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Estrace Side Effects

Common Estrace Side Effects


The most commonly reported Estrace side effects (click to view or check a box to report):

Breast Cancer (247)
Oestrogen Receptor Assay Positive (33)
Progesterone Receptor Assay Positive (32)
Breast Cancer Female (25)
Breast Cancer In Situ (21)
Ovarian Cancer (18)
Breast Cancer Metastatic (16)
Headache (12)
Depression (12)
Pain (12)
Nausea (11)
Fatigue (10)
Arthralgia (10)
Dizziness (9)
Alopecia (9)
Hot Flush (8)
Hypertension (8)
Muscle Spasms (8)
Palpitations (7)
Urinary Tract Infection (7)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Estrace Side Effects Reported to FDA

The following Estrace reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Estrace on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Local Swelling, Trigger Finger, Arthralgia
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: vulvovaginal dryness, who was treated with Estrace Cream (dosage: NA, start time: Jan 02, 2014), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Local Swelling
  • Trigger Finger
  • Arthralgia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrace Cream treatment in female patients, resulting in local swelling side effect.

Electrocardiogram Abnormal, Nausea, Myalgia, Breast Tenderness, Chest Discomfort, Decreased Appetite, Dyspepsia, Headache
This report suggests a potential Estrace Cream, 0.01% Electrocardiogram Abnormal, Nausea, Myalgia, Breast Tenderness, Chest Discomfort, Decreased Appetite, Dyspepsia, Headache side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: vaginal disorder and used Estrace Cream, 0.01% (dosage: One Finger Full Daily, Vaginal) starting 201309. Soon after starting Estrace Cream, 0.01% the patient began experiencing various side effects, including:
  • Electrocardiogram Abnormal
  • Nausea
  • Myalgia
  • Breast Tenderness
  • Chest Discomfort
  • Decreased Appetite
  • Dyspepsia
  • Headache
Drugs used concurrently:
  • Multivit (vitamins Nos)
  • B12 /00056201/ (cyanocobalamin)?
The patient was hospitalized. Although Estrace Cream, 0.01% demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as electrocardiogram abnormal, may still occur.

Hospitalisation, Supraventricular Tachycardia, Pulmonary Hypertension, Vomiting, Viral Infection
This Hospitalisation, Supraventricular Tachycardia, Pulmonary Hypertension, Vomiting, Viral Infection problem was reported by a consumer or non-health professional from US. A 58-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: vulvovaginal dryness,vaginal haemorrhage. On Nov 19, 2013 this consumer started treatment with Estrace (dosage: 1 G Daily For Two Weeks, Vaginal). The following drugs were being taken at the same time: NA. When commencing Estrace, the patient experienced the following unwanted symptoms/side effects:
  • Hospitalisation
  • Supraventricular Tachycardia
  • Pulmonary Hypertension
  • Vomiting
  • Viral Infection
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hospitalisation, may become evident only after a product is in use by the general population.

Hip Fracture, Urinary Tract Infection, Kidney Infection
This is a report of a 80-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Estrace Cream, 0.01% (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Hip Fracture
  • Urinary Tract Infection
  • Kidney Infection
The patient was hospitalized. This opens a possibility that Estrace Cream, 0.01% treatment could cause the above reactions, including hip fracture, and some female subjects may be more susceptible.


Sepsis, Chills, Pyrexia, Tremor, Feeling Cold, Fungal Infection, Vulvovaginal Mycotic Infection, Cystitis
A 68-year-old female patient (weight: NA) from US with the following symptoms/conditions: bladder prolapse,cystitis started Estrace Cream, 0.01% treatment (dosage: NA) on 201305. Soon after starting Estrace Cream, 0.01% treatment, the subject experienced various side effects, including:
  • Sepsis
  • Chills
  • Pyrexia
  • Tremor
  • Feeling Cold
  • Fungal Infection
  • Vulvovaginal Mycotic Infection
  • Cystitis
Concurrently used drugs:
  • Macrobid
  • Prilosec /00661201/ (omeprazole)
  • Antihypertensives
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Estrace Cream, 0.01%.

