Cabergoline is an ergot derivative sold in the U.S. under 2 brand and generic names, for adenoma, hyperprolactinemia and parkinson disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Cabergoline (application ANDA078035). Other cabergoline products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage of Cabergoline Tablets, USP for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient’s serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease. Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with Cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered. After a normal serum prolactin level has been maintained for 6 months, cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with cabergoline should be reinstituted. The durability of efficacy beyond 24 months of therapy with cabergoline has not been established.
The safety of Cabergoline Tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity. In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table. Incidence of Reported Adverse Events During the 4-Week, Double-Blind, Placebo-Controlled Trial Adverse Event Reported at ≥1% for cabergoline Cabergoline (n=168) 0.125 to 1 mg two times a week Placebo (n=20) Number (percent) Gastrointestinal Nausea 45 (27) 4 (20) Constipation 16 (10) 0 Abdominal pain 9 (5) 1 (5) Dyspepsia 4 (2) 0 Vomiting 4 (2) 0 Central and Peripheral Nervous System Headache 43 (26) 5 (25) Dizziness 25 (15) 1 (5) Paresthesia 2 (1) 0 Vertigo 2 (1) 0 Body As a Whole Asthenia 15 (9) 2 (10) Fatigue 12 (7) 0 Hot flashes 2 (1) 1 (5) Psychiatric Somnolence 9 (5) 1 (5) Depression 5 (3) 1 (5) Nervousness 4 (2) 0 Autonomic Nervous System Postural hypotension 6 (4) 0 Reproductive – Female Breast pain 2 (1) 0 Dysmenorrhea 2 (1) 0 Vision Abnormal vision 2 (1) 0 In the…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $42 | View → | |
| 2 | 56/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 0;5;5420 | 0.5 mg | white | oval | — |
| P;673 | 0.5 mg | white | oval | — |
| P;U;700 | 0.5 mg | white | oval | — |
| C;5 | 0.5 mg | white | oval | — |
| IN;G;118 | 0.5 mg | white | oval | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Cabergoline Tablets, USP are contraindicated in patients with Uncontrolled hypertension or 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 (See WARNINGS ). History of pulmonary, pericardial, or retroperitoneal fibrotic disorders (See WARNINGS ).
Cabergoline should not be administered concurrently with D 2 -antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.
| $42 |
| View → |