OXYTOCIN

Oxytocin Adverse Events Reported to the FDA Over Time

How are Oxytocin adverse event reports trending over time?

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

Most Common Oxytocin Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	61 (4.94%)
Postpartum Haemorrhage	35 (2.84%)
Caesarean Section	28 (2.27%)
Uterine Atony	28 (2.27%)
Drug Ineffective	27 (2.19%)
Hypotension	26 (2.11%)
Haemorrhage	17 (1.38%)
Cardiac Arrest	16 (1.3%)
Medication Error	16 (1.3%)
Pulmonary Oedema	16 (1.3%)
Tachycardia	16 (1.3%)
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Disseminated Intravascular Coagulat...	14 (1.13%)
Oxygen Saturation Decreased	14 (1.13%)
Haemoglobin Decreased	13 (1.05%)
Heart Rate Increased	13 (1.05%)
Normal Newborn	12 (.97%)
Dyspnoea	11 (.89%)
Hysterectomy	11 (.89%)
Uterine Rupture	11 (.89%)
Bradycardia Foetal	9 (.73%)
Uterine Haemorrhage	9 (.73%)
Haematocrit Decreased	8 (.65%)
Headache	8 (.65%)
Loss Of Consciousness	8 (.65%)
Nausea	8 (.65%)
No Therapeutic Response	8 (.65%)
Retained Placenta Or Membranes	8 (.65%)
Thrombosis	8 (.65%)
Convulsion	7 (.57%)
Endotracheal Intubation	7 (.57%)
Hyperhidrosis	7 (.57%)
Incorrect Route Of Drug Administrat...	7 (.57%)
Laparotomy	7 (.57%)
Bradycardia	6 (.49%)
Cardiac Output Increased	6 (.49%)
Cerebrovascular Spasm	6 (.49%)
Chest Pain	6 (.49%)
Circulatory Collapse	6 (.49%)
Ejection Fraction Decreased	6 (.49%)
Foetal Distress Syndrome	6 (.49%)
Mean Arterial Pressure Decreased	6 (.49%)
Uterine Disorder	6 (.49%)
Vomiting	6 (.49%)
Activated Partial Thromboplastin Ti...	5 (.41%)
Apgar Score Low	5 (.41%)
Blood Pressure Decreased	5 (.41%)
Hyponatraemia	5 (.41%)
Metabolic Acidosis	5 (.41%)
Muscle Rigidity	5 (.41%)
Overdose	5 (.41%)
Pyrexia	5 (.41%)
Vascular Resistance Systemic Decrea...	5 (.41%)
Ventricular Hypokinesia	5 (.41%)
Acute Pulmonary Oedema	4 (.32%)
Anaphylactic Shock	4 (.32%)
Arrested Labour	4 (.32%)
Artificial Rupture Of Membranes	4 (.32%)
Blood Creatine Phosphokinase Increa...	4 (.32%)
Cerebral Palsy	4 (.32%)
Chest Discomfort	4 (.32%)
Death	4 (.32%)
Epidural Anaesthesia	4 (.32%)
Hypertension	4 (.32%)
Hypovolaemic Shock	4 (.32%)
Hypoxia	4 (.32%)
Left Ventricular Hypertrophy	4 (.32%)
Mechanical Ventilation	4 (.32%)
Myocardial Infarction	4 (.32%)
Pallor	4 (.32%)
Prothrombin Time Prolonged	4 (.32%)
Pulse Absent	4 (.32%)
Rales	4 (.32%)
Respiratory Rate Decreased	4 (.32%)
Resuscitation	4 (.32%)
Urine Output Decreased	4 (.32%)
Uterine Haematoma	4 (.32%)
Uterine Inversion	4 (.32%)
Vaginal Haemorrhage	4 (.32%)
Abdominal Pain	3 (.24%)
Agitation	3 (.24%)
Anaphylactic Reaction	3 (.24%)
Apnoea	3 (.24%)
Blood Pressure Immeasurable	3 (.24%)
Blood Pressure Systolic Decreased	3 (.24%)
Cerebral Artery Stenosis	3 (.24%)
Cerebral Vasoconstriction	3 (.24%)
Circumstance Or Information Capable...	3 (.24%)
Coagulopathy	3 (.24%)
Computerised Tomogram Abnormal	3 (.24%)
Death Neonatal	3 (.24%)
Dizziness	3 (.24%)
Drug Administration Error	3 (.24%)
Dystonia	3 (.24%)
Electrocardiogram St Segment Depres...	3 (.24%)
Electromechanical Dissociation	3 (.24%)
Epigastric Discomfort	3 (.24%)
Ergot Poisoning	3 (.24%)
Face Oedema	3 (.24%)
Female Sterilisation	3 (.24%)
Foetal Heart Rate Deceleration	3 (.24%)
Hemiparesis	3 (.24%)

