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Estrace Side Effects

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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.

Estrace Side Effects Reported to FDA



Estrace Side Effect Report#9849551
Local Swelling, Trigger Finger, Arthralgia
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health 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): Local Swelling, Trigger Finger, Arthralgia 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.
Estrace Side Effect Report#9789872
Electrocardiogram Abnormal, Nausea, Myalgia, Breast Tenderness, Chest Discomfort, Decreased Appetite, Dyspepsia, Headache
This report suggests a potential Estrace Cream, 0.01% Electrocardiogram Abnormal 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. 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, HeadacheAdditional 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.
Estrace Side Effect Report#9735716
Hospitalisation, Supraventricular Tachycardia, Pulmonary Hypertension, Vomiting, Viral Infection
This Hospitalisation 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 using Estrace, the patient experienced the following unwanted symptoms/side effects: Hospitalisation, Supraventricular Tachycardia, Pulmonary Hypertension, Vomiting, Viral InfectionThe 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.
Estrace Side Effect Report#9607460
Hip Fracture, Urinary Tract Infection, Kidney Infection
This Hip Fracture 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: NA.The patient was prescribed Estrace Cream, 0.01% (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Estrace Cream, 0.01% the consumer reported adverse symptoms, such as: Hip Fracture, Urinary Tract Infection, Kidney InfectionThese side effects may potentially be related to Estrace Cream, 0.01%. The patient was hospitalized.
Estrace Side Effect Report#9559874
Sepsis, Chills, Pyrexia, Tremor, Feeling Cold, Fungal Infection, Vulvovaginal Mycotic Infection, Cystitis
This is a report of a 68-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: bladder prolapse,cystitis, who was treated with Estrace Cream, 0.01% (dosage: NA, start time: 201305), combined with:
  • Macrobid
  • Prilosec /00661201/ (omeprazole)
  • Antihypertensives
and developed a serious reaction and side effect(s): Sepsis, Chills, Pyrexia, Tremor, Feeling Cold, Fungal Infection, Vulvovaginal Mycotic Infection, Cystitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrace Cream, 0.01% treatment in female patients, resulting in Sepsis side effect. The patient was hospitalized.
Estrace Side Effect Report#9535817
Muscle Rigidity, Insomnia, Myalgia, Depression, Muscle Spasms, Sensory Disturbance, Presyncope, Dyspnoea, Fatigue
This report suggests a potential Estrace Cream, 0.01% Muscle Rigidity side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: surgery and used Estrace Cream, 0.01% (dosage: NA) starting 201209. After starting Estrace Cream, 0.01% the patient began experiencing various side effects, including: Muscle Rigidity, Insomnia, Myalgia, Depression, Muscle Spasms, Sensory Disturbance, Presyncope, Dyspnoea, FatigueAdditional drugs used concurrently:
  • Fish Oil
  • Calcium W/d
  • Aspirin
  • Glucosamine W/chond
  • Mvi Pediatric
  • Lisinopril
  • Triamterene
  • Flonase
Although Estrace Cream, 0.01% demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Muscle Rigidity, may still occur.
Estrace Side Effect Report#9533176
Breast Cancer
This Breast Cancer problem was reported by a physician from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrophic vulvovaginitis. On
Aug 24, 2012 this consumer started treatment with Estrace Cream, 0.01% (dosage: NA). The following drugs were being taken at the same time:
  • Atenolol
  • Digoxin
  • Synthroid (levothyroxine Sodium)
  • Xarelto (rivaroxaban)
When using Estrace Cream, 0.01%, the patient experienced the following unwanted symptoms/side effects: Breast CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Breast Cancer, may become evident only after a product is in use by the general population.
Estrace Side Effect Report#9411553
Product Packaging Quantity Issue
This Product Packaging Quantity Issue side effect was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: menopausal symptoms.The patient was prescribed Estrace (drug dosage: NA), which was initiated on 201212. Concurrently used drugs: NA..After starting to take Estrace the consumer reported adverse symptoms, such as: Product Packaging Quantity IssueThese side effects may potentially be related to Estrace.
Estrace Side Effect Report#9280206
Flank Pain, Vaginal Discharge
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrophic vulvovaginitis, who was treated with Estrace (dosage: Small Amount Nightly To The Urethra, start time:
