Adverse reactions : תופעות לוואי

4.8. Undesirable effects
Adverse effects have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100; < 1/10); uncommon (≥ 1/1000; < 1/100); rare (≥ 1/10 000; < 1/1000); very rare (< 1/10 000); not known (cannot be estimated from the available data).


Blood and lymphatic system disorders:
Uncommon: leukopenia, neutropenia (see Section 4.4)
Rare: agranulocytosis (see Section 4.4)

Immune system disorders:
Uncommon: allergic reaction

Endocrine disorders:
Common: amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, and erectile dysfunction.
Rare: benign pituitary tumour such as prolactinoma (see sections 4.3 and 4.4) 
Metabolism and nutrition disorders:
Uncommon: hyperglycaemia (see Section 4.4), hypertriglyceridemia and hypercholesterolaemia Rare: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH) 
Psychiatric disorders:
Common: insomnia, anxiety, agitation, orgasmic dysfunction
Uncommon: confusion

Nervous system disorders
Very common: Extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia. These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication. The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50 - 300 mg/day.
Common: somnolence, acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent.
Uncommon: seizures, tardive dyskinesia characterized by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after longterm administration.
Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.
.
Rare: Neuroleptic Malignant Syndrome (see section 4.4), which is a potentially fatal complication Not known: restless legs syndrome

Eye disorders:
Common: blurred vision (see section 4.7)
Cardiac disorders:
Uncommon: bradycardia
Rare: QT interval prolongation, ventricular arrhythmias such as torsade de pointes, ventricular tachycardia, ventricular fibrillation, cardiac arrest, sudden death (see section 4.4).

Vascular disorders:
Common: hypotension
Uncommon: increase in blood pressure
Rare: venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis (see Section 4.4).

Respiratory, thoracic and mediastinal disorders:
Uncommon: nasal congestion, pneumonia aspiration (mainly in association with other antipsychotics and CNS depressants).

Gastrointestinal disorders
Common: Constipation, nausea, vomiting, dry mouth.
Hepatobiliary disorders:
Uncommon: hepatocellular injury

Skin and subcutaneous tissue disorders:
Rare: angioedema, urticaria
Not known: photosensitivity reaction
Musculoskeletal and connective tissue disorders:
Uncommon: osteopenia, osteoporosis

Renal and urinary disorders:
Uncommon: urinary retention

Pregnancy, puerperium and perinatal conditions:
Not known: drug withdrawal syndrome neonatal (see Section 4.6)
Injury, poisoning and procedural complications:
Not known: Fall as a consequence of adverse reactions compromising body balance 
Investigations
Common: Weight gain
Uncommon: Elevations of hepatic enzymes, mainly transaminases.

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 at https://sideeffects.health.gov.il.