NORGESTREL AND ETHINYL ESTRADIOL

Norgestrel And Ethinyl Estradiol Adverse Events Reported to the FDA Over Time

How are Norgestrel And Ethinyl Estradiol adverse event reports trending over time?

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

Most Common Norgestrel And Ethinyl Estradiol Adverse Events Reported to the FDA

What are the most common Norgestrel And Ethinyl Estradiol adverse events reported to the FDA?

Product Quality Issue	162 (16.14%)
Drug Ineffective	133 (13.25%)
Unintended Pregnancy	128 (12.75%)
Metrorrhagia	62 (6.18%)
Menorrhagia	38 (3.78%)
Vaginal Haemorrhage	19 (1.89%)
Abortion Spontaneous	16 (1.59%)
Vomiting	14 (1.39%)
Abdominal Pain Upper	12 (1.2%)
Abnormal Withdrawal Bleeding	12 (1.2%)
Insomnia	10 (1%)
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Menstruation Irregular	10 (1%)
Muscle Spasms	10 (1%)
Dysmenorrhoea	9 (.9%)
Inappropriate Schedule Of Drug Admi...	9 (.9%)
Fatigue	8 (.8%)
Mood Swings	8 (.8%)
Pregnancy On Oral Contraceptive	8 (.8%)
Amenorrhoea	7 (.7%)
Arterial Thrombosis Limb	7 (.7%)
Hypoaesthesia	7 (.7%)
Menstrual Disorder	7 (.7%)
Migraine	7 (.7%)
Nausea	7 (.7%)
Circumstance Or Information Capable...	6 (.6%)
Drug Ineffective For Unapproved Ind...	6 (.6%)
Ectopic Pregnancy	6 (.6%)
Headache	6 (.6%)
Malaise	6 (.6%)
Pain In Extremity	6 (.6%)
Acne	5 (.5%)
Alanine Aminotransferase Increased	5 (.5%)
Aspartate Aminotransferase Increase...	5 (.5%)
Asthenia	5 (.5%)
Genital Haemorrhage	5 (.5%)
Abdominal Pain	4 (.4%)
Fall	4 (.4%)
Feeling Abnormal	4 (.4%)
Joint Injury	4 (.4%)
Menstruation Delayed	4 (.4%)
Mood Altered	4 (.4%)
Myalgia	4 (.4%)
Peripheral Coldness	4 (.4%)
Personality Change	4 (.4%)
Thrombosis	4 (.4%)
Abdominal Distension	3 (.3%)
Anxiety	3 (.3%)
Back Pain	3 (.3%)
Deep Vein Thrombosis	3 (.3%)
Gamma-glutamyltransferase Increased	3 (.3%)
General Physical Health Deteriorati...	3 (.3%)
Hormone Level Abnormal	3 (.3%)
Hot Flush	3 (.3%)
Oedema Peripheral	3 (.3%)
Ovarian Cyst	3 (.3%)
Pain	3 (.3%)
Premenstrual Syndrome	3 (.3%)
Pulmonary Embolism	3 (.3%)
Pulmonary Infarction	3 (.3%)
Rash	3 (.3%)
Abdominal Discomfort	2 (.2%)
Abortion Threatened	2 (.2%)
Acne Cystic	2 (.2%)
Anaemia	2 (.2%)
Anovulatory Cycle	2 (.2%)
Blindness	2 (.2%)
Blood Alkaline Phosphatase Increase...	2 (.2%)
Blood Bilirubin Increased	2 (.2%)
Blood Immunoglobulin E Increased	2 (.2%)
Blood Lactate Dehydrogenase Increas...	2 (.2%)
Blood Ph Increased	2 (.2%)
Breast Pain	2 (.2%)
Cardiomegaly	2 (.2%)
Chromaturia	2 (.2%)
Condition Aggravated	2 (.2%)
Cyst	2 (.2%)
Cytolytic Hepatitis	2 (.2%)
Decreased Appetite	2 (.2%)
Diabetic Ketoacidosis	2 (.2%)
Diarrhoea	2 (.2%)
Disseminated Intravascular Coagulat...	2 (.2%)
Drug Effect Decreased	2 (.2%)
Dysfunctional Uterine Bleeding	2 (.2%)
Fibrin D Dimer Increased	2 (.2%)
Hepatic Function Abnormal	2 (.2%)
Hypoxia	2 (.2%)
Inadequate Analgesia	2 (.2%)
Inflammation	2 (.2%)
Influenza Like Illness	2 (.2%)
Irritability	2 (.2%)
Liver Disorder	2 (.2%)
Nasopharyngitis	2 (.2%)
Ovarian Cyst Ruptured	2 (.2%)
Platelet Count Increased	2 (.2%)
Protein C Decreased	2 (.2%)
Protein S Decreased	2 (.2%)
Pulse Pressure Decreased	2 (.2%)
Respiratory Alkalosis	2 (.2%)
Systemic Inflammatory Response Synd...	2 (.2%)
Tachycardia	2 (.2%)
Vaginitis Bacterial	2 (.2%)

