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Estradiol Side Effects

Common Estradiol Side Effects


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

Application Site Pruritus (133)
Application Site Erythema (124)
Application Site Rash (84)
Hot Flush (63)
Headache (56)
Application Site Irritation (47)
Nausea (35)
Application Site Pain (32)
Pain (28)
Rash (26)
Vomiting (24)
Dizziness (24)
Product Adhesion Issue (24)
Pruritus (24)
Insomnia (23)
Fatigue (23)
Depression (22)
Pregnancy On Oral Contraceptive (22)
Product Substitution Issue (21)
Pulmonary Embolism (20)

➢ 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.

Estradiol Side Effects Reported to FDA

The following Estradiol 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 Estradiol 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.
Stupor, Hot Flush, Insomnia
This is a report of a 79-year-old patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Estradiol (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Stupor
  • Hot Flush
  • Insomnia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol treatment in patients, resulting in stupor side effect.

Product Adhesion Issue, Hot Flush, Product Physical Consistency Issue, Vulvovaginal Dryness, Skin Disorder, Extra Dose Administered
This report suggests a potential Estradiol Hemihydrate Product Adhesion Issue, Hot Flush, Product Physical Consistency Issue, Vulvovaginal Dryness, Skin Disorder, Extra Dose Administered 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 Estradiol Hemihydrate (dosage: 0.075 Mg, Unk) starting 2009. Soon after starting Estradiol Hemihydrate the patient began experiencing various side effects, including:
  • Product Adhesion Issue
  • Hot Flush
  • Product Physical Consistency Issue
  • Vulvovaginal Dryness
  • Skin Disorder
  • Extra Dose Administered
Drugs used concurrently: NA. Although Estradiol Hemihydrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as product adhesion issue, may still occur.

Hot Flush, Irritability
This Hot Flush, Irritability problem was reported by a pharmacist from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 1972 this consumer started treatment with Estradiol Hemihydrate (dosage: 0.1 Mg, Ow). The following drugs were being taken at the same time:
  • Levothyroxine (112 ?g, Qd)
  • Omeprazole (40 Mg, Qd)
When commencing Estradiol Hemihydrate, the patient experienced the following unwanted symptoms/side effects:
  • Hot Flush
  • Irritability
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hot flush, may become evident only after a product is in use by the general population.

Abdominal Adhesions, Cervical Dysplasia, Dyspareunia, Menometrorrhagia, Mood Altered, Adnexa Uteri Pain, Endometriosis, Hot Flush, Abdominal Pain
This is a report of a 25-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Estradiol (dosage: 1 In 1 D) starting Oct 17, 2013. Concurrently used drugs:
  • Progestin (progesterone) (1 In 1 D)
  • Lupron Depot (1 M)
  • Flonase
  • Prenatal Vitamins
  • Vitamin C
Soon after that, the consumer experienced the following side effects:
  • Abdominal Adhesions
  • Cervical Dysplasia
  • Dyspareunia
  • Menometrorrhagia
  • Mood Altered
  • Adnexa Uteri Pain
  • Endometriosis
  • Hot Flush
  • Abdominal Pain
This opens a possibility that Estradiol treatment could cause the above reactions, including abdominal adhesions, and some female subjects may be more susceptible.


Application Site Irritation, Application Site Erythema, Device Material Issue, Product Packaging Quantity Issue, Off Label Use
A 77-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Estradiol Hemihydrate (patch) treatment (dosage: 5 Mcg/24hr, Cont) on 2000. Soon after starting Estradiol Hemihydrate (patch) treatment, the subject experienced various side effects, including:
  • Application Site Irritation
  • Application Site Erythema
  • Device Material Issue
  • Product Packaging Quantity Issue
  • Off Label Use
Concurrently used drugs:
  • Escitalopram (10 Mg, Qd)
  • Levothroid (Unk)
This finding indicates that some female patients could be more vulnerable to Estradiol Hemihydrate (patch).

