OGEN

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Ogen Adverse Events Reported to the FDA Over Time

How are Ogen adverse event reports trending over time?

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

Most Common Ogen Adverse Events Reported to the FDA

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

Breast Cancer	137 (20.63%)
Breast Cancer Female	100 (15.06%)
Breast Cancer In Situ	14 (2.11%)
Anxiety	13 (1.96%)
Breast Cancer Metastatic	11 (1.66%)
Pain	10 (1.51%)
Drug Ineffective	7 (1.05%)
Breast Disorder	6 (.9%)
Breast Operation	6 (.9%)
Contralateral Breast Cancer	6 (.9%)
Deformity	6 (.9%)
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Mastectomy	6 (.9%)
Migraine	6 (.9%)
Ovarian Cancer	6 (.9%)
Pneumonia	6 (.9%)
Uterine Cancer	6 (.9%)
Depression	5 (.75%)
Fallopian Tube Disorder	5 (.75%)
Hot Flush	5 (.75%)
Insomnia	5 (.75%)
Irritability	5 (.75%)
Labile Hypertension	5 (.75%)
Malaise	5 (.75%)
Menorrhagia	5 (.75%)
Muscle Spasms	5 (.75%)
Uterine Leiomyoma	5 (.75%)
Asthenia	4 (.6%)
Body Height Decreased	4 (.6%)
Breast Calcifications	4 (.6%)
Breast Hyperplasia	4 (.6%)
Breast Pain	4 (.6%)
Hypersensitivity	4 (.6%)
Hypothyroidism	4 (.6%)
Injury	4 (.6%)
Marital Problem	4 (.6%)
Myocardial Infarction	4 (.6%)
Abdominal Pain	3 (.45%)
Breast Necrosis	3 (.45%)
Cerebrovascular Accident	3 (.45%)
Feeling Abnormal	3 (.45%)
General Physical Health Deteriorati...	3 (.45%)
Incorrect Dose Administered	3 (.45%)
Mental Impairment	3 (.45%)
Oestrogen Receptor Assay Positive	3 (.45%)
Pyrexia	3 (.45%)
Scar	3 (.45%)
Vulvovaginal Dryness	3 (.45%)
Abdominal Pain Lower	2 (.3%)
Adenomyosis	2 (.3%)
Arterial Thrombosis Limb	2 (.3%)
Asthma	2 (.3%)
Autoimmune Thyroiditis	2 (.3%)
Biopsy Breast	2 (.3%)
Blindness	2 (.3%)
Blood Cholesterol Increased	2 (.3%)
Breast Lump Removal	2 (.3%)
Breast Mass	2 (.3%)
Breast Reconstruction	2 (.3%)
Breast Tenderness	2 (.3%)
Bronchitis	2 (.3%)
Chemotherapy	2 (.3%)
Corneal Dystrophy	2 (.3%)
Corneal Oedema	2 (.3%)
Diabetes Mellitus	2 (.3%)
Drug Hypersensitivity	2 (.3%)
Dry Eye	2 (.3%)
Dry Mouth	2 (.3%)
Dysphagia	2 (.3%)
Exploratory Operation	2 (.3%)
Eye Injury	2 (.3%)
Eye Irritation	2 (.3%)
Eye Pain	2 (.3%)
Eye Swelling	2 (.3%)
Eyelid Disorder	2 (.3%)
Fibrocystic Breast Disease	2 (.3%)
Headache	2 (.3%)
Hyperglycaemia	2 (.3%)
Hypertension	2 (.3%)
Lung Disorder	2 (.3%)
Lung Infection	2 (.3%)
Lymphadenectomy	2 (.3%)
Malignant Breast Lump Removal	2 (.3%)
Middle Insomnia	2 (.3%)
Mobility Decreased	2 (.3%)
Nasal Dryness	2 (.3%)
Nausea	2 (.3%)
Neoplasm Malignant	2 (.3%)
Night Sweats	2 (.3%)
Oedema	2 (.3%)
Osteoarthritis	2 (.3%)
Osteopenia	2 (.3%)
Osteoporosis	2 (.3%)
Ovarian Cancer Metastatic	2 (.3%)
Ovarian Cyst	2 (.3%)
Peripheral Coldness	2 (.3%)
Progesterone Receptor Assay Positiv...	2 (.3%)
Psoriasis	2 (.3%)
Radiotherapy	2 (.3%)
Rash	2 (.3%)
Road Traffic Accident	2 (.3%)
Sinusitis	2 (.3%)

