Cabergoline
Tablet · Oral
Uses
1 INDICATIONS AND USAGE CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. ( 1 ) Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions. ( 5.4 )
Dosage and administration
• Before initiating CABERGOLINE evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer CABERGOLINE. ( 2.1 )
• Recommended starting dosage of CABERGOLINE is 0.25 mg orally twice weekly. ( 2.2 )
• Titrate CABERGOLINE to achieve normal serum prolactin levels by increasing CABERGOLINE by 0.25 mg orally twice weekly at intervals of no less than 4 weeks. ( 2.2 )
• Maximum recommended dosage is 1 mg orally, twice weekly. ( 2.2 ) 2.1 Recommended Evaluation Before Initiating CABERGOLINE Before initiating CABERGOLINE evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer CABERGOLINE [see Contraindications (4) and Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage The recommended starting dosage of CABERGOLINE is 0.25 mg orally twice weekly. Titrate CABERGOLINE to achieve normal serum prolactin levels by increasing CABERGOLINE by 0.25 mg orally twice weekly at intervals of no less than 4 weeks. The maximum recommended dosage is 1 mg orally, twice weekly [see Warnings and Precautions (5.2) ] . Administer CABERGOLINE with or without food [see Clinical Pharmacology (12.3) ] . If CABERGOLINE is discontinued, monitor the serum prolactin level periodically to determine whether CABERGOLINE should be reinstituted.
Dosage forms and strengths
Tablets: 0.5 mg, white, with functional score, oblong scored on one side with the letter P and the letter U on either side of the breakline, engraved with the number 700 on the opposite side. Tablets: 0.5 mg, white, with functional score. ( 3 )
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 )
Warnings and precautions
• Cardiac Valvulopathy and Pericardial Fibrosis : Before initiating CABERGOLINE, perform a cardiovascular evaluation, including echocardiogram, to evaluate for valvular disease. During CABERGOLINE treatment, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated and monitor for chest pain and signs and symptoms of heart failure (if heart failure occurs, exclude valvular fibrosis and pericarditis). Consider additional clinical and diagnostic monitoring at baseline and as necessary during CABERGOLINE treatment. Use CABERGOLINE in patients treated with other drugs associated with valvulopathy only if the potential benefit of CABERGOLINE outweighs the risk. Discontinue CABERGOLINE if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. ( 5.1 )
• 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. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue CABERGOLINE. ( 5.2 )
• Orthostatic Hypotension : Check blood pressure at baseline and during treatment with CABERGOLINE and monitor for orthostatic hypotension. ( 5.3 )
• Risks with Use of CABERGOLINE for Postpartum Lactation Inhibition or Suppression : Avoid use of CABERGOLINE for the inhibition or suppression of physiologic lactation. Use of bromocriptine, another dopamine agonist for this unapproved use has been associated with cases of hypertension, stroke, myocardial infarction, seizures, and death. ( 5.4 )
• Impulse Control Disorders and Compulsive Behaviors : Specifically ask patients about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with CABERGOLINE. Consider dosage reduction or stopping CABERGOLINE if a patient develops such urges while taking CABERGOLINE. ( 5.5 ) 5.1 Cardiac Valvulopathy and Pericardial Fibrosis Before initiating CABERGOLINE, perform a cardiovascular evaluation, including with an echocardiogram, to evaluate for valvular disease. CABERGOLINE is contraindicated in the presence of valvular disease or pericardial fibrosis [see Contraindications (4) ] . Cases of valvular and pericardial fibrosis have often manifested as heart failure. Following CABERGOLINE treatment initiation, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated with new onset edema, cardiac murmur, dyspnea, or heart failure. During CABERGOLINE treatment, monitor for chest pain and signs and symptoms of heart failure and if heart failure occurs, valvular fibrosis and pericarditis should be excluded. Consider clinical and diagnostic monitoring such as erythrocyte sedimentation rate, serum creatinine measurements, chest-x- ray, and other investigations and cardiac imaging at baseline and as necessary while patients are treated with during CABERGOLINE treatment. Use CABERGOLINE in patients treated with other drugs associated with valvulopathy only if the potential benefit of CABERGOLINE outweighs the risk. Discontinue CABERGOLINE if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. Postmarketing cases of cardiac valvulopathy have been reported in patients who received CABERGOLINE. These cases have generally occurred during administration of high doses of CABERGOLINE (>2 mg/day) for the treatment of Parkinson’s disease (PD) (CABERGOLINE is not approved for the treatment of PD). Cases of cardiac valvulopathy have also been reported in patients who received lower dosages of CABERGOLINE for the treatment of hyperprolactinemic disorders. In a 12-year, multi-country retrospective cohort study, the use of CABERGOLINE for PD was associated with an increased risk of cardiac valvular regurgitation (CVR). Compared to non-ergot-derived dopamine agonists and levodopa, CVR with CABERGOLINE use had an incidence rate per 10,000 person years of 68 (95% CI: 37, 115) versus 10 (95% CI: 5, 19) for non-ergot dopamine agonists and 11 (95% CI: 7, 17) for levodopa. 5.2 Pleural, Pulmonary and Retroperitoneal Fibrosis CABERGOLINE is contraindicated in patients with a history of pleural, pulmonary, or retroperitoneal fibrosis. During CABERGOLINE treatment monitor for signs and symptoms of progressive fibrosis, including:
• Pleuro-pulmonary disease (e.g., dyspnea, shortness of breath, persistent cough, chest pain).