Muscle Rigidity, Insomnia, Myalgia, Depression, Muscle Spasms, Sensory Disturbance, Presyncope, Dyspnoea, Fatigue
A 73-year-old female patient from US (weight: NA) experienced symptoms, such as: surgery and was treated with Estrace Cream, 0.01%(dosage: NA). The treatment was initiated on 201209. After that a consumer reported the following side effect(s):
  • Muscle Rigidity
  • Insomnia
  • Myalgia
  • Depression
  • Muscle Spasms
  • Sensory Disturbance
  • Presyncope
  • Dyspnoea
  • Fatigue
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Estrace Cream, 0.01% efficacy:
  • Fish Oil
  • Calcium W/d
  • Aspirin
  • Glucosamine W/chond
  • Mvi Pediatric
  • Lisinopril
  • Triamterene
  • Flonase


Breast Cancer
In this report, Estrace Cream, 0.01% was administered for the following condition: atrophic vulvovaginitis.A female consumer from US (weight: NA) started Estrace Cream, 0.01% treatment (dosage: NA) on Aug 24, 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Breast Cancer
A possible interaction with other drugs could have contributed to this reaction:
  • Atenolol
  • Digoxin
  • Synthroid (levothyroxine Sodium)
  • Xarelto (rivaroxaban)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Estrace Cream, 0.01% treatment could be related to the listed above side effect(s).

Product Packaging Quantity Issue
This is a report of the following Estrace side effect(s):
  • Product Packaging Quantity Issue
A 53-year-old female patient from US (weight: NA) presented with the following condition: menopausal symptoms and received a treatment with Estrace (dosage: NA) starting: 201212.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Estrace treatment could be associated with the listed above side effect(s).

Flank Pain, Vaginal Discharge
This Estrace report was submitted by a 63-year-old female consumer from US (weight: NA). The patient was diagnosed with: atrophic vulvovaginitis and Estrace was administered (dosage: Small Amount Nightly To The Urethra) starting: Sep 19, 2013. The consumer developed a set of symptoms:
  • Flank Pain
  • Vaginal Discharge
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Estrace treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Abdominal Pain, Nausea, Abdominal Pain Upper, Blood Triglycerides Increased
This is a report of a possible correlation between Estrace use and the following symptoms/side effect(s):
  • Abdominal Pain
  • Nausea
  • Abdominal Pain Upper
  • Blood Triglycerides Increased
which could contribute to an assessment of Estrace risk profile.A 54-year-old female consumer from US (weight: NA) was suffering from vulvovaginal dryness and was treated with Estrace (dosage: NA) starting Mar 15, 2013.Other concurrent medications: NA.

Upper Respiratory Tract Infection, Urinary Tract Infection, Tonsillar Disorder, Sinus Tachycardia, Electrocardiogram T Wave Inversion, Pharyngitis, Rhinitis
A 64-year-old female patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Estrace (dosage: Every Monday, Wednesday And Friday, Vaginal) experienced the following side effect(s):
  • Upper Respiratory Tract Infection
  • Urinary Tract Infection
  • Tonsillar Disorder
  • Sinus Tachycardia
  • Electrocardiogram T Wave Inversion
  • Pharyngitis
  • Rhinitis
The treatment was started on NS. Estrace was used in combination with the following drugs:
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Ranitidine (ranitidine)
  • Enjuvia
The patient was hospitalized.This report could alert potential Estrace consumers.

Arthralgia, Decreased Appetite, Weight Decreased, Insomnia, Nausea
In this report, a 34-year-old female patient from US (weight: NA) was affected by a possible Estrace side effect.The patient was diagnosed with NA. After a treatment with Estrace (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Arthralgia
  • Decreased Appetite
  • Weight Decreased
  • Insomnia
  • Nausea
The following simultaneously used drugs could have led to this reaction:
  • Chorionic Gonadotropin
  • Gonal-f
  • Menopur
  • Celebrex
The findings here stress that side effects should be taken into consideration when evaluating a Estrace treatment.

Pulmonary Mass, Dyspnoea
This is a report of a 34-year-old female patient from GB (weight: NA), who used Estrace (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Pulmonary Mass
  • Dyspnoea
The following drugs could possibly have interacted with the Estrace treatment
  • Chorionic Gonadotropin
  • Gonal-f
  • Menopur
  • Celebrex
The patient was hospitalized.Taken together, these observations suggest that a Estrace treatment could be related to side effect(s), such as Pulmonary Mass, Dyspnoea.

