Applies to cabergoline: oral tablet.
Serious side effects of Cabergoline
Along with its needed effects, cabergoline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking cabergoline:
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chills
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- general feeling of discomfort or illness
- rapid weight gain
- swelling around the eyes
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Chest pain or tightness
- continuing loss of appetite
- continuing or severe abdominal or stomach pain
- continuing or severe nausea and vomiting
- cough
- decreased ability to exercise
- fever
- increased frequency of urination
- loss of appetite
- lower abdominal or stomach pain
- lower back pain
- nausea
- trouble breathing
- vomiting
- weakness
Get emergency help immediately if any of the following symptoms of overdose occur while taking cabergoline:
Symptoms of overdose
- Fainting
- seeing, hearing, or feeling things that are not there
- stuffy nose
Other side effects of Cabergoline
Some side effects of cabergoline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Difficulty having a bowel movement (stool)
- dizziness
- excess air or gas in the stomach or intestines
- full feeling
- headache
- lack or loss of strength
- passing gas
Less common
- Abdominal or stomach pain
- acid or sour stomach
- anxiety
- belching
- blemishes on the skin
- breast pain
- burning, itching, or stinging of the skin
- changes in vision
- cramps
- depression
- diarrhea
- difficulty with moving
- dry mouth or toothache
- feeling of constant movement of self or surroundings
- feeling of warmth
- gas
- heartburn
- heavy bleeding
- indigestion
- itching skin
- joint pain
- muscle aches and pains
- muscle stiffness
- pimples
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- sensation of spinning
- shivering
- sleepiness or unusual drowsiness
- sneezing
- sore throat
- stomach discomfort or upset
- sudden sweating
- trouble sleeping
- weight loss
Rare
- Bloody nose
- difficulty in concentrating
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
Incidence not known
- Attack, assault, or force
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- hair loss or thinning of the hair
- pathological gambling
- severe mood or mental changes
- unusual behavior
For Healthcare Professionals
Applies to cabergoline: oral tablet.
Gastrointestinal
Very common (10% or more): Nausea (up to 29%)
Common (1% to 10%): Constipation, dyspepsia, gastritis, vomiting, abdominal pain, dyspepsia, dry mouth, diarrhea, flatulence, throat irritation, toothache[Ref]
Nervous system
Very common (10% or more): Headache (up to 26%), dizziness (up to 17%)
Common (1% to 10%): Dizziness/vertigo, dyskinesia, paresthesia, somnolence
Uncommon (0.1% to 1%): Hyperkinesia
Frequency not reported: Sudden sleep onset, syncope, tremor[Ref]
Other
Common (1% to 10%): Asthenia
Uncommon (0.1% to 1%): Fatigue, malaise[Ref]
Psychiatric
Common (1% to 10%): Hallucinations sleep disturbance, increased libido, confusion, depression, anxiety, insomnia, nervousness
Uncommon (0.1% to 1%): Delusions, psychotic disorder
Frequency not reported: Aggression, hypersexuality, pathological gambling[Ref]
Cardiovascular
Very common (10% or more): Peripheral edema
Common (1% to 10%): Angina (with concomitant levodopa use), postural hypotension, hot flashes, cardiac valvulopathy, hypotension, dependent edema, palpitation
Uncommon (0.1% to 1%): Erythromelalgia
Rare (less than 0.1%): Syncope, heart failure
Frequency not reported: Constrictive pericarditis, digital vasospasm
Postmarketing reports: Cardiac valvulopathy, pericarditis, pericardial effusion[Ref]
Reports of cardiac valvulopathy have generally been received in patients on higher doses (greater than 2 mg/day); however, there have been cases in patients receiving lower doses for the treatment of hyperprolactinemic disorders. In a multi-country, retrospective cohort study, record review looking for an association between the new use of dopamine agonists (including this drug; n=27,812) and cardiac valvular regurgitation (CVR), other fibrosis, and other cardiopulmonary events found an increased risk of CVR among patients with Parkinson's disease when compared to non-ergot derived dopamine agonists and levodopa. Analysis in patients with hyperprolactinemia treated with this drug (n=8386) found that compared to non-users, exposed persons did not have an elevated risk of CVR. These findings are consistent with other published studies.[Ref]
Musculoskeletal
Frequency not reported: Leg cramps[Ref]
Dermatologic
Uncommon (0.1% to 1%): Rash, acne, pruritus
Frequency not reported: Alopecia[Ref]
Respiratory
Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Pleural effusion, pulmonary fibrosis, rhinitis
Very rare (less than 0.01%): Fibrosis (including pleural fibrosis)
Frequency not reported: Respiratory disorder, respiratory failure, pleuritic, chest pain[Ref]
Ocular
Uncommon (0.1% to 1%): Periorbital edema, abnormal vision[Ref]
Endocrine
Common (1% to 10%): Breast pain
Uncommon (0.1% to 1%): Dysmenorrhea[Ref]
General
Adverse effects are generally dose related. At lower doses, the more commonly reported adverse reactions included nausea, headache, dizziness/vertigo, abdominal pain/dyspepsia/gastritis, asthenia/fatigue; at higher doses, additional events of valvulopathy, dyspnea, dyskinesia, orthostatic hypotension, hallucination, and constipation have been commonly reported.[Ref]
Hepatic
Uncommon (0.1% to 1%): Hepatic function abnormalities
Postmarketing reports: Liver function test abnormal[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reaction[Ref]
