ORTHO NOVUM

Ortho Novum Adverse Events Reported to the FDA Over Time

How are Ortho Novum adverse event reports trending over time?

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

Most Common Ortho Novum Adverse Events Reported to the FDA

What are the most common Ortho Novum adverse events reported to the FDA?

Off Label Use	33 (6.78%)
Drug Exposure During Pregnancy	18 (3.7%)
Pregnancy On Oral Contraceptive	15 (3.08%)
Metrorrhagia	12 (2.46%)
Drug Interaction	10 (2.05%)
Electrocardiogram Qt Prolonged	8 (1.64%)
Headache	8 (1.64%)
Breast Cancer	7 (1.44%)
Nausea	7 (1.44%)
Uterine Leiomyoma	7 (1.44%)
Anaemia	6 (1.23%)
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Chest Pain	6 (1.23%)
Intracranial Venous Sinus Thrombosi...	6 (1.23%)
Menometrorrhagia	6 (1.23%)
Menorrhagia	6 (1.23%)
Thrombosis	6 (1.23%)
Cerebral Venous Thrombosis	5 (1.03%)
Paraesthesia	5 (1.03%)
Surgery	5 (1.03%)
Abdominal Pain Lower	4 (.82%)
Blood Pressure Increased	4 (.82%)
Breast Cancer In Situ	4 (.82%)
Focal Nodular Hyperplasia	4 (.82%)
Hypertension	4 (.82%)
Hypoaesthesia	4 (.82%)
Medication Error	4 (.82%)
Mental Disorder	4 (.82%)
Oedema Peripheral	4 (.82%)
Pain In Extremity	4 (.82%)
Pulmonary Embolism	4 (.82%)
Suicide Attempt	4 (.82%)
Weight Decreased	4 (.82%)
Abdominal Discomfort	3 (.62%)
Abdominal Distension	3 (.62%)
Abortion Spontaneous	3 (.62%)
Computerised Tomogram Abnormal	3 (.62%)
Drug Prescribing Error	3 (.62%)
Dyspnoea	3 (.62%)
Feeling Abnormal	3 (.62%)
Hemiparesis	3 (.62%)
Inappropriate Schedule Of Drug Admi...	3 (.62%)
Intra-uterine Death	3 (.62%)
Irritability	3 (.62%)
Menstruation Irregular	3 (.62%)
Mood Swings	3 (.62%)
Ovarian Cyst	3 (.62%)
Palpitations	3 (.62%)
Premenstrual Syndrome	3 (.62%)
Product Quality Issue	3 (.62%)
Sensation Of Heaviness	3 (.62%)
Superior Sagittal Sinus Thrombosis	3 (.62%)
Thrombophlebitis Superficial	3 (.62%)
Ultrasound Scan Abnormal	3 (.62%)
Varicose Vein	3 (.62%)
Vomiting	3 (.62%)
Abdominal Pain Upper	2 (.41%)
Abnormal Withdrawal Bleeding	2 (.41%)
Anaphylactic Reaction	2 (.41%)
Angiopathy	2 (.41%)
Ankyloglossia Congenital	2 (.41%)
Appendix Disorder	2 (.41%)
Arrhythmia	2 (.41%)
Autoimmune Hepatitis	2 (.41%)
Blood Cholesterol Increased	2 (.41%)
Cardio-respiratory Arrest	2 (.41%)
Cerebral Infarction	2 (.41%)
Contact Lens Intolerance	2 (.41%)
Deafness Neurosensory	2 (.41%)
Death	2 (.41%)
Deep Vein Thrombosis	2 (.41%)
Demyelination	2 (.41%)
Dermatitis	2 (.41%)
Diplopia	2 (.41%)
Extrasystoles	2 (.41%)
Eye Swelling	2 (.41%)
Feeding Disorder Neonatal	2 (.41%)
Gastritis	2 (.41%)
Gastrooesophageal Reflux Disease	2 (.41%)
Haemorrhagic Tumour Necrosis	2 (.41%)
Hepatic Adenoma	2 (.41%)
Hepatic Function Abnormal	2 (.41%)
Hyperreflexia	2 (.41%)
Hypersexuality	2 (.41%)
Idiopathic Thrombocytopenic Purpura	2 (.41%)
Incorrect Dose Administered	2 (.41%)
Insomnia	2 (.41%)
Jaw Disorder	2 (.41%)
Lip Disorder	2 (.41%)
Mammogram Abnormal	2 (.41%)
Mass	2 (.41%)
Migraine	2 (.41%)
Mood Altered	2 (.41%)
Muscular Weakness	2 (.41%)
Myocardial Infarction	2 (.41%)
Nervousness	2 (.41%)
Oligomenorrhoea	2 (.41%)
Pituitary Tumour	2 (.41%)
Product Blister Packaging Issue	2 (.41%)
Smear Cervix Abnormal	2 (.41%)
Stress	2 (.41%)
Systemic Lupus Erythematosus	2 (.41%)

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

What are the most common Ortho Novum adverse events reported to the FDA?

