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Headache (2)
Asthenia (1)
Hair Loss (1)
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Estradiol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 689 

Nausea, Influenza Like Illness (8386054-9)
on May 18, 2012 Female from UNITED STATES , weighting 315.3 lb, was treated with Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: nausea, influenza like illness. Estradiol dosage: 0.025 Mg, Unk.
Associated medications used:
  • Levothyroxine Sodium (125 Mg, Unk)
  • Thyrogen (0.9 Mg, Qd)
  • Lunesta (2 Mg, Unk)


Fall, Limb Injury, Fracture, Thrombosis, Ankle Operation, Ankle Fracture, Tendon Injury (8384859-1)
Patient was taking Estradiol. Patient felt the following Estradiol side effects: fall, limb injury, fracture, thrombosis, ankle operation, ankle fracture, tendon injury on May 18, 2012 from UNITED STATES Additional patient health information: Female , weighting 216.9 lb, . Estradiol dosage: Unk.
Multiple prescriptions taken:
  • Celebrex (200 Mg, 2x/day)
  • Lisinopril (Unk)
  • Tramadol (Unk)


Alopecia, Muscle Fatigue, Myalgia, Dizziness, Pain In Extremity (8364812-4)
Adverse event was reported on May 08, 2012 by a Female taking Estradiol Valerate/dienogest (Dosage: Unk) . Location: BRAZIL , 30 years of age, After Estradiol was administered, patient encountered several Estradiol side effects: alopecia, muscle fatigue, myalgia, dizziness, pain in extremity.

Incorrect Dose Administered (8361687-4)
on Oct 03, 2011 Female from UNITED STATES , weighting 120.1 lb, was treated with Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: incorrect dose administered. Estradiol dosage: N/A.
Associated medications used:
  • Prometrium
  • Prometrium
  • Levothyroxine Sodium
  • Crinone



Gait Disturbance, Granulomatous Liver Disease, Influenza Like Illness, Pyrexia, Blood Triglycerides Increased, Hepatic Enzyme Increased, Asthenia (8357215-X)
on May 01, 2012 Female from UNITED STATES , weighting 138.3 lb, was treated with Estradiol. Patient felt the following Estradiol side effects: gait disturbance, granulomatous liver disease, influenza like illness, pyrexia, blood triglycerides increased, hepatic enzyme increased, asthenia. Estradiol dosage: N/A.
Multiple prescriptions taken:
  • Zyprexa (Unk)
  • Zyprexa
  • Amitriptyline Hcl (100 Mg, Each Evening)
  • Medroxyprogesterone
Patient was hospitalized.

Amenorrhoea, Vomiting, Caesarean Section, Pregnancy On Oral Contraceptive (8352698-3)
Patient was taking Estradiol Valerate/dienogest. After Estradiol was administered, patient encountered several Estradiol side effects: amenorrhoea, vomiting, caesarean section, pregnancy on oral contraceptive on May 03, 2012 from FRANCE Additional patient health information: Female , 28 years of age, weighting 141.0 lb, . Estradiol Valerate/dienogest dosage: Unk.

Autoimmune Hepatitis (8344775-8)
Adverse event was reported on Apr 30, 2012 by a Female taking Estradiol Valerate/dienogest (Dosage: Unk) was diagnosed with
  • contraception
  • headache
and. Location: AUSTRIA , 22 years of age, Directly after, patient experienced the unwanted or unexpected Estradiol side effects: autoimmune hepatitis.
Associated medications used:
  • Parkemed (Unk)
  • Acetylsalicylic Acid/paracetamol (Unk)
  • Mexalen (Unk)
  • Cefixime (Unk)


Depression, Mental Impairment, Fatigue, Glucose Tolerance Impaired, Thinking Abnormal, Feeling Abnormal, Arthralgia, Blood Glucose Increased, Asthenia (8344505-X)
on Apr 27, 2012 Female from UNITED STATES , weighting 185.6 lb, was treated with Estradiol. Patient felt the following Estradiol side effects: depression, mental impairment, fatigue, glucose tolerance impaired, thinking abnormal, feeling abnormal, arthralgia, blood glucose increased, asthenia. Estradiol dosage: N/A.
Multiple prescriptions taken:
  • Cafergot
  • Gabapentin
  • Somatropin (0.2 Mg, Qd)
  • Somatropin
  • Levothyroxine Sodium


