This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vivelle (Estradiol Transdermal) 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 (15)
Reports by Reaction Type
Dysarthria (8),
Hypertension (8),
Mental Status Changes (6),
Hypokalaemia (6),
Polymedication (6),
Condition Aggravated (4),
Lymphadenopathy (3),
Uterine Leiomyoma (3),
Lymphoedema (3),
Breast Cancer (3),
Osteoarthritis (3),
Anxiety (3)
Possible Vivelle side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: 49 year old female
Reactions: Malaise, Nausea
Drug(s) suspected as cause:
Vivelle
Dosage: 0.1mg patches on arms, feet, legs except breast
Estradiol
Premarin
Estrace
Possible Vivelle side effects in 12 year old female
Reported by a individual with unspecified qualification from United States on 2012-05-11
Patient: 12 year old female, weighing 32.7 kg (71.8 pounds)
Reactions: Alopecia
Drug(s) suspected as cause:
Vivelle
Possible Vivelle side effects in female
Reported by a physician from United States on 2012-05-03
Patient: female, weighing 76.6 kg (168.6 pounds)
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Bactrim
Dosage: unk
Penicillin G Potassium
Dosage: unk
Azithromycin
Dosage: unk
Morphine Sulfate
Dosage: unk
Vivelle
Dosage: unk
Possible Vivelle side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-15
Patient: female, weighing 89.4 kg (196.7 pounds)
Reactions: Dysarthria, Polymedication, Mental Status Changes, Headache, Hypertension, Asthenia, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lexapro
Administration route: Oral
Indication: Post-Traumatic Stress Disorder
Ambien
Administration route: Oral
Indication: Insomnia
Lyrica
Administration route: Oral
Indication: Fibromyalgia
Clonazepam
Administration route: Oral
Indication: Bipolar Disorder
Ibuprofen
Administration route: Oral
Indication: Fibromyalgia
Placebo
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Lexapro
Administration route: Oral
Indication: Bipolar Disorder
Robaxin
Indication: Fibromyalgia
Zestoretic
Dosage: 20/12.5 daily
Administration route: Oral
Indication: Hypertension
Start date: 2008-12-04
Desvenlafaxine Succinate Monohydrate
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Placebo
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Loratadine
Administration route: Oral
Indication: Seasonal Allergy
Vicodin
Dosage: 5/500 as needed
Administration route: Oral
Indication: Fibromyalgia
Vivelle
Indication: Hormone Replacement Therapy
Desvenlafaxine Succinate Monohydrate
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Abilify
Administration route: Oral
Indication: Bipolar I Disorder
Fluticasone
Indication: Seasonal Allergy
Possible Vivelle side effects in female
Reported by a physician from United States on 2012-03-13
Patient: female, weighing 89.4 kg (196.7 pounds)
Reactions: Dysarthria, Polymedication, Mental Status Changes, Condition Aggravated, Hypertension, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abilify
Dosage: 15 mg, 2x/day
Administration route: Oral
Indication: Bipolar I Disorder
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Lexapro
Dosage: 20 mg, 1x/day
Administration route: Oral
Indication: Post-Traumatic Stress Disorder
Fluticasone
Dosage: 2 sprays daily route: in
Indication: Seasonal Allergy
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Lyrica
Dosage: 75 mg, 1x/day
Administration route: Oral
Indication: Fibromyalgia
Robaxin
Dosage: 750 mg, 3x/day
Administration route: Oral
Indication: Fibromyalgia
Clonazepam
Dosage: 1 mg, 2x/day
Administration route: Oral
Indication: Bipolar Disorder
Vicodin
Dosage: 5/500 prn
Administration route: Oral
Indication: Fibromyalgia
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Loratadine
