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Vagifem (Estradiol Vaginal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vagifem (Estradiol Vaginal) 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 (42)
Death (6)

Reports by Reaction Type

Headache (7)Vomiting (7)Cerebral Haemorrhage (6)Fall (5)Extrasystoles (4)Snoring (4)Muscle Rigidity (4)Viith Nerve Paralysis (4)Speech Disorder (4)Facial Paresis (4)Neck Pain (4)Facial Asymmetry (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Vagifem (Estradiol Vaginal). For a complete list or a specific selection of reports, please use the links above.

Possible Vagifem side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 68 year old female, weighing 47.2 kg (103.8 pounds)

Reactions: Uterine Leiomyoma, Vaginal Haemorrhage

Drug(s) suspected as cause:
Vagifem
    Dosage: 5 a?g, qd
    Start date: 2002-01-01

Vagifem
    Dosage: 10 a?g, qd
    Indication: Atrophic Vulvovaginitis
    Start date: 2002-01-01

Other drugs received by patient: Vitamins / 00067501 /; Melatonin; Glucosamine



Possible Vagifem side effects in 59 year old female

Reported by a consumer/non-health professional from Sweden on 2012-08-27

Patient: 59 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Weight Increased, Abscess

Drug(s) suspected as cause:
Vagifem
    Dosage: unk
    Indication: Atrophic Vulvovaginitis

Vagifem
    Dosage: unk



Possible Vagifem side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 67 year old female, weighing 71.7 kg (157.6 pounds)

Reactions: Transient Ischaemic Attack

Drug(s) suspected as cause:
Vagifem



Possible Vagifem side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 74 year old female, weighing 60.3 kg (132.7 pounds)

Reactions: Bladder Spasm, Drug Dose Omission, Bladder Prolapse, Drug Ineffective, Vulvovaginal Dryness, Pollakiuria, Expired Drug Administered, Vulvovaginal Pain

Drug(s) suspected as cause:
Oxybutynin
    Dosage: unk
    Indication: Urge Incontinence

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Vulvovaginal Dryness

Premarin
    Dosage: 0.625 mg, 2x/day
    Indication: Vulvovaginal Dryness
    Start date: 2012-06-08

Premarin
    Indication: Vulvovaginal Discomfort

Toviaz
    Dosage: 4 mg, daily
    Administration route: Oral
    Indication: Urge Incontinence
    Start date: 2012-06-08

Vagifem
    Dosage: unk



Possible Vagifem side effects in 59 year old female

Reported by a pharmacist from United States on 2012-08-14

Patient: 59 year old female, weighing 67.1 kg (147.7 pounds)

Reactions: Drug Ineffective, Product Solubility Abnormal

Drug(s) suspected as cause:
Vagifem



Possible Vagifem side effects in 56 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 56 year old female, weighing 67.1 kg (147.7 pounds)

Reactions: Irritability, Hot Flush, Acne, Hair Growth Abnormal, Vaginal Discharge, Seborrhoea

Drug(s) suspected as cause:
Vagifem



Possible Vagifem side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 66 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Road Traffic Accident, Femur Fracture, Drug Ineffective

Drug(s) suspected as cause:
Vagifem
    Dosage: 10 a?g, qd
    Indication: Vulvovaginal Dryness
    Start date: 2010-01-01

Vagifem
    Dosage: 10 a?g, tid
    Indication: Vulvovaginal Pain

Vagifem
    Dosage: 10 a?g, bid

Vagifem
    Dosage: 10 a?g, prn
    End date: 2012-06-25

Other drugs received by patient: Humulin / 00646003 /; Insulin Isophane; Lipitor; Lipitor



Possible Vagifem side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 71 year old female, weighing 90.7 kg (199.5 pounds)

Reactions: Joint Swelling, Rash Erythematous, Hypoaesthesia

Drug(s) suspected as cause:
Vagifem
    Dosage: 10 mcg, twice weekly
    Indication: Vulvovaginal Dryness
    End date: 2012-06-03

Vagifem
    Indication: Postmenopause

Vagifem
    Indication: Prophylaxis

Other drugs received by patient: Allegra; Verapamil



Possible Vagifem side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-10

Patient: 66 year old female

Reactions: Snoring, Headache, Hemiparesis, Fall, Muscle Rigidity, Viith Nerve Paralysis, Cerebral Haemorrhage, Speech Disorder, Facial Paresis, Cardio-Respiratory Arrest, Neck Pain, Babinski Reflex Test, Hypertonia, Facial Asymmetry, Defaecation Urgency, Pupillary Reflex Impaired, Vomiting, Visual Field Defect, Muscular Weakness, General Physical Health Deterioration, Micturition Urgency, Stress, Cerebrovascular Accident, Muscle Twitching, Convulsion, Hypertensive Crisis, Dysarthria, Limb Asymmetry, Essential Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clobetasol Propionate
    Dosage: bid; topical
    Administration route: Topical
    Start date: 2012-02-17

