Cabergoline Side Effects

Some side effects of cabergoline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cabergoline: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking cabergoline: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using cabergoline and call your doctor at once if you have a serious side effect such as:

• feeling short of breath on exertion;

• chest discomfort, dry cough or hack;

• feeling weak or tired, loss of appetite, rapid weight loss;

• feeling like you might pass out;

• lower back pain;

• urinating less than usual or not at all; or

• swelling in your ankles or feet.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking cabergoline.

Less serious side effects of cabergoline may include:

• nausea, vomiting, stomach pain, gas, indigestion, constipation;

• headache, depressed mood;

• dizziness, spinning sensation;

• drowsiness, nervousness;

• hot flashes;

• numbness or tingly feeling; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to cabergoline: oral tablet

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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