Therapeutic Procedures And Supporti...	38 (7.8%)
Menstrual Cycle And Uterine Bleedin...	36 (7.39%)
Gastrointestinal Signs	26 (5.34%)
Chemical Injury And Poisoning	19 (3.9%)
Central Nervous System Vascular	18 (3.7%)
Neurological	18 (3.7%)
Pregnancy, Labour, Delivery And Pos...	18 (3.7%)
Cardiac And Vascular Investigations	13 (2.67%)
Therapeutic And Nontherapeutic Effe...	13 (2.67%)
Embolism And Thrombosis	12 (2.46%)
Medication Errors	12 (2.46%)
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Breast Neoplasms Malignant And Unsp...	11 (2.26%)
Headaches	11 (2.26%)
Musculoskeletal And Connective Tiss...	8 (1.64%)
Abortions And Stillbirth	7 (1.44%)
Cardiac Arrhythmias	7 (1.44%)
Reproductive Neoplasms Female Benig...	7 (1.44%)
Anemias Nonhemolytic And Marrow Dep...	6 (1.23%)
Hepatic And Biliary Neoplasms Benig...	6 (1.23%)
Investigations, Imaging And Histopa...	6 (1.23%)
Physical Examination Topics	6 (1.23%)
Vision	6 (1.23%)
Epidermal And Dermal Conditions	5 (1.03%)
Hepatic And Hepatobiliary	5 (1.03%)
Mood Disorders	5 (1.03%)
Product Quality Issues	5 (1.03%)
Respiratory	5 (1.03%)
Anxiety Disorders	4 (.82%)
Movement Disorders	4 (.82%)
Muscle	4 (.82%)
Ovarian And Fallopian Tube	4 (.82%)
Psychiatric	4 (.82%)
Pulmonary Vascular	4 (.82%)
Reproductive Organ And Breast Inves...	4 (.82%)
Sexual Dysfunctions, Disturbances A...	4 (.82%)
Suicidal And Self-injurious Behavio...	4 (.82%)
Vascular	4 (.82%)
Vascular Hypertensive	4 (.82%)
Allergic Conditions	3 (.62%)
Bone Disorders	3 (.62%)
Cardiac Disorder Signs	3 (.62%)
Dental And Gingival Conditions	3 (.62%)
Gastrointestinal Tract Disorders Co...	3 (.62%)
Oral Soft Tissue Conditions	3 (.62%)
Venous Varices	3 (.62%)
Appetite And General Nutritional	2 (.41%)
Breast	2 (.41%)
Connective Tissue Disorders	2 (.41%)
Coronary Artery	2 (.41%)
Demyelinating	2 (.41%)
Endocrine Neoplasms Malignant And U...	2 (.41%)
Eye	2 (.41%)
Fatal Outcomes	2 (.41%)
Gastrointestinal Conditions	2 (.41%)
Gastrointestinal Inflammatory Condi...	2 (.41%)
Gastrointestinal Motility And Defec...	2 (.41%)
Hearing	2 (.41%)
Infections - Pathogen Unspecified	2 (.41%)
Joint	2 (.41%)
Lipid Analyses	2 (.41%)
Mental Impairment	2 (.41%)
Neoplasm Related Morbidities	2 (.41%)
Obstetric And Gynecological Therape...	2 (.41%)
Ocular Sensory Symptoms	2 (.41%)
Platelet	2 (.41%)
Reproductive Tract	2 (.41%)
Skin Appendage Conditions	2 (.41%)
Sleep Disorders	2 (.41%)
Thyroid Gland	2 (.41%)
Tissue	2 (.41%)
Bacterial Infectious	1 (.21%)
Bronchial Disorders	1 (.21%)
Coagulopathies And Bleeding Diathes...	1 (.21%)
Deliria	1 (.21%)
Endocrine Investigations	1 (.21%)
Family Issues	1 (.21%)
Fetal Complications	1 (.21%)
Hematology Investigations	1 (.21%)
Hepatobiliary Neoplasms Malignant A...	1 (.21%)
Increased Intracranial Pressure And...	1 (.21%)
Inner Ear And Viiith Cranial Nerve	1 (.21%)
Malabsorption Conditions	1 (.21%)
Maternal Complications Of Labour An...	1 (.21%)
Musculoskeletal And Soft Tissue Inv...	1 (.21%)
Personality Disorders	1 (.21%)
Pigmentation	1 (.21%)
Procedural And Device Related Injur...	1 (.21%)
Respiratory And Mediastinal Neoplas...	1 (.21%)
Seizures	1 (.21%)
Upper Respiratory Tract Disorders	1 (.21%)
Vascular Hemorrhagic	1 (.21%)
Viral Infectious	1 (.21%)
Vulvovaginal Disorders	1 (.21%)

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