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).
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, increased gambling or sexual urges); chest pain; confusion; cough; depression; fainting; hallucinations; irregular heartbeat; mood or mental changes; shortness of breath; sudden unexplained weight gain; swelling of hands or feet; vision disturbances.
Cabergoline Side Effects - 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.
Post-marketing Surveillance data
The following events have been reported in association with Cabergoline: valvulopathy and fibrosis,.
Others events have been reported in association with Cabergoline: hypersexuality, increased libido, pathological gambling. In addition, during post-marketing surveillance, 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.
TopSide Effects by Body System
Gastrointestinal
Gastrointestinal side effects including nausea (10% to 31%), constipation (7% to 10%), abdominal pain (5% to 7%), dyspepsia (2% to 5%), vomiting (2% to 4%), dry mouth (2%), diarrhea (2%), and flatulence (2%), throat irritation (1%), and toothache (1%) have been reported.
Nervous system
Nervous system effects including headache (13% to 30%), dizziness (13% to 25%), postural hypotension (4%), vertigo (1% to 4%), and paresthesia (1% to 2%) have been reported.
Other
Other side effects including fatigue (5% to 13%), asthenia (4% to 9%), somnolence (5%), hot flashes (1% to 3%), syncope (1%), influenza-like symptoms (1%), malaise (1%), periorbital edema (1%), and facial edema (< 1%) have been reported.
Psychiatric
Psychiatric side effects including somnolence (2% to 5%), depression (3%), nervousness (1% to 2%), anorexia (1%), anxiety (1%), insomnia (1%), and impaired concentration (1%) have been reported.
Psychiatric side effects reported during postmarketing surveillance have included aggression and psychotic disorder.
Cardiovascular
Cardiovascular effects including hypotension (1%), dependent edema (1%), palpitation (1%), and syncope (less than 1%) have been reported. Valvulopathy has been reported following long-term administration of cabergoline. A case of mitral valve regurgitation has also been reported.
Genitourinary
Genitourinary side effects including breast pain (1% to 4%), dysmenorrhea (1%) and increased libido (<1%) have been reported. A case of recurrent penile erections had also been reported.
Musculoskeletal
Musculoskeletal side effects including pain (2%) and arthralgia (1%) have been reported.
Dermatologic
Dermatologic side effects including acne (1%), pruritus (1%), and alopecia have been reported. A case of erythema nodosum has been reported. A case of scalp irritation has also been reported which, (along with facial edema) lead to discontinuation of therapy.
Respiratory
Respiratory side effects including rhinitis (1%), nasal stuffiness (<1%), and epistaxis (<1%) have been reported. Pleural effusion and pulmonary fibrosis have been reported following long-term administration of cabergoline. A case of progressive pleuropulmonary abnormalities and systemic illness possibly caused by cabergoline has been reported.
Ocular
Ocular side effects including abnormal vision (1%) have been reported.
Metabolic
Metabolic side effects including both weight loss (< 1%) and weight gain (< 1%) have been reported.
Oncologic
Oncologic side effects have been reported in animal studies which showed a slight increase in the incidence of both cervical and uterine leiomyomas as well as uterine leiomyosarcomas in mice. Studies also showed a slight increase in malignant tumors of the cervix and uterus and interstitial cell adenomas in rats.
TopMore resources:
Cabergoline - Includes detailed dosage instructions.
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