SUFENTANIL CITRATE

Sufentanil Citrate Adverse Events Reported to the FDA Over Time

How are Sufentanil Citrate adverse event reports trending over time?

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

Most Common Sufentanil Citrate Adverse Events Reported to the FDA

What are the most common Sufentanil Citrate adverse events reported to the FDA?

Anaphylactic Shock	73 (6.07%)
Hypotension	46 (3.83%)
Bronchospasm	41 (3.41%)
Cardiac Arrest	33 (2.75%)
Circulatory Collapse	25 (2.08%)
Bradycardia	23 (1.91%)
Erythema	23 (1.91%)
Urticaria	17 (1.41%)
Cytolytic Hepatitis	16 (1.33%)
Rash	15 (1.25%)
Shock	14 (1.16%)
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Stevens-johnson Syndrome	14 (1.16%)
Tachycardia	14 (1.16%)
Drug Exposure During Pregnancy	13 (1.08%)
Angioedema	11 (.92%)
Anuria	11 (.92%)
Oxygen Saturation Decreased	11 (.92%)
Renal Failure Acute	11 (.92%)
Pruritus	10 (.83%)
Toxic Skin Eruption	10 (.83%)
Generalised Erythema	9 (.75%)
Anaesthetic Complication	8 (.67%)
Anaphylactoid Shock	8 (.67%)
Overdose	8 (.67%)
Cauda Equina Syndrome	7 (.58%)
Cyanosis	7 (.58%)
Dyspnoea	7 (.58%)
Oedema	7 (.58%)
Vomiting	7 (.58%)
Blood Pressure Decreased	6 (.5%)
Hyperhidrosis	6 (.5%)
Hypertension	6 (.5%)
Hypothermia	6 (.5%)
Nausea	6 (.5%)
Pulse Absent	6 (.5%)
Pyrexia	6 (.5%)
Respiratory Depression	6 (.5%)
Septic Shock	6 (.5%)
Ventricular Fibrillation	6 (.5%)
Anaphylactic Reaction	5 (.42%)
Asthenia	5 (.42%)
Blood Pressure Systolic Decreased	5 (.42%)
Cholestasis	5 (.42%)
Coma	5 (.42%)
Foetal Arrhythmia	5 (.42%)
Hypocapnia	5 (.42%)
Laryngeal Oedema	5 (.42%)
Lymphopenia	5 (.42%)
Maternal Drugs Affecting Foetus	5 (.42%)
Pancreatitis Acute	5 (.42%)
Peripheral Ischaemia	5 (.42%)
Pityriasis	5 (.42%)
Pleural Effusion	5 (.42%)
Proteinuria	5 (.42%)
Rales	5 (.42%)
Respiratory Arrest	5 (.42%)
Respiratory Distress	5 (.42%)
Anaemia	4 (.33%)
Anaphylactoid Reaction	4 (.33%)
C-reactive Protein Increased	4 (.33%)
Drug Rash With Eosinophilia And Sys...	4 (.33%)
Dysphagia	4 (.33%)
Haematuria	4 (.33%)
Histamine Level Increased	4 (.33%)
Hypercapnia	4 (.33%)
Hyperthermia	4 (.33%)
Hypotonia	4 (.33%)
International Normalised Ratio Incr...	4 (.33%)
Intestinal Ischaemia	4 (.33%)
Lung Disorder	4 (.33%)
Myocardial Infarction	4 (.33%)
Prothrombin Level Abnormal	4 (.33%)
Renal Disorder	4 (.33%)
Sedation	4 (.33%)
Transaminases Increased	4 (.33%)
Tryptase Increased	4 (.33%)
Acute Generalised Exanthematous Pus...	3 (.25%)
Acute Respiratory Distress Syndrome	3 (.25%)
Alanine Aminotransferase Increased	3 (.25%)
Apgar Score Low	3 (.25%)
Aspartate Aminotransferase Increase...	3 (.25%)
Atrioventricular Block	3 (.25%)
Blood Creatinine Increased	3 (.25%)
Blood Pressure Immeasurable	3 (.25%)
Brain Injury	3 (.25%)
Bundle Branch Block Left	3 (.25%)
Cardiovascular Insufficiency	3 (.25%)
Conjunctivitis	3 (.25%)
Dermatomyositis	3 (.25%)
General Physical Health Deteriorati...	3 (.25%)
Haemodynamic Instability	3 (.25%)
Hypersensitivity	3 (.25%)
Hypertonia	3 (.25%)
Ischaemic Hepatitis	3 (.25%)
Leg Amputation	3 (.25%)
Liver Disorder	3 (.25%)
Lymphocele	3 (.25%)
Metabolic Acidosis	3 (.25%)
Muscular Weakness	3 (.25%)
Mydriasis	3 (.25%)
Neoplasm	3 (.25%)

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

What are the most common Sufentanil Citrate adverse events reported to the FDA?

