PLENDIL

Plendil Adverse Events Reported to the FDA Over Time

How are Plendil adverse event reports trending over time?

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

Most Common Plendil Adverse Events Reported to the FDA

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

Oedema Peripheral	20 (2.07%)
Asthenia	19 (1.97%)
Pruritus	19 (1.97%)
Headache	18 (1.87%)
Blood Pressure Increased	16 (1.66%)
Bradycardia	16 (1.66%)
Anorexia	15 (1.55%)
Hypotension	14 (1.45%)
Myocardial Infarction	14 (1.45%)
Dizziness	13 (1.35%)
Dyspnoea	12 (1.24%)
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Erythema	12 (1.24%)
Swelling	12 (1.24%)
Arthralgia	11 (1.14%)
Fatigue	11 (1.14%)
Temperature Intolerance	11 (1.14%)
Drug Interaction	10 (1.04%)
Scratch	10 (1.04%)
Skin Disorder	10 (1.04%)
Skin Warm	10 (1.04%)
Weight Decreased	10 (1.04%)
Atrial Fibrillation	9 (.93%)
Depressed Level Of Consciousness	9 (.93%)
Drug Ineffective	9 (.93%)
General Physical Health Deteriorati...	9 (.93%)
Hypertension	9 (.93%)
Nausea	9 (.93%)
Cardiac Failure	8 (.83%)
Rash	8 (.83%)
Abdominal Pain	7 (.73%)
Diarrhoea	7 (.73%)
Gingival Swelling	7 (.73%)
Orthostatic Hypotension	7 (.73%)
Pain	7 (.73%)
Eczema	6 (.62%)
Heart Rate Increased	6 (.62%)
International Normalised Ratio Decr...	6 (.62%)
Renal Failure Acute	6 (.62%)
Rhabdomyolysis	6 (.62%)
Seborrhoeic Dermatitis	6 (.62%)
Tremor	6 (.62%)
Vasculitic Rash	6 (.62%)
Balance Disorder	5 (.52%)
Blood Pressure Systolic Decreased	5 (.52%)
Body Temperature Increased	5 (.52%)
C-reactive Protein Increased	5 (.52%)
Drug Hypersensitivity	5 (.52%)
Haemoglobin Decreased	5 (.52%)
Myalgia	5 (.52%)
Recurrent Cancer	5 (.52%)
Renal Failure	5 (.52%)
Tooth Loss	5 (.52%)
Angina Pectoris	4 (.41%)
Blood Creatine Phosphokinase Increa...	4 (.41%)
Blood Creatinine Increased	4 (.41%)
Blood Pressure Decreased	4 (.41%)
Blood Pressure Diastolic Decreased	4 (.41%)
Cardiac Pacemaker Insertion	4 (.41%)
Coma	4 (.41%)
Drug Eruption	4 (.41%)
Dry Skin	4 (.41%)
Epilepsy	4 (.41%)
Fall	4 (.41%)
Gingival Hyperplasia	4 (.41%)
Hearing Impaired	4 (.41%)
Jaundice	4 (.41%)
Lip Swelling	4 (.41%)
Malaise	4 (.41%)
Medication Error	4 (.41%)
Muscle Spasms	4 (.41%)
Nervous System Disorder	4 (.41%)
Oral Cavity Neoplasm Surgery	4 (.41%)
Paraesthesia	4 (.41%)
Rash Generalised	4 (.41%)
Rash Vesicular	4 (.41%)
Sleep Disorder	4 (.41%)
Swelling Face	4 (.41%)
Tongue Neoplasm Malignant Stage Uns...	4 (.41%)
Vomiting	4 (.41%)
White Blood Cell Count Decreased	4 (.41%)
Wrong Drug Administered	4 (.41%)
Wrong Technique In Drug Usage Proce...	4 (.41%)
Accidental Overdose	3 (.31%)
Adverse Drug Reaction	3 (.31%)
Arrhythmia	3 (.31%)
Atrioventricular Block Complete	3 (.31%)
Bladder Tamponade	3 (.31%)
Blood Pressure Inadequately Control...	3 (.31%)
Cardiomegaly	3 (.31%)
Cerebrovascular Accident	3 (.31%)
Condition Aggravated	3 (.31%)
Death	3 (.31%)
Decreased Appetite	3 (.31%)
Dermatitis Allergic	3 (.31%)
Dysgeusia	3 (.31%)
Erectile Dysfunction	3 (.31%)
Fluid Intake Reduced	3 (.31%)
Hyperkalaemia	3 (.31%)
Hypovolaemia	3 (.31%)
Muscular Weakness	3 (.31%)
Neurological Symptom	3 (.31%)

