TADALAFIL

Tadalafil Adverse Events Reported to the FDA Over Time

How are Tadalafil adverse event reports trending over time?

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

Most Common Tadalafil Adverse Events Reported to the FDA

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

Cardiac Failure	33 (3.51%)
Syncope	21 (2.24%)
Drug Ineffective	20 (2.13%)
Cardiac Failure Congestive	18 (1.92%)
Fall	18 (1.92%)
Headache	17 (1.81%)
Pulmonary Oedema	15 (1.6%)
Mitral Valve Incompetence	12 (1.28%)
Hypotension	11 (1.17%)
Dyspnoea	10 (1.06%)
Death	9 (.96%)
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Dizziness	9 (.96%)
Fluid Retention	9 (.96%)
Nausea	9 (.96%)
Pneumonia	9 (.96%)
Infection	8 (.85%)
Oesophageal Achalasia	8 (.85%)
Vision Blurred	8 (.85%)
Acute Respiratory Failure	7 (.75%)
Back Pain	7 (.75%)
Chest Pain	7 (.75%)
Epistaxis	7 (.75%)
Loss Of Consciousness	7 (.75%)
Myalgia	7 (.75%)
Optic Ischaemic Neuropathy	7 (.75%)
Sepsis	7 (.75%)
Vomiting	7 (.75%)
Completed Suicide	6 (.64%)
Disease Progression	6 (.64%)
Transaminases Increased	6 (.64%)
Arrhythmia	5 (.53%)
Atrial Fibrillation	5 (.53%)
Blindness Unilateral	5 (.53%)
Convulsion	5 (.53%)
Drug Interaction	5 (.53%)
Dyspepsia	5 (.53%)
Glaucoma	5 (.53%)
Heart Rate Increased	5 (.53%)
Histiocytosis Haematophagic	5 (.53%)
Hypoxia	5 (.53%)
Intentional Drug Misuse	5 (.53%)
Intraocular Pressure Increased	5 (.53%)
Liver Disorder	5 (.53%)
Musculoskeletal Stiffness	5 (.53%)
Oedema	5 (.53%)
Off Label Use	5 (.53%)
Pulmonary Arterial Hypertension	5 (.53%)
Supraventricular Tachyarrhythmia	5 (.53%)
Tachycardia	5 (.53%)
Therapeutic Response Decreased	5 (.53%)
Anaemia	4 (.43%)
Aortic Stenosis	4 (.43%)
Aphasia	4 (.43%)
Blood Pressure Increased	4 (.43%)
Breast Cancer Recurrent	4 (.43%)
Cardiac Arrest	4 (.43%)
Dyspnoea Exertional	4 (.43%)
Facial Palsy	4 (.43%)
Haemoglobin Decreased	4 (.43%)
Hemiparesis	4 (.43%)
Hepatic Function Abnormal	4 (.43%)
Hepatitis C	4 (.43%)
Hot Flush	4 (.43%)
Hypersensitivity	4 (.43%)
Hypertension	4 (.43%)
Lung Infection	4 (.43%)
Pain	4 (.43%)
Pain In Extremity	4 (.43%)
Partial Seizures	4 (.43%)
Prostate Cancer	4 (.43%)
Pulmonary Hypertension	4 (.43%)
Renal Disorder	4 (.43%)
Renal Failure Acute	4 (.43%)
Respiratory Arrest	4 (.43%)
Tricuspid Valve Incompetence	4 (.43%)
Urinary Tract Infection	4 (.43%)
Visual Acuity Reduced	4 (.43%)
Visual Impairment	4 (.43%)
Abdominal Pain	3 (.32%)
Acute Myocardial Infarction	3 (.32%)
Arthritis	3 (.32%)
Blood Glucose Increased	3 (.32%)
Cardiac Disorder	3 (.32%)
Cardio-respiratory Arrest	3 (.32%)
Cataract	3 (.32%)
Cerebral Haemorrhage	3 (.32%)
Cerebral Ischaemia	3 (.32%)
Cerebrovascular Accident	3 (.32%)
Chorioretinopathy	3 (.32%)
Condition Aggravated	3 (.32%)
Depression	3 (.32%)
Diabetes Mellitus	3 (.32%)
Hepatitis B Antibody Positive	3 (.32%)
Hyperaemia	3 (.32%)
Hypoaesthesia	3 (.32%)
Hypoglycaemia	3 (.32%)
Nasal Congestion	3 (.32%)
Oedema Peripheral	3 (.32%)
Optic Neuropathy	3 (.32%)
Painful Erection	3 (.32%)
Pancreatitis Acute	3 (.32%)

