DrugCite
Search

VIVELLE DOT

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Vivelle Dot Adverse Events Reported to the FDA Over Time

How are Vivelle Dot adverse event reports trending over time?

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

Most Common Vivelle Dot Adverse Events Reported to the FDA

What are the most common Vivelle Dot adverse events reported to the FDA?

Hot Flush
110 (3.47%)
Drug Ineffective
82 (2.59%)
Feeling Abnormal
64 (2.02%)
Depression
62 (1.96%)
Headache
56 (1.77%)
Fatigue
53 (1.67%)
Insomnia
53 (1.67%)
Dizziness
46 (1.45%)
Pain
42 (1.33%)
Nausea
38 (1.2%)
Anxiety
36 (1.14%)
Show More Show More
Malaise
35 (1.1%)
Rash
31 (.98%)
Dyspnoea
30 (.95%)
Abdominal Distension
26 (.82%)
Erythema
26 (.82%)
Hypertension
26 (.82%)
Pain In Extremity
25 (.79%)
Asthenia
24 (.76%)
Alopecia
23 (.73%)
Breast Cancer
23 (.73%)
Menopausal Symptoms
22 (.69%)
Chest Pain
19 (.6%)
Muscle Spasms
19 (.6%)
Nervousness
19 (.6%)
Weight Increased
19 (.6%)
Back Pain
18 (.57%)
Breast Pain
18 (.57%)
Crying
18 (.57%)
Incorrect Dose Administered
18 (.57%)
Wrong Technique In Drug Usage Proce...
18 (.57%)
Hyperhidrosis
17 (.54%)
Palpitations
17 (.54%)
Burning Sensation
16 (.51%)
Surgery
16 (.51%)
Condition Aggravated
15 (.47%)
Dyspepsia
15 (.47%)
Hypersensitivity
15 (.47%)
Pruritus
15 (.47%)
Vision Blurred
15 (.47%)
Cough
14 (.44%)
Fall
14 (.44%)
Loss Of Consciousness
14 (.44%)
Panic Attack
14 (.44%)
Tremor
14 (.44%)
Vaginal Haemorrhage
14 (.44%)
Vomiting
14 (.44%)
Abdominal Pain
13 (.41%)
Application Site Erythema
13 (.41%)
Application Site Rash
13 (.41%)
Blood Pressure Decreased
13 (.41%)
Cerebrovascular Accident
13 (.41%)
Chest Discomfort
13 (.41%)
Cold Sweat
13 (.41%)
Feeling Hot
13 (.41%)
Oedema Peripheral
13 (.41%)
Retching
13 (.41%)
Abdominal Pain Upper
12 (.38%)
Paraesthesia
12 (.38%)
Swelling
12 (.38%)
Arthralgia
11 (.35%)
Arthritis
11 (.35%)
Asthma
11 (.35%)
Blood Pressure Increased
11 (.35%)
Breast Cancer Female
11 (.35%)
Chills
11 (.35%)
Dry Eye
11 (.35%)
Dry Mouth
11 (.35%)
Hormone Level Abnormal
11 (.35%)
Hysterectomy
11 (.35%)
Lethargy
11 (.35%)
Migraine
11 (.35%)
Night Sweats
11 (.35%)
Poor Quality Sleep
11 (.35%)
Scar
11 (.35%)
Skin Burning Sensation
11 (.35%)
Suicidal Ideation
11 (.35%)
Syncope
11 (.35%)
Weight Decreased
11 (.35%)
Amnesia
10 (.32%)
Anger
10 (.32%)
Blood Triglycerides Increased
10 (.32%)
Breast Tenderness
10 (.32%)
Bruxism
10 (.32%)
Convulsion
10 (.32%)
Diarrhoea
10 (.32%)
Mood Swings
10 (.32%)
Muscular Weakness
10 (.32%)
Product Quality Issue
10 (.32%)
Pulmonary Embolism
10 (.32%)
Urticaria
10 (.32%)
Application Site Reaction
9 (.28%)
Breast Mass
9 (.28%)
Coordination Abnormal
9 (.28%)
Dermatitis
9 (.28%)
Dysphonia
9 (.28%)
Irritability
9 (.28%)
Memory Impairment
9 (.28%)
Mental Impairment
9 (.28%)
Sleep Disorder
9 (.28%)
Tendonitis
9 (.28%)

ExportShare/Embed GraphExport Export Data

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

What are the most common Vivelle Dot adverse events reported to the FDA?

Show More Show More

ExportShare/Embed Graph Export Export Data

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

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

Hormone Replacement Therapy
188
Menopause
77
Menopausal Symptoms
35
Drug Use For Unknown Indication
30
Product Used For Unknown Indication
23
Hot Flush
20
Show More Show More
Hysterectomy
19
Osteoporosis
11
Oestrogen Replacement Therapy
11
Hormone Therapy
8
Artificial Menopause
7
Night Sweats
7
Blood Oestrogen
6
Oestrogen Therapy
5
Prophylaxis
4
Hormone Level Abnormal
4
Contraception
4
Prostate Cancer
4
Dementia
2
Blood Oestrogen Abnormal
2
Hypopituitarism
2
Angiopathy
2
Postmenopause
2
Autonomic Nervous System Imbalance
2
Anxiety
1
Infertility
1
Oral Contraception
1
Chills
1
Depression
1
Presyncope
1
Migraine Prophylaxis
1
Premature Menopause
1
Oophorectomy
1
Bone Density Decreased
1
Menopausal Symptoms Prophylaxis
1
Atrophic Vulvovaginitis
1
Nervousness
1
Oestrogen Deficiency
1
Blood Oestrogen Decreased
1
Insomnia
1

Drug Labels

LabelLabelerEffective
Vivelle DotNovartis Pharmaceuticals Corporation07-FEB-10
Vivelle DotPhysicians Total Care, Inc.17-FEB-12

Vivelle Dot Case Reports

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

Powered by Google

About Results

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

Comments

Share your experience with Vivelle Dot.