Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The most common adverse reactions reported were nervous system disorders. Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).

Tabulated list of adverse reactions

In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.
Frequency categories are defined as follows: 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).

Table 1 – Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class       Very common         Common                  Uncommon Metabolism and                                                       Decreased appetite, nutrition disorders                                                  Hypertriglyceridaemia Psychiatric disorders                        Abnormal dreams,        Anxiety, Hallucination,          Depression,
Hallucination visual,   Hallucination auditory,
Insomnia                Nightmare,
Sleep disorder


Nervous system             Dyskinesia               Dizziness,              Dysgeusia, disorders                                           Headache,               Hyperkinesia, Somnolence              Syncope
Eye disorders                                                               Dry eye Ear and labyrinth                                                           Ear congestion disorders
Cardiac disorders                                                           Palpitations Vascular disorders                                  Orthostatic             Hypertension, Hypotension             Hypotension
Respiratory, thoracic                                                       Dyspnoea and mediastinal disorders
Gastrointestinal                                    Constipation,           Abdominal distention, disorders                                           Dry mouth,              Abdominal pain, Nausea,                 Abdominal pain upper,
Vomiting                Dyspepsia
Musculoskeletal and                                 Muscle spasms           Muscle twitching, connective tissue                                                           Musculoskeletal disorders                                                                   stiffness, Myalgia,
Pain in extremity
Renal and urinary                                                           Chromaturia, disorders                                                                   Nocturia Investigations                                      Blood creatine          Weight decreased phosphokinase increased
Injury, poisoning and                                                       Fall procedural complications
General disorders and                                                       Fatigue administration site conditions

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