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Index of reports
> Cases with Mental Status Changes (6)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vivelle (Estradiol Transdermal) where reactions include mental status changes. The selected reports were submitted to the FDA during the sample period of about a year.
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 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
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