Product Adhesion Issue, Hot Flush, Product Quality Issue
A 68-year-old female patient from US (weight: NA) experienced symptoms, such as: hot flush and was treated with Estradiol Hemihydrate(dosage: 0.025 Mg, Ow). The treatment was initiated on 201310. After that a consumer reported the following side effect(s):
  • Product Adhesion Issue
  • Hot Flush
  • Product Quality Issue
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Estradiol Hemihydrate efficacy: NA.

Fungal Infection
In this report, Estradiol Hemihydrate was administered for the following condition: hot flush.A 68-year-old female consumer from US (weight: NA) started Estradiol Hemihydrate treatment (dosage: 0.1 Mg, Ow) on 1995.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Fungal Infection
A possible interaction with other drugs could have contributed to this reaction:
  • Vivelle-dot (Unk)
  • Progesterone (100 Mg, Qd)
  • Vitamin D (Unk)
  • B-complex [vitamin B Nos] (Unk)
  • Gluborid (10 Mg, Qd)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Estradiol Hemihydrate treatment could be related to the listed above side effect(s).

Pulmonary Embolism, Dyspnoea
This is a report of the following Estradiol Valerate side effect(s):
  • Pulmonary Embolism
  • Dyspnoea
A 46-year-old female patient from GB (weight: NA) presented with the following condition: NA and received a treatment with Estradiol Valerate (dosage: 3 Mg, Qd) starting: NS.The following concurrently used drugs could have generated interactions:
  • Hydroxychloroquine
  • Mirtazapine
  • Mst Continus
  • Omeprazole
  • Paracetamol
  • Tramadol
  • Seretide
  • Spironolactone
The patient was hospitalized.This report suggests that a Estradiol Valerate treatment could be associated with the listed above side effect(s).

Fatigue, Emotional Disorder, Sinusitis, Product Substitution Issue
This Estradiol Valerate report was submitted by a 46-year-old female consumer from US (weight: NA). The patient was diagnosed with: NA and Estradiol Valerate was administered (dosage: 1 Ml Weekly Into The Muscle) starting: Jan 12, 2014. The consumer developed a set of symptoms:
  • Fatigue
  • Emotional Disorder
  • Sinusitis
  • Product Substitution Issue
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Estradiol Valerate treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Blood Disorder, Depression, Suicidal Ideation
This is a report of a possible correlation between Estradiol use and the following symptoms/side effect(s):
  • Blood Disorder
  • Depression
  • Suicidal Ideation
which could contribute to an assessment of Estradiol risk profile.A 29-year-old female consumer from US (weight: NA) was suffering from depression and was treated with Estradiol (dosage: 1 Unit) starting Aug 19, 2013.Other concurrent medications: NA.The patient was hospitalized.

Aphagia, Fungal Infection, Mouth Ulceration, Cyst, Weight Decreased, Malaise, Mobility Decreased
A 43-year-old female patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Estradiol (dosage: NA) experienced the following side effect(s):
  • Aphagia
  • Fungal Infection
  • Mouth Ulceration
  • Cyst
  • Weight Decreased
  • Malaise
  • Mobility Decreased
The treatment was started on 201201. Estradiol was used in combination with the following drugs:
  • Lansoprazole (15 Milligram Daily; 24 Hr, Slow Release)
  • Fluconazole
  • Clindamycin
This report could alert potential Estradiol consumers.

Burning Sensation, Insomnia, Feeling Abnormal
In this report, a 87-year-old female patient from US (weight: NA) was affected by a possible Estradiol side effect.The patient was diagnosed with NA. After a treatment with Estradiol (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Burning Sensation
  • Insomnia
  • Feeling Abnormal
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Estradiol treatment.

Viith Nerve Paralysis, Cerebrovascular Accident, Carotid Artery Occlusion, Unresponsive To Stimuli, Convulsion, Oedema
This is a report of a 48-year-old female patient from US (weight: NA), who used Estradiol (dosage: 1 Patch, Every 3 Days, Transdermal) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Viith Nerve Paralysis
  • Cerebrovascular Accident
  • Carotid Artery Occlusion
  • Unresponsive To Stimuli
  • Convulsion
  • Oedema
The following drugs could possibly have interacted with the Estradiol treatment NA.Taken together, these observations suggest that a Estradiol treatment could be related to side effect(s), such as Viith Nerve Paralysis, Cerebrovascular Accident, Carotid Artery Occlusion, Unresponsive To Stimuli, Convulsion, Oedema.

