Amisulpride Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 3, 2020.
For the Consumer
Applies to amisulpride: intravenous solution
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
Common side effects may include:
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
IV: The most commonly reported side effects included infusion site pain, increased serum prolactin, chills, and hypokalemia.
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]
Postmarketing reports: Dystonia, extrapyramidal disorder, neuroleptic malignant syndrome, seizure, somnolence
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
Common (1% to 10%): Abdominal distention
Postmarketing reports: Agitation, anxiety, confusional state, insomnia
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]
Common (1% to 10%): Procedural hypotension
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]
Common (1% to 10%): Amenorrhea, galactorrhea, menstrual disorder, vaginitis
Uncommon (0.1% to 1%): Urinary retention
Common (1% to 10%): Rigidity, spasm torticollis, trismus
Postmarketing reports: Urticaria
Common (1% to 10%): Increased sweating, pruritus
Rare (0.01% to 0.1%): Urticaria
Frequency not reported: Photosensitivity reaction[Ref]
Common (1% to 10%): Increased serum prolactin
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]
Common (1% to 10%): Chills
Common (1% to 10%): Fatigue
Rare (0.01% to 0.1%): Sudden death
Frequency not reported: Neonatal drug withdrawal syndrome[Ref]
Common (1% to 10%): Blurred vision, oculogyric crisis[Ref]
Common (1% to 10%): Infusion site pain[Ref]
Postmarketing reports: Increased liver enzymes
Uncommon (0.1% to 1%): Hepatocellular injury, liver enzyme elevations, transaminase elevations[Ref]
Rare (0.01% to 0.1%): Fatal pulmonary embolism, pulmonary embolism[Ref]
Postmarketing reports: Agranulocytosis
Uncommon (0.1% to 1%): Leukopenia, neutropenia
Rare (0.01% to 0.1%): Agranulocytosis[Ref]
Postmarketing reports: Angioedema, hypersensitivity
Uncommon (0.1% to 1%): Allergic reactions
Rare (0.01% to 0.1%): Angioedema[Ref]
Common (1% to 10%): Hypokalemia
Common (1% to 10%): Decreased weight, increased weight/weight gain
Uncommon (0.1% to 1%): Hypercholesterolemia, hyperglycemia, hypertriglyceridemia
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
More about amisulpride
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 4 Reviews
- Drug class: atypical antipsychotics
- Other brands
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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.