Is cabergoline FDA-approved?

Yes, as specific products: generic cabergoline tablets are FDA-approved for the uses in their labels, and they're prescription only. The Dostinex brand was approved but is listed as discontinued.

Checked 25 Oct 2026. The sources are below.

Cabergoline

Also: FCE 21336, Dostinex, Cabaser

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
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.

  • Generic cabergoline tablets, from several manufacturers

    Oral

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Dostinex (cabergoline) tablets, discontinued in the US

    Oral

    Approved; Drugs@FDA lists it as Discontinued.

    Source: Drugs@FDA, 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

Add cabergoline 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. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the TRT tracker app page.

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

More sources

  • FDA, Drugs@FDA, checked 25 Oct 2026: product, route and marketing status for ANDA 077750 (generic cabergoline tablets, Teva) and NDA 020664 (Dostinex, discontinued).
  • FDA, Global Substance Registration System, Cabergoline, checked 25 Oct 2026: the names FCE 21336, Dostinex and Cabaser.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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