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This graph shows the top adverse events submitted to the FDA for Norgestrel And Ethinyl Estradiol, 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 Norgestrel And Ethinyl Estradiol 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 Norgestrel And Ethinyl Estradiol

What are the most common Norgestrel And Ethinyl Estradiol adverse events reported to the FDA?

Product Quality Issues	163 (16.24%)
Menstrual Cycle And Uterine Bleedin...	156 (15.54%)
Therapeutic And Nontherapeutic Effe...	144 (14.34%)
Pregnancy, Labour, Delivery And Pos...	137 (13.65%)
Gastrointestinal Signs	42 (4.18%)
Vulvovaginal Disorders	20 (1.99%)
Abortions And Stillbirth	19 (1.89%)
Embolism And Thrombosis	16 (1.59%)
Hepatobiliary	15 (1.49%)
Medication Errors	15 (1.49%)
Muscle	14 (1.39%)
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Headaches	13 (1.29%)
Mood Disorders	13 (1.29%)
Hematology Investigations	11 (1.1%)
Sleep Disorders	11 (1.1%)
Neurological	10 (1%)
Musculoskeletal And Connective Tiss...	9 (.9%)
Hepatic And Hepatobiliary	8 (.8%)
Maternal Complications Of Pregnancy	7 (.7%)
Respiratory	7 (.7%)
Skin Appendage Conditions	7 (.7%)
Injuries	6 (.6%)
Pulmonary Vascular	6 (.6%)
Arteriosclerosis, Stenosis, Vascula...	5 (.5%)
Endocrine Investigations	5 (.5%)
Ovarian And Fallopian Tube	5 (.5%)
Reproductive Tract	5 (.5%)
Bacterial Infectious	4 (.4%)
Bone And Joint Injuries	4 (.4%)
Enzyme	4 (.4%)
Personality Disorders	4 (.4%)
Anxiety Disorders	3 (.3%)
Breast	3 (.3%)
Cardiac And Vascular Investigations	3 (.3%)
Epidermal And Dermal Conditions	3 (.3%)
Gastrointestinal Motility And Defec...	3 (.3%)
Infections - Pathogen Unspecified	3 (.3%)
Metabolic, Nutritional And Blood Ga...	3 (.3%)
Vascular	3 (.3%)
Vision	3 (.3%)
Anemias Nonhemolytic And Marrow Dep...	2 (.2%)
Appetite And General Nutritional	2 (.2%)
Bone Disorders	2 (.2%)
Cardiac Arrhythmias	2 (.2%)
Central Nervous System Vascular	2 (.2%)
Coagulopathies And Bleeding Diathes...	2 (.2%)
Diabetic Complications	2 (.2%)
Endocrine Disorders Of Gonadal Func...	2 (.2%)
Gastrointestinal Vascular Condition...	2 (.2%)
Immunology And Allergy	2 (.2%)
Joint	2 (.2%)
Myocardial	2 (.2%)
Physical Examination Topics	2 (.2%)
Procedural And Device Related Injur...	2 (.2%)
Tissue	2 (.2%)
Urinary Tract Signs	2 (.2%)
Uterine, Pelvic And Broad Ligament	2 (.2%)
Blood And Lymphatic System Disorder...	1 (.1%)
Communication Disorders	1 (.1%)
Increased Intracranial Pressure And...	1 (.1%)
Mental Impairment	1 (.1%)
Microbiology And Serology	1 (.1%)
Ocular Infections, Irritations And ...	1 (.1%)
Seizures	1 (.1%)
Skin And Subcutaneous Tissue	1 (.1%)
Sleep Disturbances	1 (.1%)
Spleen, Lymphatic And Reticulendoth...	1 (.1%)
Thyroid Gland	1 (.1%)
Toxicology And Therapeutic Drug Mon...	1 (.1%)
Upper Respiratory Tract Disorders	1 (.1%)

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This graph shows the top categories of adverse events submitted to the FDA for Norgestrel And Ethinyl Estradiol, 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 Norgestrel And Ethinyl Estradiol 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.