Hypersensitivity
This hypersensitivity side effect was reported by a consumer or non-health professional from US. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: blood oestrogen decreased. The patient was prescribed Estradiol (dosage: One Weekly Applied To A Surface?usually The Skin), which was started on Sep 23, 2013. Concurrently used drugs: NA. When starting to take Estradiol the consumer reported the following symptoms:
  • Hypersensitivity
These side effects may potentially be related to Estradiol.

Dyskinesia, Therapeutic Response Unexpected, Off Label Use
This is a Estradiol Hemihydrate (patch) side effect report of a 53-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: feminisation acquired, who was treated with Estradiol Hemihydrate (patch) (dosage:0.1 Mg, Unk, start time: NS), combined with:
  • Spironolactone (50 Mg, Unk)
  • Carbidopa W/levodopa (25/100)
  • Carbidopa W/levodopa (Reduced To 3 Tabs Daily (nos))
  • Ropinirole (6 Mg, Bid)
  • Ropinirole (8 Mg, Unk)
  • Amantadine (100 Mg, Bid)
, and developed a serious reaction and a dyskinesia side effect. The patient presented with:
  • Dyskinesia
  • Therapeutic Response Unexpected
  • Off Label Use
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Estradiol Hemihydrate (patch) treatment in male patients suffering from feminisation acquired, resulting in dyskinesia.

Vaginal Haemorrhage, Abdominal Pain Lower, Endometrial Hypertrophy, Thrombophlebitis Superficial
This report suggests a potential Estradiol (watson Laboratories) vaginal haemorrhage side effect(s) that can have serious consequences. A 86-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): breast cancer recurrent,skin mass and used Estradiol (watson Laboratories) (dosage: 2 Mg, Daily) starting Jul 15, 2013. Soon after starting Estradiol (watson Laboratories) the patient began experiencing various side effects, including:
  • Vaginal Haemorrhage
  • Abdominal Pain Lower
  • Endometrial Hypertrophy
  • Thrombophlebitis Superficial
Drugs used concurrently:NA. Although Estradiol (watson Laboratories) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as vaginal haemorrhage, may still occur.

Premature Baby, Low Birth Weight Baby, Foetal Exposure During Pregnancy
This premature baby problem was reported by a health professional from IL. A patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Estradiol (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Estradiol, the patient experienced the following unwanted symptoms /side effects:
  • Premature Baby
  • Low Birth Weight Baby
  • Foetal Exposure During Pregnancy
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as premature baby, may become evident only after a product is in use by the general population.

Blood Thyroid Stimulating Hormone Increased
This is a Estradiol side effect report of a 33-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Estradiol (dosage: 12 Mg, Unk) starting NS. Concurrently used drugs:
  • Progesterone (100 Mg, Unk)
  • Levothyroxine
Soon after that, the consumer experienced the following of symptoms:
  • Blood Thyroid Stimulating Hormone Increased
This opens a possibility that Estradiol could cause blood thyroid stimulating hormone increased and that some female patients may be more susceptible.

Hot Flush, Alopecia, Weight Loss Poor
A 66-year-old female patient (weight: NA) from US with the following symptoms: NA started Estradiol Hemihydrate (patch) treatment (dosage: 0.025 Mg/d, Unk) on 1993. Soon after starting Estradiol Hemihydrate (patch) treatment, the consumer experienced several side effects, including:
  • Hot Flush
  • Alopecia
  • Weight Loss Poor
. Concurrently used drugs:
  • Fenofibrate (67 Mg, Qd)
  • Vitamin C [ascorbic Acid] (1 G, Qd)
  • Fish Oil (1 G, Qd)
  • Glucosamine/msm (1500 Mg, Qd)
  • Calcium D3 [calcium Carbonate,colecalciferol] (600 Mg, Qd)
This finding indicates that some patients can be more vulnerable to developing Estradiol Hemihydrate (patch) side effects, such as hot flush.

