 1 and 2 tab every 8 days
    Indication: Platelet Count Increased
    End date: 2012-04-15

Other drugs received by patient: ACC 200; Cotrim



Possible Hydrea side effects in 88 year old male

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

Patient: 88 year old male

Reactions: Skin Ulcer, Stasis Dermatitis, Lymphoedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea

Other drugs received by patient: Pentoxifylline; Pantoprazole Sodium; Esidrix; Simvastatin; Duragesic-100; Nitroglycerin



Possible Hydrea side effects in 49 year old male

Reported by a pharmacist from United States on 2012-06-28

Patient: 49 year old male, weighing 69.4 kg (152.7 pounds)

Reactions: Granulocytopenia, Leukopenia

Drug(s) suspected as cause:
Hydrea
    Administration route: Oral
    Indication: Leukaemia

Clozapine
    Indication: Psychotic Disorder
    End date: 2010-10-01

Clozapine
    Dosage: 50mg qam, 100mg at 5pm, and 250m gqhs
    Start date: 2010-10-01
    End date: 2011-03-01

Other drugs received by patient: Hytrin; Depakote ER; Ditropan; Glucophage; Neurontin



Possible Hydrea side effects in 75 year old female

Reported by a consumer/non-health professional from France on 2012-06-27

Patient: 75 year old female

Reactions: Myelofibrosis, Anaemia, Iron Deficiency

Drug(s) suspected as cause:
Hydrea

Other drugs received by patient: Imovane; Sulfarlem; Tenormin; Levothyroxine Sodium



Possible Hydrea side effects in 88 year old male

Reported by a physician from France on 2012-06-24

Patient: 88 year old male

Reactions: Skin Ulcer, Stasis Dermatitis, Lymphoedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea

Other drugs received by patient: Duragesic-100; Esidrix; Pentoxifylline; Nitroglycerin; Simvastatin; Pantoprazole Sodium



Possible Hydrea side effects in 67 year old female

Reported by a consumer/non-health professional from Brazil on 2012-06-18

Patient: 67 year old female, weighing 61.0 kg (134.2 pounds)

Reactions: Product Counterfeit, Nail Discolouration, Anaemia, Platelet Count Increased

Drug(s) suspected as cause:
Hydrea



Possible Hydrea side effects in 50 year old male

Reported by a physician from Spain on 2012-06-15

Patient: 50 year old male

Reactions: Subcutaneous Abscess, Bone Marrow Failure, Respiratory Tract Infection

Drug(s) suspected as cause:
Hydrea
    Dosage: 1df=1 tab
    Start date: 2012-03-20
    End date: 2012-03-27

Sprycel
    Indication: Blast Crisis in Myelogenous Leukaemia
    Start date: 2012-03-24
    End date: 2012-04-23

Other drugs received by patient: Allopurinol; Imatinib Mesylate



Possible Hydrea side effects in

Reported by a pharmacist from Australia on 2012-06-08

Patient:

Reactions: Impaired Healing, Gastric Ulcer

Drug(s) suspected as cause:
Hydrea



Possible Hydrea side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-29

Patient: 68 year old female

Reactions: Intestinal Ischaemia, Dermatitis Bullous, Gastrointestinal Necrosis, Aplasia, Septic Shock, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Vancomycin
    Start date: 2012-01-05

Zyvox
    Start date: 2011-12-30

Tazobactam
    Start date: 2011-12-28
    End date: 2012-01-04

Hydrea
    Start date: 2011-12-26
    End date: 2011-12-28

Idarubicin HCL
    Indication: Acute Leukaemia
    Start date: 2011-12-28
    End date: 2012-01-03

Valacyclovir Hydrochloride
    Start date: 2011-12-28

Amiodarone HCL
    Start date: 2011-12-30

Emend
    Administration route: Oral
    Start date: 2011-12-29

Levofloxacin
    Start date: 2011-12-29

Fasturtec
    Start date: 2011-12-28

Cytarabine
    Indication: Acute Leukaemia
    Start date: 2011-12-28
    End date: 2012-01-03

Other drugs received by patient: Metoclopramide; Noxafil; Zofran; Xyzal



Possible Hydrea side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-23

Patient: female, weighing 48.0 kg (105.6 pounds)

Reactions: Dyspnoea, Normal Newborn, Nausea, Maternal Exposure During Pregnancy, Pyrexia, Malaise, Interstitial Lung Disease, Suicide Attempt, Pleural Effusion, Delivery, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gleevec
    Dosage: 600 mg, unk
    Start date: 2005-05-01

Gleevec
    Dosage: 100 mg, daily
    Administration route: Oral
    Start date: 2004-10-21

Gleevec
    Dosage: 400 mg, per day

Gleevec
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2004-09-30
    End date: 2004-10-10

Hydrea
    Dosage: 1 g, qd
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2004-09-09
    End date: 2004-09-29

Gleevec
    Dosage: 100 mg, per day



Possible Hydrea side effects in 19 year old male

Reported by a physician from United States on 2012-05-22

Patient: 19 year old male

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Sprycel

Hydrea



Possible Hydrea side effects in 63 year old male

Reported by a physician from Japan on 2012-05-08

Patient: 63 year old male

Reactions: Haemorrhage, Laceration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea



Possible Hydrea side effects in 59 year old female

Reported by a consumer/non-health professional from Brazil on 2012-05-04

Patient: 59 year old female

Reactions: Capsule Physical Issue, Angioedema, Oedema, Urticaria Chronic, Laryngeal Oedema, Erythema, Arrhythmia

Drug(s) suspected as cause:
Hydrea



Possible Hydrea side effects in 75 year old female

Reported by a physician from France on 2012-05-02

Patient: 75 year old female

Reactions: Pericarditis

Drug(s) suspected as cause:
Hydrea

Other drugs received by patient: Actonel; Cirkan; Colchicine; Allopurinol



Possible Hydrea side effects in 56 year old female

Reported by a physician from France on 2012-04-30

Patient: 56 year old female

Reactions: Pancytopenia, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrea

Other drugs received by patient possibly interacting with the suspect drug:
Hydrea
    Dosage: also taken 1g daily 3rd course started on 14mar12
    Administration route: Oral
    Indication: Bile Duct Cancer
    Start date: 2010-05-10
    End date: 2012-02-02

Cisplatin
    Dosage: d1 (01-feb-2012) 25 mg/m2 d8 (09-feb-2012) of first course 3 courses
    Indication: Bile Duct Cancer
    Start date: 2012-02-01

Gemzar
    Dosage: 3rd course started on 14mar12
    Start date: 2012-02-01

Gemzar
    Dosage: gemzar 1000 mg,powder for solution pour infu(gemcitabine) 1000 mg/m2 d1 01feb2012 and d8 09feb2012
    Indication: Bile Duct Cancer
    Start date: 2012-02-01

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