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Amisulpride Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 3, 2020.

For the Consumer

Applies to amisulpride: intravenous solution

Warning

Before you are treated with amisulpride, tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • sudden dizziness (like you might pass out);

  • fast or pounding heartbeats, fluttering in your chest;

  • shortness of breath; or

  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • low potassium;

  • feeling light-headed;

  • stomach bloating; or

  • pain where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to amisulpride: intravenous solution

General

IV: The most commonly reported side effects included infusion site pain, increased serum prolactin, chills, and hypokalemia.

Oral: The most commonly reported side effects included extrapyramidal disorder, insomnia, anxiety, and increased weight.[Ref]

Nervous system

Acute dystonia was usually reversible without discontinuation of this drug when given concurrently with an antiparkinsonian agent. Acute dystonia included oculogyric crisis, spasm torticollis, and/or trismus.

Extrapyramidal symptoms (EPS) were usually mild at optimal doses, and were partially reversible without discontinuation of this drug when given concurrently with an antiparkinsonian agent. EPS included akathisia, dyskinesia, hypersalivation, hypokinesia, rigidity, and/or tremor.

Neuroleptic malignant syndrome was potentially fatal.

Tardive dyskinesia typically occurred after prolonged administration. Antiparkinsonian agents were ineffective, and/or possibly induced symptom aggravation.[Ref]

IV:

Postmarketing reports: Dystonia, extrapyramidal disorder, neuroleptic malignant syndrome, seizure, somnolence

Oral:

Very common (10% or more): Extrapyramidal disorder (up to 11%)

Common (1% to 10%): Acute dystonia/dystonia, akathisia, dizziness, dyskinesia, headache, hypokinesia, somnolence, tremor

Uncommon (0.1% to 1%): Seizures, tardive dyskinesia

Rare (0.01% to 0.1%): Neuroleptic malignant syndrome

Frequency not reported: Restless legs syndrome with/without akathisia[Ref]

Gastrointestinal

IV:

Common (1% to 10%): Abdominal distention

Oral:

Common (1% to 10%): Abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, hypersalivation, nausea, vomiting[Ref]

Psychiatric

IV:

Postmarketing reports: Agitation, anxiety, confusional state, insomnia

Oral:

Common (1% to 10%): Aggressive reaction, agitation, anxiety, depression, insomnia, nervousness, orgasmic dysfunction, suicide attempt

Uncommon (0.1% to 1%): Confusion, sleep-related eating disorder, somnambulism/sleepwalking[Ref]

Somnambulism included sleep-related eating disorder and other sleep-related behaviors.[Ref]

Cardiovascular

Ventricular arrhythmias included Torsade de pointes and ventricular tachycardia, and may result in cardiac arrest, ventricular fibrillation, and/or sudden death.

Venous thromboembolism included deep vein thrombosis and fatal/nonfatal pulmonary embolism.[Ref]

IV:

Common (1% to 10%): Procedural hypotension

Postmarketing reports: Bradycardia, hypotension, QT prolongation (by ECG), Torsade de pointes, ventricular tachycardia

Oral:

Common (1% to 10%): Hypertension/increased blood pressure, hypotension, postural hypotension, QT interval prolongation

Uncommon (0.1% to 1%): Bradycardia

Rare (0.01% to 0.1%): Cardiac arrest, deep vein thrombosis, Torsade de pointes, venous thromboembolism, ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia[Ref]

Genitourinary

Oral:

Common (1% to 10%): Amenorrhea, galactorrhea, menstrual disorder, vaginitis

Uncommon (0.1% to 1%): Urinary retention

Frequency not reported: Breast pain, erectile dysfunction[Ref]

Musculoskeletal

Oral:

Common (1% to 10%): Rigidity, spasm torticollis, trismus

Uncommon (0.1% to 1%): Osteopenia, osteoporosis[Ref]

Dermatologic

IV:

Postmarketing reports: Urticaria

Oral:

Common (1% to 10%): Increased sweating, pruritus

Rare (0.01% to 0.1%): Urticaria

Frequency not reported: Photosensitivity reaction[Ref]

Endocrine

IV:

Common (1% to 10%): Increased serum prolactin

Oral:

Common (1% to 10%): Reversible increase in plasma prolactin levels

Rare (0.01% to 0.1%): Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Frequency not reported: Gynecomastia[Ref]

Female patients given a single, 5 to 10 mg IV dose over 1 to 2 minutes had serum prolactin levels that increased from a baseline of 10 ng/mL to 32 ng/mL; male patients given the same treatment had serum prolactin levels that increased from a baseline of 10 ng/mL to 19 ng/mL.

Reversible plasma prolactin level increases (upon drug discontinuation) resulted in amenorrhea, breast pain, erectile dysfunction, galactorrhea, and/or gynecomastia.[Ref]

Other

IV:

Common (1% to 10%): Chills

Oral:

Common (1% to 10%): Fatigue

Rare (0.01% to 0.1%): Sudden death

Frequency not reported: Neonatal drug withdrawal syndrome[Ref]

Ocular

Oral:

Common (1% to 10%): Blurred vision, oculogyric crisis[Ref]

Local

IV:

Common (1% to 10%): Infusion site pain[Ref]

Hepatic

IV:

Postmarketing reports: Increased liver enzymes

Oral:

Uncommon (0.1% to 1%): Hepatocellular injury, liver enzyme elevations, transaminase elevations[Ref]

Respiratory

Oral:

Uncommon (0.1% to 1%): Aspiration pneumonia, nasal congestion

Rare (0.01% to 0.1%): Fatal pulmonary embolism, pulmonary embolism[Ref]

Aspiration pneumonia usually occurred in combination with other antipsychotics and central nervous system depressants.[Ref]

Hematologic

IV:

Postmarketing reports: Agranulocytosis

Oral:

Uncommon (0.1% to 1%): Leukopenia, neutropenia

Rare (0.01% to 0.1%): Agranulocytosis[Ref]

Hypersensitivity

IV:

Postmarketing reports: Angioedema, hypersensitivity

Oral:

Uncommon (0.1% to 1%): Allergic reactions

Rare (0.01% to 0.1%): Angioedema[Ref]

Oncologic

Oral:

Rare (0.01% to 0.1%): Benign pituitary tumor, prolactinoma[Ref]

Metabolic

IV:

Common (1% to 10%): Hypokalemia

Oral:

Common (1% to 10%): Decreased weight, increased weight/weight gain

Uncommon (0.1% to 1%): Hypercholesterolemia, hyperglycemia, hypertriglyceridemia

Rare (0.01% to 0.1%): Hyponatremia[Ref]

References

1. "Product Information. Barhemsys (amisulpride)." Acacia Pharma, Inc, Indianapolis, IN.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.