Sep 19, 2013), combined with: NA. and developed a serious reaction and side effect(s): Flank Pain, Vaginal Discharge after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrace treatment in female patients, resulting in Flank Pain side effect.
Estrace Side Effect Report#9229873
Abdominal Pain, Nausea, Abdominal Pain Upper, Blood Triglycerides Increased
This report suggests a potential Estrace Abdominal Pain side effect(s) that can have serious consequences. A 54-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: vulvovaginal dryness and used Estrace (dosage: NA) starting
Mar 15, 2013. After starting Estrace the patient began experiencing various side effects, including: Abdominal Pain, Nausea, Abdominal Pain Upper, Blood Triglycerides IncreasedAdditional drugs used concurrently: NA. Although Estrace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Estrace Side Effect Report#9154955
Upper Respiratory Tract Infection, Urinary Tract Infection, Tonsillar Disorder, Sinus Tachycardia, Electrocardiogram T Wave Inversion, Pharyngitis, Rhinitis
This Upper Respiratory Tract Infection problem was reported by a health professional from US. A 64-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Estrace (dosage: Every Monday, Wednesday And Friday, Vaginal). The following drugs were being taken at the same time:
  • Hydrochlorothiazide (hydrochlorothiazide)
  • Ranitidine (ranitidine)
  • Enjuvia
When using Estrace, the patient experienced the following unwanted symptoms/side effects: Upper Respiratory Tract Infection, Urinary Tract Infection, Tonsillar Disorder, Sinus Tachycardia, Electrocardiogram T Wave Inversion, Pharyngitis, RhinitisThe 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 Upper Respiratory Tract Infection, may become evident only after a product is in use by the general population.
Estrace Side Effect Report#9126861
Arthralgia, Decreased Appetite, Weight Decreased, Insomnia, Nausea
This Arthralgia side effect was reported by a consumer or non-health professional from US. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estrace (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Chorionic Gonadotropin
  • Gonal-f
  • Menopur
  • Celebrex
.After starting to take Estrace the consumer reported adverse symptoms, such as: Arthralgia, Decreased Appetite, Weight Decreased, Insomnia, NauseaThese side effects may potentially be related to Estrace.
Estrace Side Effect Report#9124570
Pulmonary Mass, Mass, Dyspnoea
This is a report of a 34-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Estrace (dosage: NA, start time: NS), combined with:
  • Chorionic Gonadotropin
  • Gonal-f
  • Menopur
  • Celebrex
and developed a serious reaction and side effect(s): Pulmonary Mass, Mass, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrace treatment in female patients, resulting in Pulmonary Mass side effect. The patient was hospitalized.
Estrace Side Effect Report#9122623
Breast Cancer
This report suggests a potential Estrace Breast Cancer side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Estrace (dosage: Tab) starting NS. After starting Estrace the patient began experiencing various side effects, including: Breast CancerAdditional drugs used concurrently:
  • Medroxyprogesterone (Tab)
  • Premarin
The patient was hospitalized. Although Estrace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Breast Cancer, may still occur.
Estrace Side Effect Report#9057802
Alopecia
This Alopecia problem was reported by a consumer or non-health professional from US. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: vulvovaginal dryness. On
Aug 01, 2012 this consumer started treatment with Estrace (dosage: 1/3 Applicatorful 1x/week Vag). The following drugs were being taken at the same time: NA. When using Estrace, the patient experienced the following unwanted symptoms/side effects: AlopeciaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Alopecia, may become evident only after a product is in use by the general population.
Estrace Side Effect Report#8818177
Colitis Ischaemic
This Colitis Ischaemic side effect was reported by a consumer or non-health professional from GB. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estrace (drug dosage: Low Dose.), which was initiated on NS. Concurrently used drugs:
  • Bisacodyl (3tabs)
  • Bisacodyl (3tabs)
.After starting to take Estrace the consumer reported adverse symptoms, such as: Colitis IschaemicThese side effects may potentially be related to Estrace. The patient was hospitalized.
Estrace Side Effect Report#8805147
Product Packaging Quantity Issue, Device Malfunction
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: vaginal dryness,vaginal discomfort, who was treated with Estrace (dosage: 1/2 Applicatorful -2 Grams- 3 Times Per Week Vag, start time:
Oct 01, 2010), combined with: NA. and developed a serious reaction and side effect(s): Product Packaging Quantity Issue, Device Malfunction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrace treatment in female patients, resulting in Product Packaging Quantity Issue side effect.