Breast Cancer
This breast cancer side effect was reported by a consumer or non-health professional from US. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Estrace (dosage: Tab), which was started on NS. Concurrently used drugs:
  • Medroxyprogesterone (Tab)
  • Premarin
When starting to take Estrace the consumer reported the following symptoms:
  • Breast Cancer
The patient was hospitalized. These side effects may potentially be related to Estrace.

Alopecia
This is a Estrace side effect report of a 39-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: vulvovaginal dryness, who was treated with Estrace (dosage:1/3 Applicatorful 1x/week Vag, start time: Aug 01, 2012), combined with: NA., and developed a serious reaction and a alopecia side effect. The patient presented with:
  • Alopecia
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Estrace treatment in female patients suffering from vulvovaginal dryness, resulting in alopecia.

Colitis Ischaemic
This report suggests a potential Estrace colitis ischaemic side effect(s) that can have serious consequences. A 54-year-old female patient from GB (weight:NA) was diagnosed with the following health condition(s): NA and used Estrace (dosage: Low Dose.) starting NS. Soon after starting Estrace the patient began experiencing various side effects, including:
  • Colitis Ischaemic
Drugs used concurrently:
  • Bisacodyl (3tabs)
  • Bisacodyl (3tabs)
The patient was hospitalized. Although Estrace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as colitis ischaemic, may still occur.

Product Packaging Quantity Issue, Device Malfunction
This product packaging quantity issue problem was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): vaginal dryness,vaginal discomfort.On Oct 01, 2010 a consumer started treatment with Estrace (dosage: 1/2 Applicatorful -2 Grams- 3 Times Per Week Vag). The following drugs/medications were being taken at the same time: NA. When commencing Estrace, the patient experienced the following unwanted symptoms /side effects:
  • Product Packaging Quantity Issue
  • Device Malfunction
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as product packaging quantity issue, may become evident only after a product is in use by the general population.

Breast Cyst, Papilloma, Nipple Exudate Bloody, Vulvovaginal Burning Sensation, Chest Pain, Pain In Extremity
This is a Estrace side effect report of a 85-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: vaginal dryness and was treated with Estrace (dosage: Small Amount 2-3 Times Per Week) starting May 01, 2012. Concurrently used drugs:
  • Amlodipine
  • Levothyroxine
Soon after that, the consumer experienced the following of symptoms:
  • Breast Cyst
  • Papilloma
  • Nipple Exudate Bloody
  • Vulvovaginal Burning Sensation
  • Chest Pain
  • Pain In Extremity
This opens a possibility that Estrace could cause breast cyst and that some female patients may be more susceptible.

Loss Of Consciousness, Head Injury, Joint Injury, Back Injury, Headache, Dizziness, Asthenia, Palpitations
A 70-year-old female patient (weight: NA) from US with the following symptoms: vulvovaginal dryness,atrophic vulvovaginitis started Estrace treatment (dosage: 1 Gram Daily At Bedtime For 14 Days, Vaginal) on Aug 06, 2012. Soon after starting Estrace treatment, the consumer experienced several side effects, including:
  • Loss Of Consciousness
  • Head Injury
  • Joint Injury
  • Back Injury
  • Headache
  • Dizziness
  • Asthenia
  • Palpitations
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Estrace side effects, such as loss of consciousness.

Urticaria
This urticaria side effect was reported by a consumer or non-health professional from US. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: vulvovaginal atrophy.The patient was prescribed Estrace (dosage: 1 6m 2-3 Xwk Vaginal), which was started on Aug 04, 2012. Concurrently used drugs: NA..When starting to take Estrace the consumer reported symptoms, such as:
  • Urticaria
These side effects may potentially be related to Estrace.

Basal Cell Carcinoma
This is a report of a female patient (weight: NA) from CANADA, suffering from the following symptoms/conditions: NA, who was treated with Estrace (dosage: NA, start time: NS), combined with:
  • Remicade
  • Permethrin
  • Imuran
  • Acetylsalicylic Acid Srt
  • Apple Cider Vinegar (dietary Supplement)
  • Vitamin D
  • Vimovo
  • Actonel
and developed a serious reaction and side effect(s). The consumer presented with:
  • Basal Cell Carcinoma
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrace treatment in female patients, resulting in basal cell carcinoma side effect.

