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Zaroxolyn (Metolazone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zaroxolyn (Metolazone) 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 (14)
Death (1)
Life Threatening Events (3)

Reports by Reaction Type

Hyponatraemia (6)Bronchitis (6)Confusional State (4)Dyspnoea (4)Cardiac Failure Congestive (3)Heart Rate Decreased (3)Renal Failure (3)Micturition Disorder (3)Dysuria (3)Gait Disturbance (3)Asthenia (3)Cardiac Discomfort (2)

Possible Zaroxolyn side effects in 87 year old male

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

Patient: 87 year old male, weighing 84.8 kg (186.6 pounds)

Reactions: Renal Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Spironolactone
    Indication: Cardiac Failure Congestive
    Start date: 2009-01-21

Tafamidis Meglumine
    Administration route: Oral
    Indication: Amyloidosis
    Start date: 2008-12-05

Torsemide
    Indication: Cardiac Failure Congestive
    Start date: 2010-08-25

Zaroxolyn
    Indication: Cardiac Failure Congestive
    Start date: 2012-01-29

Other drugs received by patient: Ambien; Synthroid; Coumadin; Lipitor; Allopurinol; Colchicine; Colchicine



Possible Zaroxolyn side effects in 87 year old male

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

Patient: 87 year old male, weighing 84.8 kg (186.6 pounds)

Reactions: Renal Failure, Cardiac Failure Congestive

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Spironolactone
    Dosage: 12.5 mg (12.5 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2009-01-21

Tafamidis Meglumine
    Dosage: 20 mg (20 mg, 1 in 1 d),oral
    Administration route: Oral
    Indication: Amyloidosis
    Start date: 2008-12-05

Torsemide
    Dosage: 200 mg (100 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2010-08-25

Zaroxolyn
    Dosage: as needed (2.5 mg),oral
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2010-01-29

Other drugs received by patient: Ambien; Synthroid; Colchicine; Lipitor; Allopurinol; Coumadin



Possible Zaroxolyn side effects in 87 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: 87 year old male, weighing 84.8 kg (186.6 pounds)

Reactions: Renal Failure, Peritoneal Dialysis, Condition Aggravated, Cardiac Failure Congestive

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Spironolactone
    Indication: Cardiac Failure Congestive
    Start date: 2009-01-21

Tafamidis Meglumine
    Dosage: 20mg (20 mg, 1 in 1 d),oral
    Administration route: Oral
    Indication: Amyloidosis
    Start date: 2008-12-05

Torsemide
    Indication: Cardiac Failure Congestive
    Start date: 2010-08-25

Zaroxolyn
    Indication: Cardiac Failure Congestive
    Start date: 2012-01-29

Other drugs received by patient: Ambien; Warfarin Sodium; Colchicine (Colchidine); Allopurinol; Synthroid; Lipitor



Possible Zaroxolyn side effects in 90 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16

Patient: 90 year old female

Reactions: Multiple Drug Overdose Accidental, Bradycardia, Shock

Drug(s) suspected as cause:
Atenolol
    Dosage: 200 mg, once oral, (2 mg, daily oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Diltiazem HCL
    Dosage: 960 mg,one oral, 240 mg, daily, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Furosemide
    Dosage: 160 mg, once, oral (40 mg, daily, oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Glyburide
    Dosage: 20 mg once oral (5 mg, daily, oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Hydralazine HCL
    Dosage: 100 mg once oral (25 mg daily oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lisinopril
    Dosage: 20 mg, once oral (5 mg, daily oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Potassium Chloride
    Dosage: 80 mg once oral, (20 mg, daily oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Dosage: 8 mg, once, oral, 2 mg daily oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zaroxolyn
    Dosage: 20 mg once oral (5 mg daily, oral)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Zaroxolyn side effects in 90 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-09

Patient: 90 year old female

Reactions: Bradycardia, Accidental Overdose, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Atenolol
    Administration route: Oral

Atenolol
    Administration route: Oral

Diltiazem HCL
    Dosage: controlled delivery
    Administration route: Oral

Diltiazem HCL
    Administration route: Oral

Furosemide
    Administration route: Oral

Furosemide
    Administration route: Oral

Glyburide
    Administration route: Oral

Glyburide
    Administration route: Oral

Hydralazine Hydrochloride
    Administration route: Oral

Hydralazine Hydrochloride
    Administration route: Oral

Lisinopril
    Administration route: Oral

Lisinopril
    Administration route: Oral

Potassium Chloride
    Administration route: Oral

Potassium Chloride
    Administration route: Oral

Warfarin Sodium
    Administration route: Oral

Warfarin Sodium
    Administration route: Oral

Zaroxolyn
    Administration route: Oral

Zaroxolyn
    Administration route: Oral



Possible Zaroxolyn side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 65 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Dyspnoea, Body Height Abnormal, Heart Rate Decreased, Micturition Disorder, Dysuria, Gait Disturbance, Blood Pressure Abnormal, Asthenia, Myocardial Infarction

Drug(s) suspected as cause:
Revatio
    Administration route: Oral
    Indication: Lung Disorder
    End date: 2012-04-11

