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VALSARTAN AND HYDROCHLOROTHIAZIDE

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Valsartan And Hydrochlorothiazide Adverse Events Reported to the FDA Over Time

How are Valsartan And Hydrochlorothiazide adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Valsartan And Hydrochlorothiazide, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Valsartan And Hydrochlorothiazide is flagged as the suspect drug causing the adverse event.

Most Common Valsartan And Hydrochlorothiazide Adverse Events Reported to the FDA

What are the most common Valsartan And Hydrochlorothiazide adverse events reported to the FDA?

Renal Failure Acute
49 (1.88%)
Hyponatraemia
45 (1.72%)
Fall
39 (1.49%)
Hypotension
37 (1.42%)
Blood Creatinine Increased
33 (1.26%)
Renal Failure
32 (1.23%)
Malaise
30 (1.15%)
Hypokalaemia
29 (1.11%)
Vomiting
28 (1.07%)
Pruritus
27 (1.03%)
Dehydration
26 (1%)
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Syncope
26 (1%)
Asthenia
22 (.84%)
Death
22 (.84%)
Myocardial Infarction
22 (.84%)
General Physical Health Deteriorati...
18 (.69%)
Nausea
18 (.69%)
Somnolence
18 (.69%)
Bradycardia
17 (.65%)
Hypertension
17 (.65%)
Loss Of Consciousness
17 (.65%)
Diabetes Mellitus
16 (.61%)
Dyspnoea
16 (.61%)
Fatigue
16 (.61%)
Headache
16 (.61%)
Blood Urea Increased
15 (.57%)
Dizziness
15 (.57%)
Oedema Peripheral
15 (.57%)
Orthostatic Hypotension
15 (.57%)
Diarrhoea
14 (.54%)
Eczema
14 (.54%)
Gamma-glutamyltransferase Increased
14 (.54%)
Haematoma
14 (.54%)
Hyperkalaemia
14 (.54%)
Sudden Death
14 (.54%)
Confusional State
13 (.5%)
Drug Interaction
13 (.5%)
Blood Pressure Inadequately Control...
12 (.46%)
Completed Suicide
12 (.46%)
Pulmonary Embolism
12 (.46%)
Rash
12 (.46%)
Skin Lesion
12 (.46%)
Cardiac Failure
11 (.42%)
Cerebrovascular Accident
11 (.42%)
Condition Aggravated
11 (.42%)
Generalised Oedema
11 (.42%)
Hepatic Function Abnormal
11 (.42%)
Lactic Acidosis
11 (.42%)
Pyrexia
11 (.42%)
Blood Bilirubin Increased
10 (.38%)
Blood Pressure Decreased
10 (.38%)
Cardiac Arrest
10 (.38%)
Chest Pain
10 (.38%)
Drug Rash With Eosinophilia And Sys...
10 (.38%)
Ocular Discomfort
10 (.38%)
Oedema
10 (.38%)
Overdose
10 (.38%)
Pain
10 (.38%)
Vogt-koyanagi-harada Syndrome
10 (.38%)
Alanine Aminotransferase Increased
9 (.34%)
Anaemia Haemolytic Autoimmune
9 (.34%)
C-reactive Protein Increased
9 (.34%)
Chest Discomfort
9 (.34%)
Convulsion
9 (.34%)
Creatinine Renal Clearance Decrease...
9 (.34%)
Dry Skin
9 (.34%)
Heart Rate Increased
9 (.34%)
Hypercholesterolaemia
9 (.34%)
Skin Exfoliation
9 (.34%)
Acute Pulmonary Oedema
8 (.31%)
Aspartate Aminotransferase Increase...
8 (.31%)
Blister
8 (.31%)
Blood Pressure Increased
8 (.31%)
Erythema
8 (.31%)
Face Injury
8 (.31%)
Infection
8 (.31%)
Rhabdomyolysis
8 (.31%)
Shock
8 (.31%)
Suicide Attempt
8 (.31%)
Abasia
7 (.27%)
Abdominal Pain
7 (.27%)
Angina Pectoris
7 (.27%)
Angioedema
7 (.27%)
Blood Creatine Phosphokinase Increa...
7 (.27%)
Cognitive Disorder
7 (.27%)
Decreased Appetite
7 (.27%)
Depressed Level Of Consciousness
7 (.27%)
Gait Disturbance
7 (.27%)
Hypercalcaemia
7 (.27%)
Hyperglycaemia
7 (.27%)
Hypoglycaemia
7 (.27%)
Inappropriate Antidiuretic Hormone ...
7 (.27%)
Insomnia
7 (.27%)
Multi-organ Failure
7 (.27%)
Muscular Weakness
7 (.27%)
Myalgia
7 (.27%)
Staphylococcal Bacteraemia
7 (.27%)
Weight Increased
7 (.27%)
Atrial Fibrillation
6 (.23%)
Bronchitis
6 (.23%)
Cardio-respiratory Arrest
6 (.23%)

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This graph shows the top adverse events submitted to the FDA for Valsartan And Hydrochlorothiazide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Valsartan And Hydrochlorothiazide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Valsartan And Hydrochlorothiazide

What are the most common Valsartan And Hydrochlorothiazide adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Valsartan And Hydrochlorothiazide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Valsartan And Hydrochlorothiazide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Valsartan And Hydrochlorothiazide According to Those Reporting Adverse Events

Why are people taking Valsartan And Hydrochlorothiazide, according to those reporting adverse events to the FDA?

Hypertension
510
Product Used For Unknown Indication
45
Drug Use For Unknown Indication
33
Essential Hypertension
15
Blood Pressure Increased
6
Ill-defined Disorder
4
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Musculoskeletal Pain
3
Drug Exposure During Pregnancy
3
Suicide Attempt
3
Cardiac Failure
3
Blood Pressure
2
Hypertonia
2
Renal Hypertension
2
Overdose
1
Vertigo
1
Diuretic Therapy
1
Oedema
1
Aortic Valve Disease
1

Drug Labels

LabelLabelerEffective
Diovan Hct PD-Rx Pharmaceuticals, Inc.11-FEB-11
Diovan HctLake Erie Medical & Surgical Supply DBA Quality Care Products LLC16-NOV-11
Exforge HctPhysicians Total Care, Inc.19-DEC-11
Diovan HctPhysicians Total Care, Inc.09-JAN-12
Diovan HctPD-Rx Pharmaceuticals, Inc.22-FEB-12
Diovan HctLake Erie Medical & Surgical Supply DBA Quality Care Products LLC28-FEB-12
Diovan HctCardinal Health23-JUL-12
Valsartan And HydrochlorothiazideWatson Laboratories, Inc.01-OCT-12
Diovan HctDispensing Solutions, Inc.10-OCT-12
Diovan HctDispensing Solutions, Inc.10-OCT-12
Diovan HctNovartis Pharmaceuticals Corporation10-OCT-12
Valsartan And HydrochlorothiazideMylan Pharmaceuticals Inc.16-OCT-12
Valsartan And HydrochlorothiazideSandoz Inc19-OCT-12
Exforge HctNovartis Pharmaceuticals Corporation30-NOV-12
Diovan HctLake Erie Medical DBA Quality Care Products LLC20-FEB-13
Valsartan And HydrochlorothiazideAurobindo Pharma Limited21-MAR-13
Valsartan And HydrochlorothiazideLupin Pharmaceuticals, Inc.21-MAR-13
Valsartan And HydrochlorothiazideQualitest Pharmaceuticals25-MAR-13

Valsartan And Hydrochlorothiazide Case Reports

What Valsartan And Hydrochlorothiazide safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Valsartan And Hydrochlorothiazide. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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