Dosage: 10 mg, 1x/day
Administration route: Oral
Indication: Seasonal Allergy
Robaxin
Dosage: unknown
Lexapro
Indication: Bipolar Disorder
Vivelle
Dosage: 0.1 mg, unk
Indication: Hormone Replacement Therapy
Ibuprofen
Dosage: 800 mg, 3x/day
Administration route: Oral
Indication: Fibromyalgia
Ambien
Dosage: 10 mg, 1x/day
Administration route: Oral
Indication: Insomnia
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Zestoretic
Dosage: 20/12.5 daily
Administration route: Oral
Indication: Hypertension
Start date: 2008-12-04
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Possible Vivelle side effects in female
Reported by a physician from United States on 2012-02-10
Patient: female
Reactions: Thrombosis, Asthma, Lymphadenopathy, Hypoglycaemia, Osteomyelitis, Lipids Increased, Cerebrovascular Disorder, Peripheral Sensory Neuropathy, Oedema Peripheral, Uterine Leiomyoma, Irritable Bowel Syndrome, Postmenopausal Haemorrhage, Hypoxia, Breast Cancer, Pneumonia, Pain in Extremity, Mastitis, Breast Mass, Hypoaesthesia, Diverticulum Intestinal, Adenomyosis, Diabetic Neuropathy, Staphylococcal Infection, Nervous System Disorder, Gastric Polyps, non-Hodgkin's Lymphoma, Sleep Apnoea Syndrome, Uterine Haemorrhage, Aphasia, Viith Nerve Paralysis, Fibrocystic Breast Disease, Neuropathy Peripheral, Fibromyalgia, Obesity, Depression, Lymphoedema, Transient Ischaemic Attack, Migraine, Abdominal Pain Lower, Type 2 Diabetes Mellitus, Motor Dysfunction, Urinary Tract Infection, Cognitive Disorder, Cystitis, Amnesia, Cerebrovascular Accident, Anxiety, Osteoarthritis, Dysarthria, Diarrhoea, Arthralgia, Dysuria, Flank Pain, Alopecia, Gait Disturbance, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Estraderm
Dosage: 0.5 mg, unk
Indication: Hormone Replacement Therapy
Start date: 1994-04-01
End date: 1997-06-01
Vivelle
Dosage: 0.1 mg, unk
Indication: Hormone Replacement Therapy
Start date: 1997-10-01
End date: 1997-12-01
Provera
Dosage: 2.5 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-03-01
End date: 1994-08-01
Premarin
Indication: Hormone Replacement Therapy
Medroxyprogesterone Acetate
Dosage: 2.5 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-09-01
End date: 2000-02-16
Estraderm
Dosage: 0.1 mg, unk
Start date: 1997-08-01
End date: 2000-02-01
Possible Vivelle side effects in female
Reported by a lawyer from United States on 2012-01-12
Patient: female
Reactions: Asthma, Thrombosis, Lymphadenopathy, Hypoglycaemia, Cerebrovascular Disorder, Lipids Increased, Peripheral Sensory Neuropathy, Uterine Leiomyoma, Irritable Bowel Syndrome, Hypoxia, Postmenopausal Haemorrhage, Breast Cancer, Pneumonia, Pain in Extremity, Breast Mass, Hypoaesthesia, Diverticulum Intestinal, Adenomyosis, Staphylococcal Infection, Diabetic Neuropathy, Nervous System Disorder, Gastric Polyps, non-Hodgkin's Lymphoma, Sleep Apnoea Syndrome, Uterine Haemorrhage, Aphasia, Viith Nerve Paralysis, Neuropathy Peripheral, Fibrocystic Breast Disease, Fibromyalgia, Obesity, Depression, Lymphoedema, Transient Ischaemic Attack, Migraine, Abdominal Pain Lower, Type 2 Diabetes Mellitus, Motor Dysfunction, Cognitive Disorder, Amnesia, Cerebrovascular Accident, Osteoarthritis, Dysarthria, Anxiety, Arthralgia, Diarrhoea, Gait Disturbance, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Estraderm
Dosage: 0.5 mg, unk
Indication: Hormone Replacement Therapy
Start date: 1994-04-01
End date: 1997-06-01
Vivelle
Dosage: 0.1 mg, unk
Indication: Hormone Replacement Therapy
Start date: 1997-10-01
End date: 1997-12-01
Premarin
Indication: Hormone Replacement Therapy
Provera
Dosage: 2.5 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-03-01
