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Spironolactone (Spironolactone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Spironolactone 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 (536)
Death (83)
Life Threatening Events (58)
Disability (6)

Reports by Reaction Type

Hyperkalaemia (117)Renal Failure Acute (104)Blood Creatinine Increased (49)Dyspnoea (42)Hypotension (41)Atrial Fibrillation (36)Drug Interaction (35)Nausea (34)Dehydration (32)Oedema Peripheral (31)Toxic Epidermal Necrolysis (29)Haemoglobin Decreased (29)

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

Possible Spironolactone side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-24

Patient: male

Reactions: Malaise, Dyspnoea, Hyperkalaemia, Hypotension, Bradycardia, Renal Failure Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atacand
    Dosage: 8 mg
    Administration route: Oral
    Indication: Hypertensive Heart Disease
    End date: 2012-06-21

Nebivolol
    Dosage: 2.5 mg
    Administration route: Oral
    Indication: Hypertensive Heart Disease
    End date: 2012-06-21

Spironolactone
    Dosage: 25 mg
    Administration route: Oral
    Indication: Hypertensive Heart Disease
    End date: 2012-06-21

Other drugs received by patient: Aspirin; VI-DE 3; Calcimagon D3; Torsemide; Lantus; Allopurinol; Atorvastatin Calcium; Humalog; Marcumar



Possible Spironolactone side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-23

Patient: 62 year old male

Reactions: Emphysema, Metabolic Alkalosis, Dyspnoea, Glomerular Filtration Rate Decreased, Renin Increased, Drug Abuse, Electrolyte Depletion, Hypokalaemia, Respiratory Acidosis, Ventricular Tachycardia, Oedema, Hyperaldosteronism, Hypertension, Alkalosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furosemide
    Dosage: 40 mg, per day
    Indication: Oedema Peripheral

Licorice
    Dosage: 300 mg, daily
    Indication: Product Used FOR Unknown Indication

Perindopril
    Dosage: 4 mg, per day
    Indication: Hypertension

Spironolactone
    Dosage: 50 mg, per day
    Indication: Hypertension

Other drugs received by patient: Tiotropium; Salmeterol; Fluticasone



Possible Spironolactone side effects in

Reported by a pharmacist from United Kingdom on 2012-08-23

Patient:

Reactions: Pruritus, Hypersensitivity, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Stevens-Johnson Syndrome, Blister, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, Toxic Epidermal Necrolysis, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide

Clarithromycin
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone

Zocor
    Administration route: Oral

Other drugs received by patient: Amiodarone HCL; Amoxicillin and Clavulanate Potassium; Furosemide; Methotrexate; Adenosine; Dioralyte; Fortisip; Heparin; Omeprazole; Adcal-D3; Teicoplanin; Warfarin Sodium; Dalteparin Sodium; Diclofenac Diethylamine; Folic Acid; Gentamicin; Metoclopramide; Bisoprolol Fumarate; Candesartan Cilexetil; Acetaminophen and Codeine Phosphate; Clotrimazole; Acetaminophen; Tramadol Hydrochloride



Possible Spironolactone side effects in 81 year old male

Reported by a pharmacist from Italy on 2012-08-23

Patient: 81 year old male

Reactions: Hyperkalaemia, Pain

Drug(s) suspected as cause:
Enalapril Maleate
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2012-01-01
    End date: 2012-07-12

Spironolactone
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2012-01-01
    End date: 2012-07-12

Other drugs received by patient: Acetylsalicylic Acid SRT; Calcitriol; Furosemide



Possible Spironolactone side effects in 72 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-23

Patient: 72 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Coronary Artery Disease, Blood Pressure Decreased, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Irbesartan

Irbesartan
    Start date: 2012-01-01

Irbesartan
    Dosage: 1 df=150/12.5 mg. or 150 mg in the morning
    Indication: Hypertension

