Cabergoline Side Effects
Brand Names: Dostinex
Please note - some side effects for Cabergoline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Cabergoline - for the consumer
Cabergoline
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cabergoline:
Seek medical attention right away if any of these SEVERE side effects occur when using Cabergoline:Constipation; dizziness; headache; indigestion; nausea; tiredness or weakness; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes (eg, aggression); chest pain; confusion; cough; depression; fainting; hallucinations; irregular heartbeat; mood or mental changes; shortness of breath; swelling of hands or feet; vision disturbances.
For the professional
Cabergoline
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.
| 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 |
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.
| 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) |
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.
TopMore resources:
Cabergoline - Includes detailed dosage instructions.
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