Cardiac Arrhythmias	114 (9.48%)
Epidermal And Dermal Conditions	109 (9.07%)
Allergic Conditions	96 (7.99%)
Decreased And Nonspecific Blood Pre...	89 (7.4%)
Respiratory	54 (4.49%)
Bronchial Disorders	43 (3.58%)
Hepatic And Hepatobiliary	36 (3%)
Cardiac And Vascular Investigations	35 (2.91%)
Neurological	34 (2.83%)
Renal Disorders	31 (2.58%)
Angiedema And Urticaria	28 (2.33%)
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Procedural And Device Related Injur...	22 (1.83%)
Chemical Injury And Poisoning	19 (1.58%)
Gastrointestinal Signs	19 (1.58%)
Body Temperature Conditions	18 (1.5%)
Metabolic, Nutritional And Blood Ga...	17 (1.41%)
Urinary Tract Signs	16 (1.33%)
Hepatobiliary	15 (1.25%)
Infections - Pathogen Unspecified	13 (1.08%)
Medication Errors	12 (1%)
Hematology Investigations	11 (.92%)
Therapeutic And Nontherapeutic Effe...	11 (.92%)
Anemias Nonhemolytic And Marrow Dep...	10 (.83%)
Cardiac Disorder Signs	10 (.83%)
Neuromuscular	10 (.83%)
White Blood Cell	10 (.83%)
Skin Appendage Conditions	9 (.75%)
Electrolyte And Fluid Balance Condi...	8 (.67%)
Immunology And Allergy	8 (.67%)
Ocular Neuromuscular	8 (.67%)
Physical Examination Topics	8 (.67%)
Protein And Chemistry Analyses	8 (.67%)
Spinal Cord And Nerve Root	8 (.67%)
Acid-base	7 (.58%)
Bacterial Infectious	7 (.58%)
Lower Respiratory Tract Disorders	7 (.58%)
Muscle	7 (.58%)
Seizures	6 (.5%)
Upper Respiratory Tract Disorders	6 (.5%)
Vascular Hypertensive	6 (.5%)
Arteriosclerosis, Stenosis, Vascula...	5 (.42%)
Exocrine Pancreas Conditions	5 (.42%)
Gastrointestinal Vascular Condition...	5 (.42%)
Injuries	5 (.42%)
Musculoskeletal And Connective Tiss...	5 (.42%)
Pleural	5 (.42%)
Spleen, Lymphatic And Reticulendoth...	5 (.42%)
Vascular	5 (.42%)
Bone And Joint Therapeutic Procedur...	4 (.33%)
Coronary Artery	4 (.33%)
Gastrointestinal Hemorrhages	4 (.33%)
Mental Impairment	4 (.33%)
Movement Disorders	4 (.33%)
Myocardial	4 (.33%)
Obstetric And Gynecological Therape...	4 (.33%)
Renal And Urinary Tract Investigati...	4 (.33%)
Tissue	4 (.33%)
Deliria	3 (.25%)
Embolism And Thrombosis	3 (.25%)
Gastrointestinal Inflammatory Condi...	3 (.25%)
Gastrointestinal Motility And Defec...	3 (.25%)
Hematological	3 (.25%)
Joint	3 (.25%)
Lymphatic Vessel	3 (.25%)
Microbiology And Serology	3 (.25%)
Miscellaneous And Site Unspecified ...	3 (.25%)
Ocular Infections, Irritations And ...	3 (.25%)
Oral Soft Tissue Conditions	3 (.25%)
Pulmonary Vascular	3 (.25%)
Structural Brain	3 (.25%)
Vision	3 (.25%)
Anxiety Disorders	2 (.17%)
Bone And Joint Injuries	2 (.17%)
Cardiac Therapeutic Procedures	2 (.17%)
Central Nervous System Infections A...	2 (.17%)
Central Nervous System Vascular	2 (.17%)
Cranial Nerve Disorders	2 (.17%)
Encephalopathies	2 (.17%)
Enzyme	2 (.17%)
Fatal Outcomes	2 (.17%)
Fetal Complications	2 (.17%)
Gastrointestinal Ulceration And Per...	2 (.17%)
Glucose Metabolism Disorders	2 (.17%)
Headaches	2 (.17%)
Hearing	2 (.17%)
Heart Failures	2 (.17%)
Nephropathies	2 (.17%)
Platelet	2 (.17%)
Psychiatric	2 (.17%)
Administration Site Reactions	1 (.08%)
Appetite And General Nutritional	1 (.08%)
Bone, Calcium, Magnesium And Phosph...	1 (.08%)
Disturbances In Thinking	1 (.08%)
Fetal And Neonatal	1 (.08%)
Fungal Infectious	1 (.08%)
Hematological And Lymphoid Tissue T...	1 (.08%)
Hematopoietic Neoplasms	1 (.08%)
Investigations, Imaging And Histopa...	1 (.08%)
Maternal Complications Of Labour An...	1 (.08%)
Maternal Complications Of Pregnancy	1 (.08%)
Neonatal And Perinatal Conditions	1 (.08%)

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