Irbesartan and Hydrochlorothiazide

Spironolactone
    Dosage: half tab
    End date: 2012-07-18

Other drugs received by patient: Insulin



Possible Spironolactone side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-22

Patient: female

Reactions: Autoimmune Disorder, Skin Discolouration, Blood Thyroid Stimulating Hormone Increased, Injection Site Nodule

Drug(s) suspected as cause:
Amlodipine
    Indication: Autoimmune Disorder

Hydroxychloroquine Sulfate
    Indication: Autoimmune Disorder

Methotrexate
    Indication: Autoimmune Disorder

Prednisone TAB
    Indication: Autoimmune Disorder

Rebif
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01

Spironolactone
    Indication: Autoimmune Disorder



Possible Spironolactone side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded NO Treatment Received
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Ibuprofen

Ilaris
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Lasix
    Dosage: 40 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Losartan Potassium
    Dosage: 25 mg, bid
    Start date: 2011-12-01
    End date: 2012-03-29

Metformin HCL
    Dosage: 1000 mg, bid
    Start date: 2011-09-01
    End date: 2012-03-29

Omeprazole
    Dosage: 20 mg, qd
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2011-09-01
    End date: 2012-03-29

Placebo
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Spironolactone
    Dosage: 25 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Victoza
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-02-14
    End date: 2012-03-24

Other drugs received by patient: Crestor; Aspirin; Potassium; Carvedilol; Multi-Vitamins



Possible Spironolactone side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded NO Treatment Received
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Ibuprofen

Ilaris
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Lasix
    Dosage: 40 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Losartan Potassium
    Dosage: 25 mg, bid
    Start date: 2011-12-01
    End date: 2012-03-29

Metformin
    Dosage: 1000 mg, bid
    Start date: 2011-09-01
    End date: 2012-03-29

Omeprazole
    Dosage: 20 mg, qd
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2011-09-01
    End date: 2012-03-29

Placebo
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Spironolactone
    Dosage: 25 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Victoza
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-02-14
    End date: 2012-03-24

Other drugs received by patient: Aspirin; Carvedilol; Multi-Vitamins; Potassium; Crestor



Possible Spironolactone side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-21

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Hypersensitivity, Pruritus, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, Toxic Epidermal Necrolysis, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide
    Dosage: unk

Clarithromycin
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone
    Dosage: unk

Zocor
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Amiodarone HCL; Diclofenac Diethylammonium Salt; Gentamicin; Adenosine; Furosemide; Candesartan Cilexetil; Amoxicillin and Clavulanate Potassium; Bisoprolol Fumarate; Adcal-D3; Dalteparin Sodium; Heparin; Clotrimazole; Fortisip; Omeprazole; Teicoplanin; Methotrexate; Folic Acid; Acetaminophen and Codeine Phosphate; Dioralyte; Metoclopramide; Tramadol HCL; Warfarin Sodium; Paracetamol



Possible Spironolactone side effects in 72 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-21

Patient: 72 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Coronary Arterial Stent Insertion, Transient Ischaemic Attack, Blood Pressure Decreased

Adverse event resulted in: hospitalization

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

Irbesartan
    Dosage: 1 df=150/12.5 mg. or 150 mg in the morning
    Indication: Hypertension

Spironolactone
    Dosage: half tab
    End date: 2012-07-18

Other drugs received by patient: Insulin



Possible Spironolactone side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-20

Patient: female

Reactions: Hyponatraemia, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Escitalopram
    Dosage: 10 mg
    Administration route: Oral
    Indication: Depression
    End date: 2012-04-05

Spironolactone
    Dosage: 1 df
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-05

Other drugs received by patient: Vitamin B-12; Ergocalciferol; Levothyroxine Sodium; Cordarone; Lercanidipine



Possible Spironolactone side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-20

Patient: 79 year old female, weighing 55.4 kg (121.9 pounds)