Acne, Erythema, Pruritus, Pain, Skin Disorder
This acne side effect was reported by a consumer or non-health professional from US. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estradiol Hemihydrate (patch) (dosage: 0.05 Mg/d, Ow), which was started on 2010. Concurrently used drugs:
  • Nexium (40 Mg, Qd)
  • Progesterone (300 Mg, Qd)
  • Losartan Potassium (25 Mg, Qd)
.When starting to take Estradiol Hemihydrate (patch) the consumer reported symptoms, such as:
  • Acne
  • Erythema
  • Pruritus
  • Pain
  • Skin Disorder
These side effects may potentially be related to Estradiol Hemihydrate (patch).

Application Site Pruritus, Erythema, Multiple Allergies
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Estradiol Hemihydrate (patch) (dosage: 01 Mg, Qd, start time: 200805), combined with:
  • Prometrium (100 Mg, Qd)
  • Fluticasone (Unk Unk, Prn)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Application Site Pruritus
  • Erythema
  • Multiple Allergies
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol Hemihydrate (patch) treatment in female patients, resulting in application site pruritus side effect.

Application Site Rash, Dermatitis Contact
This report suggests a potential Estradiol Hemihydrate (patch) Application Site Rash, Dermatitis Contact side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Estradiol Hemihydrate (patch) (dosage: Unk) starting Aug 15, 2013. Soon after starting Estradiol Hemihydrate (patch) the patient began experiencing various side effects, including:
  • Application Site Rash
  • Dermatitis Contact
Drugs used concurrently: NA. Although Estradiol Hemihydrate (patch) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as application site rash, may still occur.

Angioedema
This Angioedema problem was reported by a pharmacist from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On May 29, 2013 this consumer started treatment with Estradiol Transdermal System, Usp (dosage: Changed Qweek). The following drugs were being taken at the same time: NA. When commencing Estradiol Transdermal System, Usp, the patient experienced the following unwanted symptoms/side effects:
  • Angioedema
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as angioedema, may become evident only after a product is in use by the general population.

Dysgeusia
This is a report of a 74-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Estradiol Hemihydrate (patch) (dosage: 0.05 Mg, Qd) starting Aug 09, 2013. Concurrently used drugs:
  • Omeprazole (20 Mg, Qd)
Soon after that, the consumer experienced the following side effects:
  • Dysgeusia
This opens a possibility that Estradiol Hemihydrate (patch) treatment could cause the above reactions, including dysgeusia, and some female subjects may be more susceptible.

Underdose, Product Adhesion Issue
A 77-year-old female patient (weight: NA) from US with the following symptoms/conditions: blood disorder,hot flush started Estradiol Hemihydrate (patch) treatment (dosage: 0.075 Mg, Qd) on NS. Soon after starting Estradiol Hemihydrate (patch) treatment, the subject experienced various side effects, including:
  • Underdose
  • Product Adhesion Issue
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Estradiol Hemihydrate (patch).

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Estradiol Side Effects

    Did You Have a Estradiol Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Estradiol for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Estradiol Safety Alerts, Active Ingredients, Usage Information

    NDC0009-0271
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDepo-Estradiol
    Nameestradiol cypionate
    Dosage FormINJECTION
    RouteINTRAMUSCULAR
    On market since19790815
    LabelerPharmacia and Upjohn Company
    Active Ingredient(s)ESTRADIOL CYPIONATE
    Strength(s)5
    Unit(s)mg/mL
    Pharma ClassEstradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]

    Estradiol Dosage, Warnings, Usage.

    Side Effects reported to FDA: 927

    Estradiol safety alerts: 2014 2012 2010 2006 2005 2003 2002

    Reported deaths: 20

    Reported hospitalizations: 95

    Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw

     

    [Posted 06/06/2012]

    AUDIENCE: Consumer, Pharmacy

    ISSUE: Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

    The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012. 

    BACKGROUND: Introvale is an extended-cycle oral contraceptive. Sandoz is not aware of any reports of related adverse events.

    RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

    Healthcare professionals and patients are encouraged to report adverse events, side effects, or quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [06/05/2012 - Press Release - Sandoz]

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