Cabergoline (Dostinex)

  Pfizer Limited (formerly Pharmacia & Upjohn, part of Pfizer since 2003) manufactures Cabergoline under the brand name Dostinex; it was originally developed by Farmitalia Carlo Erba (now part of Pfizer), with generics from Teva and others since 2005.wikipedia+3

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Approved in Europe (1992, Netherlands) and US (1996) for hyperprolactinemia, initial trials listed common effects: nausea, headache, dizziness, vertigo, asthenia, constipation, dyspepsia, gastritis, and postural hypotension.medicines+2

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Studies in 2007 linked it to valvular heart disease (fibrosis of heart valves), prompting FDA warnings and pergolide withdrawal; labels added cardiac valvulopathy monitoring.wikipedia+1

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Updates included impulse control disorders (pathological gambling, hypersexuality), pulmonary/pericardial/retroperitoneal fibrotic disorders, somnolence/sudden sleep onset, depression, epistaxis, and rare hypersensitivity reactions; current SmPCs refine frequencies like ≥1/10 for nausea.accessdata.fda+2

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1. https://en.wikipedia.org/wiki/Cabergoline
2. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2007/Teva-Receives-Approval-For-Generic-Dostinex-Tablets/default.aspx
3. https://www.medicines.ie/medicines/dostinex-500-microgram-tablets-31916/doc-history
4. https://www.medicines.org.uk/emc/product/1691/smpc
5. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020664s011lbl.pdf
6. https://www.medicines.org.uk/emc/product/1691/pil
7. https://labeling.pfizer.com/ShowLabeling.aspx?id=1776
8. https://synapse.patsnap.com/article/what-is-cabergoline-used-for
9. https://www.sahpra.org.za/wp-content/uploads/2020/08/Dostinex_PI_Pfizer_MCC-Format04-August-2010-Copy.pdf