ETONOGESTREL

Etonogestrel Adverse Events Reported to the FDA Over Time

How are Etonogestrel adverse event reports trending over time?

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

Most Common Etonogestrel Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	48 (3.22%)
Pregnancy With Implant Contraceptiv...	48 (3.22%)
Breast Cancer Female	28 (1.88%)
Headache	24 (1.61%)
Metrorrhagia	24 (1.61%)
Drug Interaction	21 (1.41%)
Vaginal Haemorrhage	21 (1.41%)
Epilepsy	20 (1.34%)
Paraesthesia	19 (1.28%)
Abortion Spontaneous	17 (1.14%)
Device Migration	15 (1.01%)
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Dizziness	14 (.94%)
Weight Increased	14 (.94%)
Nausea	13 (.87%)
Menorrhagia	12 (.81%)
Complication Of Device Removal	11 (.74%)
Amenorrhoea	10 (.67%)
Ectopic Pregnancy	10 (.67%)
Ovarian Cyst	10 (.67%)
Anxiety	9 (.6%)
Depression	9 (.6%)
Menstruation Irregular	9 (.6%)
Mood Swings	9 (.6%)
Pulmonary Embolism	9 (.6%)
Urticaria	9 (.6%)
Convulsion	8 (.54%)
Device Breakage	8 (.54%)
Implant Site Reaction	8 (.54%)
Maternal Drugs Affecting Foetus	8 (.54%)
Pain	8 (.54%)
Premature Baby	8 (.54%)
Procedural Complication	8 (.54%)
Scar	8 (.54%)
Uterine Leiomyoma	8 (.54%)
Abdominal Pain	7 (.47%)
Back Pain	7 (.47%)
Chest Pain	7 (.47%)
Hypersensitivity	7 (.47%)
Hypoaesthesia	7 (.47%)
Pain In Extremity	7 (.47%)
Palpitations	7 (.47%)
Anaemia	6 (.4%)
Benign Intracranial Hypertension	6 (.4%)
Complication Of Device Insertion	6 (.4%)
Grand Mal Convulsion	6 (.4%)
Implant Site Pain	6 (.4%)
Intracranial Pressure Increased	6 (.4%)
Medical Device Complication	6 (.4%)
Migraine	6 (.4%)
Myocardial Infarction	6 (.4%)
Oedema Peripheral	6 (.4%)
Oestrogen Receptor Assay Positive	6 (.4%)
Renal Impairment	6 (.4%)
Weight Decreased	6 (.4%)
Alopecia	5 (.34%)
Anaphylactic Reaction	5 (.34%)
Blood Creatinine Increased	5 (.34%)
Caesarean Section	5 (.34%)
Death Neonatal	5 (.34%)
Deep Vein Thrombosis	5 (.34%)
Eczema	5 (.34%)
Implant Site Infection	5 (.34%)
Jaundice	5 (.34%)
Malaise	5 (.34%)
Metastases To Lymph Nodes	5 (.34%)
Pelvic Inflammatory Disease	5 (.34%)
Progesterone Receptor Assay Positiv...	5 (.34%)
Retinal Vein Occlusion	5 (.34%)
Syncope	5 (.34%)
Twin Pregnancy	5 (.34%)
Abdominal Pain Upper	4 (.27%)
Abortion Induced	4 (.27%)
Blindness Unilateral	4 (.27%)
Condition Aggravated	4 (.27%)
Contraceptive Device Complication	4 (.27%)
Death	4 (.27%)
Discomfort	4 (.27%)
Dysaesthesia	4 (.27%)
Facial Palsy	4 (.27%)
Fatigue	4 (.27%)
Hypertension	4 (.27%)
Implant Site Erythema	4 (.27%)
Implant Site Necrosis	4 (.27%)
Implant Site Nerve Injury	4 (.27%)
Injected Limb Mobility Decreased	4 (.27%)
Intra-uterine Death	4 (.27%)
Laceration	4 (.27%)
Loss Of Consciousness	4 (.27%)
Muscular Weakness	4 (.27%)
Myalgia	4 (.27%)
Neoplasm Malignant	4 (.27%)
Nervousness	4 (.27%)
Post Procedural Complication	4 (.27%)
Pregnancy	4 (.27%)
Premature Labour	4 (.27%)
Pruritus	4 (.27%)
Ruptured Ectopic Pregnancy	4 (.27%)
Sleep Disorder	4 (.27%)
Tachycardia	4 (.27%)
Thrombophlebitis	4 (.27%)
Vision Blurred	4 (.27%)

