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Index of reports
> Cases with Insomnia (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vivelle-DOT (Estradiol) where reactions include insomnia. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 2012-08-02
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 2012-07-12
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 female
Reported by a consumer/non-health professional from United States on 2012-07-02
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 67 year old female
Reported by a consumer/non-health professional from United States on 2012-03-26
Patient: 67 year old female, weighing 13.6 kg (29.9 pounds)
Reactions: Weight Increased, Insomnia, Feeling Abnormal
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 2012-03-26
Patient: female
Reactions: Hot Flush, Drug Ineffective, Insomnia, Depression
Drug(s) suspected as cause:
Vivelle-DOT
Possible Vivelle-DOT side effects in female
Reported by a individual with unspecified qualification from United States on 2011-12-14
Patient: female
Reactions: Hypersensitivity, Drug Ineffective, Urticaria, Sleep Talking, Pyrexia, Erythema, Application Site Pruritus, Abdominal Discomfort, Malaise, Pharyngeal Oedema, Oedema Peripheral, Cold Sweat, Muscle Spasms, Pain in Extremity, Application Site Pain, Application Site Rash, Middle Insomnia, Insomnia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Antibiotics
Flagyl
Metoprolol Succinate
Dosage: 50 mg, qd
Ranitidine Hydrochloride
Dosage: 150 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Vivelle-DOT
Dosage: 0.05 mg, qw2
Start date: 1995-01-01
Vivelle-DOT
Dosage: 0.05 mg, qw2
Other drugs received by patient: Ascorbic Acid; Vitamin E; Vitamin B NOS; Naproxen Sodium; Vitamin D; Zinc; Similasan; Toprol-XL; Vitamin A; Potassium Chloride; Tylenol-500; Equate (Acetylsalicylic Acid); Zantac
Possible Vivelle-DOT side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-30
Patient: female, weighing 61.7 kg (135.7 pounds)
Reactions: Pharyngeal Inflammation, Asthma, Increased Upper Airway Secretion, Dysphagia, Upper-Airway Cough Syndrome, Hot Flush, DRY Mouth, Insomnia, DRY Throat, Nasal Inflammation, Nasal Dryness, Cough, Aphonia
Drug(s) suspected as cause:
Azelastine HCL
Dosage: one or two puffs as needed
Indication: Upper-Airway Cough Syndrome
Start date: 2011-01-01
Climara
Start date: 2011-01-01
End date: 2011-10-03
Climara
Dosage: eleven plus years ago
Climara
Indication: Hysterectomy
Start date: 2011-01-01
End date: 2011-01-01
Climara
Start date: 2011-01-01
Medrol
Indication: Increased Upper Airway Secretion
Start date: 2011-01-01
End date: 2011-01-01
Medrol
Indication: Cough
Start date: 2011-01-01
End date: 2011-01-01
Vivelle-DOT
Indication: Hysterectomy
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Indication: Cough
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Dosage: as per the course
Indication: Increased Upper Airway Secretion
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Dosage: as per the course
Start date: 2011-01-01
End date: 2011-01-01
Zyrtec
Dosage: splitting the tablets in half
Administration route: Oral
Indication: Antiallergic Therapy
Start date: 2011-01-01
Zyrtec
Administration route: Oral
Start date: 2011-01-01
End date: 2011-01-01
Other drugs received by patient: Cozaar
Possible Vivelle-DOT side effects in female
Reported by a individual with unspecified qualification from United States on 2011-11-28
Patient: female
Reactions: Hypersensitivity, Drug Ineffective, Urticaria, Sleep Talking, Pyrexia, Erythema, Application Site Pruritus, Abdominal Discomfort, Pharyngeal Oedema, Malaise, Oedema Peripheral, Cold Sweat, Muscle Spasms, Pain in Extremity, Application Site Rash, Insomnia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Antibiotics
Flagyl
Metoprolol Succinate
Dosage: 50 mg, qd
Ranitidine Hydrochloride
Dosage: 150 mg, qd
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Vivelle-DOT
Dosage: 0.05 mg, qw2
Start date: 1995-01-01
Vivelle-DOT
Dosage: 0.05 mg, qw2
Other drugs received by patient: Similasan; Zinc; Vitamin A; Naproxen Sodium; Equate (Acetylsalicylic Acid); Zantac; Ascorbic Acid; Vitamin E; Potassium Acetate; Toprol-XL; Vitamin D; Vitamin B NOS; Tylenol-500
Possible Vivelle-DOT side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-18
Patient: female, weighing 61.7 kg (135.7 pounds)
Reactions: Asthma, Pharyngeal Inflammation, Increased Upper Airway Secretion, Dysphagia, Upper-Airway Cough Syndrome, Hot Flush, Insomnia, DRY Throat, DRY Mouth, Nasal Inflammation, Nasal Dryness, Cough, Aphonia
Drug(s) suspected as cause:
Azelastine HCL
Dosage: one or two puffs as needed
Indication: Upper-Airway Cough Syndrome
Start date: 2011-01-01
Climara
Dosage: eleven plus years ago
Climara
Indication: Hysterectomy
Start date: 2011-01-01
End date: 2011-01-01
Climara
Start date: 2011-01-01
End date: 2011-10-03
Climara
Start date: 2011-01-01
Medrol
Indication: Increased Upper Airway Secretion
Start date: 2011-01-01
End date: 2011-01-01
Medrol
Indication: Cough
Start date: 2011-01-01
End date: 2011-01-01
Vivelle-DOT
Indication: Hysterectomy
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Dosage: as per the course
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Indication: Cough
Start date: 2011-01-01
End date: 2011-01-01
Zithromax
Dosage: as per the course
Indication: Increased Upper Airway Secretion
Start date: 2011-01-01
End date: 2011-01-01
Zyrtec
Dosage: splitting the tablets in half
Administration route: Oral
Indication: Antiallergic Therapy
Start date: 2011-01-01
Zyrtec
Administration route: Oral
Start date: 2011-01-01
End date: 2011-01-01
Other drugs received by patient: Cozaar
Possible Vivelle-DOT side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2011-11-18
Patient: 60 year old female, weighing 61.7 kg (135.7 pounds)
Reactions: Aphagia, Asthma, Nightmare, Increased Upper Airway Secretion, Upper-Airway Cough Syndrome, Upper Respiratory Tract Inflammation, Hot Flush, Insomnia, DRY Throat, DRY Mouth, Nasal Dryness, Cough, Aphonia
Drug(s) suspected as cause:
Climara
Dosage: 0375 mg, unk
Indication: Hysterectomy
Start date: 2011-01-01
End date: 2011-10-03
Climara
Dosage: 0.375 mg, unk
Indication: Autonomic Nervous System Imbalance
Start date: 2000-01-01
Vivelle-DOT
Dosage: 0.275 mg, q2wk
Indication: Hysterectomy
Start date: 2011-01-01
Other drugs received by patient: Losartan
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