End date: 1994-08-01
Estraderm
Dosage: 0.1 mg, unk
Start date: 1997-08-01
End date: 2000-02-01
Medroxyprogesterone Acetate
Dosage: 2.5 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-09-01
End date: 2000-02-16
Possible Vivelle side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-05
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Abdominal Discomfort, Wrong Technique in Drug Usage Process, Fatigue
Drug(s) suspected as cause:
Vivelle
Dosage: 1 in 3 d, patch, applied to skin
Indication: Hormone Replacement Therapy
Synthroid
Dosage: daily in morning
Administration route: Oral
Indication: Hypothyroidism
Start date: 2010-11-19
Possible Vivelle side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-23
Patient: female, weighing 89.4 kg (196.7 pounds)
Reactions: Dysarthria, Polymedication, Mental Status Changes, Headache, Hypertension, Asthenia, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Desvenlafaxine Succinate Monohydrate
Administration route: Oral
Start date: 2008-09-09
End date: 2008-11-22
Lexapro
Indication: Ill-Defined Disorder
Fluticasone Furoate
Indication: Ill-Defined Disorder
Loratadine
Indication: Ill-Defined Disorder
Vicodin
Dosage: 5/500 as needed
Indication: Ill-Defined Disorder
Ambien
Administration route: Oral
Indication: Ill-Defined Disorder
Lyrica
Indication: Ill-Defined Disorder
Placebo
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Abilify
Indication: Ill-Defined Disorder
Vivelle
Indication: Ill-Defined Disorder
Zestoretic
Dosage: 20/12.5 daily
Indication: Ill-Defined Disorder
Desvenlafaxine Succinate Monohydrate
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-11-29
End date: 2008-12-24
Robaxin
Indication: Ill-Defined Disorder
Ibuprofen
Indication: Ill-Defined Disorder
Placebo
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Clonazepam
Indication: Ill-Defined Disorder
Possible Vivelle side effects in female
Reported by a physician from United States on 2011-12-20
Patient: female, weighing 89.4 kg (196.7 pounds)
Reactions: Dysarthria, Polymedication, Mental Status Changes, Condition Aggravated, Hypertension, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Ibuprofen
Dosage: 800 mg, 3x/day
Robaxin
Dosage: unknown
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Clonazepam
Dosage: 1 mg, 2x/day
Lexapro
Dosage: 20 mg, 1x/day
Vicodin
Dosage: 5/500 prn
Ambien
Dosage: 10 mg, 1x/day
Administration route: Oral
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Zestoretic
Dosage: 20/12.5 daily
Lyrica
Dosage: 75 mg, 1x/day
Fluticasone Furoate
Dosage: 2 sprays daily
Abilify
Dosage: 15 mg, 2x/day
Vivelle
Dosage: 0.1 mg, unk
Loratadine
Dosage: 10 mg, 1x/day
Robaxin
Dosage: 750 mg, 3x/day
Administration route: Oral
Possible Vivelle side effects in female
Reported by a physician from United States on 2011-12-19
Patient: female, weighing 89.4 kg (196.7 pounds)
Reactions: Dysarthria, Polymedication, Mental Status Changes, Condition Aggravated, Hypertension, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abilify
Dosage: 15 mg, 2x/day
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Fluticasone Propionate
Dosage: 2 sprays daily
Vicodin
Dosage: 5/500 prn
Ambien
Dosage: 10 mg, 1x/day
Administration route: Oral
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Lyrica
Dosage: 75 mg, 1x/day
Vivelle
Dosage: 0.1 mg, unk
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Robaxin
Dosage: 750 mg, 3x/day
Administration route: Oral
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Ibuprofen
Dosage: 800 mg, 3x/day
Clonazepam
Dosage: 1 mg, 2x/day
Loratadine
Dosage: 10 mg, 1x/day
Zestoretic
Dosage: 20/12.5 daily
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Lexapro
