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Zestoretic (Lisinopril / Hydrochlorothiazide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zestoretic (Lisinopril / Hydrochlorothiazide) 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 (46)
Death (2)
Life Threatening Events (5)

Reports by Reaction Type

Hypertension (11)Hypokalaemia (8)Transient Ischaemic Attack (8)Headache (7)Hyponatraemia (7)Mental Status Changes (6)Polymedication (6)Cerebrovascular Accident (6)Dysarthria (6)Ear Haemorrhage (5)Pain (5)Deafness (5)

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

Possible Zestoretic side effects in 83 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 83 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: Weight Increased, Body Height Decreased, LIP Swelling, Back Pain, Asthenopia, Abdominal Distension, Musculoskeletal Discomfort, Arthritis

Drug(s) suspected as cause:
Zestoretic
    Dosage: 20.5 mg 1 or 2 tablets prn
    Administration route: Oral
    Indication: Hypertension

Symbicort
    Dosage: unknown
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Amlodipine Besylape; Symvastatin; Spiriva; Hydrochlorothiazide; Diavan; Tramadole



Possible Zestoretic side effects in 66 year old male

Reported by a physician from United States on 2012-08-09

Patient: 66 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Hyponatraemia, Hiccups

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vegf Trap-EYE / Laser
    Indication: Diabetic Retinal Oedema
    Start date: 2011-10-31

Zestoretic
    Dosage: 20+12.5 mg two times per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-05

Other drugs received by patient: Lipitor; Actoplus MET; Astepro; Omeprazole; Lantus; Amlodipine; Fluticasone Propionate



Possible Zestoretic side effects in male

Reported by a physician from France on 2012-08-01

Patient: male

Reactions: Dysuria, Osteomyelitis, Hyponatraemia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levofloxacin
    Administration route: Oral
    Indication: Osteitis
    Start date: 2012-04-04

Bactrim DS
    Administration route: Oral
    Indication: Osteitis
    Start date: 2012-04-04
    End date: 2012-04-16

Allopurinol
    Administration route: Oral
    End date: 2012-04-16

Zestoretic
    Dosage: 20/12.5 mg/d
    Administration route: Oral
    End date: 2012-04-16

Other drugs received by patient: Aspirin; Pravastatin; Leucovorin Calcium; Repaglinide



Possible Zestoretic side effects in 58 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: 58 year old female, weighing 47.6 kg (104.7 pounds)

Reactions: Off Label Use, Pollakiuria, Hypokalaemia

Drug(s) suspected as cause:
Zestoretic



Possible Zestoretic side effects in 47 year old male

Reported by a physician from Belgium on 2012-07-25

Patient: 47 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Uhthoff's Phenomenon

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampyra
    Dosage: 10 mg, bid, oral
    Administration route: Oral
    Indication: Multiple Sclerosis
    Start date: 2012-05-11
    End date: 2012-05-25

Zestoretic

Other drugs received by patient: Cymbalta; D-Cure (Colecalciferol); Tysabri; Vesicare; Aspirin; Ezetimibe / Simvastatin; Lyrica



Possible Zestoretic side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Glaucoma

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

Nexium
    Administration route: Oral

Other drugs received by patient: Eyedrops; Synthroid



Possible Zestoretic side effects in 70 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-11

Patient: 70 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Contusion, Vomiting, Gastric Disorder

Drug(s) suspected as cause:
Zestoretic
    Dosage: 10/12.5 mg once a day
    Administration route: Oral

Aspirin
    Dosage: 81 mg, once or twice a week

Aspirin

Zestoretic
    Administration route: Oral
    Indication: Blood Pressure Abnormal



Possible Zestoretic side effects in 87 year old male

Reported by a physician from Italy on 2012-06-25

Patient: 87 year old male

Reactions: Drug Eruption, Angioedema

Drug(s) suspected as cause:
Zestoretic

Other drugs received by patient: Omeprazole; Jumex (Selegiline Hydrochloride); Sinemet; Plavix



Possible Zestoretic side effects in 41 year old male

Reported by a pharmacist from United States on 2012-06-21

Patient: 41 year old male, weighing 59.4 kg (130.7 pounds)

