Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000;<1/100); rare (≥1/10,000;<1/1,000); very rare (<1/10,000), frequency not known (cannot be estimated from the available data).
Clinical trial data
The following adverse effects have been observed in controlled clinical trials. It should be noted that in some instances it can be difficult to differentiate adverse events from symptoms of the underlying disease.- 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: Acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. Somnolence.Uncommon: Tardive dyskinesia characterized by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long term administration. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms. Seizures.- Psychiatric disorders:Common: Insomnia, anxiety, agitation, orgasmic dysfunction.- Gastrointestinal disorders:Common: Constipation, nausea, vomiting, dry mouth.- 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.- Metabolism and nutrition disorders:Uncommon: Hyperglycemia (see section 4.4 Special Warnings and Special Precautions for Use).- Cardiovascular disorders:Common: Hypotension.Uncommon: Bradycardia.- Investigations:Common: Weight gain.Uncommon: Elevations of hepatic enzymes, mainly transaminases.- Immune system disorders:Uncommon: Allergic reaction.
Post Marketing data:
In addition, cases of the following adverse reactions have been reported through spontaneous reporting only:- Metabolism and nutrition disordersFrequency not known: hypertriglyceridemia and hypercholesterolemia.- Psychiatric disordersFrequency not known: confusion.- Nervous system disordersFrequency not known: Neuroleptic Malignant Syndrome (see section 4.4 Special Warnings and Special Precautions for Use) which is a potentially fatal complication.- Eye DisordersFrequency not known: blurred vision.- Endocrine disordersFrequency not known: Benign pituitary tumour such as prolactinoma (see section 3 and section 4.4).- Metabolism and nutrition disordersFrequency not known: Hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH).- Cardiac disorders
Frequency not known: QT interval prolongation and ventricular arrhythmias such as torsade de pointes, ventricular tachycardia, which may result in ventricular fibrillation or cardiac arrest, sudden death (see section 4.4 Special Warnings and Special Precautions for Use).- Vascular disordersFrequency not known: Venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis (see section 4.4 Special Warnings and Special Precautions for Use).- Skin and subcutaneous tissue disorders:Frequency not known: Angioedema, urticaria- Musculoskeletal and connective tissue disorders:Frequency not known: Osteopenia, osteoporosis.- Blood and Lymphatic system disordersFrequency not known: Leukopenia, neutropenia and agranulocytosis (see Section 4.5)- Pregnancy, puerperium and perinatal conditions
Frequency not known: Drug withdrawal syndrome neonatal (see Section 4.6)- Respiratory, thoracic and mediastinal disorders:Frequency not known: Nasal congestion.
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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.