Trimethoprim
    Dosage: 200 mg; bid
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Vagifem
    Dosage: 25 mcg; vaginal
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Other drugs received by patient: Nitroglycerin; Fluoxetine; Acetylsalicylic Acid SRT; Albuterol Sulate; Levothyroxine Sodium; Simvastatin; Amitriptyline Hydrochloride; Trinitrate; Ramipril; Metformin Hydrochloride; Nebivolol; Gliclazide; Mebeverine; Salmeterol



Possible Vagifem side effects in 59 year old female

Reported by a consumer/non-health professional from Sweden on 2012-07-10

Patient: 59 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Breast Discomfort, Abscess

Drug(s) suspected as cause:
Vagifem
    Dosage: 10 mcg, unk
    Indication: Product Used FOR Unknown Indication

Vagifem
    Dosage: 25 mcg, unk



Possible Vagifem side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-09

Patient: 66 year old female

Reactions: Snoring, Headache, Muscle Rigidity, Extensor Plantar Response, Fall, Viith Nerve Paralysis, Cerebral Haemorrhage, Speech Disorder, Facial Paresis, Neck Pain, Hypertonia, Facial Asymmetry, Defaecation Urgency, Pupillary Reflex Impaired, Vomiting, Visual Field Defect, Muscular Weakness, Micturition Urgency, Cerebrovascular Accident, Muscle Twitching, Convulsion, Dysarthria, Limb Asymmetry, Essential Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clobetasol Propionate
    Dosage: 2/
    Administration route: Topical
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Trimethoprim
    Dosage: 200 mg, bid
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Vagifem
    Dosage: 25 a?g, unk
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Other drugs received by patient: Fluoxetine; Amitriptyline HCL; Aspirin; Nebivolol; Albuterol Sulate; Ramipril; Gliclazide; Levothyroxine Sodium; Metformin HCL; Salmeterol; Nitroglycerin; Mebeverine; Simvastatin



Possible Vagifem side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 68 year old female, weighing 47.6 kg (104.8 pounds)

Reactions: Uterine Leiomyoma

Drug(s) suspected as cause:
Vagifem
    Dosage: 10 mcg twice a week rectal ; 10 mcg once a week rectal 9 months twice a week
    Indication: Atrophic Vulvovaginitis
    Start date: 2008-01-01
    End date: 2011-11-01

Vagifem
    Dosage: 10 mcg twice a week rectal ; 10 mcg once a week rectal 9 months twice a week
    Indication: Atrophic Vulvovaginitis
    Start date: 2011-11-01
    End date: 2012-05-02



Possible Vagifem side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: female, weighing 53.5 kg (117.7 pounds)

Reactions: Surgery, Breast Tenderness, Knee Arthroplasty, Urinary Retention, Post Procedural Discomfort, Constipation, Cystocele

Drug(s) suspected as cause:
Acetaminophen
    Dosage: unk

Celebrex
    Dosage: unk

Darifenacin
    Dosage: unk

Mobic
    Dosage: unk

Premarin
    Dosage: 0.625 mg, 1x/day
    Administration route: Oral
    Start date: 2010-09-27
    End date: 2010-10-01

Premarin
    Dosage: 0.3 mg, 1x/day
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1970-01-01
    End date: 2006-01-01

Premarin
    Dosage: 0.3 mg, 1x/day
    Administration route: Oral
    Start date: 2010-08-01
    End date: 2010-09-27

Vagifem
    Dosage: unk
    Start date: 2010-08-27



Possible Vagifem side effects in 66 year old female

Reported by a physician from United Kingdom on 2012-07-05

Patient: 66 year old female

Reactions: Snoring, Hemiparesis, Headache, Fall, Muscle Rigidity, Viith Nerve Paralysis, Cerebral Haemorrhage, Speech Disorder, Facial Paresis, Neck Pain, Babinski Reflex Test, Facial Asymmetry, Hypertonia, Defaecation Urgency, Pupillary Reflex Impaired, Vomiting, Visual Field Defect, Muscle Twitching, Cerebrovascular Accident, Micturition Urgency, Hypertensive Crisis, Convulsion, Dysarthria, Limb Asymmetry, Essential Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clobetasol Propionate
    Administration route: Topical
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Trimethoprim
    Dosage: 400mg per day
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Vagifem
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Other drugs received by patient: Levothyroxine Sodium; Salmeterol; Gliclazide; Ramipril; Amitriptyline HCL; Fluoxetine; Nebivolol; Metformin HCL; Albuterol Sulate; Mebeverine; Simvastatin; Nitroglycerin; Gliclazide; Aspirin; Nebivolol