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

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

Procedural And Device Related Injur...	82 (5.5%)
Menstrual Cycle And Uterine Bleedin...	70 (4.7%)
Neurological	68 (4.56%)
Pregnancy, Labour, Delivery And Pos...	63 (4.23%)
Chemical Injury And Poisoning	58 (3.89%)
Administration Site Reactions	56 (3.76%)
Seizures	39 (2.62%)
Breast Neoplasms Malignant And Unsp...	38 (2.55%)
Infections - Pathogen Unspecified	34 (2.28%)
Epidermal And Dermal Conditions	31 (2.08%)
Gastrointestinal Signs	30 (2.01%)
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Headaches	30 (2.01%)
Therapeutic And Nontherapeutic Effe...	29 (1.95%)
Vulvovaginal Disorders	27 (1.81%)
Abortions And Stillbirth	26 (1.74%)
Coronary Artery	22 (1.48%)
Injuries	21 (1.41%)
Physical Examination Topics	21 (1.41%)
Maternal Complications Of Pregnancy	20 (1.34%)
Ovarian And Fallopian Tube	20 (1.34%)
Anxiety Disorders	19 (1.28%)
Musculoskeletal And Connective Tiss...	19 (1.28%)
Allergic Conditions	18 (1.21%)
Hepatic And Hepatobiliary	18 (1.21%)
Embolism And Thrombosis	16 (1.07%)
Endocrine Investigations	14 (.94%)
Reproductive Neoplasms Female Benig...	14 (.94%)
Vision	14 (.94%)
Mood Disorders	13 (.87%)
Muscle	13 (.87%)
Cardiac Arrhythmias	12 (.81%)
Depressed Mood Disorders	12 (.81%)
Increased Intracranial Pressure And...	12 (.81%)
Skin Appendage Conditions	12 (.81%)
Angiedema And Urticaria	11 (.74%)
Bacterial Infectious	11 (.74%)
Fatal Outcomes	10 (.67%)
Obstetric And Gynecological Therape...	10 (.67%)
Pulmonary Vascular	10 (.67%)
Renal And Urinary Tract Investigati...	10 (.67%)
Reproductive Neoplasms Female Malig...	10 (.67%)
Suicidal And Self-injurious Behavio...	9 (.6%)
Cardiac Disorder Signs	8 (.54%)
Central Nervous System Vascular	8 (.54%)
Hematology Investigations	8 (.54%)
Neonatal And Perinatal Conditions	8 (.54%)
Renal Disorders	8 (.54%)
Anemias Nonhemolytic And Marrow Dep...	7 (.47%)
Bone And Joint Injuries	7 (.47%)
Cornification And Dystrophic Skin	6 (.4%)
Decreased And Nonspecific Blood Pre...	6 (.4%)
Miscellaneous And Site Unspecified ...	6 (.4%)
Movement Disorders	6 (.4%)
Myocardial	6 (.4%)
Peripheral Neuropathies	6 (.4%)
Respiratory	6 (.4%)
Uterine, Pelvic And Broad Ligament	6 (.4%)
Cervix Disorders	5 (.34%)
Enzyme	5 (.34%)
Metastases	5 (.34%)
Oral Soft Tissue Conditions	5 (.34%)
Pleural	5 (.34%)
Reproductive Tract And Breast Disor...	5 (.34%)
Retina, Choroid And Vitreous Hemorr...	5 (.34%)
Sleep Disorders	5 (.34%)
Arteriosclerosis, Stenosis, Vascula...	4 (.27%)
Bone Disorders	4 (.27%)
Breast	4 (.27%)
Cardiac And Vascular Investigations	4 (.27%)
Cranial Nerve Disorders	4 (.27%)
Gastrointestinal Motility And Defec...	4 (.27%)
Glucose Metabolism Disorders	4 (.27%)
Immunology And Allergy	4 (.27%)
Lifestyle Issues	4 (.27%)
Maternal Complications Of Labour An...	4 (.27%)
Metabolic, Nutritional And Blood Ga...	4 (.27%)
Personality Disorders	4 (.27%)
Reproductive Tract	4 (.27%)
Skin And Subcutaneous Tissue	4 (.27%)
Vascular	4 (.27%)
Vascular Hemorrhagic	4 (.27%)
Vascular Hypertensive	4 (.27%)
Appetite And General Nutritional	3 (.2%)
Autoimmune	3 (.2%)
Body Temperature Conditions	3 (.2%)
Bronchial Disorders	3 (.2%)
Chromosomal Abnormalities And Abnor...	3 (.2%)
Dental And Gingival Conditions	3 (.2%)
Endocrine Neoplasms Benign	3 (.2%)
Eye	3 (.2%)
Family Issues	3 (.2%)
Fetal Complications	3 (.2%)
Fungal Infectious	3 (.2%)
Hepatobiliary	3 (.2%)
Hypothalamus And Pituitary Gland	3 (.2%)
Leukemias	3 (.2%)
Mycobacterial Infectious	3 (.2%)
Neonatal Respiratory	3 (.2%)
Ocular Infections, Irritations And ...	3 (.2%)
Ocular Structural Change, Deposit A...	3 (.2%)
Platelet	3 (.2%)

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