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Diovan HCT (Valsartan / Hydrochlorothiazide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Diovan HCT (Valsartan / 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 (1166)
Death (217)
Life Threatening Events (37)
Disability (30)

Reports by Reaction Type

Death (108)Diabetes Mellitus (106)Blood Pressure Increased (100)Malaise (84)Hypertension (77)Cerebrovascular Accident (74)Fall (71)Dyspnoea (66)Blood Pressure Inadequately Controlled (50)Dizziness (49)Blood Pressure Fluctuation (47)Headache (45)

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

Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: female

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Metformin HCL; Calcium Carbonate; Levothyroxine Sodium; Glimepiride



Possible Diovan HCT side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Diabetes Mellitus, Incorrect Dose Administered

Drug(s) suspected as cause:
Adalat

Diovan HCT
    Dosage: 160 mg vals and 12.5 mg hct

Other drugs received by patient: Neurontin; Metformin HCL; Toprol-XL; Amaryl; Lipitor; Ambien



Possible Diovan HCT side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: male

Reactions: Wrong Technique in Drug Usage Process, Diabetes Mellitus, Blood Triglycerides Increased, Blood Glucose Increased

Drug(s) suspected as cause:
Diovan HCT
    Dosage: unk ukn, qd
    Indication: Hypertension

Diovan HCT
    Dosage: 0.5 df, unk



Possible Diovan HCT side effects in 69 year old female

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

Patient: 69 year old female

Reactions: Hypersensitivity, Influenza

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 tablet daily
    Indication: Hypertension

Influenza Virus Vacc Seasonal INN
    Dosage: 1 df
    Indication: Immunisation



Possible Diovan HCT side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Asthma, Sleep Apnoea Syndrome

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Pristiq; Symbicort; Nuvigil; Aller-EZE; Multi-Vitamin; Amantadine HCL; Gilenya; Topiramate



Possible Diovan HCT side effects in male

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

Patient: male

Reactions: Drug Intolerance, Swelling, Headache, Blood Pressure Fluctuation, Cardiac Disorder

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df (160/12.5 mg), unk
    Indication: Hypertension

Losartan Potassium
    Dosage: 3 df, daily

Other drugs received by patient: Clonazepam



Possible Diovan HCT side effects in male

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

Patient: male

Reactions: Swelling, Drug Intolerance, Headache, Blood Pressure Fluctuation, Cardiac Disorder

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df (160/12.5 mg), unk
    Indication: Hypertension

Losartan Potassium
    Dosage: 3 df, daily

Other drugs received by patient: Clonazepam



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Uterine Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Metformin



Possible Diovan HCT side effects in male

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

Patient: male

Reactions: Diabetes Mellitus, Arthralgia, Platelet Count Increased, Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Latanoprost; Metformin; Metformin Hydrochloride



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Blood Pressure Increased, Vomiting, Cataract, Fall, Neck Pain, Blood Pressure Inadequately Controlled, Dizziness, Limb Asymmetry, Scar, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df, qd
    Indication: Hypertension

Diovan HCT
    Dosage: one tablet (160/25 mg) daily

Other drugs received by patient: Amlodipine Besylate



Possible Diovan HCT side effects in male

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

Patient: male

Reactions: Respiratory Failure, Urinary Tract Infection, Septic Shock, Cerebrovascular Accident, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Acetylsalicylic Acid (Somaldin Cardio); Omeprazole; Atenolol; Zoladex; Simvastatin



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Osteoarthritis, Syncope, Blood Pressure Decreased, Fall

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df(vals 160 mg and 12.5 mg hctz), qd
    Administration route: Oral
    Start date: 2012-06-20

Diovan HCT
    Dosage: 1 df(vals 320 mg and hctz12.5 mg),qd
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-06-20

Other drugs received by patient: Glucosamine Sulfate W / Chondroitin



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Blood Pressure Inadequately Controlled, Carotid Artery Occlusion

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Adalat; Atenolol



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Vomiting, Paralysis, Lacrimation Increased, Eye Pain

Drug(s) suspected as cause:
Diovan HCT



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Abdominal Pain, Colon Cancer, Abdominal Distension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df (80/12.5 mg), unk
    End date: 2012-08-01

Diovan HCT
    Dosage: 1 df daily (160 mg vals and 12.5 mg hydr)
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01



Possible Diovan HCT side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Asthma, Aphagia, Dyspnoea, Vomiting, Nausea, Headache, Hypokinesia, Oedema Peripheral, Blood Pressure Inadequately Controlled, Dizziness, Feeling Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 tablet in morning
    Start date: 2010-01-01

Diovan HCT
    Dosage: 1 tablet in morning
    Indication: Blood Pressure
    Start date: 2010-01-01

Diovan HCT
    Dosage: 1 tablet in the morning, 1 tablet in the afternoon and sometimes 1 in the dawn



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Osteoporosis, Deafness, Visual Acuity Reduced

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Alpartan



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Blood Pressure Increased, Cardiomegaly