Reactions: Fatigue, Palpitations, Wrong Drug Administered, Chest Pain, Dizziness, Drug Prescribing Error, Drug Dispensing Error

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zestoretic



Possible Zestoretic side effects in 58 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-19

Patient: 58 year old female, weighing 47.6 kg (104.7 pounds)

Reactions: Off Label Use, Pollakiuria, Hypokalaemia

Drug(s) suspected as cause:
Zestoretic
    Dosage: 10+12.5 mg daily
    Administration route: Oral

Zestoretic
    Dosage: 10+12.5 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2001-03-01



Possible Zestoretic side effects in 72 year old female

Reported by a physician from Belgium on 2012-06-04

Patient: 72 year old female

Reactions: Colitis Ischaemic, Intestinal Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Start date: 2007-10-26

Zestoretic
    Administration route: Oral

Other drugs received by patient: Zocor; Mobic; Diuretics; Lipitor; Ains



Possible Zestoretic side effects in 72 year old female

Reported by a physician from Belgium on 2012-05-25

Patient: 72 year old female

Reactions: Colitis Ischaemic, Intestinal Infarction

Adverse event resulted in: hospitalization

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

Crestor
    Administration route: Oral
    Start date: 2007-10-26

Other drugs received by patient: Zocor; Lipitor; Mobic; Ains; Diuretics



Possible Zestoretic side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: 68 year old female

Reactions: Apparent Death, Drug Hypersensitivity, Pancreatitis, Ulcer Haemorrhage, Tremor, Gastritis

Adverse event resulted in: life threatening event

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

Zestoretic
    Administration route: Oral
    Indication: Blood Pressure Abnormal

Toprol-XL
    Administration route: Oral

Other drugs received by patient: Simvastatin; Procardia XL



Possible Zestoretic side effects in 72 year old female

Reported by a physician from Belgium on 2012-05-09

Patient: 72 year old female

Reactions: Colitis Ischaemic, Intestinal Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Start date: 2011-01-01

Zestoretic
    Administration route: Oral

Other drugs received by patient: Diuretics; Ains; Lipitor; Zocor



Possible Zestoretic side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-04-30

Patient: 68 year old female

Reactions: Apparent Death, Drug Hypersensitivity, Pancreatitis, Ulcer Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zestoretic
    Administration route: Oral
    Indication: Blood Pressure Abnormal

Toprol-XL
    Administration route: Oral

Other drugs received by patient: Nexium; Procardia XL; Simvastatin



Possible Zestoretic side effects in female

Reported by a physician from Belgium on 2012-04-27

Patient: female

Reactions: Transient Ischaemic Attack, Epilepsy, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Start date: 2012-03-16

Zestoretic
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Rheumatoid Arthritis
    End date: 2012-01-29

Other drugs received by patient: Escitalopram Oxalate; Prednisolone; Aspirin; Methotrexate



Possible Zestoretic side effects in 1020 month old male

Reported by a physician from France on 2012-04-19

Patient: 1020 month old male

Reactions: Acute Pulmonary Oedema, C-Reactive Protein Increased, Cytolytic Hepatitis, Cholestasis, Neutrophilia, Erysipelas

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isosorbide Mononitrate
    Administration route: Oral
    End date: 2012-02-01

Aspegic 1000
    Administration route: Oral
    End date: 2012-02-01

Diamicron
    Administration route: Oral
    End date: 2012-02-01

Pyostacine
    Administration route: Oral
    Indication: Erysipelas
    End date: 2012-01-28

Morphine Sulfate
    Administration route: Oral
    End date: 2012-02-01

Macrogol Biogaran
    Administration route: Oral
    End date: 2012-02-01

Spasfon
    Administration route: Oral
    Start date: 2012-01-29
    End date: 2012-01-30

Rilmenidine Servier
    Administration route: Oral
    End date: 2012-02-01

Amitriptyline HCL
    Administration route: Oral
    End date: 2012-02-01

Zestoretic
    Dosage: 20 mg / 12.5 mg 1 df daily
    Administration route: Oral
    End date: 2012-02-01

Other drugs received by patient: Lantus; Isosorbide LP



Possible Zestoretic side effects in female

Reported by a physician from Belgium on 2012-04-05

Patient: female

Reactions: Transient Ischaemic Attack, Epilepsy, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    End date: 2012-01-29

