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Diovan (Valsartan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Diovan (Valsartan) 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 (2134)
Death (322)
Life Threatening Events (62)
Disability (36)

Reports by Reaction Type

Blood Pressure Increased (164)Cerebrovascular Accident (143)Hypertension (140)Death (139)Malaise (111)Dizziness (110)Fall (103)Diabetes Mellitus (101)Dyspnoea (87)Headache (74)Pneumonia (73)Fatigue (70)

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

Possible Diovan side effects in male

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

Patient: male

Reactions: Thrombosis, Renal Impairment, Hyperkalaemia, Shunt Occlusion, Cerebrovascular Accident

Drug(s) suspected as cause:
Diovan
    Indication: Hypertension

Rasilez
    Indication: Hypertension
    Start date: 2007-01-01
    End date: 2012-08-22

Other drugs received by patient: Actos; Torsemide; Tamsulosin HCL; Digitoxin TAB; Amlodipine; Ezetimibe; Captopril



Possible Diovan side effects in male

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

Patient: male

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in male

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

Patient: male

Reactions: Neuropathy Peripheral, Renal Disorder, Dementia Alzheimer's Type, Abasia, Anaemia, Hypertension, Scrotal Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan
    Dosage: 1 df (320 mg), daily
    Administration route: Oral

Diovan
    Dosage: 1 df (160 mg), daily
    Administration route: Oral
    Indication: Blood Pressure

Furosemide
    Dosage: 2 df (two tablets in morning and two tablets in afternoon), bid
    Administration route: Oral
    Indication: Swelling

Furosemide
    Dosage: 1 df (1 tablet in the morning and 1 tablet in the afternoon), bid
    Administration route: Oral

Other drugs received by patient: Allopurinol; Atorvastatin; Insulin; Atorvastatin; Carvedilol; Acetylsalicylic Acid(aas Protector)



Possible Diovan side effects in female

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

Patient: female

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

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

Patient: female

Reactions: Back Pain, Dyspnoea, Pulmonary Embolism, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan

Other drugs received by patient: Warfarin Sodium; Synthroid



Possible Diovan side effects in male

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

Patient: male

Reactions: Vomiting, Dehydration, Head and Neck Cancer, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan

Other drugs received by patient: Ondansetron; Cisplatin; Omeprazole; Hydromorphone Hydrochloride; Dexamethasone; Prochlorperazine; Levofloxacin; Pilocarpine



Possible Diovan side effects in female

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

Patient: female

Reactions: Asthma

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

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

Patient: female

Reactions: Blood Pressure Inadequately Controlled, Coma, Headache, Blood Glucose Increased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diovan
    Dosage: 160/12.5/5 mg, unk

Metformin HCL
    Dosage: 1000/50 mg, unk

Other drugs received by patient: Aglucose; Atenolol; Aglitil



Possible Diovan side effects in female

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

Patient: female

Reactions: Coeliac Disease

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

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

Patient: female

Reactions: Systemic Lupus Erythematosus

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

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

Patient: female

Reactions: Staphylococcal Infection, Pain in Extremity, Abscess, Immune System Disorder, Stress, Upper Extremity Mass

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

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

Patient: female

Reactions: Pancreatitis Acute, Abdominal Pain, Death

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in male

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

Patient: male

Reactions: Femur Fracture, Upper Limb Fracture, Lower Limb Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in male

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

Patient: male

Reactions: Accident, Joint Dislocation, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

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

Patient: female

Reactions: Weight Decreased, Dyspnoea, Swelling Face, Sluggishness, Blood Glucose Increased

Drug(s) suspected as cause:
Diovan

Insulin

Other drugs received by patient: Carvedilol; Levothyroxine Sodium; Metformin HCL; Digoxin; Paroxetine HCL; Sleep AID; Cholesterol Medicine



Possible Diovan side effects in female

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

Patient: female, weighing 106.0 kg (233.2 pounds)

Reactions: Weight Decreased, Glaucoma, Diabetes Mellitus, Thirst, Somnolence, Dizziness, Decreased Appetite, Blood Glucose Increased

Drug(s) suspected as cause:
Diovan
    Dosage: 80 mg, unk

Diovan
    Dosage: 160 mg, unk

Other drugs received by patient: Synthroid



Possible Diovan side effects in male

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

Patient: male

Reactions: Blood Pressure Increased, Fatigue, Pancreatic Cyst, Lipase Increased, Somnolence

Drug(s) suspected as cause:
Diovan

Other drugs received by patient: Aspirin; Bisoprolol Fumarate; Levothyroxine Sodium; Digoxin; Atorvastatin Calcium; Ezetimibe; Q10



