Prescription medicine
Cabergoline First approved as Dostinex
Cabergoline (Dostinex) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $1.30 per cabergoline 0.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cabergoline FDA label on DailyMed (effective June 30, 2026, Mylan Pharmaceuticals Inc.); the NDA 20664 record on Drugs@FDA; every cabergoline label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults.
Forms and strengths
- 0.5 mg
Tablet.
On the market
- Earliest approval on file
- December 23, 1996 Dostinex, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first December 29, 2005; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.30 per tablet Cabergoline 0.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2012 0 Class I among all firms' recalls; latest April 24, 2012
- FAERS reports
- 4,839 through July 30, 2026
What is cabergoline used for?
From the label: indications and usageCABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ]. CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. ( 1 ) Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions.
FDA pharmacologic class: Ergot Derivative.
Source: FDA drug label (Cabergoline), NDA020664 (Pfizer), as published by Mylan Pharmaceuticals Inc., effective June 30, 2026 (SPL set e497366b-a124-4d7f-bd45-a883c392d4bb), via openFDA; the full label on DailyMed
Is there a generic for cabergoline (Dostinex)?
The FDA approved the first generic cabergoline on December 29, 2005. 10 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cabergoline from 8 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2005 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cabergoline (Dostinex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.30 per Cabergoline 0.5 mg tablet, down 15% from $1.53 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cabergoline 0.5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cabergoline 0.5 mg tablet | Generic | $1.30 per tablet | $38.86 | -15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cabergoline been recalled?
The FDA's Enforcement Report lists 1 recall naming cabergoline since 2012: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 24, 2012 | Class III | Teva Pharmaceuticals USA, Inc. | Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cabergoline label say about other medicines?
The cabergoline label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name cabergoline. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bromocriptine | warnings and precautions | Use of bromocriptine, another dopamine agonist for this unapproved use has been associated with cases of hypertension, stroke, myocardial infarction, seizures, and death. |
| Levodopa | warnings and precautions | Compared to non-ergot-derived dopamine agonists and levodopa, CVR with CABERGOLINE use had an incidence rate per 10,000 person years of 68 (95% CI: |
| Metoclopramide | drug interactions | DRUG INTERACTIONS CABERGOLINE, a dopamine receptor agonist, is not recommended for concomitant use with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide. |
Other labels that name cabergoline
Source: FDA drug label (Cabergoline), NDA020664 (Pfizer), as published by Mylan Pharmaceuticals Inc., effective June 30, 2026 (SPL set e497366b-a124-4d7f-bd45-a883c392d4bb), via openFDA; the full label on DailyMed
What do FAERS reports show for cabergoline?
The FDA Adverse Event Reporting System holds 4,839 reports that list cabergoline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 253 are coded as a death and 1,607 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other ergot derivatives
- the pharmacologic class, with prices and generics
- Cabergoline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other