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Prempro Adverse Events Reported to the FDA Over Time

How are Prempro adverse event reports trending over time?

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

Most Common Prempro Adverse Events Reported to the FDA

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

Breast Cancer
3710 (30.29%)
Breast Cancer Female
1664 (13.59%)
Breast Cancer Metastatic
385 (3.14%)
Drug Ineffective
224 (1.83%)
Hot Flush
142 (1.16%)
Cerebrovascular Accident
125 (1.02%)
Ovarian Cancer
122 (1%)
Breast Operation
105 (.86%)
Anxiety
102 (.83%)
Myocardial Infarction
100 (.82%)
Pulmonary Embolism
100 (.82%)
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Thrombosis
92 (.75%)
Deep Vein Thrombosis
91 (.74%)
Headache
90 (.73%)
Breast Cancer In Situ
88 (.72%)
Oestrogen Receptor Assay Positive
77 (.63%)
Vaginal Haemorrhage
71 (.58%)
Depression
70 (.57%)
Insomnia
68 (.56%)
Mastectomy
68 (.56%)
Metrorrhagia
67 (.55%)
Pain
62 (.51%)
Feeling Abnormal
61 (.5%)
Progesterone Receptor Assay Positiv...
59 (.48%)
Condition Aggravated
54 (.44%)
Irritability
54 (.44%)
Weight Increased
53 (.43%)
Nausea
50 (.41%)
Night Sweats
49 (.4%)
Malaise
48 (.39%)
Dizziness
47 (.38%)
Pain In Extremity
47 (.38%)
Alopecia
46 (.38%)
Fatigue
46 (.38%)
Hypertension
43 (.35%)
Inappropriate Schedule Of Drug Admi...
40 (.33%)
Injury
40 (.33%)
Muscle Spasms
39 (.32%)
Asthenia
35 (.29%)
Lymphoedema
34 (.28%)
Drug Withdrawal Syndrome
32 (.26%)
Endometrial Cancer
30 (.24%)
Migraine
30 (.24%)
Chest Pain
27 (.22%)
Weight Decreased
27 (.22%)
Product Quality Issue
26 (.21%)
Abdominal Distension
25 (.2%)
Arthralgia
25 (.2%)
Dyspnoea
25 (.2%)
Breast Mass
24 (.2%)
Pruritus
24 (.2%)
Suicidal Ideation
24 (.2%)
Blood Pressure Increased
23 (.19%)
Rash
23 (.19%)
Scar
23 (.19%)
Wrong Technique In Drug Usage Proce...
23 (.19%)
Anaemia
22 (.18%)
Dementia
22 (.18%)
Metastases To Lymph Nodes
22 (.18%)
Abdominal Pain
21 (.17%)
Back Pain
21 (.17%)
Breast Tenderness
21 (.17%)
Hyperhidrosis
21 (.17%)
Mood Altered
21 (.17%)
Ovarian Cancer Metastatic
21 (.17%)
Psychiatric Symptom
21 (.17%)
Sinusitis
21 (.17%)
Systemic Lupus Erythematosus
21 (.17%)
Anger
20 (.16%)
Menorrhagia
20 (.16%)
Asthma
19 (.16%)
Breast Disorder
19 (.16%)
Cardiac Disorder
19 (.16%)
Coronary Artery Occlusion
19 (.16%)
Drug Effect Decreased
19 (.16%)
Blood Cholesterol Increased
18 (.15%)
Crying
18 (.15%)
Emotional Distress
18 (.15%)
Hypersensitivity
18 (.15%)
Osteoporosis
18 (.15%)
Radiotherapy
18 (.15%)
Uterine Leiomyoma
18 (.15%)
Agitation
17 (.14%)
Breast Pain
17 (.14%)
Gastrooesophageal Reflux Disease
17 (.14%)
Oedema Peripheral
17 (.14%)
Arthritis
16 (.13%)
Breast Cancer Stage Iii
16 (.13%)
Emotional Disorder
16 (.13%)
Heart Rate Increased
16 (.13%)
Palpitations
16 (.13%)
Surgery
16 (.13%)
Therapeutic Response Unexpected
16 (.13%)
Tremor
16 (.13%)
Vision Blurred
16 (.13%)
Breast Enlargement
15 (.12%)
Breast Lump Removal
15 (.12%)
Coeliac Disease
15 (.12%)
Haemorrhage
15 (.12%)
Neoplasm Malignant
15 (.12%)
Post Procedural Complication
15 (.12%)

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

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

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

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

Hormone Replacement Therapy
16152
Menopausal Symptoms
1492
Menopause
761
Hot Flush
465
Osteoporosis
149
Drug Use For Unknown Indication
142
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Hormone Therapy
130
Prophylaxis
111
Product Used For Unknown Indication
87
Osteoporosis Prophylaxis
45
Night Sweats
43
Oestrogen Replacement Therapy
31
Hormone Level Abnormal
26
Cardiac Disorder
23
Mood Swings
21
Vulvovaginal Dryness
20
Menstruation Irregular
17
Postmenopause
17
Insomnia
13
Menorrhagia
12
Hysterectomy
11
Arthritis
11
Premature Menopause
11
Off Label Use
10
Osteopenia
9
Ill-defined Disorder
8
Bone Density Decreased
7
Irritability
7
Menopausal Disorder
6
Premenstrual Syndrome
6
Oophorectomy
6
Cardiovascular Event Prophylaxis
6
Myocardial Infarction
5
Sleep Disorder
5
Vulvovaginal Discomfort
4
Rheumatoid Arthritis
4
Emotional Disorder
4
Anxiety
4
Artificial Menopause
4
Vaginal Disorder
3
Dysmenorrhoea
3
Dysfunctional Uterine Bleeding
3
Crying
3
Libido Decreased
3
Bone Disorder
3
Endocrine Disorder
3
Depression
3
Menometrorrhagia
2
Supplementation Therapy
2
Metrorrhagia
2
Dyspareunia
2

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

Prempro Case Reports

What Prempro 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 Prempro. 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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