• 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. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue CABERGOLINE. Postmarketing cases of pleural, pulmonary, and retroperitoneal fibrosis have been reported following CABERGOLINE administration. Some reports were in patients previously treated with other ergotinic dopamine agonists. CABERGOLINE-treated patients who developed a pleural effusion or pulmonary fibrosis and subsequently discontinued CABERGOLINE had improvement of their pulmonary symptoms. 5.3 Orthostatic Hypotension Check blood pressure at baseline and during treatment with CABERGOLINE and monitor for orthostatic hypotension.
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling:
• Cardiac Valvulopathy and Pericardial Fibrosis [see Warnings and Precautions (5.1) ] .
• Pleural, Retroperitoneal, and Pulmonary Fibrosis [see Warnings and Precautions (5.2) ] .
• Orthostatic Hypotension [see Warnings and Precautions (5.3) ] .
• Impulse Control Disorders and Compulsive Behaviors [see Warnings and Precautions (5.5) ] . The most common adverse reactions (incidence >10%) are nausea, headache, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1‑877‑4‑INFO‑RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CABERGOLINE has been evaluated in more than 900 patients with hyperprolactinemic disorders. In a 4-week, double-blind, placebo-controlled trial (CABERGOLINE vs. placebo) [see Clinical Studies (14) ] , the incidence of the most common adverse reactions during the placebo-controlled trial in patients with hyperprolactinemic disorders is presented in Table 1. Table 1. Adverse Reactions (n (%)) Adverse reactions that occurred ≥1% in the CABERGOLINE group and frequency more than that reported in the placebo group. During the 4-Week, Double-Blind, Placebo-Controlled Trial in Hyperprolactinemic Females CABERGOLINE (n=168) Placebo (n=20) Nausea 45 (27%) 4 (20%) Headache 43 (26%) 5 (25%) Dizziness 25 (15%) 1 (5%) Constipation 16 (10%) 0% Fatigue 12 (7%) 0% Postural hypotension 6 (4%) 0% Dyspepsia 4 (2%) 0% Vomiting 4 (2%) 0% Nervousness 4 (2%) 0% Vertigo 2 (1%) 0% Paresthesia 2 (1%) 0% Breast pain 2 (1%) 0% Dysmenorrhea 2 (1%) 0% Abnormal vision 2 (1%) 0% In the 8-week, double-blind period of the comparative trial with bromocriptine, 2% (4/221) of CABERGOLINE-treated patients (0.5 mg twice weekly) discontinued treatment because of an adverse event and 6% (14/231) of bromocriptine-treated patients (at a dose of 2.5 mg twice daily) discontinued treatment because of an adverse event. The most common reasons for CABERGOLINE discontinuation were headache, nausea, and vomiting (3, 2, and 2 patients, respectively). The incidence of the most common adverse events during the double-blind period of the comparative trial with bromocriptine is presented in Table 2. Table 2. Adverse Events Adverse events reported ≥1% in the CABERGOLINE group. Abbreviation: n=number of patients. During the 8-Week, Double-Blind Period of the Comparative Trial in Hyperprolactinemic Females CABERGOLINE (n=221) Bromocriptine (n=231) Nausea 63 (29%) 100 (43%) Headache 58 (26%) 62 (27%) Dizziness 38 (17%) 42 (18%) Constipation 15 (7%) 21 (9%) Asthenia 13 (6%) 15 (6%) Abdominal pain 12 (5%) 19 (8%) Dyspepsia 11 (5%) 16 (7%) Fatigue 10 (5%) 18 (8%) Vertigo 9 (4%) 10 (4%) Vomiting 9 (4%) 16 (7%) Depression 7 (3%) 5 (2%) Hot flashes 6 (3%) 3 (1%) Breast pain 5 (2%) 8 (3%) Dry mouth 5 (2%) 2 (1%) Paresthesia 5 (2%) 6 (3%) Somnolence 5 (2%) 5 (2%) Diarrhea 4 (2%) 7 (3%) Flatulence 4 (2%) 3 (1%) Pain 4 (2%) 6 (3%) Acne 3 (1%) 0% Anorexia 3 (1%) 3 (1%) Anxiety 3 (1%) 3 (1%) Hypotension 3 (1%) 4 (2%) Insomnia 3 (1%) 2 (1%) Syncope 3 (1%) 3 (1%) Abnormal vision 2 (1%) 2 (1%) Arthralgia 2 (1%) 0% Dependent edema 2 (1%) 1 (<1%) Dysmenorrhea 2 (1%) 1 (<1%) Impaired concentration 2 (1%) 1 (<1%) Influenza-like symptoms 2 (1%) 0% Malaise 2 (1%) 0% Nervousness 2 (1%) 5 (2%) Palpitation 2 (1%) 5 (2%) Periorbital edema 2 (1%) 2 (1%) Peripheral edema 2 (1%) 1 (<1%) Pruritus 2 (1%) 1 (<1%) Rhinitis 2 (1%) 9 (4%) Throat irritation 2 (1%) 0% Toothache 2 (1%) 0% Events that were reported at an incidence of <1% in the clinical studies follow:
• Body As a Whole: facial edema, influenza-like symptoms, malaise
• Cardiovascular System: hypotension, syncope, palpitations
• Digestive System: dry mouth, flatulence, diarrhea, anorexia
• Metabolic and Nutritional System: weight loss, weight gain
• Nervous System: somnolence, nervousness, paresthesia, insomnia, anxiety
• Respiratory System: nasal stuffiness, epistaxis
• Skin and Appendages: acne, pruritus
• Special Senses: abnormal vision
• Urogenital System: dysmenorrhea, increased libido 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of CABERGOLINE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Psychiatric: impulse control disorders and compulsive behaviors including, hypersexuality, increased libido, pathological gambling; psychotic disorder, aggression
• Skin and subcutaneous: alopecia
Drug interactions
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 )
Use in specific populations
Pregnancy : If conception occurs during CABERGOLINE therapy, discontinue CABERGOLINE if the risks to the mother or fetus outweigh the benefits to the mother. ( 8.1 ) 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 (approximately 300 times the maximum recommended human dose). 8.2 Lactation Risk Summary CABERGOLINE is not recommended in postpartum women who are breastfeeding or who are planning to breastfeed. Avoid use of CABERGOLINE for the inhibition or suppression of physiologic lactation [see Indications and Usage (1) and Warnings and Precautions (5.4) ] . 8.4 Pediatric Use Safety and effectiveness of CABERGOLINE in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of CABERGOLINE did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. 8.6 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 (12.3) ] , which may increase the risk of CABERGOLINE-associated adverse reactions.
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 (approximately 300 times the maximum recommended human dose).
