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METOLAZONE

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Metolazone Adverse Events Reported to the FDA Over Time

How are Metolazone adverse event reports trending over time?

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

Most Common Metolazone Adverse Events Reported to the FDA

What are the most common Metolazone adverse events reported to the FDA?

Renal Failure Acute
105 (6.12%)
Dehydration
58 (3.38%)
Hypokalaemia
58 (3.38%)
Asthenia
42 (2.45%)
Nausea
39 (2.27%)
Dizziness
34 (1.98%)
Confusional State
33 (1.92%)
Blood Creatinine Increased
31 (1.81%)
Hypotension
26 (1.52%)
Syncope
26 (1.52%)
Vomiting
25 (1.46%)
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Dyspnoea
24 (1.4%)
Hyponatraemia
24 (1.4%)
Blood Potassium Decreased
18 (1.05%)
Cardiac Failure Congestive
18 (1.05%)
Diarrhoea
18 (1.05%)
Fatigue
18 (1.05%)
Medication Error
18 (1.05%)
Somnolence
18 (1.05%)
Weight Decreased
18 (1.05%)
Azotaemia
16 (.93%)
Chest Pain
15 (.87%)
Blood Glucose Increased
14 (.82%)
Cardiac Arrest
14 (.82%)
Electrocardiogram Qt Prolonged
14 (.82%)
Decreased Appetite
13 (.76%)
Oedema
13 (.76%)
Renal Failure
13 (.76%)
Torsade De Pointes
13 (.76%)
Cardiac Failure
12 (.7%)
Disease Progression
12 (.7%)
Drug Interaction
12 (.7%)
Haemoglobin Decreased
12 (.7%)
Malaise
12 (.7%)
Sepsis
12 (.7%)
Constipation
11 (.64%)
Death
11 (.64%)
Fall
11 (.64%)
Ventricular Tachycardia
11 (.64%)
Weight Increased
11 (.64%)
Acute Prerenal Failure
10 (.58%)
Blood Sodium Decreased
10 (.58%)
Hypomagnesaemia
10 (.58%)
Renal Failure Chronic
10 (.58%)
Oedema Peripheral
9 (.52%)
Orthopnoea
9 (.52%)
Polyuria
9 (.52%)
Urine Output Decreased
9 (.52%)
Visual Impairment
9 (.52%)
Blood Electrolytes Abnormal
8 (.47%)
Blood Urea Increased
8 (.47%)
Condition Aggravated
8 (.47%)
Haematocrit Decreased
8 (.47%)
Hyperkalaemia
8 (.47%)
Loss Of Consciousness
8 (.47%)
Therapeutic Agent Toxicity
8 (.47%)
Angina Pectoris
7 (.41%)
Back Pain
7 (.41%)
Disorientation
7 (.41%)
Drug Dispensing Error
7 (.41%)
Haemodialysis
7 (.41%)
Pain
7 (.41%)
Poisoning
7 (.41%)
Anorexia
6 (.35%)
Blood Creatine Phosphokinase Increa...
6 (.35%)
Blood Pressure Increased
6 (.35%)
Hyperhidrosis
6 (.35%)
Insomnia
6 (.35%)
Orthostatic Hypotension
6 (.35%)
Pancreatitis
6 (.35%)
Sinus Bradycardia
6 (.35%)
Ventricular Extrasystoles
6 (.35%)
Atrial Fibrillation
5 (.29%)
Blood Pressure Decreased
5 (.29%)
Cardio-respiratory Arrest
5 (.29%)
Concomitant Disease Progression
5 (.29%)
Cough
5 (.29%)
Delirium
5 (.29%)
Drug Ineffective
5 (.29%)
Dyspnoea Exertional
5 (.29%)
Electrolyte Imbalance
5 (.29%)
Eye Oedema
5 (.29%)
Headache
5 (.29%)
Hypovolaemia
5 (.29%)
Incorrect Dose Administered
5 (.29%)
Memory Impairment
5 (.29%)
Mental Impairment
5 (.29%)
Nasal Disorder
5 (.29%)
Oxygen Saturation Decreased
5 (.29%)
Pallor
5 (.29%)
Pneumonia
5 (.29%)
Renal Impairment
5 (.29%)
Respiratory Arrest
5 (.29%)
Shock
5 (.29%)
Agitation
4 (.23%)
Anaemia
4 (.23%)
Arrhythmia
4 (.23%)
Blood Creatine Phosphokinase Mb Inc...
4 (.23%)
Bradycardia
4 (.23%)
Cellulitis
4 (.23%)
Chest Discomfort
4 (.23%)

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This graph shows the top adverse events submitted to the FDA for Metolazone, 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 Metolazone 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 Metolazone

What are the most common Metolazone adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Metolazone, 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 Metolazone 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 Metolazone According to Those Reporting Adverse Events

Why are people taking Metolazone, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
108
Drug Use For Unknown Indication
103
Hypertension
76
Cardiac Failure Congestive
47
Diuretic Therapy
41
Fluid Retention
39
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Oedema
36
Oedema Peripheral
19
Cardiac Failure
9
Swelling
8
Polyuria
7
Renal Failure
6
Renal Failure Acute
5
Essential Hypertension
5
Weight Increased
5
Pulmonary Hypertension
4
Cardiac Failure Chronic
4
Cardiac Disorder
4
Fluid Imbalance
4
Pulmonary Arterial Hypertension
3
Blood Pressure
3
Renal Failure Chronic
3
Fluid Overload
2
Benign Prostatic Hyperplasia
2
Ischaemic Cardiomyopathy
2
Chronic Obstructive Pulmonary Disea...
2
Generalised Oedema
2
Renal Disorder
2
Chest Discomfort
1
Nephrogenic Anaemia
1
Complex Regional Pain Syndrome
1
Pain
1
Ill-defined Disorder
1
Sleep Disorder
1
Ascites
1
Cough
1
Blood Creatinine Increased
1
Acute Prerenal Failure
1
Dyspnoea
1
Diastolic Dysfunction
1
Hypovolaemia
1
Gastrooesophageal Reflux Disease
1
Asthma
1
Pancreatitis
1
Rheumatoid Arthritis
1
Renal Hypertension
1
Fluid Replacement
1
Oedema Due To Cardiac Disease
1
Haemorrhage
1
Basedows Disease
1

Drug Labels

LabelLabelerEffective
MetolazoneMylan Pharmaceuticals Inc.18-JAN-10
MetolazoneUDL Laboratories, Inc.23-JUL-10
MetolazoneAmerican Health Packaging04-OCT-10
MetolazoneEon Labs, Inc.28-SEP-11
MetolazonePhysicians Total Care, Inc.24-APR-12
MetolazoneNCS HealthCare of KY, Inc dba Vangard Labs08-MAY-12
MetolazoneUpstate Pharma, LLC08-JUN-12
MetolazoneCardinal Health23-JUL-12
ZaroxolynUCB Manufacturing, Inc.30-AUG-12
MetolazoneMcKesson Packaging Services a business unit of McKesson Corporation31-AUG-12

Metolazone Case Reports

What Metolazone 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 Metolazone. 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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