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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