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ALDALIX

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Aldalix Adverse Events Reported to the FDA Over Time

How are Aldalix adverse event reports trending over time?

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

Most Common Aldalix Adverse Events Reported to the FDA

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

Hyperkalaemia
73 (6.77%)
Renal Failure Acute
64 (5.93%)
Hyponatraemia
38 (3.52%)
Dehydration
31 (2.87%)
Drug Interaction
19 (1.76%)
Renal Failure
19 (1.76%)
Anaemia
18 (1.67%)
Blood Creatinine Increased
18 (1.67%)
Bradycardia
18 (1.67%)
Confusional State
18 (1.67%)
Fall
18 (1.67%)
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Asthenia
16 (1.48%)
Vomiting
16 (1.48%)
Malaise
15 (1.39%)
Metabolic Acidosis
15 (1.39%)
Orthostatic Hypotension
13 (1.2%)
Diarrhoea
12 (1.11%)
Hypotension
10 (.93%)
Arrhythmia
9 (.83%)
Lactic Acidosis
9 (.83%)
Lung Disorder
9 (.83%)
Nausea
9 (.83%)
Cardiac Failure
8 (.74%)
Dermatitis Exfoliative
8 (.74%)
Dyspnoea
7 (.65%)
Face Oedema
7 (.65%)
General Physical Health Deteriorati...
7 (.65%)
Hypoglycaemia
7 (.65%)
Pruritus
7 (.65%)
Pulmonary Embolism
7 (.65%)
Angina Pectoris
6 (.56%)
Cardiac Arrest
6 (.56%)
Gastrointestinal Haemorrhage
6 (.56%)
Overdose
6 (.56%)
Creatinine Renal Clearance Decrease...
5 (.46%)
Disorientation
5 (.46%)
Eosinophilia
5 (.46%)
Gastric Ulcer
5 (.46%)
Loss Of Consciousness
5 (.46%)
Multi-organ Failure
5 (.46%)
Somnolence
5 (.46%)
Tachycardia
5 (.46%)
Tremor
5 (.46%)
Aggression
4 (.37%)
Anorexia
4 (.37%)
Blood Urea Increased
4 (.37%)
C-reactive Protein Increased
4 (.37%)
Cardiomyopathy
4 (.37%)
Chest Pain
4 (.37%)
Cognitive Disorder
4 (.37%)
Coma
4 (.37%)
Condition Aggravated
4 (.37%)
Gastric Ulcer Haemorrhage
4 (.37%)
Haemodynamic Instability
4 (.37%)
Hallucinations, Mixed
4 (.37%)
Hypovolaemia
4 (.37%)
International Normalised Ratio Incr...
4 (.37%)
Neuropathy Peripheral
4 (.37%)
Oedema Peripheral
4 (.37%)
Pain In Extremity
4 (.37%)
Pancreatitis Haemorrhagic
4 (.37%)
Pancreatitis Necrotising
4 (.37%)
Psychomotor Retardation
4 (.37%)
Pyrexia
4 (.37%)
Renal Artery Stenosis
4 (.37%)
Renal Artery Thrombosis
4 (.37%)
Urinary Retention
4 (.37%)
Urinary Tract Infection
4 (.37%)
Wound
4 (.37%)
Atrial Fibrillation
3 (.28%)
Atrioventricular Block
3 (.28%)
Azotaemia
3 (.28%)
Cholelithiasis
3 (.28%)
Delirium
3 (.28%)
Depressed Level Of Consciousness
3 (.28%)
Dialysis
3 (.28%)
Dysstasia
3 (.28%)
Hypoalbuminaemia
3 (.28%)
Hypothyroidism
3 (.28%)
Hypoxia
3 (.28%)
Interstitial Lung Disease
3 (.28%)
Pemphigoid
3 (.28%)
Pleural Effusion
3 (.28%)
Renal Disorder
3 (.28%)
Renal Infarct
3 (.28%)
Respiratory Failure
3 (.28%)
Shock
3 (.28%)
Skin Fissures
3 (.28%)
Skin Lesion
3 (.28%)
Skin Ulcer
3 (.28%)
Thirst
3 (.28%)
Thrombocytopenia
3 (.28%)
Ventricular Hypokinesia
3 (.28%)
Vertigo
3 (.28%)
Volume Blood Decreased
3 (.28%)
Weight Decreased
3 (.28%)
Agitation
2 (.19%)
Arrhythmia Supraventricular
2 (.19%)
Atrioventricular Block Second Degre...
2 (.19%)
Basal Cell Carcinoma
2 (.19%)
Blood Creatine Increased
2 (.19%)

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

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

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

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

Hypertension
49
Drug Use For Unknown Indication
33
Essential Hypertension
21
Ill-defined Disorder
17
Cardiac Failure
15
Product Used For Unknown Indication
10
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Hypertensive Cardiomyopathy
4
Arrhythmia
3
Oedema Peripheral
3
Cardiac Failure Congestive
2
Oedema
2
Hypertensive Heart Disease
1
Chronic Hepatitis
1
Cardiovascular Disorder
1
Oedema Due To Cardiac Disease
1
Cardiac Disorder
1

Aldalix Case Reports

What Aldalix 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 Aldalix. 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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