Index of reports
> Cases with Pneumonia (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Hydroxyurea where reactions include pneumonia. The selected reports were submitted to the FDA during the sample period of about a year.
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 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:
Inc424
Dosage: 15 mg, bid
Administration route: Oral
Indication: Myelofibrosis
Start date: 2012-02-28
End date: 2012-04-22
Hydroxyurea
Other drugs received by patient: Metoprolol Tartrate; Levothyroxine Sodium; Clopidogrel
Possible Hydroxyurea side effects in male
Reported by a physician from Germany on 2012-06-12
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:
Inc424
Dosage: 15 mg, bid
Administration route: Oral
Indication: Myelofibrosis
Start date: 2012-02-28
End date: 2012-04-22
Hydroxyurea
Possible Hydroxyurea side effects in 82 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04
Patient: 82 year old male, weighing 65.0 kg (143.0 pounds)
Reactions: Pulmonary Sepsis, Pneumonia, Hypotension, Somnolence
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Gemtuzumab Ozogamicin
Dosage: over 2 hrs on day 8,2nd course on 19jan12 5.6mg,last therapy on 26jan12
Indication: Acute Myeloid Leukaemia
Start date: 2012-01-05
Hydroxyurea
Dosage: 2nd course on 19jan12
Administration route: Oral
Indication: Acute Myeloid Leukaemia
Start date: 2012-01-05
Azacitidine
Dosage: route of adm:sc or iv over 10-40min on days 1-7,2nd course on 19jan12 980mg,last therapy on 25jan12
Indication: Acute Myeloid Leukaemia
Start date: 2012-01-05
Other drugs received by patient: Omeprazole; Ciprofloxacin; Biotin; Metoprolol Tartrate; Gabapentin; Fluconazole; Acyclovir
Possible Hydroxyurea side effects in male
Reported by a consumer/non-health professional from Germany on 2012-04-25
Patient: male
Reactions: Pneumonia, Platelet Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Hydroxyurea
Possible Hydroxyurea side effects in male
Reported by a health professional (non-physician/pharmacist) from Poland on 2012-04-02
Patient: male
Reactions: Pneumonia, Neoplasm Malignant, Acute Myeloid Leukaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Dasatinib
Dosage: then 80mg/d for 17 months
Indication: Chronic Myeloid Leukaemia
Start date: 2008-11-01
End date: 2010-07-01
Daunorubicin HCL
Indication: Chronic Myeloid Leukaemia
Azacitidine
Indication: Chronic Myeloid Leukaemia
Imatinib Mesylate
Dosage: dose reduced to 300mg/d
Indication: Chronic Myeloid Leukaemia
Start date: 2003-01-01
End date: 2007-12-01
Hydroxyurea
Indication: Chronic Myeloid Leukaemia
Nilotinib
Indication: Chronic Myeloid Leukaemia
Start date: 2008-01-01
End date: 2008-07-01
Cytarabine
Indication: Chronic Myeloid Leukaemia
Possible Hydroxyurea side effects in female
Reported by a physician from Mexico on 2012-03-28
Patient: female
Reactions: Death, Pneumonia, Respiratory Failure, Maternal Exposure During Pregnancy, Venous Insufficiency, Leukocytosis, Splenomegaly, Chronic Myeloid Leukaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Hydroxyurea
Dosage: 1500 mg, unk
Start date: 2011-09-15
Gleevec
Dosage: 800 mg, unk
Gleevec
Dosage: 400 mg, day
Indication: Chronic Myeloid Leukaemia
Start date: 2011-02-15
Possible Hydroxyurea side effects in 57 year old male
Reported by a physician from Germany on 2012-03-27
