Bromocriptine (Parlodel)

  Novartis Pharmaceuticals Corporation (formerly Sandoz, which discovered it in 1965) manufactures Bromocriptine under the brand Parlodel; generics are produced by companies like ANI Pharmaceuticals, Mylan, and Zydus Lifesciences.accessdata.fda+2

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Approved in 1974 (Europe) and 1978 (US) for hyperprolactinemia and Parkinson's, initial trials noted nausea/vomiting (most common), dizziness, headache, fatigue, constipation, abdominal cramps, nasal congestion, hypotension, and Raynaud's phenomenon.drugbank+2

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FDA withdrew lactation suppression indication in 1995 due to risks like seizures, strokes, and myocardial infarction; labels added psychiatric effects (hallucinations, confusion), erythromelalgia, and pleural/pericardial effusion.wikipedia+1

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Post-marketing added retroperitoneal fibrosis, impulse control disorders (gambling, hypersexuality), somnolence/sudden sleep onset, dopamine agonist withdrawal syndrome, and rare cardiac valvulopathy; current warnings emphasize monitoring for fibrosis and psychiatric symptoms.accessdata.fda+1

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1. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/017962_s063_s064_ParlodelTOC.cfm
2. https://www.rarediseaseadvisor.com/therapies/parlodel-bromocriptine/
3. https://go.drugbank.com/drugs/DB01200
4. https://en.wikipedia.org/wiki/Bromocriptine
5. https://firstwordpharma.com/story/1569055
6. https://clinicaltrials.gov/study/NCT00650520