Dosage: 20 mg, 1x/day
Possible Vivelle side effects in female
Reported by a physician from United States on 2011-12-16
Patient: female, weighing 89.4 kg (196.7 pounds)
Reactions: Dysarthria, Polymedication, Condition Aggravated, Mental Status Changes, Hypertension, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lexapro
Dosage: 20 mg, 1x/day
Vivelle
Dosage: 0.1 mg, unk
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Blinded NO Subject Drug
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Loratadine
Dosage: 10 mg, 1x/day
Robaxin
Dosage: unknown
Abilify
Dosage: 15 mg, 2x/day
Ibuprofen
Dosage: 800 mg, 3x/day
Clonazepam
Dosage: 1 mg, 2x/day
Fluticasone
Dosage: 2 sprays daily
Zestoretic
Dosage: 20/12.5 daily
Ambien
Dosage: 10 mg, 1x/day
Administration route: Oral
Lyrica
Dosage: 75 mg, 1x/day
Robaxin
Dosage: 750 mg, 3x/day
Administration route: Oral
Blinded Placebo
Dosage: blinded therapy daily
Administration route: Oral
Indication: Menopausal Symptoms
Start date: 2008-09-09
End date: 2008-11-22
Blinded Desvenlafaxine Succinate Monohydrate
Dosage: blinded therapy daily
Administration route: Oral
Start date: 2008-11-29
End date: 2008-12-24
Vicodin
Dosage: 5/500 prn
Possible Vivelle side effects in female
Reported by a physician from United States on 2011-12-16
Patient: female
Reactions: Dysphagia, Dysstasia, Hypotonia, Muscular Weakness, Dizziness, Asthenia
Drug(s) suspected as cause:
Prometrium
Indication: Menopausal Symptoms
Start date: 2011-01-01
End date: 2011-01-01
Vivelle
Dosage: patch
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
End date: 2011-01-01
Possible Vivelle side effects in female
Reported by a physician from United States on 2011-12-02
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Lymphadenopathy, Uterine Leiomyoma, Oedema Peripheral, Arteriosclerosis, Breast Pain, Breast Cancer, Cellulitis, Cardiac Murmur, Osteopenia, Hirsutism, Cerebral Small Vessel Ischaemic Disease, Metastases To Spine, Uterine Disorder, Scar, Bone Pain, Fall, Metastases To Lymph Nodes, Intervertebral Disc Disorder, Dizziness, Oedema, Abdominal Distension, Metastases To Peritoneum, Lymphoedema, Lymph Node Fibrosis, Breast Disorder, Musculoskeletal Pain, Cerebral Atrophy, Osteoarthritis, Anxiety, Mitral Valve Incompetence, Metastases To Bone, Deep Vein Thrombosis
Drug(s) suspected as cause:
Vivelle
Dosage: 0.05mg
Indication: Hormone Replacement Therapy
Start date: 1998-12-30
Combipatch
Dosage: 50/140mcg
Indication: Menopause
Start date: 1998-12-19
Gynodiol
Dosage: 1 mg, unk
Vivelle
Dosage: 0.025mg
Administration route: Topical
Prometrium
Dosage: 100mg
Indication: Hormone Replacement Therapy
Start date: 1998-12-30
Prempro
Dosage: 2.5mg
Indication: Menopause
Start date: 1998-03-13
Vagifem
Dosage: 25 ug, unk
Vivelle
Dosage: .075 mg, unk
Estradiol
Dosage: 1 mg, unk
Gynodiol
Dosage: 0.5 mg, unk
Indication: Hormone Replacement Therapy
Estradiol
Dosage: 0.5mg
Indication: Menopause
Start date: 1999-03-12
Other drugs received by patient: Aldactone; Wellbutrin; Femara; Remeron; Paxil; Dyazide; Spironolactone; Nolvadex; Prozac; Zyban; Xenical; Miacalcin; Aromasin; Alprazolam; Hydrochlorothiazide; Proventil; Zyrtec; Buspar
Possible Vivelle side effects in 57 year old female
Reported by a pharmacist from United States on 2011-11-07
Patient: 57 year old female
Reactions: Confusional State
Drug(s) suspected as cause:
Klor-CON
Dosage: unk
Lipitor
Dosage: 40 mg, unk
Bystolic
Dosage: unk
Lasix
Dosage: unk
Nexium
Dosage: unk
Vivelle
Dosage: unk
Paxil
Dosage: unk
Flexeril
Dosage: unk
Xanax
Dosage: unk
Imdur
Dosage: unk
Actonel
Dosage: unk
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