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Tenormin



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Pancreatic Carcinoma

Drug(s) suspected as cause:
Diovan HCT



Possible Diovan HCT side effects in 77 year old female

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

Patient: 77 year old female

Reactions: Bile Duct Stone, Haemobilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT



Possible Diovan HCT side effects in 77 year old female

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

Patient: 77 year old female

Reactions: Pneumonia, Hypoglycaemia, Abdominal Neoplasm, Malaise, Syncope, Metastases To Kidney, Asthenia, Fluid Retention, Metastases To Lung

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Chemotherapeutics; Chemotherapeutics



Possible Diovan HCT side effects in female

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

Patient: female

Reactions: Upper Limb Fracture, Fall

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df (vals 160 mg, hydr 12.5 mg), qd (in the morning)
    Administration route: Oral
    Indication: Arterial Occlusive Disease

Metformin HCL
    Dosage: 2 df (metf 850 mg, vild 50 mg), daily
    Administration route: Oral
    Indication: Diabetes Mellitus

Other drugs received by patient: Lipitor; Vastarel



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Neck Pain, Retching, Dizziness, Blood Pressure Abnormal, Headache, Arrhythmia

Drug(s) suspected as cause:
Diovan HCT

Other drugs received by patient: Hydrochlorothiazide; Clonazepam; Citalopram Hydrobromide; Captopril



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Weight Decreased, Dyspnoea, Diabetes Mellitus, Osteoarthritis, Speech Disorder, Fatigue, Malaise, DRY Mouth, Insomnia, Blood Pressure Inadequately Controlled, Chest Pain, Blood Cholesterol Increased, Venous Occlusion

Adverse event resulted in: hospitalization

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

Atorvastatin
    Dosage: unk

Cardizem
    Dosage: 60 mg, unk

Carvedilol
    Dosage: unk

Clopidogrel

Diovan HCT
    Dosage: 1 tablet (320 mg val/125 mg hct) twice a day
    Indication: Hypertension

Enalapril Maleate
    Dosage: unk

Losartan Potassium
    Dosage: unk
    Indication: Blood Pressure

Metformin Hydrochloride

Omeprazole
    Dosage: unk

Sertraline Hydrochloride
    Dosage: unk

Simvastatin
    Dosage: unk

Topiramate
    Dosage: unk

Zantac
    Dosage: unk

Other drugs received by patient: Clonidine Hydrochloride



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Agitation, Medical Device Complication, Aphagia, Dysphagia, Dyspnoea, Disorientation, Cerebrovascular Accident, Multi-Organ Failure, Illogical Thinking, Lack of Spontaneous Speech, Septic Shock, Nervousness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan HCT



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Syncope, Anaemia, Blood Pressure Inadequately Controlled, Varicose Vein, Venous Pressure, Cerebrovascular Accident, Fall

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df (160mg vals/ 12.5mg hct), unk

Diovan HCT
    Dosage: 1 df (160mg vals/ 25 mg hct),
    Indication: Hypertension

Exelon
    Dosage: 3 ml, bid
    Administration route: Oral
    Indication: Dementia Alzheimer's Type



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-17

Patient: female

Reactions: Weight Decreased, Dyspnoea, Diabetes Mellitus, Osteoarthritis, Speech Disorder, Malaise, Fatigue, Insomnia, Chest Pain, Blood Pressure Inadequately Controlled, DRY Mouth, Blood Cholesterol Increased, Venous Occlusion

Adverse event resulted in: hospitalization

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

Atorvastatin
    Dosage: unk

Cardizem
    Dosage: 60 mg, unk

Carvedilol
    Dosage: unk

Clopidogrel

Diovan HCT
    Dosage: 1 tablet (320 mg val/125 mg hct) twice a day
    Indication: Hypertension

Enalapril Maleate
    Dosage: unk

Losartan Potassium
    Dosage: unk
    Indication: Blood Pressure

Metformin Hydrochloride

Omeprazole
    Dosage: unk

Sertraline Hydrochloride
    Dosage: unk

Simvastatin
    Dosage: unk

Topiramate
    Dosage: unk

Zantac
    Dosage: unk

Other drugs received by patient: Clonidine Hydrochloride



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Germany on 2012-08-17

Patient: female

Reactions: Weight Decreased, Muscle Atrophy, Muscular Weakness, Muscular Dystrophy, Muscle Twitching, Frequent Bowel Movements, Arthropathy, Pharyngeal Oedema, Limb Discomfort, Pollakiuria

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df (160mg vals/25mg hct), unk
    Indication: Hypertension
    End date: 2008-08-01

Diovan HCT
    Dosage: 1 df (160mg vals/25mg hct), unk



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-17

Patient: female

Reactions: Diabetes Mellitus

Adverse event resulted in: death

Drug(s) suspected as cause:
Diovan HCT



Possible Diovan HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Endometrial Cancer, Cough

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df, daily

Lisinopril
    Dosage: 1 df, daily (10 mg)

Micardis
    Dosage: 1 df, daily

Other drugs received by patient: Glimepiride; Amlodipine; Metformin HCL; Fish OIL

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