Editing Cabergoline (section)

==Side effects==
Side effects are mostly dose dependent. Much more severe side effects are reported for treatment of Parkinson's disease and (off-label treatment) for [[restless leg syndrome]] which both typically require very high doses. The side effects are considered mild when used for treatment of hyperprolactinemia and other endocrine disorders or gynecologic indications where the typical dose is one hundredth to one tenth that for Parkinson's disease.{{Citation needed|date=August 2011}}

Cabergoline requires slow dose titration (2–4 weeks for hyperprolactinemia, often much longer for other conditions) to minimize side effects. The extremely long bioavailability of the medication may complicate dosing regimens during titration and require particular precautions.

Cabergoline is considered the best tolerable option for hyperprolactinemia treatment although the newer and less tested [[quinagolide]] may offer similarly favourable side effect profile with quicker titration times.

Approximately 200 patients with newly diagnosed Parkinson's disease participated in a [[Clinical trial|clinical study]] of cabergoline monotherapy.<ref>{{cite journal | vauthors = Rinne UK, Bracco F, Chouza C, Dupont E, Gershanik O, Marti Masso JF, Montastruc JL, Marsden CD, Dubini A, Orlando N, Grimaldi R | title = Cabergoline in the treatment of early Parkinson's disease: results of the first year of treatment in a double-blind comparison of cabergoline and levodopa. The PKDS009 Collaborative Study Group | journal = Neurology | volume = 48 | issue = 2 | pages = 363–368 | date = February 1997 | pmid = 9040722 | doi = 10.1212/WNL.48.2.363 | s2cid = 34955541 }}</ref> Seventy-six (76) percent reported at least one side effect. These side effects were chiefly mild or moderate:
* GI tract: Side effects were extremely frequent. Fifty-three percent of patients reported side effects.  Very frequent: [[Nausea]] (30%), [[constipation]] (22%), and dry mouth (10%). Frequent:  Gastric irritation (7%), [[vomiting]] (5%), and [[dyspepsia]] (2%).
* [[psychiatry|Psychiatric]] disturbances and [[central nervous system]] (CNS): Altogether 51 percent of patients were affected.  Very frequent: Sleep disturbances ([[somnolence]] 18%, [[insomnia]] 11%), [[Vertigo (medical)|vertigo]] (27%), and [[Clinical depression|depression]] (13%). Frequent: [[dyskinesia]] (4%) and [[hallucinations]] (4%).
* Cardiovascular: Approximately 30 percent of patients experienced side effects. Most frequent were hypotension (10%), peripheral [[edema]] (14%) and non-specific edema (2%). [[Arrhythmias]] were encountered in 4.8%, [[palpitations]] in 4.3%, and [[angina pectoris]] in 1.4%.

In a combination study with 2,000 patients also treated with levodopa, the incidence and severity of side effects was comparable to monotherapy. Encountered side effects required a termination of cabergoline treatment in 15% of patients. Additional side effects were infrequent cases of [[hematology|hematological]] side effects, and an occasional increase in liver [[enzymes]] or [[Blood serum|serum]] [[creatinine]] without [[Medical sign|sign]]s or [[symptoms]].

As with other ergot derivatives, [[pleuritis]], [[exudative]] pleura disease, pleura [[fibrosis]], [[lung]] fibrosis, and [[pericarditis]] are seen. These side effects are noted in less than 2% of patients. They require immediate termination of treatment. Clinical improvement and normalization of [[X-ray]] findings are normally seen soon after cabergoline [[Drug withdrawal|withdrawal]]. It appears that the dose typically used for treatment of hyperprolactinemia is too low to cause this type of side effects.

===Valvular heart disease===
In two studies published in the ''[[New England Journal of Medicine]]'' on January 4, 2007, cabergoline was implicated along with [[pergolide]] in causing [[valvular heart disease]].<ref>{{cite journal | vauthors = Schade R, Andersohn F, Suissa S, Haverkamp W, Garbe E | title = Dopamine agonists and the risk of cardiac-valve regurgitation | journal = The New England Journal of Medicine | volume = 356 | issue = 1 | pages = 29–38 | date = January 2007 | pmid = 17202453 | doi = 10.1056/NEJMoa062222 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Zanettini R, Antonini A, Gatto G, Gentile R, Tesei S, Pezzoli G | title = Valvular heart disease and the use of dopamine agonists for Parkinson's disease | journal = The New England Journal of Medicine | volume = 356 | issue = 1 | pages = 39–46 | date = January 2007 | pmid = 17202454 | doi = 10.1056/NEJMoa054830 | doi-access = free }}</ref>  As a result of this, the [[Food and Drug Administration|FDA]] removed pergolide from the U.S. market on March 29, 2007.<ref>{{cite web |url=https://www.fda.gov/cder/drug/advisory/pergolide.htm |title=Food and Drug Administration Public Health Advisory |website=[[Food and Drug Administration]] |date=2007-03-29 |access-date=2007-04-27 |archive-url = https://web.archive.org/web/20070408111551/https://www.fda.gov/cder/drug/advisory/pergolide.htm <!-- Bot retrieved archive --> |archive-date = 2007-04-08}}</ref>  Since cabergoline is not approved in the U.S. for Parkinson's Disease, but for hyperprolactinemia, the drug remains on the market.  The lower doses required for treatment of hyperprolactinemia have been found to be '''not''' associated with clinically significant valvular heart disease or cardiac valve regurgitation.<ref>{{cite journal | vauthors = Bogazzi F, Buralli S, Manetti L, Raffaelli V, Cigni T, Lombardi M, Boresi F, Taddei S, Salvetti A, Martino E | title = Treatment with low doses of cabergoline is not associated with increased prevalence of cardiac valve regurgitation in patients with hyperprolactinaemia | journal = International Journal of Clinical Practice | volume = 62 | issue = 12 | pages = 1864–1869 | date = December 2008 | pmid = 18462372 | doi = 10.1111/j.1742-1241.2008.01779.x | s2cid = 7822137 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Wakil A, Rigby AS, Clark AL, Kallvikbacka-Bennett A, Atkin SL | title = Low dose cabergoline for hyperprolactinaemia is not associated with clinically significant valvular heart disease | journal = European Journal of Endocrinology | volume = 159 | issue = 4 | pages = R11–R14 | date = October 2008 | pmid = 18625690 | doi = 10.1530/EJE-08-0365 | doi-access = free }}</ref>