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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
on Mar 11, 2014 Patient from US , 79 years of age, was treated with Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: stupor, hot flush, insomnia. Estradiol dosage: Unk.

Product Adhesion Issue, Hot Flush, Product Physical Consistency Issue, Vulvovaginal Dryness, Skin Disorder, Extra Dose Administered
Patient was taking Estradiol Hemihydrate. Patient felt the following Estradiol side effects: product adhesion issue, hot flush, product physical consistency issue, vulvovaginal dryness, skin disorder, extra dose administered on Mar 11, 2014 from US Additional patient health information: Female , 56 years of age, . Estradiol Hemihydrate dosage: 0.075 Mg, Unk.

Hot Flush, Irritability
Adverse event was reported on Mar 10, 2014 by a Female taking Estradiol Hemihydrate (Dosage: 0.1 Mg, Ow) . Location: US , 67 years of age, weighting 150.0 lb, After Estradiol was administered, patient encountered several Estradiol side effects: hot flush, irritability.
Multiple concurrent drugs taken:
  • Levothyroxine (112 ?g, Qd)
  • Omeprazole (40 Mg, Qd)


Abdominal Adhesions, Cervical Dysplasia, Dyspareunia, Menometrorrhagia, Mood Altered, Adnexa Uteri Pain, Endometriosis, Hot Flush, Abdominal Pain
on Mar 06, 2014 Female from US , 25 years of age, was treated with Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: abdominal adhesions, cervical dysplasia, dyspareunia, menometrorrhagia, mood altered, adnexa uteri pain, endometriosis, hot flush, abdominal pain. Estradiol dosage: 1 In 1 D.
Associated medications used:
  • Progestin (progesterone) (1 In 1 D)
  • Lupron Depot (1 M)
  • Flonase
  • Prenatal Vitamins
  • Vitamin C



Application Site Irritation, Application Site Erythema, Device Material Issue, Product Packaging Quantity Issue, Off Label Use
on Feb 13, 2014 Female from US , 77 years of age, weighting 110.0 lb, was treated with Estradiol Hemihydrate (patch). Patient felt the following Estradiol side effects: application site irritation, application site erythema, device material issue, product packaging quantity issue, off label use. Estradiol Hemihydrate (patch) dosage: 5 Mcg/24hr, Cont.
Multiple prescriptions taken:
  • Escitalopram (10 Mg, Qd)
  • Levothroid (Unk)


Product Adhesion Issue, Hot Flush, Product Quality Issue
Patient was taking Estradiol Hemihydrate. After Estradiol was administered, patient encountered several Estradiol side effects: product adhesion issue, hot flush, product quality issue on Feb 10, 2014 from US Additional patient health information: Female , 68 years of age, weighting 200.0 lb, was diagnosed with and. Estradiol Hemihydrate dosage: 0.025 Mg, Ow.

Fungal Infection
Adverse event was reported on Feb 10, 2014 by a Female taking Estradiol Hemihydrate (Dosage: 0.1 Mg, Ow) was diagnosed with and. Location: US , 68 years of age, weighting 149.9 lb, Directly after, patient experienced the unwanted or unexpected Estradiol side effects: fungal infection.
Associated medications used:
  • Vivelle-dot (Unk)
  • Progesterone (100 Mg, Qd)
  • Vitamin D (Unk)
  • B-complex [vitamin B Nos] (Unk)
  • Gluborid (10 Mg, Qd)


Pulmonary Embolism, Dyspnoea
on Jan 29, 2014 Female from GB , 46 years of age, weighting 251.0 lb, was treated with Estradiol Valerate. Patient felt the following Estradiol side effects: pulmonary embolism, dyspnoea. Estradiol Valerate dosage: 3 Mg, Qd.
Multiple prescriptions taken:
  • Hydroxychloroquine
  • Mirtazapine
  • Mst Continus
  • Omeprazole
  • Paracetamol
  • Tramadol
  • Seretide
  • Spironolactone
Patient was hospitalized.

Fatigue, Emotional Disorder, Sinusitis, Product Substitution Issue
on Jan 27, 2014 Female from US , 46 years of age, weighting 160.0 lb, was treated with Estradiol Valerate. After Estradiol was administered, patient encountered several Estradiol side effects: fatigue, emotional disorder, sinusitis, product substitution issue. Estradiol Valerate dosage: 1 Ml Weekly Into The Muscle.

Blood Disorder, Depression, Suicidal Ideation
Patient was taking Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: blood disorder, depression, suicidal ideation on Jan 21, 2014 from US Additional patient health information: Female , 29 years of age, weighting 215.6 lb, was diagnosed with and. Estradiol dosage: 1 Unit. Patient was hospitalized.

Aphagia, Fungal Infection, Mouth Ulceration, Cyst, Weight Decreased, Malaise, Mobility Decreased
Adverse event was reported on Jan 16, 2014 by a Female taking Estradiol (Dosage: N/A) . Location: US , 43 years of age, weighting 153.1 lb, Patient felt the following Estradiol side effects: aphagia, fungal infection, mouth ulceration, cyst, weight decreased, malaise, mobility decreased.
Multiple prescriptions taken:
  • Lansoprazole (15 Milligram Daily; 24 Hr, Slow Release)
  • Fluconazole
  • Clindamycin


Burning Sensation, Insomnia, Feeling Abnormal
on Jan 14, 2014 Female from US , 87 years of age, was treated with Estradiol. After Estradiol was administered, patient encountered several Estradiol side effects: burning sensation, insomnia, feeling abnormal. Estradiol dosage: N/A.

