Adverse reactions : תופעות לוואי

4.8.    Undesirable effects

Adverse events are generally dose-related. In patients known to be intolerant to dopaminergic drugs, the likelihood of adverse events may be lessened by starting therapy with cabergoline at reduced doses, e.g. 0.25 mg once a week, with subsequent gradual increase until the 
 therapeutic dosage is reached. If persistent or severe adverse events occur, temporary reduction of dosage followed by a more gradual increase, e.g. increments of 0.25 mg/week every two weeks, may increase tolerability.
The following undesirable effects have been observed and reported during treatment with cabergoline with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).



MedDRA                            Frequency                  Undesirable Effects System Organ Class
Valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial
Very Common effusion)
Cardiac disorders
Uncommon                   Palpitations
Not Known                  Angina pectoris
Dyspnea, pleural effusion, fibrosis, (including
Uncommon pulmonary fibrosis), epistaxis
Respiratory, thoracic and         Very rare                  Pleural fibrosis mediastinal disorders
Respiratory disorder, respiratory failure,
Not Known pleuritis, chest pain
Uncommon                   Hypersensitivity reaction
Immune system disorders
Nervous system disorders          Very common                Headache*, dizziness/vertigo* Common                     somnolence
Uncommon                   Transient hemianopsia, syncope, paresthesia Not Known                  Sudden sleep onset, tremor
Eye disorders                     Not Known                  Visual impairment Common                     Depression
Uncommon                   Increased libido
Psychiatric disorders                                        Aggression, delusions, hypersexuality, Not Known                  pathological gambling, psychotic disorder, hallucinations
Vascular disorders                Common                     Cabergoline generally exerts a hypotensive effect in patients on long-term treatment;
Postural hypotension, hot flushes**
Uncommon                   Digital vasospasm, fainting
Nausea*, dyspepsia, gastritis, abdominal pain*
Gastrointestinal disorders        Very common
Common                     Constipation, vomiting**
Rare                       Epigastric pain
General disorders and             Very Common                Asthenia***, fatigue administration site conditions                               Oedema, peripheral oedema Uncommon
Hepato-biliary disorders          Not Known                  Hepatic function abnormal Skin and subcutaneous tissue      Uncommon                   Rash, alopecia disorders
Musculoskeletal and connective    Uncommon                   Leg cramps tissue disorders
Reproductive system and           Common                     Breast pain breast disorders
Investigations                    Common                     Asymptomatic decreases in blood pressure ( 20 mmHg systolic and  10 mmHg diastolic)
Uncommon                   A decrease in haemoglobin values have been observed in amenhorrheic women during the first few months after menses.
Not Known                  Blood creatinine phosphokinase increased, liver function tests abnormal

*Very common in patients treated for hyperprolactinaemin disorders; Common in patients treated for inhibition/supression of lactation
** Common in patients treated for hyperprolactinaemin disorders; Uncommon in patients treated for inhibition/supression of lactation
*** Very common in patients treated for hyperprolactinaemin disorders; Uncommon in patients treated for inhibition/supression of lactation


Impulse control disorders
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Dostinex® (see section 4.4).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.