Reactions: Pruritus, Pulmonary Embolism, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Toxic Epidermal Necrolysis, Skin Tightness, Staphylococcal Scalded Skin Syndrome, Exfoliative Rash, Vasculitis, Rash Maculo-Papular, Hypersensitivity, Skin Exfoliation, Scab, Adverse Drug Reaction, Pain, Petechiae, Skin Swelling, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Atrial Fibrillation, DRY Skin, Rash, Pulmonary Fibrosis, Skin Irritation, Mucosal Erosion, Haemoglobin Decreased, Diarrhoea, Skin Erosion

Adverse event resulted in: death

Drug(s) suspected as cause:
Amiodarone HCL
    Indication: Product Used FOR Unknown Indication

Amoxicillin
    Indication: Product Used FOR Unknown Indication

Bumetanide
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Methotrexate
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Dalteparin Sodium; Candesartan Cilexetil; Bisoprolol Fumarate; Bisoprolol Fumarate; Clotrimazole; Fortisip; Diclofenac Diethylammonium Salt; Adenosine; Furosemide; Acetaminophen; Tramadol HCL; Acetaminophen and Codeine Phosphate; Teicoplanin; Adcal-D3; Dioralyte; Gentamicin; Amoxicillin and Clavulanate Potassium; Heparin; Folic Acid; Omeprazole; Metoclopramide



Possible Spironolactone side effects in male

Reported by a pharmacist from Japan on 2012-08-20

Patient: male

Reactions: Drug-Induced Liver Injury

Drug(s) suspected as cause:
Spironolactone



Possible Spironolactone side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 85 year old female, weighing 58.5 kg (128.7 pounds)

Reactions: Weight Decreased, Optic Nerve Disorder, Haemorrhage, Pain, Paralysis, Headache, Hypoacusis, Neck Pain, Dizziness, Blindness Transient, Dysgraphia, Decreased Appetite, Pain in Extremity, Musculoskeletal Pain, Painful Respiration, Tremor, Eye Pain, Anxiety, Arthralgia, Skin Mass, Sepsis, Flank Pain, Visual Impairment, Colour Blindness Acquired, Gait Disturbance, Blindness, Arthritis, Feeling Abnormal, Mobility Decreased

Drug(s) suspected as cause:
Felodipine
    Dosage: 2.5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-04-18

Spironolactone
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Lanoxin; Dyrenium; Norpace



Possible Spironolactone side effects in 79 year old female

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

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Pruritus, Hypersensitivity, Scab, Pain, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Stevens-Johnson Syndrome, Renal Failure Acute, Blister, Fluid Overload, Rash Generalised, Toxic Epidermal Necrolysis, Atrial Fibrillation, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone
    Indication: Product Used FOR Unknown Indication

Zocor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Gentamicin; Heparin; Metoclopramide; Methotrexate; Dioralyte / 00386201 /; Candesartan Cilexetil; Amiodarone; Diclofenac Diethylamine; Warfarin Sodium; Amoxicillin and Clavulanate Potassium; Fortisip; Dalteparin Sodium; Bisoprolol; Tramadol HCL; Omeprazole; Furosemide; Adcal D3; Acetaminophen and Codeine Phosphate; Adenosine; Teicoplanin; Acetaminophen; Clotrimazole; Folic Acid



Possible Spironolactone side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-17

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Hypersensitivity, Pruritus, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Renal Failure Acute, Stevens-Johnson Syndrome, Fluid Overload, Rash Generalised, Toxic Epidermal Necrolysis, Atrial Fibrillation, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide
    Dosage: unk

Clarithromycin
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone
    Dosage: unk

Zocor
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Candesartan Cilexetil; Bisoprolol; Fortisip; Folic Acid; Diclofenac Diethylammonium Salt; Amiodarone; Tramadol HCL; Dioralyte; Gentamicin; Dalteparin Sodium; Clotrimazole; Amoxicillin and Clavulanate Potassium; Metoclopramide; Acetaminophen and Codeine Phosphate; Warfarin Sodium; Adenosine; Teicoplanin; Heparin; Acetaminophen; Omeprazole; Furosemide; Paracetamol; Methotrexate; Adcal-D3



