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Premphase Adverse Events Reported to the FDA Over Time

How are Premphase adverse event reports trending over time?

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

Most Common Premphase Adverse Events Reported to the FDA

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

Breast Cancer Female
200 (23.7%)
Breast Cancer
199 (23.58%)
Breast Cancer Metastatic
39 (4.62%)
Ovarian Cancer
13 (1.54%)
Anxiety
12 (1.42%)
Hot Flush
9 (1.07%)
Myocardial Infarction
7 (.83%)
Pulmonary Embolism
7 (.83%)
Breast Operation
6 (.71%)
Cerebrovascular Accident
6 (.71%)
Cholelithiasis
6 (.71%)
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Death
6 (.71%)
Deep Vein Thrombosis
6 (.71%)
Mastectomy
6 (.71%)
Medication Residue
6 (.71%)
Pain
6 (.71%)
Swelling Face
6 (.71%)
Vaginal Haemorrhage
6 (.71%)
Abdominal Discomfort
5 (.59%)
Acne
5 (.59%)
Anger
5 (.59%)
Asthma
5 (.59%)
Biliary Tract Disorder
5 (.59%)
Breast Cancer Stage Iii
5 (.59%)
Dry Mouth
5 (.59%)
Fatigue
5 (.59%)
Gallbladder Cancer
5 (.59%)
Liver Injury
5 (.59%)
Nosophobia
5 (.59%)
Rash
5 (.59%)
Scleroderma
5 (.59%)
Suicidal Ideation
5 (.59%)
Systemic Lupus Erythematosus
5 (.59%)
Vascular Dementia
5 (.59%)
Weight Decreased
5 (.59%)
Abdominal Pain Lower
4 (.47%)
Breast Cancer In Situ
4 (.47%)
Diabetes Mellitus
4 (.47%)
Drug Dispensing Error
4 (.47%)
Feeling Abnormal
4 (.47%)
Hypersensitivity
4 (.47%)
Insomnia
4 (.47%)
Marital Problem
4 (.47%)
Metastases To Lymph Nodes
4 (.47%)
Oestrogen Receptor Assay Positive
4 (.47%)
Drug Effect Decreased
3 (.36%)
Hyperhidrosis
3 (.36%)
Inappropriate Schedule Of Drug Admi...
3 (.36%)
Lymphoedema
3 (.36%)
Medication Error
3 (.36%)
Neoplasm Malignant
3 (.36%)
Palpitations
3 (.36%)
Sinusitis
3 (.36%)
Stress
3 (.36%)
Vertigo
3 (.36%)
Abnormal Behaviour
2 (.24%)
Breast Mass
2 (.24%)
Chest Pain
2 (.24%)
Crying
2 (.24%)
Depression
2 (.24%)
Drug Ineffective
2 (.24%)
Drug Withdrawal Syndrome
2 (.24%)
Dyspnoea
2 (.24%)
Fluid Retention
2 (.24%)
Headache
2 (.24%)
Heat Rash
2 (.24%)
Injury
2 (.24%)
Lymphadenectomy
2 (.24%)
Menstruation Irregular
2 (.24%)
Metrorrhagia
2 (.24%)
Nightmare
2 (.24%)
Post Procedural Complication
2 (.24%)
Pruritus
2 (.24%)
Rash Generalised
2 (.24%)
Uterine Cyst
2 (.24%)
Vision Blurred
2 (.24%)
Vomiting
2 (.24%)
Vulvovaginal Dryness
2 (.24%)
Weight Increased
2 (.24%)
Alopecia
1 (.12%)
Amenorrhoea
1 (.12%)
Anaemia
1 (.12%)
Anaphylactic Reaction
1 (.12%)
Arthralgia
1 (.12%)
Asthenia
1 (.12%)
B-cell Lymphoma
1 (.12%)
Bladder Irritation
1 (.12%)
Blood Follicle Stimulating Hormone ...
1 (.12%)
Body Height Decreased
1 (.12%)
Bone Density Decreased
1 (.12%)
Bone Disorder
1 (.12%)
Bone Pain
1 (.12%)
Brain Neoplasm
1 (.12%)
Breast Cyst
1 (.12%)
Breast Disorder
1 (.12%)
Breast Fibrosis
1 (.12%)
Breast Lump Removal
1 (.12%)
Breast Oedema
1 (.12%)
Breast Tenderness
1 (.12%)
Cancer Gene Carrier
1 (.12%)
Cardiac Disorder
1 (.12%)

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

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

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

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

Hormone Replacement Therapy
1094
Menopausal Symptoms
71
Menopause
44
Hormone Therapy
12
Hot Flush
10
Drug Use For Unknown Indication
6
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Postmenopause
5
Metrorrhagia
4
Off Label Use
4
Mood Swings
3
Osteoporosis
3
Product Used For Unknown Indication
3
Depression
2
Osteoporosis Prophylaxis
2
Dizziness
1
Hysterectomy
1
Menstruation Irregular
1
Libido Decreased
1
Oophorectomy
1
Ovarian Failure
1
Menstrual Disorder
1
Postmenopausal Haemorrhage
1

Drug Labels

LabelLabelerEffective
PremphaseWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-SEP-12
PremproWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-SEP-12
PremproPhysicians Total Care, Inc.01-NOV-12
PremphasePhysicians Total Care, Inc.26-NOV-12
PremproDispensing Solutions, Inc.27-FEB-13

Premphase Case Reports

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

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About Results

This report contains aggregated drug side effects and adverse events for Premphase. 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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