Viith Nerve Paralysis, Cerebrovascular Accident, Carotid Artery Occlusion, Unresponsive To Stimuli, Convulsion, Oedema
on Dec 04, 2013 Female from US , 48 years of age, weighting 122.8 lb, was treated with Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: viith nerve paralysis, cerebrovascular accident, carotid artery occlusion, unresponsive to stimuli, convulsion, oedema. Estradiol dosage: 1 Patch, Every 3 Days, Transdermal.

Hypersensitivity
Patient was taking Estradiol. Patient felt the following Estradiol side effects: hypersensitivity on Dec 02, 2013 from US Additional patient health information: Female , 52 years of age, was diagnosed with and. Estradiol dosage: One Weekly Applied To A Surface?usually The Skin.

Dyskinesia, Therapeutic Response Unexpected, Off Label Use
Adverse event was reported on Oct 18, 2013 by a Male taking Estradiol Hemihydrate (patch) (Dosage: 0.1 Mg, Unk) was diagnosed with and. Location: US , 53 years of age, After Estradiol was administered, patient encountered several Estradiol side effects: dyskinesia, therapeutic response unexpected, off label use.
Multiple concurrent drugs taken:
  • 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)


Vaginal Haemorrhage, Abdominal Pain Lower, Endometrial Hypertrophy, Thrombophlebitis Superficial
on Oct 11, 2013 Female from US , 86 years of age, weighting 92.59 lb, was diagnosed with and was treated with Estradiol (watson Laboratories). Directly after, patient experienced the unwanted or unexpected Estradiol side effects: vaginal haemorrhage, abdominal pain lower, endometrial hypertrophy, thrombophlebitis superficial. Estradiol (watson Laboratories) dosage: 2 Mg, Daily.

Premature Baby, Low Birth Weight Baby, Foetal Exposure During Pregnancy
on Oct 07, 2013 Patient from IL , weighting 1.10 lb, was treated with Estradiol. Patient felt the following Estradiol side effects: premature baby, low birth weight baby, foetal exposure during pregnancy. Estradiol dosage: N/A. Patient was hospitalized.

Blood Thyroid Stimulating Hormone Increased
Patient was taking Estradiol. After Estradiol was administered, patient encountered several Estradiol side effects: blood thyroid stimulating hormone increased on Oct 07, 2013 from US Additional patient health information: Female , 33 years of age, . Estradiol dosage: 12 Mg, Unk.
Multiple concurrent drugs taken:
  • Progesterone (100 Mg, Unk)
  • Levothyroxine


Hot Flush, Alopecia, Weight Loss Poor
Adverse event was reported on Sep 28, 2013 by a Female taking Estradiol Hemihydrate (patch) (Dosage: 0.025 Mg/d, Unk) . Location: US , 66 years of age, weighting 124.0 lb, Directly after, patient experienced the unwanted or unexpected Estradiol side effects: hot flush, alopecia, weight loss poor.
Associated medications used:
  • 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)


Acne, Erythema, Pruritus, Pain, Skin Disorder
on Sep 27, 2013 Female from US , 48 years of age, weighting 189.6 lb, was treated with Estradiol Hemihydrate (patch). Patient felt the following Estradiol side effects: acne, erythema, pruritus, pain, skin disorder. Estradiol Hemihydrate (patch) dosage: 0.05 Mg/d, Ow.
Multiple prescriptions taken:
  • Nexium (40 Mg, Qd)
  • Progesterone (300 Mg, Qd)
  • Losartan Potassium (25 Mg, Qd)


Application Site Pruritus, Erythema, Multiple Allergies
on Sep 18, 2013 Female from US , 53 years of age, weighting 130.1 lb, was treated with Estradiol Hemihydrate (patch). After Estradiol was administered, patient encountered several Estradiol side effects: application site pruritus, erythema, multiple allergies. Estradiol Hemihydrate (patch) dosage: 01 Mg, Qd.
Multiple concurrent drugs taken:
  • Prometrium (100 Mg, Qd)
  • Fluticasone (Unk Unk, Prn)


Application Site Rash, Dermatitis Contact
Patient was taking Estradiol Hemihydrate (patch). Directly after, patient experienced the unwanted or unexpected Estradiol side effects: application site rash, dermatitis contact on Sep 11, 2013 from US Additional patient health information: Female , 57 years of age, . Estradiol Hemihydrate (patch) dosage: Unk.

Angioedema
Adverse event was reported on Aug 26, 2013 by a Female taking Estradiol Transdermal System, Usp (Dosage: Changed Qweek) . Location: US , 55 years of age, Patient felt the following Estradiol side effects: angioedema.

Dysgeusia
on Aug 22, 2013 Female from US , 74 years of age, weighting 169.8 lb, was treated with Estradiol Hemihydrate (patch). After Estradiol was administered, patient encountered several Estradiol side effects: dysgeusia. Estradiol Hemihydrate (patch) dosage: 0.05 Mg, Qd.
Multiple concurrent drugs taken:
  • Omeprazole (20 Mg, Qd)


Underdose, Product Adhesion Issue
on Aug 13, 2013 Female from US , 77 years of age, was diagnosed with and was treated with Estradiol Hemihydrate (patch). Directly after, patient experienced the unwanted or unexpected Estradiol side effects: underdose, product adhesion issue. Estradiol Hemihydrate (patch) dosage: 0.075 Mg, Qd.

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PillPack: Pharmacy Simplified

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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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

    Safety Alerts, Active Ingredients, Usage Information

    Alternative ESTRADIOL Names:ACTIVELLA ALORA CLIMARA CLIMARA PRO COMBIPATCH DELESTROGEN DIVIGEL ELESTRIN ESTRACE ESTRASORB ESTRING ESTROGEL EVAMIST FEMRING FEMTRACE MENOSTAR MIMVEY NATAZIA PREFEST VAGIFEM VIVELLE DOT

    Active Ingredient: ESTRADIOL

    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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