ALPROSTADIL

Alprostadil Adverse Events Reported to the FDA Over Time

How are Alprostadil adverse event reports trending over time?

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

Most Common Alprostadil Adverse Events Reported to the FDA

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

Pyrexia	47 (2.1%)
Cardiac Failure	33 (1.48%)
Condition Aggravated	29 (1.3%)
Infantile Apnoeic Attack	29 (1.3%)
Dyspnoea	28 (1.25%)
Apnoeic Attack	26 (1.16%)
Chills	22 (.98%)
Drug Ineffective	22 (.98%)
Pulmonary Oedema	22 (.98%)
White Blood Cell Count Increased	20 (.89%)
Platelet Count Decreased	19 (.85%)
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Priapism	19 (.85%)
Pleural Effusion	18 (.81%)
Pain	17 (.76%)
Cerebral Infarction	16 (.72%)
Myocardial Infarction	15 (.67%)
Pneumonia	14 (.63%)
Aspartate Aminotransferase Increase...	13 (.58%)
Blood Pressure Increased	13 (.58%)
C-reactive Protein Increased	13 (.58%)
Oxygen Saturation Decreased	13 (.58%)
Pain In Extremity	13 (.58%)
Alanine Aminotransferase Increased	12 (.54%)
Blood Alkaline Phosphatase Increase...	12 (.54%)
Loss Of Consciousness	12 (.54%)
Neonatal Disorder	12 (.54%)
Apnoea	11 (.49%)
Bradycardia	11 (.49%)
Haemoglobin Decreased	11 (.49%)
Hypotension	11 (.49%)
Infusion Related Reaction	11 (.49%)
Interstitial Lung Disease	11 (.49%)
Oedema	11 (.49%)
Post Procedural Complication	11 (.49%)
Respiratory Rate Increased	11 (.49%)
Sepsis	11 (.49%)
Shock	11 (.49%)
Vomiting	11 (.49%)
Abdominal Distension	10 (.45%)
Body Temperature Increased	10 (.45%)
Cardiac Arrest	10 (.45%)
Chest Pain	10 (.45%)
Gastrointestinal Haemorrhage	10 (.45%)
Generalised Oedema	10 (.45%)
Heart Rate Increased	10 (.45%)
Hypoxia	10 (.45%)
Leg Amputation	10 (.45%)
Malaise	10 (.45%)
Pulmonary Congestion	10 (.45%)
Renal Failure Acute	10 (.45%)
Respiratory Arrest	10 (.45%)
Skin Ulcer	10 (.45%)
Cardiac Failure Congestive	9 (.4%)
Feeling Abnormal	9 (.4%)
Inflammation	9 (.4%)
Painful Erection	9 (.4%)
Syncope	9 (.4%)
Acute Myocardial Infarction	8 (.36%)
Cardiomegaly	8 (.36%)
Disease Progression	8 (.36%)
Drug Effect Decreased	8 (.36%)
Hepatic Function Abnormal	8 (.36%)
Hyponatraemia	8 (.36%)
Palpitations	8 (.36%)
Respiratory Failure	8 (.36%)
Anaemia	7 (.31%)
Blood Lactate Dehydrogenase Increas...	7 (.31%)
Blood Pressure Decreased	7 (.31%)
Bronchopneumonia	7 (.31%)
Bursitis	7 (.31%)
Fall	7 (.31%)
Gait Disturbance	7 (.31%)
Haematocrit Decreased	7 (.31%)
Infection	7 (.31%)
Oedema Peripheral	7 (.31%)
Off Label Use	7 (.31%)
Overdose	7 (.31%)
Patent Ductus Arteriosus	7 (.31%)
Somnolence	7 (.31%)
Tachycardia	7 (.31%)
Asthenia	6 (.27%)
Back Pain	6 (.27%)
Cellulitis	6 (.27%)
Diarrhoea	6 (.27%)
Erythema	6 (.27%)
Exostosis	6 (.27%)
Haematemesis	6 (.27%)
Haematuria	6 (.27%)
Left Ventricular Failure	6 (.27%)
Nausea	6 (.27%)
Necrosis	6 (.27%)
Necrosis Ischaemic	6 (.27%)
No Adverse Event	6 (.27%)
Po2 Decreased	6 (.27%)
Pulmonary Embolism	6 (.27%)
Rash Generalised	6 (.27%)
Rhabdomyolysis	6 (.27%)
Supraventricular Tachycardia	6 (.27%)
Urinary Tract Infection	6 (.27%)
Urine Output Decreased	6 (.27%)
White Blood Cell Count Decreased	6 (.27%)

