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Hyzaar (Losartan / Hydrochlorothiazide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Hyzaar (Losartan / 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 (130)
Death (14)
Life Threatening Events (19)
Disability (5)

Reports by Reaction Type

Hyponatraemia (17)Drug Ineffective (11)Rhabdomyolysis (9)Hypokalaemia (9)Malaise (9)Cough (9)Aortic Dissection (8)Dehydration (8)Loss of Consciousness (7)Dizziness (7)Decreased Appetite (7)Altered State of Consciousness (7)

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

Possible Hyzaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-26

Patient:

Reactions: Hypotension

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

Metoprolol Tartrate



Possible Hyzaar side effects in

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

Patient:

Reactions: Gout, Blood Glucose Abnormal

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

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

Patient:

Reactions: Angioedema

Drug(s) suspected as cause:
Hyzaar

Other drugs received by patient: Omega-3-Acid Ethyl Esters; Amlodipine Besylate; Metformin Hydrochloride; Hydrochlorothiazide; Aspirin



Possible Hyzaar side effects in

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

Patient:

Reactions: Malaise, Dizziness

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Dizziness

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

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

Patient:

Reactions: Dysphagia

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-05

Patient:

Reactions: Memory Impairment

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: NO Adverse Event, Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hyzaar
    Dosage: 100mg-12.5
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01
    End date: 2012-01-01

Hyzaar
    Dosage: 50mg-12.5
    Administration route: Oral
    Start date: 2012-01-01

Other drugs received by patient: Pradaxa



Possible Hyzaar side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-07-27

Patient: male, weighing 44.5 kg (97.9 pounds)

Reactions: Renal Tubular Disorder, Renal Impairment, Hypovolaemia

Drug(s) suspected as cause:
Hyzaar
    Start date: 2009-03-23
    End date: 2009-03-23

Mannitol
    Start date: 2009-03-20
    End date: 2009-03-23

Methylprednisolone
    Start date: 2009-03-20
    End date: 2009-03-23



Possible Hyzaar side effects in

Reported by a consumer/non-health professional from France on 2012-07-24

Patient:

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amantadine HCL
    Dosage: 100 mg, bid
    Administration route: Oral

Amantadine HCL
    Dosage: 100 mg, qd
    Start date: 2012-06-04

Hyzaar
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-02

Pramipexole Dihydrochloride
    Dosage: 0.35 mg, tid
    Administration route: Oral
    Indication: Restless Legs Syndrome

Other drugs received by patient: Escitalopram; Acetaminophen; Clonazepam; Imuran; Folic Acid; Levothyroxine Sodium; Clonazepam; Levothyroxine Sodium



Possible Hyzaar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20

Patient:

Reactions: Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hyzaar
    Dosage: 50mg-12.5
    Administration route: Oral
    Start date: 2012-01-01

Hyzaar
    Dosage: 100mg-12.5
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01
    End date: 2012-01-01

Other drugs received by patient: Pradaxa



Possible Hyzaar side effects in

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient:

Reactions: Post Herpetic Neuralgia, Headache, Herpes Zoster

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

Reported by a physician from United States on 2012-07-19

Patient:

Reactions: Malaise, Adverse Event

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient:

Reactions: Syncope, Drug Intolerance, Hypertension

Drug(s) suspected as cause:
Hyzaar

Other drugs received by patient: Allegra; Proventil; Chondroitin; Vitamins (Unspecified); Synthroid; Lovaza; Calcium (Unspecified); Ibuprofen (Advil); Glucametacin; Diovan



Possible Hyzaar side effects in female

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

Patient: female

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amantadine HCL
    Dosage: 200 mg
    Administration route: Oral

Hyzaar
    Dosage: 50mg/12.5mg
    Administration route: Oral
    Indication: Hypertension

Pramipexole Dihydrochloride
    Dosage: 1.05 mg
    Administration route: Oral
    Indication: Restless Legs Syndrome

Other drugs received by patient: Imuran; Acetaminophen; Levothyroxine Sodium; Escitalopram; Levothyroxine Sodium; Folic Acid; Clonazepam



Possible Hyzaar side effects in 85 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-06-29

Patient: 85 year old male

Reactions: Personality Change, Confusional State, Nausea, Drug Level Increased, Renal Failure Chronic, Blood Lactic Acid Increased, Diarrhoea, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atorvastatin Calcium
    Administration route: Oral
    Indication: Hyperlipidaemia

Digoxin
    Administration route: Oral
    Indication: Myocardial Ischaemia
    End date: 2012-05-11

Hyzaar
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2012-05-11

Janumet
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-05-11

Torsemide
    Administration route: Oral
    Indication: Essential Hypertension
    End date: 2012-05-01

Other drugs received by patient: Marcumar; Aspirin; Inspra; Concor



Possible Hyzaar side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: 84 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Syncope, Dizziness, Musculoskeletal Chest Pain, Fall, Loss of Consciousness, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hyzaar

Other drugs received by patient: Aspirin; Amlodipine; Hyzaar



Possible Hyzaar side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Pain in Extremity, Alopecia, Hypertension

Drug(s) suspected as cause:
Atenolol

Atenolol
    Dosage: 50 mg, daily
    Indication: Hypertension

Atorvastatin Calcium
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    End date: 2012-06-01

