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 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 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 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 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 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 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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