Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

CABERGOLINE Tablets (GREENSTONE LLC) Adverse Reactions

ADVERSE REACTIONS

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 1.0 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*Cabergoline
(n=168)
0.125 to 1 mg two times a week
Placebo
(n=20)
 Number (percent)
*
Reported at ≥1% for cabergoline
Gastrointestinal  
  Nausea45 (27)4 (20)
  Constipation16 (10)0
  Abdominal pain9 (5)1 (5)
  Dyspepsia4 (2)0
  Vomiting4 (2)0
Central and Peripheral Nervous System  
  Headache43 (26)5 (25)
  Dizziness25 (15)1 (5)
  Paresthesia2 (1)0
  Vertigo2 (1)0
Body As a Whole  
  Asthenia15 (9)2 (10)
  Fatigue12 (7)0
  Hot flashes2 (1)1 (5)
Psychiatric  
  Somnolence9 (5)1 (5)
  Depression5 (3)1 (5)
  Nervousness4 (2)0
Autonomic Nervous System  
  Postural hypotension6 (4)0
Reproductive – Female  
  Breast pain2 (1)0
  Dysmenorrhea2 (1)0
Vision  
  Abnormal vision2 (1)0

In the 8-week, double-blind period of the comparative trial with bromocriptine, Cabergoline (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from cabergoline were headache, nausea and vomiting (3, 2 and 2 patients respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.

Incidence of Reported Adverse Events During the 8-Week, Double-Blind Period of the Comparative Trial With Bromocriptine
Adverse Event*Cabergoline
(n=221)
Bromocriptine
(n=231)
 Number (percent)
*
Reported at ≥1% for cabergoline
Gastrointestinal  
  Nausea63 (29)100 (43)
  Constipation15 (7)21 (9)
  Abdominal pain12 (5)19 (8)
  Dyspepsia11 (5)16 (7)
  Vomiting9 (4)16 (7)
  Dry mouth5 (2)2 (1)
  Diarrhea4 (2)7 (3)
  Flatulence4 (2)3 (1)
  Throat irritation2 (1)0
  Toothache2 (1)0
Central and Peripheral Nervous System  
  Headache58 (26)62 (27)
  Dizziness38 (17)42 (18)
  Vertigo9 (4)10 (4)
  Paresthesia5 (2)6 (3)
Body As a Whole  
  Asthenia13 (6)15 (6)
  Fatigue10 (5)18 (8)
  Syncope3 (1)3 (1)
  Influenza-like symptoms2 (1)0
  Malaise2 (1)0
  Periorbital edema2 (1)2 (1)
  Peripheral edema2 (1)1
Psychiatric  
  Depression7 (3)5 (2)
  Somnolence5 (2)5 (2)
  Anorexia3 (1)3 (1)
  Anxiety3 (1)3 (1)
  Insomnia3 (1)2 (1)
  Impaired concentration2 (1)1
  Nervousness2 (1)5 (2)
Cardiovascular  
  Hot flashes6 (3)3 (1)
  Hypotension3 (1)4 (2)
  Dependent edema2 (1)1
  Palpitation2 (1)5 (2)
Reproductive – Female  
  Breast pain5 (2)8 (3)
  Dysmenorrhea2 (1)1
Skin and Appendages  
  Acne3 (1)0
  Pruritus2 (1)1
Musculoskeletal  
  Pain4 (2)6 (3)
  Arthralgia2 (1)0
Respiratory  
  Rhinitis2 (1)9 (4)
Vision  
  Abnormal vision2 (1)2 (1)

Other adverse events that were reported at an incidence of <1.0% in the overall 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

The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson's disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson's disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.

Post-marketing Surveillance data

The following events have been reported in association with cabergoline: cardiac valvulopathy and extracardiac fibrotic reactions, (See WARNINGS, Cardiac Valvulopathy and Extracardiac Fibrotic Reactions).

Other events have been reported in association with cabergoline: impulse control/compulsive behavior symptoms, including hypersexuality, increased libido and pathological gambling (See PRECAUTIONS, Psychiatric). In addition, cases of alopecia, aggression, and psychotic disorder have been reported in patients taking cabergoline. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.

Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event