Pruritus, Erythema, Hypersensitivity, Swelling Face, Local Swelling, Speech Disorder, Chest Discomfort, Metrorrhagia (8343764-7)
on Apr 27, 2012 Female from GERMANY , 50 years of age, weighting 123.5 lb, was diagnosed with
  • oral contraception
and was treated with Estradiol Valerate/dienogest. After Estradiol was administered, patient encountered several Estradiol side effects: pruritus, erythema, hypersensitivity, swelling face, local swelling, speech disorder, chest discomfort, metrorrhagia. Estradiol Valerate/dienogest dosage: Unk.
Multiple concurrent drugs taken:
  • Levothyroxine Sodium


Feeling Abnormal, Poor Quality Sleep (8334918-4)
Patient was taking Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: feeling abnormal, poor quality sleep on Mar 05, 2010 from UNITED STATES Additional patient health information: Female , weighting 148.1 lb, . Estradiol dosage: N/A.
Associated medications used:
  • Prometrium
  • Lyrica
  • Alprazolam
  • Protonix (40 Milligram;)
  • Nuvigil (150 Milligram;)
  • Nuvigil
  • Vicodin


Ovarian Disorder, Menometrorrhagia, Fatigue, Gastroenteritis (8333666-4)
Adverse event was reported on Apr 25, 2012 by a Female taking Estradiol Valerate/dienogest (Dosage: Unk Ukn, Unk) . Location: FRANCE , 32 years of age, Patient felt the following Estradiol side effects: ovarian disorder, menometrorrhagia, fatigue, gastroenteritis.
Multiple prescriptions taken:
  • Desogestrel And Ethinyl Estradiol (Unk Ukn, Unk)
  • Levonorgestrel (1 Df, Qd)
  • Triella (Unk Ukn, Unk)


Lip Swelling, Flatulence, Food Intolerance, Diarrhoea, Weight Decreased, Oral Pain (8321514-8)
on Apr 30, 2012 Female from UNITED STATES , 50 years of age, weighting 112.0 lb, was diagnosed with
  • vulvovaginal dryness
  • irritability
  • hot flush
and was treated with Estradiol. After Estradiol was administered, patient encountered several Estradiol side effects: lip swelling, flatulence, food intolerance, diarrhoea, weight decreased, oral pain. Estradiol dosage: N/A.

Intracranial Pressure Increased, Hemiplegia, Carotid Artery Stenosis, Cerebrovascular Accident, Malaise (8318999-X)
on Apr 19, 2012 Female from FRANCE , 30 years of age, weighting 249.1 lb, was treated with Estradiol Valerate/dienogest. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: intracranial pressure increased, hemiplegia, carotid artery stenosis, cerebrovascular accident, malaise. Estradiol Valerate/dienogest dosage: Unk. Patient was hospitalized.

Pruritus, Oedema Peripheral, Headache, Swelling Face, Skin Disorder, Dry Skin, Weight Increased, Rash, Periorbital Oedema (8314744-2)
Patient was taking Estradiol Valerate/dienogest. Patient felt the following Estradiol side effects: pruritus, oedema peripheral, headache, swelling face, skin disorder, dry skin, weight increased, rash, periorbital oedema on Apr 18, 2012 from GERMANY Additional patient health information: Female , 42 years of age, weighting 143.3 lb, . Estradiol Valerate/dienogest dosage: Unk. Patient was hospitalized.

Night Sweats, Hot Flush (8311768-6)
Adverse event was reported on Apr 17, 2012 by a Female taking Estradiol (Dosage: Daily Dose .05 Mg) . Location: UNITED STATES , 77 years of age, After Estradiol was administered, patient encountered several Estradiol side effects: night sweats, hot flush.

