Skip to Content

Estradiol topical Side Effects

Not all side effects for estradiol topical may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to estradiol topical: vaginal cream

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast pain or tenderness; headache; hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

Seek medical attention right away if any of these SEVERE side effects occur while taking estradiol topical:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain;breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

For Healthcare Professionals

Applies to estradiol topical: transdermal film extended release, vaginal cream, vaginal ring, vaginal tablet

General

The most commonly reported side effects were headache, leukorrhea, vaginitis, vaginal pain/discomfort, and vaginal hemorrhage.[Ref]

Cardiovascular

Common (1% to 10%): Hot flushes
Frequency not reported: Deep and superficial venous thrombosis, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure, congestive heart disease[Ref]

Oncologic

Frequency not reported: Breast cancer, endometrial cancer, ovarian cancer[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity, anaphylactoid/anaphylactic reactions[Ref]

Immunologic

Very common (10% or more): Infection (12%)
Common (1% to 10%): Allergy
Postmarketing reports: Toxic shock syndrome (fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body)[Ref]

Genitourinary

Very common (10% or more): Endometrial disorder (15%), breast pain (10%)
Common (1% to 10%): Urinary tract infection, leukorrhea, vaginitis, vaginal discomfort/pain, vaginal hemorrhage, asymptomatic genital bacterial growth, genital moniliasis, vulvovaginal mycotic infection, vulvovaginal pruritus, bladder discomfort
Frequency not reported: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, application site reactions of vulvovaginal discomfort including burning and irritation, genital pruritus, endometrial hyperplasia, breast (tenderness, enlargement), nipple discharge, galactorrhea, fibrocystic breast changes
Postmarketing reports: Ring adherence to the vaginal wall, genital edema, vulval disorder, micturition frequency, urethral disorder, ovarian cancer, endometrial hyperplasia, endometrial cancer, breast cancer[Ref]

Metabolic

Frequency not reported: Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, hypocalcemia, increased triglycerides
Postmarketing reports: Fluid retention[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea, lower abdominal pain, abdominal discomfort, anorectal discomfort, dyspepsia
Frequency not reported: Vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis
Postmarketing reports: Bowel obstruction, enlarged abdomen, bloating, enlargement of hepatic hemangiomas[Ref]

Endocrine

Frequency not reported: Increased thyroid-binding globulin (TBG) levels
Postmarketing reports: Estrogen increase[Ref]

Hepatic

Frequency not reported: Enlargement of hepatic hemangiomas[Ref]

Ocular

Frequency not reported: Retinal vascular thrombosis, intolerance to contact lenses, steepening of corneal curvature
Postmarketing reports: Abnormal vision[Ref]

Other

Common (1% to 10%): Flu-like symptoms, peripheral edema
Frequency not reported: Edema[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Anxiety
Frequency not reported: Changes in libido
Postmarketing reports: Depression[Ref]

Nervous system

Very common (10% or more): Headache (13%)
Frequency not reported: Migraine, dizziness, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis
Frequency not reported: Chloasma or melasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, rash, urticaria, angioedema, vascular purpura
Postmarketing reports: Pruritus ani, erythematous rash[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, sinusitis, pharyngitis
Frequency not reported: Pulmonary embolism (venous thromboembolism or VTE), exacerbation of asthma[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthritis, arthralgia, skeletal pain
Frequency not reported: Leg cramps
Postmarketing reports: Arthropathy (including arthrosis)[Ref]

Local

Frequency not reported: Local abrasion[Ref]

References

1. "Product Information. Estrace (estradiol)." Bristol-Myers Squibb, Princeton, NJ.

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

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

(web2)