Is estradiol FDA-approved?

Yes, as specific products: brand and generic estradiol tablets, patches, gels, a spray, vaginal products and injections are FDA-approved for the uses in their labels. All are prescription only.

Checked 25 Oct 2026. The sources are below.

Estradiol

Also: 17β-estradiol, E2, oestradiol, Climara, Menostar, Minivelle, Vivelle-Dot, EstroGel, Elestrin, Divigel, Evamist, Estrace, Vagifem, Yuvafem, Imvexxy, Estring, Femring, Delestrogen, Depo-Estradiol

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
OralTopicalOtherIntramuscular
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Estradiol tablets (generic, from several manufacturers; Estrace tablets are discontinued)

    Oral

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Estradiol patches: Climara, Menostar, Minivelle, Vivelle-Dot and generic patches

    Transdermal

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Estradiol gels and spray: EstroGel, Elestrin, Divigel, Evamist and generic gels

    Transdermal

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Vaginal estradiol: Estrace cream, Vagifem and Yuvafem inserts, Imvexxy, Estring and generics

    Vaginal

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Femring (estradiol acetate) vaginal ring

    Vaginal

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Estradiol valerate injection: Delestrogen and generics

    Intramuscular

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Depo-Estradiol (estradiol cypionate) injection

    Intramuscular

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each marketed product above as "Prescription".

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

The Library has six estradiol entries, one for each form, and each shows the status label “FDA Approved”. Add the entry that matches your own product in My Protocols, and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. The list above gives the detail by product.

  • Routes by entry: “Estradiol (oral)” is oral; “Estradiol (patch)” and “Estradiol (gel/spray)” are topical; “Estradiol (vaginal)” is logged as Other; “Estradiol Valerate (injection)” and “Estradiol Cypionate (injection)” are intramuscular.
  • Logging: the amount you took and how you feel.
  • Injection sites: intramuscular doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Oral, topical and vaginal doses skip this step.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the HRT tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell estradiol or any other compound.

More sources

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