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Dostinex

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Dostinex

Dostinex

SIDE EFFECTS

The safety of DOSTINEX 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)
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
*Reported at ≥ 1% for cabergoline

In the 8-week, double-blind period of the comparative trial with bromocriptine, DOSTINEX (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 DOSTINEX 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)
Gastrointestinal
  Nausea 63 (29) 100 (43)
  Constipation 15 (7) 21 (9)
  Abdominal pain 12 (5) 19 (8)
  Dyspepsia 11 (5) 16 (7)
  Vomiting 9 (4) 16 (7)
  Dry mouth 5 (2) 2 (1)
  Diarrhea 4 (2) 7 (3)
  Flatulence 4 (2) 3 (1)
  Throat irritation 2 (1) 0
  Toothache 2 (1) 0
Central and Peripheral Nervous System
  Headache 58 (26) 62 (27)
  Dizziness 38 (17) 42 (18)
  Vertigo 9 (4) 10 (4)
  Paresthesia 5 (2) 6 (3)
Body As a Whole
  Asthenia 13 (6) 15 (6)
  Fatigue 10 (5) 18 (8)
  Syncope 3 (1) 3 (1)
  Influenza-like symptoms 2 (1) 0
  Malaise 2 (1) 0
  Periorbital edema 2 (1) 2 (1)
  Peripheral edema 2 (1) 1
Psychiatric
  Depression 7 (3) 5 (2)
  Somnolence 5 (2) 5 (2)
  Anorexia 3 (1) 3 (1)
  Anxiety 3 (1) 3 (1)
  Insomnia 3 (1) 2 (1)
  Impaired concentration 2 (1) 1
  Nervousness 2 (1) 5 (2)
Cardiovascular
  Hot flashes 6 (3) 3 (1)
  Hypotension 3 (1) 4 (2)
  Dependent edema 2 (1) 1
  Palpitation 2 (1) 5 (2)
Reproductive – Female
  Breast pain 5 (2) 8 (3)
  Dysmenorrhea 2 (1) 1
Skin and Appendages
  Acne 3 (1) 0
  Pruritus 2 (1) 1
Musculoskeletal
  Pain 4 (2) 6 (3)
  Arthralgia 2 (1) 0
Respiratory
  Rhinitis 2 (1) 9 (4)
Vision
  Abnormal vision 2 (1) 2 (1)
*Reported at ≥ 1% for cabergoline

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.

Postmarketing Surveillance data

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

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

Read the Dostinex (cabergoline) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

DOSTINEX should not be administered concurrently with D2antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.

Read the Dostinex Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/28/2011
This monograph has been modified to include the generic and brand name in many instances.

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