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Vivelle-DOT (Estradiol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vivelle-DOT (Estradiol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (123)
Life Threatening Events (5)
Disability (4)

Reports by Reaction Type

Hot Flush (26)Drug Ineffective (24)Feeling Abnormal (18)Nausea (16)Wrong Technique in Drug Usage Process (15)Fatigue (13)Depression (13)Asthenia (13)Malaise (12)Insomnia (12)Rash (10)Anxiety (10)

Below are a few examples of reports where side effects / adverse reactions may be related to Vivelle-DOT (Estradiol). For a complete list or a specific selection of reports, please use the links above.

Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Pruritus, Glaucoma, Feeling Hot, Skin Burning Sensation, Rash, Erythema, Urine Calcium Increased

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Ventilan; Albuterol; Vitamin D; Cinnamon; Lidex; Restasis; Brimonidine Tartrate; Calcium Carbonate; Zanaflex; Epipen; Nitrostat; Norco; Multivitamins, Other Combinations; Ascorbic Acid; Zofran; Vitamin D; Potassium Flouride; Valium; Multaq; Xanax; Zinc Sulfate; Sustained EYE Drop (NO Preservatives); Xopenex; Dexilant; Sumatriptan; Potassium Chloride; Lydexcium; Fioricet; Magnesium; Vitamin E; Calcium; Ipratropium Bromide



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-08-26

Patient: female

Reactions: Poor Quality Sleep, Anxiety, Breast Pain, Application Site Reaction, Breast Swelling, Hot Flush, Dermatitis, Mastitis, Breast Mass, Rash, Breast Inflammation

Drug(s) suspected as cause:
Vivelle-DOT
    Dosage: 0.1 mg, bid
    Start date: 2011-08-21

Vivelle-DOT
    Dosage: 0.1 mg, bid
    Indication: Hormone Replacement Therapy
    Start date: 2009-01-01

Vivelle-DOT
    Dosage: 0.1 mg, bid
    Start date: 2011-08-27



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Wrong Technique in Drug Usage Process, Accident AT Work, Hormone Level Abnormal, Foreign Body, Convulsion, Loss of Consciousness

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Pneumonia, Arthropathy, Bronchitis Chronic, Ear Infection, Product Adhesion Issue, Amnesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vivelle-DOT
    Dosage: 0.075 mg, twice weekly
    Start date: 2001-01-01

Vivelle-DOT
    Dosage: 0.075 ukn, unk

Other drugs received by patient: Singulair; Xopenex HFA; Hydrocodin; Lasix; Xopenex HFA; Ipratropium Bromide; Alprazolam; Methocarbamol; Furosemide; Zetia; Lexapro; Spiriva; Nexium; Verapamil; Ferrous Sulfate TAB; Chlorpromazine HCL; Potassium; Buspirone HCL; Simvastatin



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Dysmenorrhoea, Movement Disorder, Head Injury, Neoplasm Malignant, Condition Aggravated, Amnesia

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Soma



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female, weighing 45.4 kg (99.8 pounds)

Reactions: Weight Decreased, Tinnitus, Headache, Fatigue, Malaise, Dyspepsia, Neck Pain, Depression, Decreased Appetite, Nausea, Cognitive Disorder, Self Injurious Behaviour, Muscle Twitching, Tremor, Insomnia, Dehydration, Nervous System Disorder, Memory Impairment, Blood Pressure Decreased, Asthenia

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Tylenol; Aspirin



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Application Site Reaction, Breast Pain, Mastitis, Breast Mass, Rash, Anxiety, Poor Quality Sleep, Breast Swelling, Hot Flush, Dermatitis, Breast Inflammation

Drug(s) suspected as cause:
Vivelle-DOT
    Dosage: 0.1 mg, bid
    Start date: 2011-08-21

Vivelle-DOT
    Dosage: 0.1 mg, bid
    Start date: 2011-08-27

Vivelle-DOT
    Dosage: 0.1 mg, bid
    Indication: Hormone Replacement Therapy
    Start date: 2009-01-01



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female

Reactions: Pain in Extremity, Neoplasm

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Progesterone; Synthroid



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-08-09

Patient: female

Reactions: Weight Decreased, Tinnitus, Nausea, Cognitive Disorder, Headache, Self Injurious Behaviour, Muscle Twitching, Tremor, Fatigue, Malaise, Dyspepsia, Insomnia, Memory Impairment, Depression, Asthenia, Blood Pressure Decreased, Decreased Appetite