Humira
    Start date: 2012-03-16

Zestoretic
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Methotrexate; Prednisolone



Possible Zestoretic side effects in 69 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-22

Patient: 69 year old male

Reactions: Pancytopenia, Hyponatraemia, Hypertransaminasaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zestoretic
    Dosage: unknown
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-10-12

Depakene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-10-12

Other drugs received by patient: Citalopram Hydrobromide; Metformin HCL; Atorvastatin; Bisoprolol Fumarate



Possible Zestoretic side effects in 72 year old female

Reported by a physician from Belgium on 2012-03-19

Patient: 72 year old female

Reactions: Colitis Ischaemic, Intestinal Infarction

Adverse event resulted in: hospitalization

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

Crestor
    Administration route: Oral
    Start date: 2011-01-01

Other drugs received by patient: Ains; Diuretics



Possible Zestoretic side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-15

Patient: female, weighing 89.4 kg (196.7 pounds)

Reactions: Dysarthria, Polymedication, Mental Status Changes, Headache, Hypertension, Asthenia, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lexapro
    Administration route: Oral
    Indication: Post-Traumatic Stress Disorder

Ambien
    Administration route: Oral
    Indication: Insomnia

Lyrica
    Administration route: Oral
    Indication: Fibromyalgia

Clonazepam
    Administration route: Oral
    Indication: Bipolar Disorder

Ibuprofen
    Administration route: Oral
    Indication: Fibromyalgia

Placebo
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Lexapro
    Administration route: Oral
    Indication: Bipolar Disorder

Robaxin
    Indication: Fibromyalgia

Zestoretic
    Dosage: 20/12.5 daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-12-04

Desvenlafaxine Succinate Monohydrate
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Placebo
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Loratadine
    Administration route: Oral
    Indication: Seasonal Allergy

Vicodin
    Dosage: 5/500 as needed
    Administration route: Oral
    Indication: Fibromyalgia

Vivelle
    Indication: Hormone Replacement Therapy

Desvenlafaxine Succinate Monohydrate
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Abilify
    Administration route: Oral
    Indication: Bipolar I Disorder

Fluticasone
    Indication: Seasonal Allergy



Possible Zestoretic side effects in female

Reported by a physician from United States on 2012-03-13

Patient: female, weighing 89.4 kg (196.7 pounds)

Reactions: Dysarthria, Polymedication, Mental Status Changes, Condition Aggravated, Hypertension, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Dosage: 15 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar I Disorder

Blinded Desvenlafaxine Succinate Monohydrate
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Lexapro
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Post-Traumatic Stress Disorder

Fluticasone
    Dosage: 2 sprays daily route: in
    Indication: Seasonal Allergy

Blinded Placebo
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Fibromyalgia

Robaxin
    Dosage: 750 mg, 3x/day
    Administration route: Oral
    Indication: Fibromyalgia

Clonazepam
    Dosage: 1 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder

Vicodin
    Dosage: 5/500 prn
    Administration route: Oral
    Indication: Fibromyalgia

Blinded Placebo
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Loratadine
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Seasonal Allergy

Robaxin
    Dosage: unknown

Lexapro
    Indication: Bipolar Disorder

Vivelle
    Dosage: 0.1 mg, unk
    Indication: Hormone Replacement Therapy

Ibuprofen
    Dosage: 800 mg, 3x/day
    Administration route: Oral
    Indication: Fibromyalgia

Ambien
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Insomnia

Blinded Desvenlafaxine Succinate Monohydrate
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Blinded NO Subject Drug
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Zestoretic
    Dosage: 20/12.5 daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-12-04

Blinded NO Subject Drug
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24



Possible Zestoretic side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-02-24

Patient: 78 year old female

Reactions: Meningitis Pneumococcal, Coagulopathy, Hypotension, General Physical Health Deterioration, Coma, Blood Potassium Increased, Lactic Acidosis, Haemodialysis, Blood Glucose Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Dosage: 600 mg;q8h
    Indication: Bone Pain

Metformin HCL
    Dosage: 850 mg;q8h
    Indication: Product Used FOR Unknown Indication

Zestoretic
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Glipizide; Lercanidipine; Acenocoumarol (Acenocoumarol)