Atorvastatin Calcium
    Indication: Hypertension

Hyzaar
    Dosage: 100mg/ 25mg,daily
    Indication: Hypertension

Lipitor
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2005-01-01

Lipitor
    Indication: Hyperlipidaemia

Other drugs received by patient: Prilosec; Aspirin; Prednisone; Naproxen (Aleve); Vitamin D; Vitamin B-12; Multi-Vitamins; Naproxen (Aleve); Naproxen (Aleve)



Possible Hyzaar side effects in

Reported by a physician from Japan on 2012-06-22

Patient:

Reactions: Hepatitis Fulminant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hyzaar



Possible Hyzaar side effects in 90 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-06-21

Patient: 90 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Pulmonary Fibrosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Hyzaar
    Administration route: Oral
    Start date: 1980-01-01
    End date: 2009-11-01

Nitrofurantoin
    Indication: Cystitis
    Start date: 2000-01-01
    End date: 2009-12-01

Other drugs received by patient: Oxazepam; Amlodipine Maleate



Possible Hyzaar side effects in 71 year old male

Reported by a consumer/non-health professional from Colombia on 2012-06-18

Patient: 71 year old male

Reactions: Rectal Cancer

Drug(s) suspected as cause:
Hyzaar
    Administration route: Oral
    Start date: 2004-01-01

Vytorin
    Administration route: Oral
    Start date: 2004-01-01



Possible Hyzaar side effects in 84 year old female

Reported by a physician from United States on 2012-06-18

Patient: 84 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Syncope, Dizziness, Musculoskeletal Chest Pain, Fall, Hypokalaemia, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hyzaar

Other drugs received by patient: Amlodipine; Aspirin



Possible Hyzaar side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: 68 year old female

Reactions: Malaise, Drug Ineffective

Adverse event resulted in: hospitalization

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

Hyzaar
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Xanax; Clonidine



Possible Hyzaar side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-07

Patient: female, weighing 81.0 kg (178.2 pounds)

Reactions: Rash Macular

Adverse event resulted in: death

Drug(s) suspected as cause:
Atorvastatin Calcium
    Dosage: 20mg/day
    Indication: Blood Cholesterol Increased
    Start date: 2012-01-01

Hyzaar
    Dosage: 50+12.5mg/day
    Indication: Hypertension



Possible Hyzaar side effects in 85 year old female

Reported by a pharmacist from Canada on 2012-05-31

Patient: 85 year old female

Reactions: Dysstasia, Overdose, Pneumonia, Memory Impairment, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hyzaar

Other drugs received by patient: Metformin; Norvasc; Amaryl; Acebutolol



Possible Hyzaar side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-05-30

Patient: 66 year old male

Reactions: Hepatic Encephalopathy, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Furosemide
    Administration route: Oral
    Indication: Ascites
    Start date: 2011-02-28
    End date: 2011-05-23

Hyzaar
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-07-01
    End date: 2011-05-23

Propranolol HCL
    Administration route: Oral
    Indication: Varices Oesophageal
    Start date: 2011-02-01

Spironolactone
    Administration route: Oral
    Indication: Ascites
    Start date: 2011-04-29
    End date: 2011-05-23

Other drugs received by patient: Simvastatin; Spironolactone



Possible Hyzaar side effects in 87 year old female

Reported by a consumer/non-health professional from Germany on 2012-05-30

Patient: 87 year old female

Reactions: Hyperkalaemia, Dementia, Urinary Tract Infection, Renal Cyst, Blood Lactic Acid Increased, Loss of Consciousness, Renal Artery Stenosis, Sick Sinus Syndrome, Overdose, Blood Pressure Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Avapro
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-12
    End date: 2012-01-16

Hyzaar
    Dosage: preminent
    Administration route: Oral

Metformin HCL
    Dosage: unk-16jan2012 16-jan-2012-stoped
    Administration route: Oral

Other drugs received by patient: Atenolol; BUP-4; Verapamil HCL; Diltiazem HCL; Sitagliptin Phosphate; Evista; Calblock; Crestor; Mecobalamin; Nitroderm; Aspirin; Lyrica; Loxoprofen; Amaryl; Merislon



Possible Hyzaar side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Alopecia, Hypertension

Drug(s) suspected as cause:
Atenolol
    Dosage: 50 mg, daily
    Indication: Hypertension

Atorvastatin Calcium
    Dosage: 10 mg, daily
    Indication: Blood Cholesterol Increased
    Start date: 2011-12-19
    End date: 2012-04-01

Hyzaar
    Dosage: 100/25mg,daily
    Indication: Hypertension

Lipitor
    Dosage: unk
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Prilosec; Vitamin B-12; Naproxen (Aleve); Multi-Vitamins; Vitamin D; Aspirin; Naproxen (Aleve); Naproxen (Aleve)



Possible Hyzaar side effects in 71 year old male

Reported by a consumer/non-health professional from Colombia on 2012-05-25

Patient: 71 year old male

Reactions: Rectal Ulcer

Drug(s) suspected as cause:
Hyzaar
    Administration route: Oral
    Start date: 2004-01-01

Vytorin
    Administration route: Oral
    Start date: 2004-01-01

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