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Aspirin; Tylenol



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-08-09

Patient: female

Reactions: Aphasia, Condition Aggravated, Cognitive Disorder, Memory Impairment

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Topamax; Wellbutrin; Klonopin; Thyroid TAB



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Glaucoma, Pruritus, Feeling Hot, Skin Burning Sensation, Rash, Erythema, Urine Calcium Increased

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Fioricet; Vitamin E; Vitamin D; Sustained EYE Drop (NO Preservatives); Potassium Flouride; Xopenex; Magnesium; Ascorbic Acid; Lydexcium; Calcium; Zofran; Cinnamon; Zanaflex; Ventilan; Imitrex; Vitamin D; Brimonidine Tartrate; Valium; Dexilant; Epipen; Multivitamins, Other Combinations; Restasis; Calcium Carbonate; Zinc Sulfate; Potassium Chloride; Xanax; Ipratropium Bromide; Lidex; Nitrostat; Norco; Multaq; Albuterol



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Aphasia, Condition Aggravated, Cognitive Disorder, Memory Impairment

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Wellbutrin; Klonopin; Topamax; Thyroid TAB



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-08-02

Patient: female

Reactions: Weight Decreased, Tinnitus, Nausea, Headache, Cognitive Disorder, Muscle Twitching, Tremor, Fatigue, Malaise, Dyspepsia, Insomnia, Depression, Memory Impairment, Blood Pressure Decreased, Asthenia, Decreased Appetite

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Aspirin; Tylenol (Caplet)



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Peripheral Vascular Disorder, Hypoaesthesia

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Weight Increased, Fatigue, Malaise, Nausea, Headache

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-07-31

Patient: female

Reactions: Pruritus, Glaucoma, Feeling Hot, Skin Burning Sensation, Rash, Erythema, Urine Calcium Increased

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Zanaflex; Zofran; Multaq; Imitrex; Magnesium Sulfate; Restasis; Calcium; Lidex; Ventilan; Xanax; Vitamin E; Brimonidine Tartrate; Vitamin D; Dexilant; Albuterol; Ipratropium Bromide; Fioricet; Lydexcium; Calcium Carbonate; Potassium Flouride; Norco; Vitamin D; Xopenex; Potassium Chloride; Epipen; Multivitamins, Other Combinations; Ascorbic Acid; Cinnamon; Zinc Sulfate; Sustained EYE Drop (NO Preservatives); Valium; Nitrostat



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Systemic Lupus Erythematosus, Product Adhesion Issue, Hypertension

Drug(s) suspected as cause:
Vivelle-DOT
    Dosage: 0.025 ukn, unk

Vivelle-DOT
    Indication: Hormone Therapy

Vivelle-DOT
    Dosage: 0.05 ukn, qw2

Other drugs received by patient: Loratadine; Benicar; Multi-Vitamins; Acai; Acid Reducer; Prasterone; Multi-Vitamins; Naproxin; Atenolol; Vitamin B Complex CAP; Attenolle; Herbal Preparation; B Vitamin; Calcium



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-07-25

Patient: female, weighing 62.1 kg (136.7 pounds)

Reactions: Wrong Technique in Drug Usage Process, Endometrial Cancer Stage III, Endometrial Hypertrophy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Prometrium



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-07-25

Patient: female, weighing 160.0 kg (352.0 pounds)

Reactions: Hot Flush, Mood Altered, Sleep Disorder, Drug Ineffective

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: female

Reactions: Coeliac Disease, Condition Aggravated

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-07-19

Patient: female

Reactions: Systemic Lupus Erythematosus, Hypertension

Drug(s) suspected as cause:
Vivelle-DOT
    Dosage: 0.05 ukn, qw2

Vivelle-DOT
    Dosage: 0.025 ukn, unk

Other drugs received by patient: Prasterone; Multi-Vitamins; Benicar; Herbal Preparation; Atenolol; Vitamin B Complex CAP



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female

Reactions: Anxiety, Medication Error, Condition Aggravated, Depression, Headache

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Atenolol; Synthroid; Hydrochlorothiazide; Alora



