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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.

Cardiovascular Disorders

Common: Hypotension

Uncommon: Bradycardia

Body as a Whole - General Disorders

Uncommon: Allergic reactions

Investigations

Common: Weight gain

Uncommon: Elevations of hepatic enzymes, mainly transaminases

Metabolism and nutrition disorders

Uncommon: Hyperglycaemia

Psychiatric Disorders

Common: Anxiety, insomnia, orgasmic dysfunction, agitation

Endocrine Disorders

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

Gastrointestinal Disorders

Common: Nausea, constipation, vomiting, dry mouth

Post-Marketing Data

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.
  • Confusion.
  • Neonatal drug withdrawal syndrome.



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