RANOLAZINE

Ranolazine Adverse Events Reported to the FDA Over Time

How are Ranolazine adverse event reports trending over time?

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

Most Common Ranolazine Adverse Events Reported to the FDA

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

Rhabdomyolysis	54 (6.51%)
Drug Interaction	45 (5.43%)
Malaise	32 (3.86%)
Vomiting	31 (3.74%)
Chromaturia	26 (3.14%)
Dizziness	26 (3.14%)
Arthralgia	25 (3.02%)
Musculoskeletal Pain	24 (2.9%)
Renal Failure Acute	21 (2.53%)
Nausea	16 (1.93%)
Completed Suicide	15 (1.81%)
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Chest Pain	14 (1.69%)
Syncope	14 (1.69%)
Asthenia	12 (1.45%)
Decreased Appetite	12 (1.45%)
Blood Creatine Phosphokinase Increa...	11 (1.33%)
Tremor	11 (1.33%)
Blood Creatinine Increased	10 (1.21%)
Cardiac Failure Congestive	10 (1.21%)
Abdominal Pain	9 (1.09%)
Angina Pectoris	9 (1.09%)
Fall	9 (1.09%)
Fatigue	9 (1.09%)
Bradycardia	8 (.97%)
Electrocardiogram Qt Prolonged	8 (.97%)
Hypotension	8 (.97%)
Atrial Fibrillation	7 (.84%)
Confusional State	7 (.84%)
Myocardial Infarction	7 (.84%)
Sinus Bradycardia	7 (.84%)
Aspartate Aminotransferase Increase...	6 (.72%)
Lethargy	6 (.72%)
Myalgia	6 (.72%)
Blood Urea Increased	5 (.6%)
Feeling Abnormal	5 (.6%)
Suicidal Ideation	5 (.6%)
Asthma	4 (.48%)
Cardiac Failure	4 (.48%)
Condition Aggravated	4 (.48%)
Dyspnoea	4 (.48%)
Epistaxis	4 (.48%)
Hypoaesthesia	4 (.48%)
Inhibitory Drug Interaction	4 (.48%)
Loss Of Consciousness	4 (.48%)
Musculoskeletal Stiffness	4 (.48%)
Nodal Rhythm	4 (.48%)
Non-cardiac Chest Pain	4 (.48%)
Orthostatic Hypotension	4 (.48%)
Pneumonia	4 (.48%)
Pulmonary Oedema	4 (.48%)
Reflux Gastritis	4 (.48%)
Respiratory Failure	4 (.48%)
Sensation Of Pressure	4 (.48%)
Torsade De Pointes	4 (.48%)
Urinary Tract Infection	4 (.48%)
Vasculitic Rash	4 (.48%)
Ventricular Extrasystoles	4 (.48%)
Vision Blurred	4 (.48%)
Amnesia	3 (.36%)
Depression	3 (.36%)
Diabetes Mellitus Inadequate Contro...	3 (.36%)
Gastritis	3 (.36%)
Haemolytic Anaemia	3 (.36%)
Hepatitis	3 (.36%)
Hyperhidrosis	3 (.36%)
Insomnia	3 (.36%)
Lip Swelling	3 (.36%)
Liver Function Test Abnormal	3 (.36%)
Muscle Twitching	3 (.36%)
Palpitations	3 (.36%)
Pancreatitis	3 (.36%)
Renal Impairment	3 (.36%)
Thrombophlebitis Superficial	3 (.36%)
Tinnitus	3 (.36%)
Urine Output Decreased	3 (.36%)
Alanine Aminotransferase Increased	2 (.24%)
Blood Glucose Abnormal	2 (.24%)
Blood Thyroid Stimulating Hormone I...	2 (.24%)
Cardiac Disorder	2 (.24%)
Chest Discomfort	2 (.24%)
Constipation	2 (.24%)
Coronary Artery Occlusion	2 (.24%)
Cough	2 (.24%)
Death	2 (.24%)
Dehydration	2 (.24%)
Drug Level Increased	2 (.24%)
Dry Mouth	2 (.24%)
Eczema	2 (.24%)
Flushing	2 (.24%)
Hallucination	2 (.24%)
Hepatic Neoplasm Malignant	2 (.24%)
Hot Flush	2 (.24%)
Hypoglycaemia	2 (.24%)
Hypotonic Urinary Bladder	2 (.24%)
Hypoxia	2 (.24%)
Intentional Drug Misuse	2 (.24%)
International Normalised Ratio Incr...	2 (.24%)
Long Qt Syndrome	2 (.24%)
Mental Status Changes	2 (.24%)
Mobility Decreased	2 (.24%)
Myocardial Ischaemia	2 (.24%)

