Applies to amisulpride: intravenous solution.
Serious side effects of Amisulpride
Along with its needed effects, amisulpride may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking amisulpride:
Less common
- Blurred vision
- chills
- confusion
- convulsions
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- sweating
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Chest pain or discomfort
- cough or hoarseness
- fast, pounding, or irregular heartbeat or pulse
- fever with or without chills
- general feeling of tiredness or weakness
- hives, itching, or rash
- hoarseness
- irritation
- joint pain, stiffness or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- painful or difficult urination
- redness of the skin
- slow or irregular heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled swallowing
- unusual bleeding or bruising
Other side effects of Amisulpride
Some side effects of amisulpride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Pain at the injection site
Less common
- Full or bloated feeling
- pressure in the stomach
- swelling of the abdominal or stomach area
Incidence not known
- Anxiety
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- hyperventilation
- irritability
- nervousness
- restlessness
- shaking
- sleepiness or unusual drowsiness
- trouble sleeping
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]