Asthma
This report suggests a potential Estrace Asthma side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: vulvovaginal dryness and used Estrace (dosage: {1 Gram Once Per Day Vag) starting Jun 19, 2012. Soon after starting Estrace the patient began experiencing various side effects, including:
  • Asthma
Drugs used concurrently: NA. Although Estrace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as asthma, may still occur.

Fracture Delayed Union, Muscle Strain, Haemoglobin Decreased, Atypical Femur Fracture, Muscle Spasms, Arthralgia, Haematocrit Decreased, Fall, Post Procedural Complication
This Fracture Delayed Union, Muscle Strain, Haemoglobin Decreased, Atypical Femur Fracture, Muscle Spasms, Arthralgia, Haematocrit Decreased, Fall, Post Procedural Complication problem was reported by a health professional from UNITED STATES. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Oct 30, 2008 this consumer started treatment with Estrace (dosage: NA). The following drugs were being taken at the same time:
  • Senna (sennoside A+b)
  • Cipro
  • Senna S (docusate Sodium, Sennoside A+b)
  • Glucosamine (glucosamine)
  • Garlic (allium Sativum)
  • Effexor
  • Fish Oil (fish Oil)
  • Vitamin B Complex (cyanocobalamin)
When commencing Estrace, the patient experienced the following unwanted symptoms/side effects:
  • Fracture Delayed Union
  • Muscle Strain
  • Haemoglobin Decreased
  • Atypical Femur Fracture
  • Muscle Spasms
  • Arthralgia
  • Haematocrit Decreased
  • Fall
  • Post Procedural Complication
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as fracture delayed union, may become evident only after a product is in use by the general population.

Urinary Incontinence, Anxiety, Judgement Impaired, Cerebrovascular Accident, Aphasia, Balance Disorder, Renal Pain, Depression, Headache
This is a report of a 47-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Estrace (dosage: 0.01 %, Unk) starting Oct 21, 2003. Concurrently used drugs:
  • Yasmin
  • Darvocet-n 50 (1-2 Tabs Every 4-6 Hours As Needed)
  • Premarin (0.625 Mg, Unk)
  • Daypro (600 Mg, Daily)
  • Tessalon (100 Mg, Tid)
  • Vesicare (5 Mg Daily)
  • Vesicare
  • Levaquin (500 Mg, Daily)
Soon after that, the consumer experienced the following side effects:
  • Urinary Incontinence
  • Anxiety
  • Judgement Impaired
  • Cerebrovascular Accident
  • Aphasia
  • Balance Disorder
  • Renal Pain
  • Depression
  • Headache
The patient was hospitalized. This opens a possibility that Estrace treatment could cause the above reactions, including urinary incontinence, and some female subjects may be more susceptible.

Myelodysplastic Syndrome
A 55-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Estrace treatment (dosage: 0.5 Mg, Qd) on Aug 02, 2011. Soon after starting Estrace treatment, the subject experienced various side effects, including:
  • Myelodysplastic Syndrome
Concurrently used drugs:
  • Remeron (30 Mg, Qd)
  • Metoprolol Tartrate (100 Unk, Qhs)
  • Restoril (30 Mg, Qd Hs)
  • Metformin Hcl (750 Mg, Bid)
  • Lovastatin (20 Unk, Qhs)
  • Lisinopril (5 Mg, Qd)
  • Protonix (40 Unk, Qd)
  • Victoza (1.8 Mg, Qd)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Estrace.

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Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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    Estrace Safety Alerts, Active Ingredients, Usage Information

    NDC0430-0720
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameESTRACE
    Nameestradiol
    Dosage FormTABLET
    RouteORAL
    On market since20111226
    LabelerWarner Chilcott (US), LLC
    Active Ingredient(s)ESTRADIOL
    Strength(s)0.5
    Unit(s)mg/1
    Pharma ClassEstradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]

    Estrace Dosage, Warnings, Usage.

    Side Effects reported to FDA: 490

    Estrace safety alerts: No

    Reported deaths: 17

    Reported hospitalizations: 60

    Latest Estrace clinical trials