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Premarin Adverse Events Reported to the FDA Over Time

How are Premarin adverse event reports trending over time?

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

Most Common Premarin Adverse Events Reported to the FDA

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

Breast Cancer
3762 (18.13%)
Breast Cancer Female
2520 (12.15%)
Drug Ineffective
434 (2.09%)
Breast Cancer Metastatic
328 (1.58%)
Hot Flush
307 (1.48%)
Ovarian Cancer
208 (1%)
Headache
185 (.89%)
Cerebrovascular Accident
179 (.86%)
Feeling Abnormal
158 (.76%)
Vulvovaginal Burning Sensation
155 (.75%)
Thrombosis
153 (.74%)
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Nausea
149 (.72%)
Malaise
136 (.66%)
Dizziness
135 (.65%)
Pain
132 (.64%)
Breast Cancer In Situ
131 (.63%)
Insomnia
123 (.59%)
Anxiety
121 (.58%)
Pulmonary Embolism
118 (.57%)
Myocardial Infarction
112 (.54%)
Breast Operation
106 (.51%)
Depression
106 (.51%)
Dyspnoea
105 (.51%)
Oestrogen Receptor Assay Positive
101 (.49%)
Rash
98 (.47%)
Hypertension
94 (.45%)
Alopecia
93 (.45%)
Condition Aggravated
93 (.45%)
Pain In Extremity
93 (.45%)
Hyperhidrosis
91 (.44%)
Hypersensitivity
90 (.43%)
Deep Vein Thrombosis
87 (.42%)
Fatigue
84 (.4%)
Muscle Spasms
84 (.4%)
Product Quality Issue
83 (.4%)
Weight Increased
79 (.38%)
Vaginal Haemorrhage
78 (.38%)
Chest Pain
75 (.36%)
Progesterone Receptor Assay Positiv...
75 (.36%)
Arthralgia
74 (.36%)
Night Sweats
74 (.36%)
Pruritus
74 (.36%)
Vulvovaginal Discomfort
71 (.34%)
Back Pain
70 (.34%)
Mastectomy
68 (.33%)
Drug Withdrawal Syndrome
67 (.32%)
Vulvovaginal Pain
67 (.32%)
Vulvovaginal Pruritus
65 (.31%)
Burning Sensation
62 (.3%)
Vision Blurred
62 (.3%)
Asthenia
61 (.29%)
Memory Impairment
61 (.29%)
Vomiting
61 (.29%)
Weight Decreased
61 (.29%)
Migraine
60 (.29%)
Urinary Tract Infection
56 (.27%)
Breast Pain
55 (.27%)
Injury
55 (.27%)
Irritability
54 (.26%)
Vaginal Infection
53 (.26%)
Fall
52 (.25%)
Incorrect Dose Administered
52 (.25%)
Confusional State
50 (.24%)
Abdominal Discomfort
49 (.24%)
Drug Effect Decreased
49 (.24%)
Vulvovaginal Dryness
49 (.24%)
Application Site Pain
48 (.23%)
Haemorrhage
47 (.23%)
Abdominal Pain
46 (.22%)
Blood Cholesterol Increased
44 (.21%)
Nervousness
44 (.21%)
Abdominal Distension
43 (.21%)
Urticaria
43 (.21%)
Expired Drug Administered
42 (.2%)
Medication Residue
42 (.2%)
Activities Of Daily Living Impaired
41 (.2%)
Oedema Peripheral
41 (.2%)
Speech Disorder
41 (.2%)
Benign Breast Neoplasm
40 (.19%)
Arthritis
39 (.19%)
Emotional Disorder
39 (.19%)
Ovarian Cancer Metastatic
39 (.19%)
Breast Tenderness
38 (.18%)
Diarrhoea
38 (.18%)
Infection
37 (.18%)
Sleep Disorder
37 (.18%)
Mood Altered
36 (.17%)
Mood Swings
36 (.17%)
Crying
35 (.17%)
Diabetes Mellitus
35 (.17%)
Lymphoedema
35 (.17%)
Vulvovaginal Mycotic Infection
35 (.17%)
Asthma
34 (.16%)
Drug Interaction
34 (.16%)
Abdominal Pain Upper
33 (.16%)
Dementia
33 (.16%)
Heart Rate Increased
33 (.16%)
Stress
33 (.16%)
Blood Pressure Increased
32 (.15%)
Cough
32 (.15%)
Drug Hypersensitivity
32 (.15%)

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

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

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

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

Hormone Replacement Therapy
17541
Oestrogen Replacement Therapy
1889
Menopausal Symptoms
1655
Menopause
1058
Hot Flush
503
Drug Use For Unknown Indication
473
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Product Used For Unknown Indication
433
Vulvovaginal Dryness
383
Hysterectomy
274
Hormone Therapy
256
Off Label Use
130
Atrophic Vulvovaginitis
124
Osteoporosis
99
Hormone Level Abnormal
81
Prophylaxis
62
Oestrogen Therapy
45
Postmenopause
43
Osteoporosis Prophylaxis
34
Vaginal Disorder
33
Night Sweats
33
Artificial Menopause
32
Bone Disorder
31
Vulvovaginal Discomfort
30
Vulvovaginal Burning Sensation
28
Menstruation Irregular
27
Blood Oestrogen
23
Menorrhagia
23
Mood Swings
22
Dyspareunia
21
Osteopenia
19
Cardiac Disorder
18
Ill-defined Disorder
18
Blood Oestrogen Decreased
17
Vulvovaginal Pruritus
17
Insomnia
17
Vulvovaginal Pain
17
Vaginal Infection
17
Vaginal Haemorrhage
15
Ovarian Failure
13
Endometriosis
13
Amenorrhoea
12
Atrophy
12
Premature Menopause
11
Irritability
11
Depression
11
Infertility
10
Smear Cervix Abnormal
10
Bladder Prolapse
10
Incontinence
10
Contraception
9
Metrorrhagia
9

Drug Labels

LabelLabelerEffective
PremarinPhysicians Total Care, Inc.30-MAR-10
PremarinState of Florida DOH Central Pharmacy27-MAY-10
PremarinWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-NOV-10
PremarinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC21-MAR-12
PremarinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC22-MAR-12
Premarin VaginalWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.10-MAY-12
PremarinCardinal Health22-JUN-12
PremarinvaginalPhysicians Total Care, Inc.22-JUN-12
PremarinAphena Pharma Solutions - Tennessee, Inc.18-JUL-12
PremarinWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.30-JUL-12
PremarinCardinal Health17-APR-13
PremarinCardinal Health30-APR-13

Premarin Case Reports

What Premarin 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 Premarin. 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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