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Estradiol Side Effects

Report Estradiol Side Effects

If you experienced any harmful or unwanted effects of Estradiol, please share your experience. This could help to raise awareness about Estradiol side effects, identify uknown risks and inform health professionals and patients taking Estradiol.

Examples: headache, dizziness


The most commonly reported Estradiol side effects are:
Headache (2 reports)
Asthenia (1 reports)
Hair Loss (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Estradiol side effects . You can also compare Estradiol side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Application Site Pruritus, Application Site Urticaria, Application Site Dryness, Application Site Pain, Application Site Burn
on Sep 06, 2013 Female from US , 67 years of age, weighting 138.9 lb, was diagnosed with and was treated with Estradiol Hemihydrate (6.5). Directly after, patient experienced the unwanted or unexpected Estradiol side effects: application site pruritus, application site urticaria, application site dryness, application site pain, application site burn. Estradiol Hemihydrate (6.5) dosage: 0.025 Mg, Ow.
Associated medications used:
  • Famotidine (25 Mg, Prn)
  • Fioricet (40 Mg, Qd)
  • Sumatriptan (Unk Unk, Prn)
  • Atenolol (Unk Unk, Prn)
  • Atenolol


Hot Flush, Palpitations
Patient was taking Estradiol Hemihydrate. Patient felt the following Estradiol side effects: hot flush, palpitations on Aug 06, 2013 from US Additional patient health information: Female , 50 years of age, weighting 154.3 lb, . Estradiol Hemihydrate dosage: 0.05 Mg, Ow.
Multiple prescriptions taken:

Headache, Product Adhesion Issue, Hot Flush
Adverse event was reported on Aug 01, 2013 by a Female taking Estradiol Hemihydrate (patch) (Dosage: 0.05 Mg/24hr, Ow) . Location: US , 49 years of age, weighting 218.3 lb, After Estradiol was administered, patient encountered several Estradiol side effects: headache, product adhesion issue, hot flush.
Multiple concurrent drugs taken:

Product Adhesion Issue, Pruritus
on Jul 26, 2013 Female from US , 79 years of age, weighting 110.2 lb, was diagnosed with and was treated with Estradiol Hemihydrate (patch). Directly after, patient experienced the unwanted or unexpected Estradiol side effects: product adhesion issue, pruritus. Estradiol Hemihydrate (patch) dosage: 0.1 Mg, Unk.
Associated medications used:


Product Substitution Issue, Product Quality Issue
on Jul 19, 2013 Female from US , 70 years of age, was treated with Estradiol Transdermal Patch. Patient felt the following Estradiol side effects: product substitution issue, product quality issue. Estradiol Transdermal Patch dosage: N/A.

Hot Flush, Hyperhidrosis, Insomnia, Product Adhesion Issue
Patient was taking Estradiol Hemihydrate (patch). After Estradiol was administered, patient encountered several Estradiol side effects: hot flush, hyperhidrosis, insomnia, product adhesion issue on Jul 17, 2013 from US Additional patient health information: Female , 46 years of age, weighting 149.9 lb, was diagnosed with
  • hot flush
  • hypertension
  • anxiety
  • seasonal allergy
and. Estradiol Hemihydrate (patch) dosage: Daily Dose 50 Mcg/24hr.
Multiple concurrent drugs taken:
  • Metoprolol (50 Mg, Qd)
  • Citalopram (20 Mg, Qd)
  • Claritin (10 Mg, Qd)


Hot Flush, Affective Disorder, Product Adhesion Issue
Adverse event was reported on Jul 16, 2013 by a Female taking Estradiol (Dosage: N/A) . Location: US , 47 years of age, Directly after, patient experienced the unwanted or unexpected Estradiol side effects: hot flush, affective disorder, product adhesion issue.


on Aug 20, 2013 Female from NL , 30 years of age, weighting 154.3 lb, was treated with Estradiol. . Estradiol dosage: 1 Df, 1x/day.
Multiple prescriptions taken:

Hot Flush, Migraine, Night Sweats, Product Adhesion Issue
on Jun 21, 2013 Female from IN , 56 years of age, weighting 145.5 lb, was treated with Estradiol Hemihydrate (patch). After Estradiol was administered, patient encountered several Estradiol side effects: hot flush, migraine, night sweats, product adhesion issue. Estradiol Hemihydrate (patch) dosage: 1 Df, Ow.
Multiple concurrent drugs taken:

Alopecia, Gastrooesophageal Reflux Disease
Patient was taking Estradiol Hemihydrate (patch). Directly after, patient experienced the unwanted or unexpected Estradiol side effects: alopecia, gastrooesophageal reflux disease on Oct 16, 2013 from US Additional patient health information: Female , 41 years of age, weighting 125.7 lb, . Estradiol Hemihydrate (patch) dosage: 1 Df, Ow.
Associated medications used:

Dry Eye, Insomnia, Hot Flush, Product Adhesion Issue
Adverse event was reported on Jun 14, 2013 by a Female taking Estradiol Hemihydrate (patch) (Dosage: Daily Dose .025 Mg) was diagnosed with and. Location: US , 59 years of age, weighting 152.1 lb, Patient felt the following Estradiol side effects: dry eye, insomnia, hot flush, product adhesion issue.