Pediatric use
8.4 Pediatric Use Safety and effectiveness of CABERGOLINE in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use Clinical studies of CABERGOLINE did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Overdosage
Take measures to support blood pressure, if necessary. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Description
Cabergoline is an ergot derivative and dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(dimethylamino) propyl]-3-ethylurea. Its empirical formula is C 26 H 37 N 5 O 2 , and its molecular weight is 451.62. The structural formula is as follows Cabergoline is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water. CABERGOLINE tablets, for oral administration, contain 0.5 mg of cabergoline and the inactive ingredients of leucine, USP, and lactose, NF. Structural formula
Mechanism of action
12.1 Mechanism of Action Cabergoline is an ergot derivative and dopamine receptor agonist with a high affinity for D2 receptors. Results of in vitro studies demonstrate that cabergoline exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Cabergoline decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that cabergoline has low affinity for dopamine D1, α1- and α2-adrenergic, and 5-HT1- and 5-HT2-serotonin receptors.
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING CABERGOLINE tablets are white, scored, oblong, with functional score on one side with the letter P and the letter U on either side of the breakline, engraved with the number 700 on the opposite side and they are available in the following configuration: 0.5 mg strength, 8-count bottle, and NDC number 59762-1005-1. Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP]. Store the tablets in the original container.
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Fibrotic Conditions There is a risk of cardiac valvulopathy, and pericardial, pleural, pulmonary, and retroperitoneal fibrosis with CABERGOLINE treatment. Advise patients to notify their healthcare provider if they develop shortness of breath, chest pain, persistent cough, difficulty with breathing when lying down, or swelling in their extremities [see Warnings and Precautions (5.1) ] . Orthostatic Hypotension Warn patients about the risk of orthostatic hypotension and instruct patients to rise slowly from a supine or sitting position. Advise patients to notify their healthcare provider if they develop dizziness or lightheadedness [see Warnings and Precautions (5.3) ] . Impulse Control Disorders and Compulsive Behaviors Patients should be alerted to the possibility that patients may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking CABERGOLINE. Advise patients to inform their health care provider if they develop new or increased uncontrolled spending, gambling urges, sexual urges, or other urges while being treated with CABERGOLINE [see Warnings and Precautions (5.5) ] . Pregnancy Advise patients to notify their health care provider if they suspect they are pregnant, become pregnant, or intend to become pregnant during therapy. A pregnancy test should be done if there is any suspicion of pregnancy and continuation of CABERGOLINE treatment should be discussed with their health care provider [see Use in Specific Populations (8.1) ] .
Label text from the FDA structured product label by Mylan Pharmaceuticals Inc. (revised Jun 30, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Cabergoline in 12 products
Cabergoline NDC products (12)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-3157 | Cabergoline .5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5834 | Cabergoline .5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6596 | Cabergoline .5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7642 | Cabergoline .5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 69238-2693 | Cabergoline .5 mg/1 Tablet | Amneal Pharmaceuticals NY LLC | ANDA |
| 27808-315 | Cabergoline .5 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA |
| 23155-823 | Cabergoline .5 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 50742-118 | Cabergoline .5 mg/1 Tablet | Ingenus Pharmaceuticals, LLC | ANDA |
| 70512-860 | Cabergoline .5 mg/1 Tablet | SOLA Pharmaceuticals, LLC | ANDA |
| 70069-824 | Cabergoline .5 mg/1 Tablet | Somerset Therapeutics, LLC | ANDA |
| 0093-5420 | Cabergoline .5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 59762-1005 | Cabergoline .5 mg/1 Tablet | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
Cabergoline recalls
- D-128-2013 Jan 23, 2013 · Class III · Terminated
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Frequently asked questions
What is Cabergoline used for?
1 INDICATIONS AND USAGE CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . CABERGOLINE is an…
What are the side effects of Cabergoline?
The following clinically significant adverse reactions are described elsewhere in the labeling: • Cardiac Valvulopathy and Pericardial Fibrosis [see Warnings and Precautions (5.1) ] . • Pleural, Retroperitoneal, and Pulmonary Fibrosis [see Warnings and Precautions (5.2) ] . • Orthostatic Hypotension [see Warnings and Precautions (5.3) ] . • Impulse Control Disorders and Compulsive Behaviors [see… See the full label for the complete list.
Who makes Cabergoline?
Cabergoline is listed by 9 labelers in the FDA NDC directory, including A-S Medication Solutions, Amneal Pharmaceuticals NY LLC, Cranbury Pharmaceuticals, LLC, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
Has Cabergoline been recalled?
The FDA enforcement database lists 1 recall for Cabergoline, most recently D-128-2013 (class iii): Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life