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Index of reports
> Cases with Malaise (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vivelle-DOT (Estradiol) where reactions include malaise. 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 2012-08-01
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 58 year old female
Reported by a consumer/non-health professional from United States on 2012-03-26
Patient: 58 year old female
Reactions: Breast Cancer, Night Sweats, Malaise, Sleep Disorder
Drug(s) suspected as cause:
Ambien
Dosage: 1 df, qd ; 2 df
Vivelle-DOT
Dosage: 0.1 mg, qw2, transdermal
Other drugs received by patient: Motrin
Possible Vivelle-DOT side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-22
Patient: female
Reactions: Wrong Technique in Drug Usage Process, Drug Ineffective, Diverticulitis, Hyperhidrosis, Abdominal Pain Upper, Loss of Consciousness, Frequent Bowel Movements, Malaise, Vomiting, Nausea, Retching, Muscular Weakness, General Physical Health Deterioration, Cognitive Disorder, Cerebrovascular Accident, Tremor, Burning Sensation, Heart Rate Decreased, Diarrhoea, Blood Pressure Fluctuation
Drug(s) suspected as cause:
Estraderm
Dosage: 0.05 mg, unk
Estraderm
Dosage: 0.025 mg, unk
Progesterone
Vivelle-DOT
Dosage: 0.05 mg, qw2
Start date: 2012-01-08
Other drugs received by patient: Coumadin; Hydroxyurea
Possible Vivelle-DOT side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-08
Patient: female
Reactions: Wrong Technique in Drug Usage Process, Drug Ineffective, Diverticulitis, Hyperhidrosis, Loss of Consciousness, Abdominal Pain Upper, Malaise, Frequent Bowel Movements, Vomiting, Nausea, Retching, Muscular Weakness, Cognitive Disorder, Cerebrovascular Accident, Tremor, Burning Sensation, Heart Rate Decreased, Diarrhoea, Blood Pressure Fluctuation
Drug(s) suspected as cause:
Estraderm
Dosage: 0.05 mg, unk
Estraderm
Dosage: 0.025 mg, unk
Progesterone
Vivelle-DOT
Dosage: 0.05 mg, qw2
Start date: 2012-01-08
Other drugs received by patient: Coumadin; Hydroxyurea
Possible Vivelle-DOT side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-01
Patient: female
Reactions: Burning Sensation, Malaise, Fear, Scar
Drug(s) suspected as cause:
Climara
Vivelle-DOT
Dosage: 0.1 mg, unk
Vivelle-DOT
Dosage: 0.05 mg, unk
Possible Vivelle-DOT side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-25
Patient: female
Reactions: Wrong Technique in Drug Usage Process, Drug Ineffective, Diverticulitis, Hyperhidrosis, Loss of Consciousness, Abdominal Pain Upper, Malaise, Frequent Bowel Movements, Vomiting, Nausea, Retching, Muscular Weakness, Cognitive Disorder, Cerebrovascular Accident, Tremor, Burning Sensation, Heart Rate Decreased, Diarrhoea, Blood Pressure Fluctuation
Drug(s) suspected as cause:
Estraderm
Dosage: 0.025 mg, unk
Estraderm
Dosage: 0.05 mg, unk
Progesterone
Vivelle-DOT
Dosage: 0.05 mg, qw2
Start date: 2012-01-08
Other drugs received by patient: Hydroxyurea; Coumadin
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 individual with unspecified qualification from United States on 2011-12-08
Patient: female
Reactions: Breast Pain, Inappropriate Schedule of Drug Administration, Nausea, Pain, Headache, Anxiety, Malaise, Hot Flush, Alopecia, Breast Tenderness, Thyroid Disorder, Muscle Spasms, Influenza Like Illness
Drug(s) suspected as cause:
Estrogens Conjugated
Vivelle-DOT
Dosage: 0.5 mg, unk
Vivelle-DOT
Dosage: 0.0375 mg, every 2 days
Other drugs received by patient: Synthroid; Synthroid; Bystolic; Ambient CPR
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
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