PREFEST

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Prefest Adverse Events Reported to the FDA Over Time

How are Prefest adverse event reports trending over time?

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

Most Common Prefest Adverse Events Reported to the FDA

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

Breast Cancer Female	99 (38.52%)
Breast Cancer	41 (15.95%)
Anxiety	6 (2.33%)
Pain	6 (2.33%)
Breast Cancer In Situ	4 (1.56%)
Fatigue	4 (1.56%)
Marital Problem	4 (1.56%)
Arthritis	3 (1.17%)
Breast Operation	3 (1.17%)
Deafness	3 (1.17%)
Drug Ineffective	3 (1.17%)
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Eye Swelling	3 (1.17%)
Fluid Retention	3 (1.17%)
Joint Swelling	3 (1.17%)
Oral Discomfort	3 (1.17%)
Rash Macular	3 (1.17%)
Tri-iodothyronine Increased	3 (1.17%)
Weight Increased	3 (1.17%)
Arrhythmia	2 (.78%)
Body Temperature Fluctuation	2 (.78%)
Breast Discharge	2 (.78%)
Breast Hyperplasia	2 (.78%)
Fibrocystic Breast Disease	2 (.78%)
Hypersensitivity	2 (.78%)
Hyperthyroidism	2 (.78%)
Metaplasia	2 (.78%)
Myocardial Infarction	2 (.78%)
Oestrogen Deficiency	2 (.78%)
Ovarian Cancer	2 (.78%)
Pain Of Skin	2 (.78%)
Peripheral Coldness	2 (.78%)
Radiation Skin Injury	2 (.78%)
Skin Lesion	2 (.78%)
Skin Nodule	2 (.78%)
Abdominal Pain	1 (.39%)
Angina Pectoris	1 (.39%)
Anhedonia	1 (.39%)
Breast Cancer Metastatic	1 (.39%)
Bronchospasm	1 (.39%)
Chest Pain	1 (.39%)
Crying	1 (.39%)
Cyst	1 (.39%)
Drug Effect Decreased	1 (.39%)
Emotional Distress	1 (.39%)
Hot Flush	1 (.39%)
Injury	1 (.39%)
Mastectomy	1 (.39%)
Measles	1 (.39%)
Menstrual Disorder	1 (.39%)
Metastases To Lymph Nodes	1 (.39%)
Metrorrhagia	1 (.39%)
Optic Ischaemic Neuropathy	1 (.39%)
Pain In Extremity	1 (.39%)
Plastic Surgery	1 (.39%)
Rash Papular	1 (.39%)
Skin Discomfort	1 (.39%)
Skin Disorder	1 (.39%)
Staphylococcal Infection	1 (.39%)
Urticaria	1 (.39%)
Urticaria Papular	1 (.39%)
Uterine Haemorrhage	1 (.39%)
Vision Blurred	1 (.39%)

Share/Embed Graph Export Data

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

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

Breast Neoplasms Malignant And Unsp...	145 (56.42%)
Epidermal And Dermal Conditions	10 (3.89%)
Anxiety Disorders	6 (2.33%)
Breast	6 (2.33%)
Joint	6 (2.33%)
Physical Examination Topics	5 (1.95%)
Breast Therapeutic Procedures	4 (1.56%)
Family Issues	4 (1.56%)
Therapeutic And Nontherapeutic Effe...	4 (1.56%)
Coronary Artery	3 (1.17%)
Electrolyte And Fluid Balance Condi...	3 (1.17%)
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Endocrine Investigations	3 (1.17%)
Eye	3 (1.17%)
Hearing	3 (1.17%)
Oral Soft Tissue Conditions	3 (1.17%)
Tissue	3 (1.17%)
Allergic Conditions	2 (.78%)
Angiedema And Urticaria	2 (.78%)
Arteriosclerosis, Stenosis, Vascula...	2 (.78%)
Cardiac Arrhythmias	2 (.78%)
Endocrine Disorders Of Gonadal Func...	2 (.78%)
Injuries By Physical Agents	2 (.78%)
Menstrual Cycle And Uterine Bleedin...	2 (.78%)
Reproductive Neoplasms Female Malig...	2 (.78%)
Skin And Subcutaneous Tissue	2 (.78%)
Thyroid Gland	2 (.78%)
Bacterial Infectious	1 (.39%)
Bronchial Disorders	1 (.39%)
Depressed Mood Disorders	1 (.39%)
Gastrointestinal Signs	1 (.39%)
Injuries	1 (.39%)
Metastases	1 (.39%)
Mood Disorders	1 (.39%)
Musculoskeletal And Connective Tiss...	1 (.39%)
Neurological	1 (.39%)
Ocular Hemorrhages And Vascular	1 (.39%)
Therapeutic Procedures And Supporti...	1 (.39%)
Uterine, Pelvic And Broad Ligament	1 (.39%)
Vascular	1 (.39%)
Viral Infectious	1 (.39%)
Vision	1 (.39%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Prefest, 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 Prefest 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 Prefest According to Those Reporting Adverse Events

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

Hormone Replacement Therapy	202
Menopausal Symptoms	24
Menopause	7
Hot Flush	3
Oestrogen Replacement Therapy	3
Drug Use For Unknown Indication	2
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Amenorrhoea	1
Hormone Therapy	1

Drug Labels

Label	Labeler	Effective
Prefest	Teva Women's Health, Inc.	20-DEC-12

Prefest Case Reports

What Prefest 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 Prefest. 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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