Spider Naevus (8308532-0)
on Apr 10, 2012 Female from DENMARK , 48 years of age, was treated with Estradiol. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: spider naevus. Estradiol dosage: N/A.
Associated medications used:
  • Otomize
  • Candesartan Cilexetil
  • Norinyl 1+35 28-day
  • Losartan Potassium
  • Felodipine
  • Contraceptive


Pregnancy On Oral Contraceptive, Vaginal Haemorrhage, Abortion Spontaneous (8306911-9)
on Apr 16, 2012 Female from ARGENTINA , 43 years of age, was diagnosed with
  • menorrhagia
and was treated with Estradiol Valerate/dienogest. Patient felt the following Estradiol side effects: pregnancy on oral contraceptive, vaginal haemorrhage, abortion spontaneous. Estradiol Valerate/dienogest dosage: Unk.

Abortion Spontaneous, Pregnancy On Oral Contraceptive (8306910-7)
Patient was taking Estradiol Valerate/dienogest. After Estradiol was administered, patient encountered several Estradiol side effects: abortion spontaneous, pregnancy on oral contraceptive on Apr 16, 2012 from FRANCE Additional patient health information: Female , 40 years of age, . Estradiol Valerate/dienogest dosage: N/A.

Tremor, Malaise (8305613-2)
Adverse event was reported on Apr 10, 2012 by a Female taking Estradiol (Dosage: N/A) . Location: DENMARK , 51 years of age, Directly after, patient experienced the unwanted or unexpected Estradiol side effects: tremor, malaise.

Pregnancy On Oral Contraceptive, Amenorrhoea, Vomiting, Caesarean Section (8303592-5)
on Apr 11, 2012 Female from FRANCE , 28 years of age, weighting 141.0 lb, was treated with Estradiol Valerate/dienogest. Patient felt the following Estradiol side effects: pregnancy on oral contraceptive, amenorrhoea, vomiting, caesarean section. Estradiol Valerate/dienogest dosage: Unk.

Benign Hydatidiform Mole (8301380-7)
on Apr 12, 2012 Female from CHILE , 40 years of age, was treated with Estradiol Valerate/dienogest. After Estradiol was administered, patient encountered several Estradiol side effects: benign hydatidiform mole. Estradiol Valerate/dienogest dosage: Unk.

Road Traffic Accident, Haemorrhagic Stroke, Brain Oedema, Craniocerebral Injury (8300584-7)
Patient was taking Estradiol Valerate/dienogest. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: road traffic accident, haemorrhagic stroke, brain oedema, craniocerebral injury on Apr 19, 2012 from CHILE Additional patient health information: Female , 51 years of age, . Estradiol Valerate/dienogest dosage: Unk. Patient was hospitalized.

Abdominal Discomfort, Night Sweats, Sinusitis, Hot Flush (8297148-0)
Adverse event was reported on Apr 16, 2012 by a Female taking Estradiol (Dosage: 1 Mg, Daily) was diagnosed with
  • ovarian cyst ruptured
  • hypertension
  • blood cholesterol increased
and. Location: UNITED STATES , weighting 148.0 lb, Patient felt the following Estradiol side effects: abdominal discomfort, night sweats, sinusitis, hot flush.
Multiple prescriptions taken:
  • Metoprolol (25 Mg, Daily)
  • Simvastatin (80 Mg, Daily)
  • Vitamin Tab (Unk)
  • Zolpidem (10 Mg, Daily)
  • Fibercon (Unk)
  • Acetylsalicylic Acid (81 Mg, Unk)
  • Fenofibrate (48 Mg, Daily)


Dermatitis Contact (8297072-3)
on Apr 17, 2012 Female from UNITED STATES , weighting 147.7 lb, was diagnosed with
  • menopausal symptoms
and was treated with Estradiol. After Estradiol was administered, patient encountered several Estradiol side effects: dermatitis contact. Estradiol dosage: 1 Mg Transdermal Patch.

No Adverse Event, Coeliac Disease, Asthenia (8295567-X)
on Apr 10, 2012 Female from BRAZIL , 27 years of age, weighting 119.0 lb, was diagnosed with
  • contraception
and was treated with Estradiol Valerate/dienogest. Directly after, patient experienced the unwanted or unexpected Estradiol side effects: no adverse event, coeliac disease, asthenia. Estradiol Valerate/dienogest dosage: 1 Df, Qd.

Showing 1-25 of 689 

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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.

Estradiol 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: 689. View Estradiol Adverse Reports

Estradiol safety alerts: 2013 2012 2010 2006 2005 2003 2002

Reported deaths: 13

Reported hospitalizations: 74

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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