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

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

Muscle	64 (7.72%)
Neurological	60 (7.24%)
Gastrointestinal Signs	59 (7.12%)
Therapeutic And Nontherapeutic Effe...	51 (6.15%)
Cardiac Arrhythmias	43 (5.19%)
Musculoskeletal And Connective Tiss...	32 (3.86%)
Renal Disorders	27 (3.26%)
Joint	26 (3.14%)
Urinary Tract Signs	26 (3.14%)
Coronary Artery	21 (2.53%)
Renal And Urinary Tract Investigati...	20 (2.41%)
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Suicidal And Self-injurious Behavio...	20 (2.41%)
Heart Failures	14 (1.69%)
Appetite And General Nutritional	13 (1.57%)
Decreased And Nonspecific Blood Pre...	13 (1.57%)
Respiratory	13 (1.57%)
Cardiac And Vascular Investigations	12 (1.45%)
Enzyme	12 (1.45%)
Hepatobiliary	12 (1.45%)
Injuries	11 (1.33%)
Movement Disorders	11 (1.33%)
Epidermal And Dermal Conditions	9 (1.09%)
Deliria	8 (.97%)
Infections - Pathogen Unspecified	8 (.97%)
Gastrointestinal Inflammatory Condi...	7 (.84%)
Vision	6 (.72%)
Bronchial Disorders	5 (.6%)
Cardiac Disorder Signs	5 (.6%)
Electrolyte And Fluid Balance Condi...	5 (.6%)
Glucose Metabolism Disorders	5 (.6%)
Lower Respiratory Tract Disorders	5 (.6%)
Skin Vascular Abnormalities	5 (.6%)
Depressed Mood Disorders	4 (.48%)
Embolism And Thrombosis	4 (.48%)
Gastrointestinal Motility And Defec...	4 (.48%)
Oral Soft Tissue Conditions	4 (.48%)
Psychiatric	4 (.48%)
Upper Respiratory Tract Disorders	4 (.48%)
Vascular	4 (.48%)
Exocrine Pancreas Conditions	3 (.36%)
Fatal Outcomes	3 (.36%)
Hematology Investigations	3 (.36%)
Hemolyses And Related Conditions	3 (.36%)
Hepatic And Hepatobiliary	3 (.36%)
Hepatobiliary Neoplasms Malignant A...	3 (.36%)
Inner Ear And Viiith Cranial Nerve	3 (.36%)
Medication Errors	3 (.36%)
Mental Impairment	3 (.36%)
Physical Examination Topics	3 (.36%)
Skin Appendage Conditions	3 (.36%)
Sleep Disorders	3 (.36%)
Toxicology And Therapeutic Drug Mon...	3 (.36%)
Anemias Nonhemolytic And Marrow Dep...	2 (.24%)
Angiedema And Urticaria	2 (.24%)
Bacterial Infectious	2 (.24%)
Bladder And Bladder Neck Disorders	2 (.24%)
Disturbances In Thinking	2 (.24%)
Encephalopathies	2 (.24%)
Endocrine Investigations	2 (.24%)
Eye	2 (.24%)
Metabolic, Nutritional And Blood Ga...	2 (.24%)
Salivary Gland Conditions	2 (.24%)
Vulvovaginal Disorders	2 (.24%)
Arteriosclerosis, Stenosis, Vascula...	1 (.12%)
Bone And Joint Injuries	1 (.12%)
Bone Disorders	1 (.12%)
Central Nervous System Vascular	1 (.12%)
Chemical Injury And Poisoning	1 (.12%)
Gastrointestinal Hemorrhages	1 (.12%)
Gastrointestinal Vascular Condition...	1 (.12%)
Headaches	1 (.12%)
Hepatobiliary Therapeutic Procedure...	1 (.12%)
Investigations, Imaging And Histopa...	1 (.12%)
Lifestyle Issues	1 (.12%)
Lipid Metabolism	1 (.12%)
Mood Disorders	1 (.12%)
Musculoskeletal And Soft Tissue Inv...	1 (.12%)
Ocular Sensory Symptoms	1 (.12%)
Platelet	1 (.12%)
Purine And Pyrimidine Metabolism	1 (.12%)
Therapeutic Procedures And Supporti...	1 (.12%)
Vascular Hypertensive	1 (.12%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Ranolazine, 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 Ranolazine 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.