Share/Embed Graph Export Data

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

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

Breast Neoplasms Malignant And Unsp...	268 (40.36%)
Breast	28 (4.22%)
Breast Therapeutic Procedures	18 (2.71%)
Anxiety Disorders	16 (2.41%)
Reproductive Neoplasms Female Malig...	15 (2.26%)
Infections - Pathogen Unspecified	13 (1.96%)
Injuries	13 (1.96%)
Epidermal And Dermal Conditions	10 (1.51%)
Eye	9 (1.36%)
Gastrointestinal Signs	9 (1.36%)
Sleep Disorders	9 (1.36%)
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Therapeutic And Nontherapeutic Effe...	9 (1.36%)
Headaches	8 (1.2%)
Physical Examination Topics	8 (1.2%)
Ovarian And Fallopian Tube	7 (1.05%)
Therapeutic Procedures And Supporti...	7 (1.05%)
Vascular Hypertensive	7 (1.05%)
Allergic Conditions	6 (.9%)
Depressed Mood Disorders	6 (.9%)
Muscle	6 (.9%)
Thyroid Gland	6 (.9%)
Vascular	6 (.9%)
Central Nervous System Vascular	5 (.75%)
Endocrine Investigations	5 (.75%)
Menstrual Cycle And Uterine Bleedin...	5 (.75%)
Reproductive Neoplasms Female Benig...	5 (.75%)
Bone Disorders	4 (.6%)
Coronary Artery	4 (.6%)
Family Issues	4 (.6%)
Glucose Metabolism Disorders	4 (.6%)
Joint	4 (.6%)
Medication Errors	4 (.6%)
Mental Impairment	4 (.6%)
Ocular Infections, Irritations And ...	4 (.6%)
Respiratory	4 (.6%)
Skin Appendage Conditions	4 (.6%)
Vision	4 (.6%)
Body Temperature Conditions	3 (.45%)
Metastases	3 (.45%)
Miscellaneous And Site Unspecified ...	3 (.45%)
Neurological	3 (.45%)
Vulvovaginal Disorders	3 (.45%)
Arteriosclerosis, Stenosis, Vascula...	2 (.3%)
Bronchial Disorders	2 (.3%)
Decreased And Nonspecific Blood Pre...	2 (.3%)
Embolism And Thrombosis	2 (.3%)
Eye Disorders Congenital	2 (.3%)
Hematological And Lymphoid Tissue T...	2 (.3%)
Lipid Analyses	2 (.3%)
Mood Disorders	2 (.3%)
Musculoskeletal And Connective Tiss...	2 (.3%)
Reproductive Organ And Breast Inves...	2 (.3%)
Salivary Gland Conditions	2 (.3%)
Skin Neoplasms Malignant And Unspec...	2 (.3%)
Upper Respiratory Tract Disorders	2 (.3%)
Uterine, Pelvic And Broad Ligament	2 (.3%)
Viral Infectious	2 (.3%)
Administration Site Reactions	1 (.15%)
Anterior Eye Structural Change, Dep...	1 (.15%)
Bacterial Infectious	1 (.15%)
Bone, Calcium, Magnesium And Phosph...	1 (.15%)
Breast Neoplasms Benign	1 (.15%)
Connective Tissue Disorders	1 (.15%)
Cornification And Dystrophic Skin	1 (.15%)
Gastrointestinal Conditions	1 (.15%)
Gastrointestinal Neoplasms Malignan...	1 (.15%)
Glaucoma And Ocular Hypertension	1 (.15%)
Hearing	1 (.15%)
Heart Failures	1 (.15%)
Injuries By Physical Agents	1 (.15%)
Inner Ear And Viiith Cranial Nerve	1 (.15%)
Lipid Metabolism	1 (.15%)
Lower Respiratory Tract Disorders	1 (.15%)
Lymphatic Vessel	1 (.15%)
Metabolic, Nutritional And Blood Ga...	1 (.15%)
Middle Ear Disorders	1 (.15%)
Ocular Sensory Symptoms	1 (.15%)
Psychiatric And Behavioural Symptom...	1 (.15%)
Seizures	1 (.15%)
Sleep Disturbances	1 (.15%)
Urinary Tract Signs	1 (.15%)
Water, Electrolyte And Mineral	1 (.15%)
White Blood Cell	1 (.15%)

Share/Embed Graph Export Data

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

Common Uses of Ogen According to Those Reporting Adverse Events

Why are people taking Ogen, according to those reporting adverse events to the FDA?

Hormone Replacement Therapy	733
Menopausal Symptoms	72
Menopause	46
Hot Flush	22
Drug Use For Unknown Indication	18
Hysterectomy	13
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Hormone Therapy	13
Oestrogen Replacement Therapy	10
Postmenopause	8
Osteoporosis	7
Ill-defined Disorder	7
Night Sweats	5
Blood Oestrogen	5
Product Used For Unknown Indication	3
Artificial Menopause	3
Hormone Level Abnormal	2
Oophorectomy Bilateral	1
Osteoporosis Prophylaxis	1
Vulvovaginal Dryness	1

Ogen Case Reports

What Ogen safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Ogen. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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