Hot Flush, Irritability
on Jun 13, 2013 Female from US , 43 years of age, weighting 174.2 lb, was treated with Estradiol Hemihydrate (patch). After Estradiol was administered, patient encountered several Estradiol side effects: hot flush, irritability. Estradiol Hemihydrate (patch) dosage: 0.1mg/day.
Multiple concurrent drugs taken:

Headache, Product Adhesion Issue, Irritability
on Jun 21, 2013 Female from US , 56 years of age, weighting 180.8 lb, was diagnosed with and was treated with Estradiol Hemihydrate (patch). Directly after, patient experienced the unwanted or unexpected Estradiol side effects: headache, product adhesion issue, irritability. Estradiol Hemihydrate (patch) dosage: Daily Dose .1 Mg.
Associated medications used:
  • Clonidine (0.1 Mg, Bid)
  • Norvasc (0.5 Twice/day)
  • Bystolic (0.5 Mg, Bid)
  • Oxycodone/apap (10/325 Mg Once/day)
  • Relpax (5 Mg, Prn)
  • Xanax (1/2 To 1 Twice Per Day)
  • Stanback Headache (Unk Unk, Prn)


Vulvovaginal Pruritus, Vulvovaginal Pain, Vaginal Discharge
Patient was taking Estradiol. Patient felt the following Estradiol side effects: vulvovaginal pruritus, vulvovaginal pain, vaginal discharge on May 20, 2013 from US Additional patient health information: Female , 47 years of age, weighting 205.0 lb, . Estradiol dosage: N/A.

Dysphonia, Hirsutism, Hyperhidrosis, Skin Odour Abnormal
Adverse event was reported on May 20, 2013 by a Female taking Estradiol (Dosage: Using 1 1/2 Tablets) . Location: US , 58 years of age, weighting 178.0 lb, After Estradiol was administered, patient encountered several Estradiol side effects: dysphonia, hirsutism, hyperhidrosis, skin odour abnormal.
Multiple concurrent drugs taken:

Rash Pruritic, Rash Papular, Rash Erythematous
on May 20, 2013 Female from US , 41 years of age, was treated with Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: rash pruritic, rash papular, rash erythematous. Estradiol dosage: N/A.

Hot Flush, Emotional Disorder
on Apr 29, 2013 Female from US , 50 years of age, weighting 70.00 lb, was diagnosed with and was treated with Estradiol. Patient felt the following Estradiol side effects: hot flush, emotional disorder. Estradiol dosage: N/A.

Rash
Patient was taking Estradiol. After Estradiol was administered, patient encountered several Estradiol side effects: rash on Apr 18, 2013 from US Additional patient health information: Female , 58 years of age, weighting 129.0 lb, . Estradiol dosage: 0.05 Mg Qwk Derm.

Product Substitution Issue, Oestrogen Deficiency
Adverse event was reported on Apr 15, 2013 by a Female taking Estradiol (Dosage: N/A) was diagnosed with and. Location: US , 34 years of age, Directly after, patient experienced the unwanted or unexpected Estradiol side effects: product substitution issue, oestrogen deficiency.

Diabetes Mellitus
on Apr 15, 2013 Female from JP , 68 years of age, was treated with Estradiol, Norethisterone. Patient felt the following Estradiol side effects: diabetes mellitus. Estradiol, Norethisterone dosage: N/A.
Multiple prescriptions taken:
  • Adalat Cr (20 Mg Per Day)
  • Beigrace (0.9 Mg, Per Day)
  • Glufast (30 Mg, Per Day)
  • Zetia (10 Mg, Per Day)
  • Pletaal (200 Mg, Per Day)
  • Methylcobal (1500 Mg, Per Day)
Patient was hospitalized.

Dizziness, Nausea, Frustration, Vaginal Haemorrhage
on Oct 04, 2012 Female from US , 55 years of age, was treated with Estradiol And Norethindrone Acetate. After Estradiol was administered, patient encountered several Estradiol side effects: dizziness, nausea, frustration, vaginal haemorrhage. Estradiol And Norethindrone Acetate dosage: N/A.
Multiple concurrent drugs taken:

Headache, Nausea, Paraesthesia, Cognitive Disorder, Cerebrovascular Accident, Retinal Artery Occlusion
Patient was taking Estradiol 1 Mg. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: headache, nausea, paraesthesia, cognitive disorder, cerebrovascular accident, retinal artery occlusion on Mar 28, 2013 from US Additional patient health information: Female , 48 years of age, weighting 187.4 lb, was diagnosed with and. Estradiol 1 Mg dosage: Prior To Admission 1 Mg Daily Po.
Associated medications used: Patient was hospitalized.

Application Site Haemorrhage, Application Site Pain, Application Site Burn
Adverse event was reported on Mar 20, 2013 by a Female taking Estradiol Transdermal System, Usp (Dosage: Qweekly) . Location: US , 49 years of age, Patient felt the following Estradiol side effects: application site haemorrhage, application site pain, application site burn.
Multiple prescriptions taken:

Application Site Rash
on Mar 20, 2013 Female from US , 51 years of age, was treated with Estradiol Transdermal System, Usp. After Estradiol was administered, patient encountered several Estradiol side effects: application site rash. Estradiol Transdermal System, Usp dosage: Changed Qw.

Application Site Irritation
on Mar 20, 2013 Female from US , 58 years of age, was treated with Estradiol Transdermal System, Usp. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: application site irritation. Estradiol Transdermal System, Usp dosage: Qw.
Associated medications used:

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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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Discuss Estradiol Side Effects

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How Effective is Estradiol for You?

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JustAnswer.com

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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