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Vagifem Adverse Events Reported to the FDA Over Time

How are Vagifem adverse event reports trending over time?

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

Most Common Vagifem Adverse Events Reported to the FDA

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

Breast Cancer Female
88 (8.33%)
Breast Cancer
62 (5.87%)
Vaginal Haemorrhage
20 (1.89%)
Headache
15 (1.42%)
Nausea
15 (1.42%)
Deep Vein Thrombosis
14 (1.33%)
Vomiting
14 (1.33%)
Dizziness
13 (1.23%)
Blood Pressure Increased
12 (1.14%)
Endometrial Cancer
12 (1.14%)
Pulmonary Embolism
12 (1.14%)
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Chest Pain
11 (1.04%)
Chest Discomfort
10 (.95%)
Diarrhoea
10 (.95%)
Drug Ineffective
10 (.95%)
Hot Flush
10 (.95%)
Malaise
10 (.95%)
Pain
10 (.95%)
Atrial Fibrillation
9 (.85%)
Oedema Peripheral
9 (.85%)
Ovarian Cancer
8 (.76%)
Pruritus
8 (.76%)
Sensory Disturbance
8 (.76%)
Suicidal Ideation
8 (.76%)
Uterine Leiomyoma
8 (.76%)
Vaginal Discharge
8 (.76%)
Visual Impairment
8 (.76%)
Back Pain
7 (.66%)
Breast Swelling
7 (.66%)
Cerebral Haemorrhage
7 (.66%)
Cerebrovascular Accident
7 (.66%)
Depression
7 (.66%)
Hypoaesthesia
7 (.66%)
Myoclonus
7 (.66%)
Nipple Pain
7 (.66%)
Rash
7 (.66%)
Urticaria
7 (.66%)
Blood Glucose Increased
6 (.57%)
Breast Cancer Recurrent
6 (.57%)
Breast Disorder
6 (.57%)
Cluster Headache
6 (.57%)
Dyspnoea
6 (.57%)
Endometrial Cancer Stage Ii
6 (.57%)
Hemiparesis
6 (.57%)
Hyperhidrosis
6 (.57%)
Hypersensitivity
6 (.57%)
Hypertension
6 (.57%)
Hypotension
6 (.57%)
Vulvovaginal Burning Sensation
6 (.57%)
Vulvovaginal Pain
6 (.57%)
Abdominal Distension
5 (.47%)
Anxiety
5 (.47%)
Breast Cancer Metastatic
5 (.47%)
Drug Hypersensitivity
5 (.47%)
Extrasystoles
5 (.47%)
Micturition Urgency
5 (.47%)
Migraine
5 (.47%)
Mood Swings
5 (.47%)
Abdominal Pain
4 (.38%)
Abdominal Pain Lower
4 (.38%)
Abscess
4 (.38%)
Alopecia
4 (.38%)
Cholecystitis
4 (.38%)
Convulsion
4 (.38%)
Defaecation Urgency
4 (.38%)
Dysarthria
4 (.38%)
Endometrial Hyperplasia
4 (.38%)
Endometrial Hypertrophy
4 (.38%)
Essential Hypertension
4 (.38%)
Facial Paresis
4 (.38%)
Fall
4 (.38%)
Hypertonia
4 (.38%)
Insomnia
4 (.38%)
Joint Swelling
4 (.38%)
Loss Of Consciousness
4 (.38%)
Marital Problem
4 (.38%)
Metastases To Bone
4 (.38%)
Muscle Rigidity
4 (.38%)
Muscle Twitching
4 (.38%)
Neck Pain
4 (.38%)
Oestrogen Receptor Assay Positive
4 (.38%)
Ovarian Epithelial Cancer
4 (.38%)
Pupillary Reflex Impaired
4 (.38%)
Rash Erythematous
4 (.38%)
Retinal Vascular Thrombosis
4 (.38%)
Snoring
4 (.38%)
Speech Disorder
4 (.38%)
Uterine Polyp
4 (.38%)
Viith Nerve Paralysis
4 (.38%)
Visual Field Defect
4 (.38%)
Vulvovaginal Dryness
4 (.38%)
Weight Increased
4 (.38%)
Abdominal Discomfort
3 (.28%)
Babinski Reflex Test
3 (.28%)
Blindness Unilateral
3 (.28%)
Breast Cancer In Situ
3 (.28%)
Cerebral Thrombosis
3 (.28%)
Cholelithiasis
3 (.28%)
Condition Aggravated
3 (.28%)
Eczema
3 (.28%)
Epilepsy
3 (.28%)

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

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

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

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

Hormone Replacement Therapy
163
Vulvovaginal Dryness
94
Atrophic Vulvovaginitis
68
Product Used For Unknown Indication
65
Drug Use For Unknown Indication
42
Menopausal Symptoms
37
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Menopause
20
Ill-defined Disorder
13
Hormone Therapy
10
Oestrogen Deficiency
8
Hysterectomy
5
Vaginitis Atrophic
5
Postmenopause
5
Genital Discomfort
4
Vaginal Disorder
4
Uterine Prolapse
4
Blood Oestrogen Decreased
4
Sexual Dysfunction
3
Incontinence
3
Vulvovaginal Pruritus
3
Cervix Disorder
3
Senile Genital Atrophy
3
Urinary Tract Infection
3
Oestrogen Replacement Therapy
3
Mucous Membrane Disorder
3
Prophylaxis
3
Vulvovaginal Discomfort
2
Menopausal Disorder
2
Soft Tissue Disorder
2
Pruritus
2
Smear Cervix Abnormal
2
Prophylaxis Urinary Tract Infection
2
Vaginal Infection
2
Burning Sensation
2
Mucosal Dryness
2
Vulvovaginal Pain
2
Pain
2
Oestrogen Therapy
1
Urinary Incontinence
1
Local Reaction
1
Hypogonadism Female
1
Sexually Active
1
Preoperative Care
1
Cardiovascular Event Prophylaxis
1
Vaginal Dysplasia
1
Vaginal Pain
1
Myalgia
1
Genital Discharge
1
Blood Oestrogen
1
Inadequate Lubrication
1
Cystitis
1

Drug Labels

LabelLabelerEffective
VagifemPhysicians Total Care, Inc.15-MAR-12
VagifemNovo Nordisk11-APR-13

Vagifem Case Reports

What Vagifem 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 Vagifem. 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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