Possible Spironolactone side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Pruritus, Hypersensitivity, Scab, Pain, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Renal Failure Acute, Blister, Stevens-Johnson Syndrome, Fluid Overload, Rash Generalised, Toxic Epidermal Necrolysis, Atrial Fibrillation, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Clarithromycin
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Zocor
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Methotrexate; Teicoplanin; Amiodarone; Folic Acid; Heparin; Adcal-D3; Bisoprolol; Clotrimazole; Codeine Phosphate and Acetaminophen; Acetaminophen; Dioralyte; Fortisip; Candesartan Cilexetil; Diclofenac Diethylammonium Salt; Gentamicin; Metoclopramide; Omeprazole; Tramadol HCL; Adenosine; Amoxicillin and Clavulanate Potassium; Dalteparin Sodium; Furosemide; Warfarin Sodium



Possible Spironolactone side effects in 85 year old female

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

Patient: 85 year old female, weighing 58.6 kg (128.8 pounds)

Reactions: Weight Decreased, Optic Nerve Disorder, Haemorrhage, Pain, Paralysis, Headache, Hypoacusis, Neck Pain, Dizziness, Dysgraphia, Blindness Transient, Decreased Appetite, Pain in Extremity, Musculoskeletal Pain, Painful Respiration, Tremor, Eye Pain, Anxiety, Arthralgia, Flank Pain, Skin Mass, Sepsis, Visual Impairment, Gait Disturbance, Colour Blindness Acquired, Arthritis, Feeling Abnormal, Blindness, Mobility Decreased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Felodipine
    Administration route: Oral
    Indication: Hypertension
    Start date: 2006-04-18

Spironolactone
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Norpace (Disopyramide Phosphate) 150 MG 4 Times Daily, Lanoxin (Digoxi; Dyrenium (Triamterene) 60 MG Once Daily



Possible Spironolactone side effects in 53 year old male

Reported by a physician from United States on 2012-08-16

Patient: 53 year old male

Reactions: Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Furosemide
    Indication: Cardiac Failure Congestive

Spironolactone
    Indication: Cardiac Failure Congestive



Possible Spironolactone side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded NO Treatment Received
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Ibuprofen

Ilaris
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Lasix
    Dosage: 40 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Losartan Potassium
    Dosage: 25 mg, bid
    Start date: 2011-12-01
    End date: 2012-03-29

Metformin Hydrochloride
    Dosage: 1000 mg, bid
    Start date: 2011-09-01
    End date: 2012-03-29

Placebo
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Spironolactone
    Dosage: 25 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Victoza
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-02-14
    End date: 2012-03-24

Other drugs received by patient: Multi-Vitamins; Carvedilol; Aspirin; Crestor; Omeprazole; Potassium



Possible Spironolactone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

Reactions: Vomiting, Dyspnoea, Extrasystoles, Hyperhidrosis, Tremor, Suicidal Ideation, Dysgeusia, Fatigue, Palpitations, Feeling Hot, Heart Rate Increased, Asthenia

Drug(s) suspected as cause:
Multaq
    Dosage: 10am and 10pm.
    Administration route: Oral
    Indication: Atrial Fibrillation

Sotalol HCL
    Dosage: sotalol 80 mg in the morning as well as 40 mg of sotalol in the evening
    Administration route: Oral

Spironolactone
    Administration route: Oral

Other drugs received by patient: Actonel; Aspirin



Possible Spironolactone side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded NO Treatment Received
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Ibuprofen

Ilaris
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Lasix
    Dosage: 40 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Losartan Potassium
    Dosage: 25 mg, bid
    Start date: 2011-12-01
    End date: 2012-03-29

