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In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or Cabergoline at fixed doses of 0. 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. In the 8-week, double-blind period of the comparative trial with bromocriptine, Cabergoline (at a dose of 0. 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. Other adverse events that were reported at an incidence of. 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. 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 ), testo-non-10 250 mg injectable steroids sustanon (testosterone blend). 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.
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