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Vivelle (Estradiol Transdermal) - Side Effect Reports to FDA

 
 



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

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 2011-12-16

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 2011-12-02

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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