Cabergoline

FDA label, Mylan Pharmaceuticals Inc., oral, effective 2026-06-30. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Ergot Derivative

Dosing in kidney impairment

Pleural, Pulmonary and Retroperitoneal Fibrosis : During CABERGOLINE treatment monitor for signs and symptoms of progressive fibrosis, (e.g., pleuro-pulmonary disease, renal impairment, ureteral/abdominal vascular obstruction). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis at baseline and as necessary during CABERGOLINE treatment.

Renal impairment or ureteral/abdominal vascular obstruction (e.g., pain in the loin/flank, lower limb edema, abdominal masses or tenderness that may indicate retroperitoneal fibrosis). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis such as with erythrocyte sedimentation rate, serum creatinine measurements, chest-x-ray, and other investigations at baseline and as necessary during CABERGOLINE treatment.

Dosing in liver impairment

Hepatic Impairment The use of CABERGOLINE in patients with severe hepatic impairment (HI) (Child-Pugh C) is not recommended. When using CABERGOLINE in patients with moderate HI (Child-Pugh B) increase monitoring of CABERGOLINE-associated adverse reactions. The recommendations for use of CABERGOLINE in patients with mild HI (Child Pugh A) is the same as those with normal hepatic function.

Patients with moderate or severe HI had increased cabergoline exposure [see Clinical Pharmacology ] , which may increase the risk of CABERGOLINE-associated adverse reactions.

Drug interactions

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Label text (1 paragraph)

7 DRUG INTERACTIONS CABERGOLINE, a dopamine receptor agonist, is not recommended for concomitant use with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide. CABERGOLINE, a dopamine receptor agonist, is not recommended for concomitant use with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide. ( 7 )

Contraindications

4 CONTRAINDICATIONS CABERGOLINE is contraindicated in patients with: • Uncontrolled hypertension. • Known hypersensitivity to ergot derivatives. • History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis, or history of pericardial fibrosis [see Warnings and Precautions (5.1) ] . • History of pleural, pulmonary, or retroperitoneal fibrotic disorders [see Warnings and Precautions (5.2) ] . • Uncontrolled hypertension. ( 4 ) • Known hypersensitivity to ergot derivatives.

( 4 ) • History of cardiac valvular disorders, or pericardial fibrosis. ( 5.1 ) • History of pleural, pulmonary, or retroperitoneal fibrotic disorders. ( 5.2 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary If conception occurs during CABERGOLINE therapy, discontinue CABERGOLINE if the risks to the mother or fetus outweigh the benefits to the mother. There are risks to the mother associated with the use of CABERGOLINE ( see Clinical Considerations ). The estimated background risk of major birth defects and miscarriage in patients with hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S.

general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Maternal Adverse Reactions: In general, avoid use of dopamine agonists, including CABERGOLINE, during pregnancy and the postpartum period. The risks of CABERGOLINE use increase in pregnant females with pregnancy-induced hypertension, preeclampsia, and eclampsia. Data Human Data: Published case reports have not reported a clear association with CABERGOLINE and major birth defects, miscarriage, or adverse fetal outcomes when CABERGOLINE was used during early pregnancy.

However, these case reports cannot definitely establish the absence of CABERGOLINE-associated risk. Animal Data: Embryo-fetal development studies have been performed with cabergoline administered by oral gavage in mice, rats, and rabbits: • There were no teratogenic effects in the presence of maternal toxicity in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose based on body surface area) during the period of organogenesis. • A dose of 0.012 mg/kg/day (approximately 0.14 times the maximum recommended human dose) administered during the period of organogenesis in rats caused an increase in post-implantation loss.

This finding is likely due to the role of prolactin in implantation in rats and is not thought to be relevant to humans. • At doses of 0.5 mg/kg/day (approximately 19 times the maximum recommended human dose) administered during the period of organogenesis in rabbits, cabergoline caused maternal toxicity characterized by a loss of body weight and decreased food consumption. Doses of 4 mg/kg/day (approximately 150 times the maximum recommended human dose) administered during the period of organogenesis in the rabbit caused an increased occurrence of various malformations.

However, in another study in rabbits, no treatment-related malformations or embryofetal toxicity were observed at doses up to 8 mg/kg/day…

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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