Patient: 57 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Respiratory Disorder, Pneumonia, Cholestasis, Transaminases Increased, Pericardial Effusion, Neoplasm Malignant, Pleural Effusion, Thrombocytopenia, Pneumonitis, Leukopenia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Hydroxyurea
Dosage: 5 days
Start date: 2009-09-02
Interferon Alfa
Dosage: 1df= 1.0 million;08dec2009-dec2010
Indication: Chronic Myeloid Leukaemia
Start date: 2009-12-08
End date: 2010-06-01
Sprycel
Dosage: paused since 03jan2011 and discontinued on 18jan2011
Administration route: Oral
Indication: Chronic Myeloid Leukaemia
End date: 2011-01-18
Imatinib Mesylate
Dosage: 15sep2009-dec2010
Indication: Chronic Myeloid Leukaemia
Start date: 2009-09-15
Possible Hydroxyurea side effects in male
Reported by a health professional (non-physician/pharmacist) from Poland on 2012-03-25
Patient: male
Reactions: Pneumonia, Neoplasm Malignant, Acute Myeloid Leukaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Imatinib Mesylate
Dosage: dose reduced to 300mg/d
Indication: Chronic Myeloid Leukaemia
Start date: 2003-01-01
End date: 2007-12-01
Nilotinib
Indication: Chronic Myeloid Leukaemia
Start date: 2008-01-01
End date: 2008-07-01
Daunorubicin HCL
Indication: Chronic Myeloid Leukaemia
Azacitidine
Indication: Chronic Myeloid Leukaemia
Dasatinib
Dosage: then 80mg/d for 17 months
Indication: Chronic Myeloid Leukaemia
Start date: 2008-11-01
End date: 2010-07-01
Hydroxyurea
Indication: Chronic Myeloid Leukaemia
Cytarabine
Indication: Chronic Myeloid Leukaemia
Possible Hydroxyurea side effects in female
Reported by a consumer/non-health professional from Mexico on 2012-03-19
Patient: female
Reactions: Pneumonia, Drug Ineffective, Maternal Exposure During Pregnancy, Venous Insufficiency, Death, Respiratory Failure, Splenomegaly, Leukocytosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Gleevec
Dosage: 400 mg, day
Indication: Chronic Myeloid Leukaemia
Start date: 2011-02-15
Gleevec
Dosage: 800 mg, unk
Hydroxyurea
Dosage: 1500 mg, unk
Start date: 2011-09-15
Possible Hydroxyurea side effects in female
Reported by a consumer/non-health professional from Mexico on 2012-03-13
Patient: female
Reactions: Pneumonia, Drug Ineffective, Maternal Exposure During Pregnancy, Venous Insufficiency, Death, Respiratory Failure, Leukocytosis, Splenomegaly
Adverse event resulted in: death
Drug(s) suspected as cause:
Gleevec
Dosage: 400 mg, day
Indication: Chronic Myeloid Leukaemia
Start date: 2011-02-15
Hydroxyurea
Dosage: 1500 mg, unk
Start date: 2011-09-15
Gleevec
Dosage: 800 mg, unk
Start date: 2011-12-21
Possible Hydroxyurea side effects in male
Reported by a physician from Canada on 2011-11-10
Patient: male, weighing 104.2 kg (229.2 pounds)
Reactions: Renal Failure, Pneumonia, Respiratory Failure, Pain, Haematoma
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azacitidine
Dosage: 75 milligram/sq. meter
Start date: 2011-09-06
End date: 2011-09-12
Azacitidine
Dosage: 75 milligram/sq. meter
Start date: 2011-10-17
End date: 2011-10-23
Hydroxyurea
Dosage: 500 milligram
Administration route: Oral
Septra
Dosage: 400/80/ 4 tablets
Administration route: Oral
End date: 2011-10-01
Allopurinol
Dosage: 300 milligram
Administration route: Oral
Other drugs received by patient: Metoprolol; Prednisone TAB; Whole Blood; Digoxin; Levofloxacin; Tinzaparin; Acetaminophen; Flomax; Platelets; Whole Blood; Piperacillin and Tazobactam
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