Revatio
    Administration route: Oral
    Indication: Pulmonary Embolism
    End date: 2012-04-11

Zaroxolyn
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-03-30

Other drugs received by patient: Allopurinol; Tracleer



Possible Zaroxolyn side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-03

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: Body Height Decreased, Dyspnoea, Cardiac Discomfort, Heart Rate Decreased, Micturition Disorder, Dysuria, Gait Disturbance, Asthenia

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Pulmonary Embolism
    End date: 2012-04-11

Zaroxolyn
    Dosage: 2.5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-03-30

Other drugs received by patient: Allopurinol; Tracleer



Possible Zaroxolyn side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-20

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: Body Height Decreased, Heart Rate Decreased, Dyspnoea, Cardiac Discomfort, Micturition Disorder, Dysuria, Pulmonary Oedema, Gait Disturbance, Asthenia, Cardiac Failure Congestive

Drug(s) suspected as cause:
Revatio
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Pulmonary Embolism
    End date: 2012-04-11

Zaroxolyn
    Dosage: 2.5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-03-30

Other drugs received by patient: Tracleer; Allopurinol



Possible Zaroxolyn side effects in 76 year old female

Reported by a physician from Israel on 2012-02-16

Patient: 76 year old female

Reactions: Confusional State, Hyponatraemia, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apidra
    Dosage: 14 iu
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 21 iu
    Indication: Type 2 Diabetes Mellitus

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-08-12
    End date: 2011-03-10

Zaroxolyn
    Start date: 2010-12-01

Other drugs received by patient: Enoxaparin Sodium; Aldactone; Angiotensin Receptor Blocker; Hypertension Agent; Aspirin; Cadex; Coumadin; Bondormin; Clopidogrel Bisulfate; Prilosec; Calcium Antagonist; Vaben; Statin; Diuretics; Proscar



Possible Zaroxolyn side effects in 76 year old female

Reported by a physician from Israel on 2012-01-20

Patient: 76 year old female

Reactions: Confusional State, Hyponatraemia, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apidra
    Dosage: 14 iu
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 21 iu
    Indication: Type 2 Diabetes Mellitus

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-08-12
    End date: 2011-03-10

Zaroxolyn
    Start date: 2010-12-01

Other drugs received by patient: Calcium Antagonist; Coumadin; Prilosec; Aldactone; Bondormin; Statin; Diuretics; Aspirin; Clopidogrel Bisulfate; Enoxaparin Sodium; Hypertension Agent; Vaben; Angiotensin Receptor Blocker; Cadex; Proscar



Possible Zaroxolyn side effects in 76 year old female

Reported by a physician from Israel on 2011-12-22

Patient: 76 year old female

Reactions: Confusional State, Hyponatraemia, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apidra
    Dosage: 14 iu
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 21 iu
    Indication: Type 2 Diabetes Mellitus

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-08-12
    End date: 2011-03-10

Zaroxolyn
    Start date: 2010-12-01

Other drugs received by patient: Hypertension Agent; Clopidogrel Bisulfate; Bondormin; Calcium Antagonist; Prilosec; Proscar; Cadex; Coumadin; Vaben; Diuretics; Statin; Aldactone; Angiotensin Receptor Blocker; Aspirin; Enoxaparin Sodium



Possible Zaroxolyn side effects in 76 year old female

Reported by a physician from Israel on 2011-12-15

Patient: 76 year old female

Reactions: Confusional State, Hyponatraemia, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apidra
    Dosage: 14 iu
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 21 iu
    Indication: Type 2 Diabetes Mellitus

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-08-12
    End date: 2011-03-10

Zaroxolyn
    Start date: 2010-12-01

Other drugs received by patient: Statin; Enoxaparin Sodium; Prilosec; Calcium Antagonist; Proscar; Bondormin; Aldactone; Aspirin; Diuretics; Clopidogrel Bisulfate; Angiotensin Receptor Blocker; Hypertension Agent; Cadex; Coumadin; Vaben



Possible Zaroxolyn side effects in 76 year old female

Reported by a physician from Israel on 2011-10-18

Patient: 76 year old female

Reactions: Hyponatraemia, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apidra
    Dosage: 14 iu
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 21 iu
    Indication: Type 2 Diabetes Mellitus

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-08-12
    End date: 2011-03-10

Zaroxolyn
    Start date: 2010-12-01

Other drugs received by patient: Calcium Antagonist; Hypertension Agent; Statin; Clopidogrel Bisulfate; Diuretics; Angiotensin Receptor Blocker; Aspirin



Possible Zaroxolyn side effects in female

Reported by a physician from Israel on 2011-10-04

Patient: female

Reactions: Dyspnoea, Hyponatraemia, Pyrexia, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apidra
    Dosage: 14 iu
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: 21 iu
    Indication: Type 2 Diabetes Mellitus

Saxagliptin / Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-08-12
    End date: 2011-03-10

Zaroxolyn
    Start date: 2010-12-01

Other drugs received by patient: Diuretics; Hypertension Agent; Statin; Calcium Antagonist; Angiotensin Receptor Blocker; Acetylsalicylic Acid SRT; Clopidogrel Bisulfate

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