Metformin Hydrochloride
    Dosage: 1000 mg, bid
    Start date: 2011-09-01
    End date: 2012-03-29

Placebo
    Dosage: code not broken
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2011-09-29
    End date: 2012-06-29

Spironolactone
    Dosage: 25 mg, qd
    Start date: 2011-08-01
    End date: 2012-03-29

Victoza
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2012-02-14
    End date: 2012-03-24

Other drugs received by patient: Carvedilol; Crestor; Multi-Vitamins; Aspirin; Omeprazole; Potassium



Possible Spironolactone side effects in 62 year old male

Reported by a physician from Portugal on 2012-08-15

Patient: 62 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Product Quality Issue, Product Substitution Issue, Ischaemic Stroke, Drug Interaction, Hemiparesis, Hemianopia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Transient Ischaemic Attack

Amlodipine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Captopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Hypertension

Diazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enalapril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enoxaparin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Nifedipine
    Dosage: 30 mg, 2x/day
    Indication: Product Used FOR Unknown Indication

Potassium Chloride
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Warfarin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lisinopril Dihydrate; Irbesartan and Hydrochlorothiazide; Rilmenidine



Possible Spironolactone side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 70 year old male

Reactions: Renal Impairment, Hyperkalaemia, Gastric Ulcer Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 1 df : ={100mg

Blinded: Saxagliptin
    Dosage: 13dec10-19sep11,04oct11-20feb12
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-13
    End date: 2012-02-20

Gliclazide
    Dosage: m/r tabs
    Indication: Type 2 Diabetes Mellitus

Metformin HCL
    Indication: Type 2 Diabetes Mellitus

Placebo
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-12-13
    End date: 2012-02-20

Spironolactone
    Dosage: 50mg tabs
    Start date: 2011-08-30

Warfarin Sodium
    Start date: 2011-06-17

Other drugs received by patient: Nebivolol; Beclomethasone Dipropionate



Possible Spironolactone side effects in 65 year old male

Reported by a pharmacist from United States on 2012-08-14

Patient: 65 year old male, weighing 143.2 kg (315.0 pounds)

Reactions: Fluid Overload, Hyperkalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lisinopril
    Dosage: 40 mg every day po
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-03-26
    End date: 2012-04-25

Lisinopril
    Dosage: 40 mg every day po
    Administration route: Oral
    Indication: Cardiac Failure Congestive
    Start date: 2012-03-26
    End date: 2012-04-25

Spironolactone
    Dosage: 12.5 mg every day po
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-03-30
    End date: 2012-04-25

Spironolactone
    Dosage: 12.5 mg every day po
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2012-03-30
    End date: 2012-04-25



Possible Spironolactone side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-14

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Haemoglobin Decreased, Fluid Overload, Toxic Epidermal Necrolysis, Atrial Fibrillation, Renal Failure Acute, Pulmonary Fibrosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Bumetanide

Clarithromycin
    Dosage: 500mg, bid
    Administration route: Oral
    Start date: 2012-05-12
    End date: 2012-05-21

Methotrexate
    Dosage: stopped on admission. pulmonary fibrosis secondary to methotrexate and fluid overload.

Spironolactone

Zocor
    Administration route: Oral

Other drugs received by patient: Clotrimazole; Tramadol HCL; Dalteparin Sodium; Diclofenac Diethylamine; Adcal-D3; Candesartan Cilexetil; Acetaminophen; Fortisip; Adenosine; Folic Acid; Bisoprolol; Dioralyte; Heparin; Amiodarone HCL; Furosemide; Metoclopramide; Acetaminophen and Codeine Phosphate; Warfarin Sodium; Acetaminophen W / Codeine; Omeprazole; Gentamicin; Amoxicillin and Clavulanate Potassium; Teicoplanin



Possible Spironolactone side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-13