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female

Reactions: Coeliac Disease, Condition Aggravated

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in female

Reported by a physician from United States on 2012-07-13

Patient: female

Reactions: Pruritus, Glaucoma, Skin Burning Sensation, Rash, Erythema, Urine Calcium Increased

Drug(s) suspected as cause:
Vivelle-DOT

Other drugs received by patient: Multaq; Ipratropium Bromide; Norco; Imitrex; Calcium Carbonate; Zinc Sulfate; Potassium Flouride; Xopenex; Zanaflex; Albuterol; Restasis; Cinnamon; Sustained EYE Drop (NO Preservatives); Epipen; Vitamin E; Brimonidine Tartrate; Nitrostat; Dexilant; Ventilan; Xanax; Zofran; Valium; Potassium Chloride; Ascorbic Acid; Hidrocortizon; Magnesium Sulfate; Multivitamins, Other Combinations; Lydexcium; Calcium; Lidex; Fioricet; Vitamin D; Vitamin D



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: female

Reactions: Weight Decreased, Night Sweats, Back Pain, Wrong Technique in Drug Usage Process, Drug Ineffective, Nausea, Cystocele, Hot Flush, Fatigue, Insomnia, Enterocele, Multiple Sclerosis, Menopausal Symptoms

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in 58 year old female

Reported by a physician from France on 2012-07-12

Patient: 58 year old female

Reactions: Intervertebral Disc Protrusion, Monoplegia, High Density Lipoprotein Increased, Pain, Blood Triglycerides Increased, Paraesthesia, Weight Increased, Limb Discomfort, Dyspepsia, Oedema Peripheral, Blood Cholesterol Increased

Drug(s) suspected as cause:
Simvastatin
    Indication: Hyperlipidaemia

Vivelle-DOT
    Dosage: 37.5 ug,

Vivelle-DOT
    Dosage: 25 ug,
    Indication: Hormone Replacement Therapy
    Start date: 2010-03-18

Vivelle-DOT
    Dosage: 75 ug, 2 patches weekly
    Start date: 2012-06-01
    End date: 2012-06-24

Other drugs received by patient: Xanax; Esomeprazole; Amitriptyline HCL



Possible Vivelle-DOT side effects in 58 year old female

Reported by a physician from France on 2012-07-12

Patient: 58 year old female

Reactions: Intervertebral Disc Protrusion, High Density Lipoprotein Increased, Monoplegia, Pain, Blood Triglycerides Increased, Paraesthesia, Weight Increased, Limb Discomfort, Dyspepsia, Oedema Peripheral, Blood Cholesterol Increased

Drug(s) suspected as cause:
Simvastatin
    Indication: Hyperlipidaemia

Vivelle-DOT
    Dosage: 37.5 ug,

Vivelle-DOT
    Dosage: 75 ug, 2 patches weekly
    Start date: 2012-06-01
    End date: 2012-06-24

Vivelle-DOT
    Dosage: 25 ug,
    Indication: Hormone Replacement Therapy
    Start date: 2010-03-18

Other drugs received by patient: Esomeprazole; Xanax; Amitriptyline HCL



Possible Vivelle-DOT side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: female

Reactions: Wrong Technique in Drug Usage Process, Accident AT Work, Foreign Body, Hormone Level Abnormal, Loss of Consciousness, Convulsion

Drug(s) suspected as cause:
Vivelle-DOT



Possible Vivelle-DOT side effects in 58 year old female

Reported by a consumer/non-health professional from France on 2012-07-03

Patient: 58 year old female

Reactions: Intervertebral Disc Protrusion, High Density Lipoprotein Increased, Monoplegia, Pain, Blood Triglycerides Increased, Paraesthesia, Weight Increased, Limb Discomfort, Dyspepsia, Oedema Peripheral, Blood Cholesterol Increased

Drug(s) suspected as cause:
Simvastatin
    Indication: Hyperlipidaemia

Vivelle-DOT
    Dosage: 37.5 ug, unk

Vivelle-DOT
    Dosage: 75 ug, 2 patches weekly
    Start date: 2012-06-01
    End date: 2012-06-24

Vivelle-DOT
    Dosage: 25 ug, unk
    Indication: Hormone Replacement Therapy

Other drugs received by patient: Xanax; Esomeprazole; Amitriptyline HCL

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