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: 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 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 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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