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Hypersensitivity, Pruritus, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Renal Failure Acute, Stevens-Johnson Syndrome, Blister, Fluid Overload, Rash Generalised, Toxic Epidermal Necrolysis, Atrial Fibrillation, DRY Skin, Haemoglobin Decreased, Exfoliative Rash, Swelling, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide
    Dosage: unk

Clarithromycin
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone
    Dosage: unk

Zocor
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Paracetamol; Clotrimazole; Gentamicin; Adenosine; Amoxicillin and Clavulanate Potassium; Tramadol HCL; Acetaminophen; Furosemide; Candesartan Cilexetil; Metoclopramide; Adcal-D3; Diclofenac Diethylammonium Salt; Omeprazole; Dalteparin Sodium; Teicoplanin; Heparin; Fortisip; Methotrexate; Folic Acid; Warfarin Sodium; Bisoprolol; Amiodarone HCL; Acetaminophen and Codeine Phosphate; Dioralyte



Possible Spironolactone side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-10

Patient: 79 year old female

Reactions: Pruritus, Hypersensitivity, Pain, Scab, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Blister, Stevens-Johnson Syndrome, Renal Failure Acute, Fluid Overload, Rash Generalised, Toxic Epidermal Necrolysis, Atrial Fibrillation, DRY Skin, Haemoglobin Decreased, Swelling, Exfoliative Rash, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide

Clarithromycin
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone

Zocor
    Administration route: Oral

Other drugs received by patient: Adenosine; Candesartan Cilexetil; Amoxicillin and Clavulanate Potassium; Tramadol HCL; Bisoprolol Fumarate; Dioralyte; Heparin; Omeprazole; Amiodarone HCL; Codeine Phosphate and Acetaminophen; Teicoplanin; Diclofenac Diethylamine; Fortisip; Metoclopramide; Furosemide; Methotrexate; Clotrimazole; Dalteparin Sodium; Folic Acid; Adcal-D3; Gentamicin; Acetaminophen; Warfarin Sodium



Possible Spironolactone side effects in 82 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 82 year old female

Reactions: Cataract, Drug Hypersensitivity, Stress, Fall, Cerebral Haemorrhage, Malaise, Fatigue, Heart Rate Increased, Facial Bones Fracture, Dizziness, Blindness Unilateral, Gait Disturbance

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

Digoxin

Losartan Potassium

Metoprolol Tartrate
    Administration route: Oral

Spironolactone

Tikosyn
    Administration route: Oral

Tylenol

Zestril
    Administration route: Oral



Possible Spironolactone side effects in 79 year old female

Reported by a pharmacist from United Kingdom on 2012-08-09

Patient: 79 year old female, weighing 55.5 kg (122.0 pounds)

Reactions: Pruritus, Hypersensitivity, Scab, Pain, Petechiae, Eczema, Erythema, Rash Pruritic, Oedema Peripheral, Blood Creatinine Increased, Stevens-Johnson Syndrome, Renal Failure Acute, Blister, Fluid Overload, Rash Generalised, Toxic Epidermal Necrolysis, Atrial Fibrillation, DRY Skin, Haemoglobin Decreased, Swelling, Exfoliative Rash, Rash Maculo-Papular

Adverse event resulted in: death

Drug(s) suspected as cause:
Bumetanide
    Dosage: unk

Clarithromycin
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-05-12
    End date: 2012-05-21

Spironolactone
    Dosage: unk

Zocor
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Adenosine; Candesartan Cilexetil; Bisoprolol Fumarate; Amiodarone HCL; Warfarin Sodium; Clotrimazole; Acetaminophen and Codeine Phosphate; Gentamicin; Omeprazole; Folic Acid; Dioralyte; Diclofenac Diethylammonium Salt; Paracetamol; Adcal-D3; Acetaminophen; Furosemide; Fortisip; Tramadol HCL; Dalteparin Sodium; Teicoplanin; Metoclopramide; Amoxicillin and Clavulanate Potassium; Heparin; Methotrexate

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