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Estradot 75 Side Effects

Generic Name: estradiol

Note: This document contains side effect information about estradiol. Some of the dosage forms listed on this page may not apply to the brand name Estradot 75.

For the Consumer

Applies to estradiol: vaginal cream, vaginal insert extended release, vaginal tablet

Other dosage forms:

Along with its needed effects, estradiol (the active ingredient contained in Estradot 75) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol:

Less Common

Incidence Not Known

  • Change in vaginal discharge
  • clear or bloody discharge from the nipple
  • decrease in the amount of urine
  • dimpling of the breast skin
  • fast heartbeat
  • fever
  • hives, itching, or rash
  • hoarseness
  • inverted nipple
  • irritation
  • joint pain, stiffness, or swelling
  • lump in the breast or under the arm
  • noisy, rattling breathing
  • pain or feeling of pressure in the pelvis
  • pain, redness, or swelling in the arm or leg
  • persistent crusting or scaling of the nipple
  • redness of the skin
  • redness or swelling of the breast
  • sore on the skin of the breast that does not heal
  • swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
  • tightness in the chest
  • troubled breathing at rest
  • troubled breathing or swallowing
  • vaginal bleeding

Get emergency help immediately if any of the following symptoms of overdose occur while taking estradiol:

Symptoms of Overdose

Some side effects of estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Back pain
  • headache
  • itching or pain of the vagina or genital area
  • thick, white vaginal discharge with mild or no odor
  • weight gain

Less Common

Incidence Not Known

  • Feeling sad or empty
  • headache, severe and throbbing
  • irritability
  • lack of appetite
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • welts

For Healthcare Professionals

Applies to estradiol: compounding powder, intramuscular solution, oral tablet, transdermal emulsion, transdermal film extended release, transdermal gel, transdermal spray, vaginal ring

Genitourinary

Very common (10% or more): Breast pain (29%)

Common (1% to 10%): Vulvovaginal pruritus, leukorrhea, vaginal hemorrhage, vaginal discharge, vaginal discomfort, menopause symptoms, breakthrough bleeding or spotting, dysmenorrhea, breast swelling, menorrhagia, metrorrhagia, endometrial hyperplasia

Uncommon (0.1% to 1%): Urinary problems

Rare (less than 0.1%): Galactorrhea

Postmarketing reports: Vaginal irritation, vaginal pain, genital pruritus, changes in bleeding pattern, pelvic pain, breast tenderness, vaginal ulceration, uterine fibroids[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (16%),

Common (1% to 10%): Flatulence, nausea, diarrhea

Uncommon (0.1% to 1%): Vomiting

Postmarketing reports: Abdominal distension[Ref]

Musculoskeletal

Very common (10% or more): Back pain (11%), arthralgia (11%)

Common (1% to 10%): Leg cramps[Ref]

Cardiovascular

Common (1% to 10%): Varicose veins, cardiac symptoms (e.g. palpitations)

Uncommon (0.1% to 1%): Hot flush, hypertension, venous thromboembolic disease

Rare (less than 0.1%): Arterial hypertension

Postmarketing reports: Deep vein thrombosis, changes in blood pressure[Ref]

Nervous system

Very common (10% or more): Headache (18%)

Uncommon (0.1% to 1%): Vertigo, migraine

Rare (less than 0.1%): Aggravation of epilepsy

Postmarketing reports: Migraine aggravated, paresthesia, dizziness[Ref]

Oncologic

Uncommon (0.1% to 1%): Benign breast neoplasm, increased volume of uterine leiomyoma

Postmarketing reports: Endometrial cancer, breast cancer[Ref]

Other

Very common (10% or more): Pain (11%)

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Weight increased, asthenia

Postmarketing reports: Drug ineffectiveness, blood estrogen increase, fatigue, exacerbation of hereditary angioedema[Ref]

Psychiatric

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Sleep disorders, nervousness, mood swings

Rare (less than 0.1%): Change in libido

Postmarketing reports: Vaginismus, insomnia, anxiety, irritability[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Rash

Rare (less than 0.1%): Skin discoloration, acne

Postmarketing reports: Urticaria, erythematous or pruritic rash, alopecia, hyperhidrosis, night sweats, contact dermatitis, eczema[Ref]

Ocular

Uncommon (0.1% to 1%): Vision abnormal NOS

Postmarketing reports: Visual disturbances, contact lens intolerance[Ref]

Hepatic

Rare (less than 0.1%): Liver function tests abnormalities

Postmarketing reports: Cholestatic jaundice[Ref]

Metabolic

Rare (less than 0.1%): Glucose intolerance

Postmarketing reports: Fluid retention[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylactic reaction (with a past history of allergic reaction)

Postmarketing reports: Anaphylactic reactions, hypersensitivity[Ref]

Immunologic

Very common (10% or more): Upper respiratory tract infection (17%)

Common (1% to 10%): Vulvovaginal mycotic infection, pharyngitis, rhinitis, sinusitis, moniliasis genital

Uncommon (0.1% to 1%): Vaginitis/vaginal candidosis[Ref]

Local

Common (1% to 10%): Skin irritation (topical gel)

Postmarketing reports: Application site reaction[Ref]

References

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3. "Product Information. Yuvafem (estradiol topical)." AvKare Inc, Pulaski, TN.

4. Nash HA, AlvarezSanchez F, Mishell DR, Fraser IS, Maruo T, Harmon TM "Estradiol-delivering vaginal rings for hormone replacement therapy." Am J Obstet Gynecol 181 (1999): 1400-6

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7. "Product Information. Climara (estradiol)." Berlex, Richmond, CA.

8. Cerner Multum, Inc. "Australian Product Information." O 0

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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