Possible Diovan side effects in 52 year old male

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

Patient: 52 year old male

Reactions: Cataract

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in male

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

Patient: male

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Diovan

Other drugs received by patient: Simvastatin; Metformin HCL; Glyburide; Aspirin; Hydrochlorothiazide; Levothyroxine Sodium



Possible Diovan side effects in 72 year old male

Reported by a pharmacist from Japan on 2012-08-24

Patient: 72 year old male, weighing 61.0 kg (134.2 pounds)

Reactions: Weight Increased, Brain Natriuretic Peptide Increased, Blood Urea Increased, Blood Pressure Decreased, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bisoprolol Fumarate
    Dosage: 1.25 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2012-01-13
    End date: 2012-07-09

Diart
    Dosage: 30 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2011-10-06
    End date: 2012-07-09

Diovan
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2011-10-06
    End date: 2012-07-09

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Post Herpetic Neuralgia
    Start date: 2012-07-05
    End date: 2012-07-08



Possible Diovan side effects in 73 year old male

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

Patient: 73 year old male

Reactions: Hypotension, Dizziness, Oedema, Arrhythmia

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

Reported by a physician from Brazil on 2012-08-23

Patient: female

Reactions: Atrial Fibrillation, Somnolence, Cerebral Ischaemia, Cardiac Disorder, Cardiac Failure, Embolism, Respiratory Failure, Dehydration, Eye Movement Disorder, Asthenia, Respiratory Tract Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan

Other drugs received by patient: Metoprolol Succinate



Possible Diovan side effects in male

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

Patient: male

Reactions: Emphysema, Hypokinesia, Dysphagia, Neck Pain, Ischaemic Stroke, Lung Infection, Headache

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan
    Indication: Hypertension

Exforge
    Dosage: 1 df (160 mg vals and 5 mg amlo), daily
    Indication: Hypertension
    Start date: 2012-04-01



Possible Diovan side effects in 80 year old male

Reported by a physician from United States on 2012-08-23

Patient: 80 year old male, weighing 63.5 kg (139.7 pounds)

Reactions: Hypersensitivity, Dyspnoea, Swelling Face, Rash

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in 82 year old male

Reported by a physician from Japan on 2012-08-23

Patient: 82 year old male

Reactions: Renal Impairment, Hepatic Function Abnormal, Blood Creatine Phosphokinase Increased

Drug(s) suspected as cause:
Diovan
    Dosage: 40 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-25
    End date: 2012-07-18

Norvasc
    Dosage: 5 mg, day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-11-12
    End date: 2012-07-05

Rabeprazole Sodium
    Dosage: 10 mg daily
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2011-12-22
    End date: 2012-07-18



Possible Diovan side effects in female

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

Patient: female, weighing 71.0 kg (156.2 pounds)

Reactions: Pneumonia, Pain in Extremity, Scleroderma, Vasculitis, Cardiogenic Shock, Blood Pressure Decreased, Loss of Consciousness, Muscle Spasms

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in 66 year old female

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

Patient: 66 year old female

Reactions: Overdose, Insomnia, Blood Pressure Decreased, Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Calblock
    Administration route: Oral
    Indication: Insomnia

Diovan
    Dosage: 20 tablets once
    Administration route: Oral
    Start date: 2012-03-12

Diovan
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 1994-01-01

Metoprolol Tartrate
    Dosage: 20 tablete once
    Administration route: Oral
    Start date: 2012-03-12

Metoprolol Tartrate
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 1994-01-01



Possible Diovan side effects in female

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

Patient: female

Reactions: Blood Pressure Increased, Maculopathy

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

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

Patient: female

Reactions: Death, Dysphagia, Pneumonia Aspiration, Arrhythmia

Adverse event resulted in: death

Drug(s) suspected as cause:
Diovan



Possible Diovan side effects in female

Reported by a physician from Brazil on 2012-08-23

Patient: female

Reactions: Emphysema, Renal Failure, Respiratory Failure, Diabetes Mellitus, Cardiac Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan
    Dosage: 80 mg, unk
    Indication: Hypertension
    Start date: 2012-05-01
    End date: 2012-06-01

Diovan
    Dosage: 160 mg vals, 10 mg amlo and 12.5 mg hydro, one daily
    Administration route: Oral
    Indication: Hypertension

Diovan
    Dosage: 2 df, daily
    Administration route: Oral
    End date: 2012-05-01

Other drugs received by patient: Levothyroxine Sodium; Lasix; Metformin HCL; Apresoline; Amlodipine; Aspirin

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