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.

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:

Constipation; dizziness; headache; indigestion; mild stomach pain; nausea; tiredness or weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Cabergoline:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; behavior changes (eg, aggression, increased gambling or sexual urges); burning, numbness, or tingling; chest pain; confusion; decreased urination; fainting; hallucinations; irregular heartbeat; mood or mental changes (eg, depression); persistent cough; severe or persistent dizziness or light-headedness; severe stomach pain or tenderness; shortness of breath; sudden, unexplained weight gain; swelling of hands, ankles, legs, or feet; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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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 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

*Reported at ≥ 1% for Cabergoline
Adverse Event*	Cabergoline (n = 168)0.125 to 1 mg twotimes 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.

Incidence of Reported Adverse Events During the 8 Week, Double-Blind Period of the Comparative Trial With Bromocriptine

*Reported at ≥ 1% for Cabergoline
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% 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 Cabergoline: cardiac valvulopathy and extracardiac fibrotic reactions.

Others events have been reported in association with Cabergoline: hypersexuality, increased libido, pathological gambling. 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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Side Effects by Body System - for Healthcare Professionals

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 (less than 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 (less than 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 (less than 1%), and epistaxis (less than 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 (less than 1%) and weight gain (less than 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.

Endocrine

Endocrine side effects have included recurrence of hyperprolactinemia following withdrawal of long-term cabergoline therapy.

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