Estrace Side Effect Report#8797869
Breast Cyst, Papilloma, Nipple Exudate Bloody, Vulvovaginal Burning Sensation, Chest Pain, Pain In Extremity
This report suggests a potential Estrace Breast Cyst side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: vaginal dryness and used Estrace (dosage: Small Amount 2-3 Times Per Week) starting
May 01, 2012. After starting Estrace the patient began experiencing various side effects, including: Breast Cyst, Papilloma, Nipple Exudate Bloody, Vulvovaginal Burning Sensation, Chest Pain, Pain In ExtremityAdditional drugs used concurrently:
  • Amlodipine
  • Levothyroxine
Although Estrace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Breast Cyst, may still occur.
Estrace Side Effect Report#8791428
Loss Of Consciousness, Head Injury, Joint Injury, Back Injury, Headache, Dizziness, Asthenia, Palpitations
This Loss Of Consciousness problem was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: vulvovaginal dryness,atrophic vulvovaginitis. On
Aug 06, 2012 this consumer started treatment with Estrace (dosage: 1 Gram Daily At Bedtime For 14 Days, Vaginal). The following drugs were being taken at the same time: NA. When using Estrace, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, Head Injury, Joint Injury, Back Injury, Headache, Dizziness, Asthenia, PalpitationsThe 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 Loss Of Consciousness, may become evident only after a product is in use by the general population.
Estrace Side Effect Report#8762957
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 (drug dosage: 1 6m 2-3 Xwk Vaginal), which was initiated on
Aug 04, 2012. Concurrently used drugs: NA..After starting to take Estrace the consumer reported adverse symptoms, such as: UrticariaThese side effects may potentially be related to Estrace.
Estrace Side Effect Report#8479067-X
Basal Cell Carcinoma
This is a report of a female patient (weight: NA) from Canada, suffering from the following health 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): Basal Cell Carcinoma 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.
Estrace Side Effect Report#8466172-7
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. After starting Estrace the patient began experiencing various side effects, including: AsthmaAdditional drugs used concurrently: NA. Although Estrace demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Asthma, may still occur.
Estrace Side Effect Report#8458329-6
Fracture Delayed Union, Muscle Strain, Haemoglobin Decreased, Atypical Femur Fracture, Muscle Spasms, Arthralgia, Haematocrit Decreased, Fall, Post Procedural Complication
This Fracture Delayed Union 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 using 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 ComplicationThe 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.
Estrace Side Effect Report#8440680-7
Urinary Incontinence, Anxiety, Judgement Impaired, Cerebrovascular Accident, Aphasia, Balance Disorder, Renal Pain, Depression, Headache
This Urinary Incontinence side effect was reported by a health professional from United States. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estrace (drug dosage: 0.01 %, Unk), which was initiated on
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)
.After starting to take Estrace the consumer reported adverse symptoms, such as: Urinary Incontinence, Anxiety, Judgement Impaired, Cerebrovascular Accident, Aphasia, Balance Disorder, Renal Pain, Depression, HeadacheThese side effects may potentially be related to Estrace. The patient was hospitalized.
Estrace Side Effect Report#8432384-1
Myelodysplastic Syndrome
This is a report of a 55-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Estrace (dosage: 0.5 Mg, Qd, start time:
Aug 02, 2011), combined with:
  • 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)
and developed a serious reaction and side effect(s): Myelodysplastic Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estrace treatment in female patients, resulting in Myelodysplastic Syndrome side effect. The patient was hospitalized.


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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.

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Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

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

    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.

    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.

    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.

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    Discuss Estrace Side Effects

    Did You Have a Estrace Side Effect?

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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