Possible Vagifem side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: 71 year old female, weighing 90.7 kg (199.5 pounds)

Reactions: Joint Swelling, Rash Erythematous, Hypoaesthesia

Drug(s) suspected as cause:
Vagifem
    Dosage: 10 mcg, twice weekly
    Indication: Vulvovaginal Dryness
    End date: 2012-06-03

Vagifem
    Indication: Postmenopause

Vagifem
    Indication: Prophylaxis

Other drugs received by patient: Verapamil; Allegra



Possible Vagifem side effects in female

Reported by a physician from United Kingdom on 2012-06-17

Patient: female

Reactions: Snoring, Hemiparesis, Headache, Muscle Rigidity, Fall, Viith Nerve Paralysis, Cerebral Haemorrhage, Speech Disorder, Facial Paresis, Neck Pain, Babinski Reflex Test, Facial Asymmetry, Hypertonia, Defaecation Urgency, Pupillary Reflex Impaired, Vomiting, Visual Field Defect, Cerebrovascular Accident, Micturition Urgency, Muscle Twitching, Hypertensive Crisis, Convulsion, Dysarthria, Limb Asymmetry, Essential Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clobetasol Propionate
    Dosage: 0.05% 1-2- daily
    Administration route: Topical
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Trimethoprim
    Dosage: 400 milligram;
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Vagifem
    Indication: Atrophic Vulvovaginitis
    Start date: 2012-02-17

Other drugs received by patient: Levothyroxine Sodium; Gliclazide; Aspirin; Microlet Lancets 0.5mrnl28gauge; Contour Testing Strips; Nebivolol; Nebivolol; Simvastatin; Amitriptyline HCL; Gliclazide; Metformin HCL; Fluoxetine; Mebeverine; Nitroglycerin; Salmeterol 25micrograms / Dose Inhaler; Ramipril; Salbutamol 100 Micrograms Dose Braeth Acuated Inhaler CFC Free



Possible Vagifem side effects in 66 year old female

Reported by a physician from United Kingdom on 2012-06-05

Patient: 66 year old female

Reactions: Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Vagifem

Other drugs received by patient: Simvastatin; Salmeterol / Fluticasonpropionaat; Amlodipine; Nebivolol; Aspirin; Beclomethasone Dipropionate; Albuterol; Mebeverine; Bendroflumethiazide; Fluoxetine; Acetaminophen and Codeine Phosphate; Ramipril; Salmeterol; Ranitidine; Simvastatin; Levothyroxine Sodium; Metformin HCL; Amitriptyline HCL; Gliclazide; Levothyroxine Sodium



Possible Vagifem side effects in 74 year old female

Reported by a physician from Malta on 2012-06-01

Patient: 74 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Ovarian Epithelial Cancer

Drug(s) suspected as cause:
Vagifem
    Dosage: twice weekly for 10 weeks

Vagifem
    Dosage: once daily for 2 weeks
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Vagifem
    Dosage: once weekly

Other drugs received by patient: Paroxetine HCL; Perindopril Erbumine; Aspirin



Possible Vagifem side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: 72 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Breast Cancer Recurrent

Drug(s) suspected as cause:
Vagifem
    Dosage: unknown
    Indication: Vulvovaginal Dryness
    Start date: 2006-01-01
    End date: 2011-01-01

Vagifem
    Dosage: unk, biw
    Indication: Vulvovaginal Dryness
    Start date: 2011-01-01
    End date: 2012-01-05

Other drugs received by patient: Mobic



Possible Vagifem side effects in 66 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-05-24

Patient: 66 year old female

Reactions: Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Vagifem

Other drugs received by patient: Ranitidine; Acetaminophen and Codeine Phosphate; Gliclazide; Amlodipine Besylate; Amitriptyline HCL; Albuterol; Aspirin; Fluoxetine; Metformin HCL; Simvastatin; Ramipril; Salmeterol; Mebeverine; Levothyroxine Sodium; Simvastatin; Levothyroxine Sodium; Salmeterol / Fluticasonpropionaat; Bendroflumethiazide; Nebivolol; Beclomethasone Dipropionate