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

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

Epidermal And Dermal Conditions	101 (10.47%)
Neurological	56 (5.8%)
Cardiac And Vascular Investigations	43 (4.46%)
Cardiac Arrhythmias	43 (4.46%)
Therapeutic And Nontherapeutic Effe...	27 (2.8%)
Decreased And Nonspecific Blood Pre...	26 (2.69%)
Gastrointestinal Signs	23 (2.38%)
Coronary Artery	21 (2.18%)
Medication Errors	21 (2.18%)
Appetite And General Nutritional	18 (1.87%)
Headaches	18 (1.87%)
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Hematology Investigations	18 (1.87%)
Injuries	18 (1.87%)
Muscle	18 (1.87%)
Physical Examination Topics	18 (1.87%)
Respiratory	18 (1.87%)
Infections - Pathogen Unspecified	17 (1.76%)
Electrolyte And Fluid Balance Condi...	15 (1.55%)
Renal Disorders	15 (1.55%)
Dental And Gingival Conditions	14 (1.45%)
Joint	14 (1.45%)
Oral Soft Tissue Conditions	14 (1.45%)
Allergic Conditions	11 (1.14%)
Heart Failures	11 (1.14%)
Hepatic And Hepatobiliary	9 (.93%)
Sleep Disorders	9 (.93%)
Vascular Hypertensive	9 (.93%)
Central Nervous System Vascular	8 (.83%)
Gastrointestinal Motility And Defec...	8 (.83%)
Lifestyle Issues	8 (.83%)
Cardiac Disorder Signs	7 (.73%)
Gastrointestinal Neoplasms Malignan...	7 (.73%)
Movement Disorders	7 (.73%)
Seizures	7 (.73%)
Enzyme	6 (.62%)
Miscellaneous And Site Unspecified ...	6 (.62%)
Myocardial	6 (.62%)
Protein And Chemistry Analyses	6 (.62%)
Renal And Urinary Tract Investigati...	6 (.62%)
Skin Vascular Abnormalities	6 (.62%)
Urinary Tract Signs	6 (.62%)
Bone, Calcium, Magnesium And Phosph...	5 (.52%)
Hepatobiliary	5 (.52%)
Anal And Rectal Conditions	4 (.41%)
Anemias Nonhemolytic And Marrow Dep...	4 (.41%)
Cardiac Therapeutic Procedures	4 (.41%)
Disturbances In Thinking	4 (.41%)
Head And Neck Therapeutic Procedure...	4 (.41%)
Hearing	4 (.41%)
Metabolic, Nutritional And Blood Ga...	4 (.41%)
Musculoskeletal And Connective Tiss...	4 (.41%)
Sexual Function And Fertility	4 (.41%)
Vascular	4 (.41%)
Vulvovaginal Disorders	4 (.41%)
Angiedema And Urticaria	3 (.31%)
Body Temperature Conditions	3 (.31%)
Deliria	3 (.31%)
Fatal Outcomes	3 (.31%)
Inner Ear And Viiith Cranial Nerve	3 (.31%)
Mental Impairment	3 (.31%)
Nephropathies	3 (.31%)
Skin Appendage Conditions	3 (.31%)
Acid-base	2 (.21%)
Bone And Joint Injuries	2 (.21%)
Chemical Injury And Poisoning	2 (.21%)
Cornification And Dystrophic Skin	2 (.21%)
Cranial Nerve Disorders	2 (.21%)
Depressed Mood Disorders	2 (.21%)
Eye	2 (.21%)
Musculoskeletal And Soft Tissue Inv...	2 (.21%)
Neuromuscular	2 (.21%)
Pleural	2 (.21%)
Procedural And Device Related Injur...	2 (.21%)
Psychiatric	2 (.21%)
Purine And Pyrimidine Metabolism	2 (.21%)
Therapeutic Procedures And Supporti...	2 (.21%)
Vascular Inflammations	2 (.21%)
Venous Varices	2 (.21%)
Anxiety Disorders	1 (.1%)
Arteriosclerosis, Stenosis, Vascula...	1 (.1%)
Benign Neoplasms Gastrointestinal	1 (.1%)
Bone Disorders	1 (.1%)
Bronchial Disorders	1 (.1%)
Cardiac Valve	1 (.1%)
Changes In Physical Activity	1 (.1%)
Gastrointestinal Conditions	1 (.1%)
Gastrointestinal Hemorrhages	1 (.1%)
Gastrointestinal Therapeutic Proced...	1 (.1%)
Hepatobiliary Disorders Congenital	1 (.1%)
Lipid Analyses	1 (.1%)
Lipid Metabolism	1 (.1%)
Menopause And Related Conditions	1 (.1%)
Musculoskeletal And Connective Tiss...	1 (.1%)
Pericardial	1 (.1%)
Personality Disorders	1 (.1%)
Product Quality Issues	1 (.1%)
Pulmonary Vascular	1 (.1%)
Reproductive Tract	1 (.1%)
Salivary Gland Conditions	1 (.1%)
Schizophrenia And Other Psychotic	1 (.1%)
Sexual Dysfunctions, Disturbances A...	1 (.1%)

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