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

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

Cardiac And Vascular Investigations	73 (5.92%)
Cardiac Arrhythmias	70 (5.67%)
Chemical Injury And Poisoning	69 (5.59%)
Obstetric And Gynecological Therape...	60 (4.86%)
Uterine, Pelvic And Broad Ligament	53 (4.29%)
Medication Errors	45 (3.65%)
Hematology Investigations	40 (3.24%)
Respiratory	40 (3.24%)
Therapeutic And Nontherapeutic Effe...	38 (3.08%)
Decreased And Nonspecific Blood Pre...	36 (2.92%)
Postpartum And Puerperal	36 (2.92%)
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Maternal Complications Of Labour An...	33 (2.67%)
Metabolic, Nutritional And Blood Ga...	27 (2.19%)
Gastrointestinal Signs	25 (2.03%)
Lower Respiratory Tract Disorders	25 (2.03%)
Neurological	25 (2.03%)
Injuries	19 (1.54%)
Pregnancy, Labour, Delivery And Pos...	19 (1.54%)
Central Nervous System Vascular	18 (1.46%)
Coagulopathies And Bleeding Diathes...	18 (1.46%)
Vascular Hemorrhagic	17 (1.38%)
Movement Disorders	16 (1.3%)
Myocardial	16 (1.3%)
Coronary Artery	15 (1.22%)
Enzyme	13 (1.05%)
Physical Examination Topics	12 (.97%)
Respiratory Tract Therapeutic Proce...	12 (.97%)
Therapeutic Procedures And Supporti...	12 (.97%)
Allergic Conditions	10 (.81%)
Embolism And Thrombosis	10 (.81%)
Fetal Complications	10 (.81%)
Infections - Pathogen Unspecified	10 (.81%)
Vulvovaginal Disorders	10 (.81%)
Procedural And Device Related Injur...	9 (.73%)
Seizures	9 (.73%)
Skin Appendage Conditions	9 (.73%)
Acid-base	8 (.65%)
Headaches	8 (.65%)
Muscle	8 (.65%)
Vascular	8 (.65%)
Cardiac Therapeutic Procedures	7 (.57%)
Fatal Outcomes	7 (.57%)
Gastrointestinal Therapeutic Proced...	7 (.57%)
Heart Failures	7 (.57%)
Maternal Complications Of Pregnancy	7 (.57%)
Neonatal And Perinatal Conditions	7 (.57%)
Placental, Amniotic And Cavity Diso...	7 (.57%)
Electrolyte And Fluid Balance Condi...	6 (.49%)
Neonatal Respiratory	6 (.49%)
Anxiety Disorders	5 (.41%)
Body Temperature Conditions	5 (.41%)
Cardiac Disorder Signs	5 (.41%)
Epidermal And Dermal Conditions	5 (.41%)
Gastrointestinal Motility And Defec...	5 (.41%)
Abortions And Stillbirth	4 (.32%)
Cardiac Valve	4 (.32%)
Gastrointestinal Hemorrhages	4 (.32%)
Investigations, Imaging And Histopa...	4 (.32%)
Musculoskeletal And Connective Tiss...	4 (.32%)
Neurological Disorders Congenital	4 (.32%)
Renal And Urinary Tract Investigati...	4 (.32%)
Renal Disorders	4 (.32%)
Vascular Hypertensive	4 (.32%)
Vascular Therapeutic Procedures	4 (.32%)
Vision	4 (.32%)
Anemias Nonhemolytic And Marrow Dep...	3 (.24%)
Fetal And Neonatal	3 (.24%)
Neuromuscular	3 (.24%)
White Blood Cell	3 (.24%)
Administration Site Reactions	2 (.16%)
Arteriosclerosis, Stenosis, Vascula...	2 (.16%)
Bronchial Disorders	2 (.16%)
Changes In Physical Activity	2 (.16%)
Endocrine Investigations	2 (.16%)
Gastrointestinal Conditions	2 (.16%)
Hematological And Lymphoid Tissue T...	2 (.16%)
Hepatic And Hepatobiliary	2 (.16%)
Immunology And Allergy	2 (.16%)
Increased Intracranial Pressure And...	2 (.16%)
Menstrual Cycle And Uterine Bleedin...	2 (.16%)
Ocular Infections, Irritations And ...	2 (.16%)
Peritoneal And Retroperitoneal Cond...	2 (.16%)
Pleural	2 (.16%)
Product Quality Issues	2 (.16%)
Tissue	2 (.16%)
Urinary Tract Signs	2 (.16%)
Water, Electrolyte And Mineral	2 (.16%)
Age Related Factors	1 (.08%)
Appetite And General Nutritional	1 (.08%)
Cervix Disorders	1 (.08%)
Deliria	1 (.08%)
Depressed Mood Disorders	1 (.08%)
Encephalopathies	1 (.08%)
Eye	1 (.08%)
Gastrointestinal Neoplasms Malignan...	1 (.08%)
Gastrointestinal Tract Disorders Co...	1 (.08%)
Gastrointestinal Ulceration And Per...	1 (.08%)
Gastrointestinal Vascular Condition...	1 (.08%)
Hepatobiliary	1 (.08%)
Hypothalamus And Pituitary Gland	1 (.08%)
Joint	1 (.08%)

Share/Embed Graph Export Data

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