Possible Vagifem side effects in 74 year old female

Reported by a physician from Italy on 2012-05-23

Patient: 74 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Ovarian Epithelial Cancer

Drug(s) suspected as cause:
Vagifem
    Dosage: once daily for 2 weeks
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Vagifem
    Dosage: once weekly

Vagifem
    Dosage: twice weekly for 10 weeks

Other drugs received by patient: Paroxetine; Aspirin; Perindopril Erbumine



Possible Vagifem side effects in female

Reported by a consumer/non-health professional from Denmark on 2012-05-17

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Blood Pressure Increased, Tinnitus, Extrasystoles, Atrial Fibrillation

Drug(s) suspected as cause:
Norethindrone and Estradiol
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2010-08-09

Vagifem
    Dosage: unk
    Start date: 2011-03-01

Vagifem
    Dosage: 25 mg, qd
    Indication: Menopausal Symptoms
    Start date: 2011-09-27
    End date: 2011-11-01



Possible Vagifem side effects in 56 year old female

Reported by a physician from Denmark on 2012-05-16

Patient: 56 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Extrasystoles, Atrial Fibrillation

Drug(s) suspected as cause:
Norethindrone and Estradiol
    Dosage: 1 tab, qd 25 mg qd
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2010-08-09

Vagifem
    Dosage: 1 tab, qd
    Indication: Menopausal Symptoms
    End date: 2011-03-01

Vagifem
    Dosage: 1 tab, qd
    Start date: 2011-09-27
    End date: 2011-11-01



Possible Vagifem side effects in 60 year old female

Reported by a consumer/non-health professional from Canada on 2012-05-11

Patient: 60 year old female

Reactions: Leiomyoma, Condition Aggravated

Drug(s) suspected as cause:
Vagifem



Possible Vagifem side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient: female

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vagifem



Possible Vagifem side effects in 80 year old female

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: 80 year old female, weighing 50.8 kg (111.8 pounds)

Reactions: Blood Urine Present, Dysuria, Application Site Pain

Drug(s) suspected as cause:
Vagifem
    Dosage: 1 tablet 3 times weekly
    Indication: Blood Oestrogen Decreased
    Start date: 2011-06-22
    End date: 2011-07-27

Vagifem
    Dosage: 1 tablet 3 times weekly
    Indication: Urinary Tract Infection
    Start date: 2011-06-22
    End date: 2011-07-27

Vagifem
    Dosage: 1 tablet 3 times weekly
    Indication: Blood Oestrogen Decreased
    Start date: 2011-08-24
    End date: 2011-08-31

Vagifem
    Dosage: 1 tablet 3 times weekly
    Indication: Urinary Tract Infection
    Start date: 2011-08-24
    End date: 2011-08-31



Possible Vagifem side effects in 74 year old female

Reported by a physician from Italy on 2012-04-23

Patient: 74 year old female

Reactions: Adnexa Uteri Cyst, Carbohydrate Antigen 125 Increased

Drug(s) suspected as cause:
Vagifem



Possible Vagifem side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-12

Patient: 58 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Abdominal Discomfort, Dyspnoea, Vomiting, Chest Discomfort, Diarrhoea, Nausea, Chest Pain, Loss of Consciousness

Drug(s) suspected as cause:
Vagifem
    Dosage: 25 mcg, qw
    Indication: Vulvovaginal Dryness
    End date: 2010-09-01

Vagifem
    Dosage: 1 to 3 times per week
    Indication: Vulvovaginal Dryness
    Start date: 2010-09-01
    End date: 2011-12-01

Other drugs received by patient: Prilosec; Omega 3 / 01334101 /; Vitamin D; Lactobacillus; Glucosamine + Chondroitin / 01430901 /; Calcium Carbonate



Possible Vagifem side effects in 56 year old female

Reported by a consumer/non-health professional from Denmark on 2012-03-13

Patient: 56 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Extrasystoles, Atrial Fibrillation

Drug(s) suspected as cause:
Norethindrone and Estradiol
    Dosage: 1 tab, qd 25 mg qd
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2010-08-09

Vagifem
    Dosage: 1 tab, qd
    Indication: Menopausal Symptoms
    Start date: 2011-09-01
    End date: 2011-11-01



Possible Vagifem side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: female, weighing 83.5 kg (183.6 pounds)

Reactions: Dyspnoea, Vomiting, Chest Discomfort, Nausea, Headache, Tremor, Loss of Consciousness, Syncope, Chest Pain, Vision Blurred, Cold Sweat

Drug(s) suspected as cause:
Vagifem

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