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

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

Heart Failures	56 (5.96%)
Neurological	50 (5.32%)
Infections - Pathogen Unspecified	40 (4.26%)
Respiratory	35 (3.73%)
Therapeutic And Nontherapeutic Effe...	32 (3.41%)
Vision	32 (3.41%)
Cardiac Arrhythmias	29 (3.09%)
Gastrointestinal Signs	26 (2.77%)
Injuries	26 (2.77%)
Lower Respiratory Tract Disorders	24 (2.56%)
Musculoskeletal And Connective Tiss...	21 (2.24%)
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Cardiac Valve	18 (1.92%)
Headaches	17 (1.81%)
Hematology Investigations	16 (1.7%)
Central Nervous System Vascular	15 (1.6%)
Hepatic And Hepatobiliary	15 (1.6%)
Decreased And Nonspecific Blood Pre...	14 (1.49%)
Fatal Outcomes	12 (1.28%)
Vascular	12 (1.28%)
Cardiac And Vascular Investigations	11 (1.17%)
Hepatobiliary	11 (1.17%)
Pulmonary Vascular	11 (1.17%)
Electrolyte And Fluid Balance Condi...	10 (1.06%)
Gastrointestinal Motility And Defec...	10 (1.06%)
Renal Disorders	10 (1.06%)
Upper Respiratory Tract Disorders	10 (1.06%)
Coronary Artery	9 (.96%)
Epidermal And Dermal Conditions	9 (.96%)
Movement Disorders	9 (.96%)
Muscle	9 (.96%)
Seizures	9 (.96%)
Sexual Function And Fertility	9 (.96%)
Therapeutic Procedures And Supporti...	9 (.96%)
Arteriosclerosis, Stenosis, Vascula...	8 (.85%)
Ocular Hemorrhages And Vascular	8 (.85%)
Ocular Structural Change, Deposit A...	8 (.85%)
Anemias Nonhemolytic And Marrow Dep...	7 (.75%)
Gastrointestinal Hemorrhages	7 (.75%)
Glucose Metabolism Disorders	7 (.75%)
Medication Errors	7 (.75%)
Neurological, Special Senses And Ps...	7 (.75%)
Suicidal And Self-injurious Behavio...	7 (.75%)
Viral Infectious	7 (.75%)
Cranial Nerve Disorders	6 (.64%)
Joint	6 (.64%)
Microbiology And Serology	6 (.64%)
Allergic Conditions	5 (.53%)
Glaucoma And Ocular Hypertension	5 (.53%)
Hematopoietic Neoplasms	5 (.53%)
Psychiatric	5 (.53%)
Renal And Urinary Tract Investigati...	5 (.53%)
Retina, Choroid And Vitreous Hemorr...	5 (.53%)
Breast Neoplasms Malignant And Unsp...	4 (.43%)
Cardiac Disorder Signs	4 (.43%)
Connective Tissue Disorders	4 (.43%)
Metabolic, Nutritional And Blood Ga...	4 (.43%)
Musculoskeletal And Connective Tiss...	4 (.43%)
Platelet	4 (.43%)
Procedural And Device Related Injur...	4 (.43%)
Reproductive Neoplasms Male Maligna...	4 (.43%)
Urinary Tract Signs	4 (.43%)
Vascular Hypertensive	4 (.43%)
Anterior Eye Structural Change, Dep...	3 (.32%)
Anxiety Disorders	3 (.32%)
Bladder And Bladder Neck Disorders	3 (.32%)
Bronchial Disorders	3 (.32%)
Coagulopathies And Bleeding Diathes...	3 (.32%)
Depressed Mood Disorders	3 (.32%)
Embolism And Thrombosis	3 (.32%)
Exocrine Pancreas Conditions	3 (.32%)
Lipid Analyses	3 (.32%)
Neurological Disorders Of The Eye	3 (.32%)
Ocular Infections, Irritations And ...	3 (.32%)
Pleural	3 (.32%)
Sleep Disorders	3 (.32%)
Angiedema And Urticaria	2 (.21%)
Appetite And General Nutritional	2 (.21%)
Body Temperature Conditions	2 (.21%)
Bone And Joint Injuries	2 (.21%)
Bone Disorders	2 (.21%)
Changes In Physical Activity	2 (.21%)
Eye	2 (.21%)
Gastrointestinal Conditions	2 (.21%)
Gastrointestinal Inflammatory Condi...	2 (.21%)
Gastrointestinal Stenosis And Obstr...	2 (.21%)
Hearing	2 (.21%)
Male Reproductive Tract Infections ...	2 (.21%)
Menstrual Cycle And Uterine Bleedin...	2 (.21%)
Peritoneal And Retroperitoneal Cond...	2 (.21%)
Purine And Pyrimidine Metabolism	2 (.21%)
Salivary Gland Conditions	2 (.21%)
Skin Appendage Conditions	2 (.21%)
Tendon, Ligament And Cartilage	2 (.21%)
Testicular And Epididymal	2 (.21%)
Abdominal Hernias And Other Abdomin...	1 (.11%)
Aneurysms And Artery Dissections	1 (.11%)
Cardiac Therapeutic Procedures	1 (.11%)
Chemical Injury And Poisoning	1 (.11%)
Deliria	1 (.11%)
Dental And Gingival Conditions	1 (.11%)
Disturbances In Thinking	1 (.11%)

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