Possible Zestoretic side effects in 69 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-02-23

Patient: 69 year old male

Reactions: Hyponatraemia, Pancytopenia, Hypertransaminasaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zestoretic
    Dosage: unknown
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-10-12

Depakene
    Dosage: unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-10-12

Other drugs received by patient: Atorvastatin; Metformin HCL; Citalopram Hydrobromide; Bisoprolol



Possible Zestoretic side effects in 69 year old male

Reported by a physician from Spain on 2012-02-23

Patient: 69 year old male

Reactions: Hyponatraemia, Pancytopenia, Hypertransaminasaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zestoretic
    Dosage: 20 mg/12,5 mg daily
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-10-12

Depakene
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-10-12

Other drugs received by patient: Citalopram Hydrobromide; Atorvastatina; Bisoprolol Fumarate; Zomarist



Possible Zestoretic side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-02-22

Patient: 62 year old female

Reactions: Pollakiuria, Transient Ischaemic Attack

Drug(s) suspected as cause:
Zestoretic



Possible Zestoretic side effects in 35 year old male

Reported by a individual with unspecified qualification from United States on 2012-02-22

Patient: 35 year old male, weighing 154.3 kg (339.5 pounds)

Reactions: Blood Pressure Increased, Blood Glucose Decreased

Drug(s) suspected as cause:
Zestoretic
    Dosage: 20/12.5 mg daily
    Administration route: Oral

Crestor
    Administration route: Oral

Other drugs received by patient: Lantus; Aspirin; Coreg; Niaspan; Janumet; Victoza 2-PAK; Plavix; Fish OIL; Novolog



Possible Zestoretic side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-22

Patient: female

Reactions: Drug Dose Omission, Malaise, Activities of Daily Living Impaired, Drug Ineffective, Blood Pressure Inadequately Controlled

Drug(s) suspected as cause:
Tenormin

Toprol-XL
    Administration route: Oral

Toprol-XL
    Administration route: Oral

Coreg CR

Nifedipine

Metoprolol Tartrate
    Administration route: Oral

Zestoretic
    Dosage: 10+12.5 mg/tablet
    Administration route: Oral

Other drugs received by patient: Hysophen; Synthroid; Omeprazole; Celebrex



Possible Zestoretic side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-22

Patient: female

Reactions: Blood Pressure Increased, Drug Ineffective, Pollakiuria

Drug(s) suspected as cause:
Zestoretic
    Dosage: generic

Zestoretic
    Dosage: 20/12.5 mg
    Administration route: Oral
    Start date: 2011-06-11

Zestoretic
    Dosage: 20/12.5 mg
    Administration route: Oral
    Indication: Hypertension



Possible Zestoretic side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-02-13

Patient: 72 year old female, weighing 62.1 kg (136.6 pounds)

Reactions: Urethral Cancer, Respiratory Disorder, Tinnitus, Ear Haemorrhage, Anaphylactic Reaction, Deafness, Headache, Cardiac Disorder, Cardiomegaly, Balance Disorder, Blindness Unilateral, Tympanic Membrane Perforation, Bladder Cancer, Nasal Congestion, Wound Infection, Ulcer, Accident, Ischaemia, Renal Colic, Pain, Speech Disorder, Eye Haemorrhage, Overdose, Coronary Artery Occlusion, Dysgraphia, Heart Rate Irregular, Transient Ischaemic Attack, Kidney Infection, Myocardial Infarction, Eye Disorder, Decreased Appetite, Renal Disorder, Cerebral Atrophy, Purpura, Cerebrovascular Accident, Eye Pain, Arrhythmia, Renal Failure, Ureteric Cancer, Diarrhoea, Carditis, Bladder Disorder, Hypertension

Drug(s) suspected as cause:
Tenormin
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-12-01
    End date: 2008-05-01

Zestoretic
    Dosage: 10/12.5 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2002-01-01
    End date: 2005-12-01

Diovan
    Start date: 2009-09-01
    End date: 2011-10-01

Zestoretic
    Administration route: Oral

Avastin

Other drugs received by patient: Atenolol / Chlorthiadone(mylan); Vitamin TAB; Aspirin; Bactrim; Sulfadiazine

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