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SOLIAN (AMISULPRIDE): ADVERSE REACTIONS, SIDE EFFECTS
Clinical Trial Data
The following adverse effects have been observed in controlled clinical trials in at least 1% of treated patients. It should be noted that, in some instances, it can be difficult to differentiate adverse events from symptoms of the underlying disease.
Amisulpride (Solian) - Negative & Positive Schizophrenia Clinical Studies pre-1997. Adverse events reported with an incidence of 1% or greater in the Solian (Amisulpride) group
CNS Disorders: insomnia, extrapyramidal disorder, anxiety, tremor, agitation, somnolence, rigidity, headache, hypersalivation, nervousness, dyskinesia, dystonia, depression, oculogyric crisis, dizziness, suicide attempt, aggressive reaction.
Gastro-intestinal disorders: vomiting, nausea, constipation, dry mouth, abdominal pain, diarrhoea, dyspepsia.
Body as a whole disorders: weight decrease, weight increase, sweating increased, fatigue.
Reproductive disorders: galactorrhoea, amenorrhoea, menstrual disorder, vaginitis.
Cardiovascular disorders: hypertension, hypotension, hypotension postural.
Cutaneous disorders: pruritis.
Central and Peripheral Nervous System Disorders
Very common: Extrapyramidal symptoms may occur: rigidity, tremor, hypokinesia, akathisia, hypersalivation, dyskinesia. These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of anti-parkinson medication.
Common: Acute dystonia (oculogyric crisis, spasm torticollis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an anti-parkinson agent. Solmnolence.
Uncommon: Tardive dyskinesia characterised by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long-term administration. Anti-parkinsonian medication is ineffective or may induce aggravation of the symptoms. Seizures.
Body as a Whole - General Disorders
Uncommon: Allergic reactions
Common: Weight gain
Uncommon: Elevations of hepatic enzymes, mainly transaminases
Metabolism and nutrition disorders
Common: Anxiety, insomnia, orgasmic dysfunction, agitation
Common: Amisulpride (Solian) causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may lead to amenorrhoea, galactorrhoea, gynaecomastia, breast pain, erectile dysfunction
Common: Nausea, constipation, vomiting, dry mouth
Following side effects have been reported due to taking Amisulpride (Solian) tablets and oral solution:
Neutropenia, leucopenia, and agranulocytosis.
Very rare cases of Neuroleptic Malignant Syndrome, which is a potentially fatal complication.
Cases of QT interval prolongation and ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, which may result in ventricular fibrillation or cardiac arrest, sudden death.
Hypercholesterolemia and hypertriglyceridemia.
Cases of venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein thrombosis.
Angioedema and urticaria.
Neonatal drug withdrawal syndrome.
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