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RANEXA

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Ranexa Adverse Events Reported to the FDA Over Time

How are Ranexa adverse event reports trending over time?

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

Most Common Ranexa Adverse Events Reported to the FDA

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

Drug Interaction
76 (2.91%)
Dizziness
70 (2.68%)
Rhabdomyolysis
68 (2.61%)
Renal Failure Acute
49 (1.88%)
Syncope
47 (1.8%)
Chest Pain
40 (1.53%)
Nausea
38 (1.46%)
Tremor
37 (1.42%)
Vomiting
35 (1.34%)
Dyspnoea
33 (1.27%)
Torsade De Pointes
32 (1.23%)
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Death
30 (1.15%)
Asthenia
27 (1.04%)
Hypotension
27 (1.04%)
Angina Pectoris
26 (1%)
Fall
26 (1%)
Cardiac Failure
25 (.96%)
Cardiac Arrest
24 (.92%)
Fatigue
24 (.92%)
Hallucination
24 (.92%)
Loss Of Consciousness
24 (.92%)
Electrocardiogram Qt Prolonged
23 (.88%)
Oedema Peripheral
22 (.84%)
Bradycardia
21 (.81%)
Confusional State
21 (.81%)
Malaise
21 (.81%)
Myalgia
21 (.81%)
Myocardial Infarction
21 (.81%)
Rash
21 (.81%)
Abdominal Pain
19 (.73%)
Diarrhoea
19 (.73%)
Blood Creatinine Increased
18 (.69%)
Cardiac Failure Congestive
18 (.69%)
Constipation
17 (.65%)
Renal Impairment
17 (.65%)
Ventricular Tachycardia
17 (.65%)
Vision Blurred
17 (.65%)
Blood Creatine Phosphokinase Increa...
16 (.61%)
Chromaturia
16 (.61%)
Convulsion
15 (.58%)
Headache
15 (.58%)
Arthralgia
14 (.54%)
Atrial Fibrillation
14 (.54%)
Hyperhidrosis
14 (.54%)
Muscular Weakness
14 (.54%)
Therapeutic Response Unexpected
14 (.54%)
Non-cardiac Chest Pain
13 (.5%)
Renal Failure
13 (.5%)
Delirium
12 (.46%)
Sudden Death
12 (.46%)
Insomnia
11 (.42%)
Pneumonia
11 (.42%)
Hypoaesthesia
10 (.38%)
Respiratory Failure
10 (.38%)
Thrombocytopenia
10 (.38%)
Anaemia
9 (.35%)
Contusion
9 (.35%)
Dysuria
9 (.35%)
Hypoglycaemia
9 (.35%)
Hyponatraemia
9 (.35%)
Memory Impairment
9 (.35%)
Oedema
9 (.35%)
Suicidal Ideation
9 (.35%)
Urinary Tract Infection
9 (.35%)
Urine Colour Abnormal
9 (.35%)
Wrong Technique In Drug Usage Proce...
9 (.35%)
Blood Glucose Decreased
8 (.31%)
Blood Pressure Increased
8 (.31%)
Haemoglobin Decreased
8 (.31%)
Mental Status Changes
8 (.31%)
Orthostatic Hypotension
8 (.31%)
Pruritus
8 (.31%)
Weight Increased
8 (.31%)
Asthma
7 (.27%)
Back Pain
7 (.27%)
Depression
7 (.27%)
Disorientation
7 (.27%)
Dysstasia
7 (.27%)
Feeling Abnormal
7 (.27%)
Haematocrit Decreased
7 (.27%)
Hallucination, Visual
7 (.27%)
Heart Rate Decreased
7 (.27%)
International Normalised Ratio Incr...
7 (.27%)
Muscle Twitching
7 (.27%)
Musculoskeletal Pain
7 (.27%)
Neuropathy Peripheral
7 (.27%)
Presyncope
7 (.27%)
Abasia
6 (.23%)
Accidental Overdose
6 (.23%)
Alanine Aminotransferase Increased
6 (.23%)
Angina Unstable
6 (.23%)
Aspartate Aminotransferase Increase...
6 (.23%)
Balance Disorder
6 (.23%)
Blood Glucose Increased
6 (.23%)
Diplopia
6 (.23%)
Flushing
6 (.23%)
Gait Disturbance
6 (.23%)
Gastrooesophageal Reflux Disease
6 (.23%)
Hypertension
6 (.23%)
Incorrect Dose Administered
6 (.23%)
Joint Swelling
6 (.23%)

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

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

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

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

Angina Pectoris
638
Product Used For Unknown Indication
120
Drug Use For Unknown Indication
105
Cardiac Disorder
50
Coronary Artery Disease
33
Chest Pain
30
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Myocardial Ischaemia
13
Angina Unstable
11
Cardiac Failure Congestive
5
Left Ventricular Hypertrophy
4
Off Label Use
3
Atrial Fibrillation
3
Hypertension
3
Prophylaxis
3
Microvascular Angina
3
Cardiac Failure
3
Blood Cholesterol
2
Ventricular Tachycardia
2
Pulmonary Hypertension
2
Myocardial Infarction
2
Arrhythmia Prophylaxis
2
Blood Creatine Phosphokinase Increa...
2
Prinzmetal Angina
2
Ischaemia
1
Diastolic Dysfunction
1
Accidental Drug Intake By Child
1
Raynauds Phenomenon
1
Cardiac Valve Disease
1
Stent Placement
1
Arterial Disorder
1
Arrhythmia
1
Chest Discomfort
1
Heart Rate Decreased
1
Peripheral Vascular Disorder
1
Ischaemic Cardiomyopathy
1
Microangiopathy
1
Arteriosclerosis Coronary Artery
1
Arterial Spasm
1
Myasthenia Gravis
1
Pain
1

Drug Labels

LabelLabelerEffective
RanexaGilead Sciences, Inc.26-APR-10
RanexaCardinal Health06-OCT-11
RanexaGilead Sciences, Inc.12-NOV-12
RanexaCardinal Health29-APR-13

Ranexa Case Reports

What Ranexa 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 Ranexa. 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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