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

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

Respiratory	124 (5.55%)
Hematology Investigations	91 (4.07%)
Cardiac Arrhythmias	78 (3.49%)
Infections - Pathogen Unspecified	76 (3.4%)
Neurological	60 (2.68%)
Cardiac And Vascular Investigations	59 (2.64%)
Heart Failures	59 (2.64%)
Lower Respiratory Tract Disorders	55 (2.46%)
Body Temperature Conditions	51 (2.28%)
Epidermal And Dermal Conditions	42 (1.88%)
Therapeutic And Nontherapeutic Effe...	40 (1.79%)
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Hepatobiliary	38 (1.7%)
Procedural And Device Related Injur...	38 (1.7%)
Metabolic, Nutritional And Blood Ga...	37 (1.65%)
Neonatal Respiratory	37 (1.65%)
Central Nervous System Vascular	36 (1.61%)
Coronary Artery	36 (1.61%)
Physical Examination Topics	36 (1.61%)
Administration Site Reactions	35 (1.57%)
Hepatic And Hepatobiliary	35 (1.57%)
Renal Disorders	34 (1.52%)
Sexual Function And Fertility	34 (1.52%)
Gastrointestinal Signs	33 (1.48%)
Arteriosclerosis, Stenosis, Vascula...	29 (1.3%)
Enzyme	26 (1.16%)
Gastrointestinal Hemorrhages	25 (1.12%)
Renal And Urinary Tract Investigati...	25 (1.12%)
Electrolyte And Fluid Balance Condi...	24 (1.07%)
Musculoskeletal And Connective Tiss...	24 (1.07%)
Cardiac And Vascular Disorders Cong...	23 (1.03%)
Decreased And Nonspecific Blood Pre...	23 (1.03%)
Protein And Chemistry Analyses	21 (.94%)
Cardiac Disorder Signs	20 (.89%)
Medication Errors	20 (.89%)
Myocardial	20 (.89%)
Pleural	20 (.89%)
Bacterial Infectious	19 (.85%)
Neonatal And Perinatal Conditions	18 (.81%)
Bone And Joint Therapeutic Procedur...	17 (.76%)
Urinary Tract Signs	17 (.76%)
Bone Disorders	16 (.72%)
Muscle	16 (.72%)
Gastrointestinal Ulceration And Per...	15 (.67%)
Injuries	13 (.58%)
Platelet	13 (.58%)
Tissue	13 (.58%)
Cardiac Valve	12 (.54%)
Pulmonary Vascular	12 (.54%)
Skin And Subcutaneous Tissue	12 (.54%)
Hematological And Lymphoid Tissue T...	11 (.49%)
Anemias Nonhemolytic And Marrow Dep...	10 (.45%)
Embolism And Thrombosis	10 (.45%)
Movement Disorders	10 (.45%)
Penile And Scrotal Disorders	10 (.45%)
Seizures	10 (.45%)
Skin Appendage Conditions	10 (.45%)
Appetite And General Nutritional	9 (.4%)
Coagulopathies And Bleeding Diathes...	9 (.4%)
Fatal Outcomes	9 (.4%)
Gastrointestinal Motility And Defec...	9 (.4%)
Vascular	9 (.4%)
Vascular Hemorrhagic	9 (.4%)
Water, Electrolyte And Mineral	9 (.4%)
Joint	8 (.36%)
Therapeutic Procedures And Supporti...	8 (.36%)
Glucose Metabolism Disorders	7 (.31%)
Hemolyses And Related Conditions	7 (.31%)
Synovial And Bursal	7 (.31%)
Allergic Conditions	6 (.27%)
Changes In Physical Activity	6 (.27%)
Gastrointestinal Inflammatory Condi...	6 (.27%)
Lifestyle Issues	6 (.27%)
Viral Infectious	6 (.27%)
White Blood Cell	6 (.27%)
Bronchial Disorders	5 (.22%)
Chemical Injury And Poisoning	5 (.22%)
Gastrointestinal Conditions	5 (.22%)
Peritoneal And Retroperitoneal Cond...	5 (.22%)
Urethral Disorders	5 (.22%)
Vascular Therapeutic Procedures	5 (.22%)
Vision	5 (.22%)
Aneurysms And Artery Dissections	4 (.18%)
Gastrointestinal Therapeutic Proced...	4 (.18%)
Nervous System, Skull And Spine The...	4 (.18%)
Oral Soft Tissue Conditions	4 (.18%)
Reproductive Tract	4 (.18%)
Skin Vascular Abnormalities	4 (.18%)
Acid-base	3 (.13%)
Connective Tissue Disorders	3 (.13%)
Deliria	3 (.13%)
Gastrointestinal Stenosis And Obstr...	3 (.13%)
Gastrointestinal Vascular Condition...	3 (.13%)
Hematopoietic Neoplasms	3 (.13%)
Lipid Analyses	3 (.13%)
Mental Impairment	3 (.13%)
Neuromuscular	3 (.13%)
Obstetric And Gynecological Therape...	3 (.13%)
Pericardial	3 (.13%)
Protein And Amino Acid Metabolism	3 (.13%)
Psychiatric And Behavioural Symptom...	3 (.13%)
Reproductive Neoplasms Male Maligna...	3 (.13%)

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