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Amisulpride: uses, dosing, side effects & brands

Amisulpride is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Available as
Injectable
Sold as
Barhemsys
Prescription?
Prescription only
Generic available?
Not in our catalog

How amisulpride is dosed

From the FDA label for Barhemsys (application NDA209510). Other amisulpride products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

The recommended dosage of BARHEMSYS: Prevention of PONV, either alone or in combination with another antiemetic : 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia. ( 2.1 ) Treatment of PONV : 10 mg as a single intravenous dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure. ( 2.1 ) See full prescribing information for preparation and administration instructions . ( 2.2 ) 2.1 Recommended Dosage The recommended adult dosage of BARHEMSYS and infusion rate by indication is shown in the table below: Indication Adult Dosage Regimen Prevention of PONV 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia [see Dosage and Administration (2.2) ] . Treatment of PONV 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure [see Dosage and Administration (2.2) ] . 2.2 Preparation and Administration Dilution of BARHEMSYS is not required before administration. BARHEMSYS is chemically and physically compatible with Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer's Solution (also known as Ringer's Lactate Solution, Compound Sodium Lactate Solution, and Hartmann's Solution), any of which may be used to flush an intravenous…

Amisulpride side effects

Most common adverse reactions (≥ 2%) are: Prevention of PONV : increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distension. ( 6.1 ) Treatment of PONV : infusion site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to BARHEMSYS in 1,166 patients treated in placebo-controlled trials. 748 of these patients received a dose of 5 mg for prevention of PONV (of whom 572 received another antiemetic concomitantly) and 418 patients received 10 mg for treatment of PONV [see Clinical Studies (14.1 , 14.2) ] . The mean age of the population was 49 years (range 18 to 91 years), 87% female, 80% White/Caucasian, 9% Black, and 1% Asian. Prevention of PONV Common adverse reactions reported in at least 2% of adult patients who received BARHEMSYS 5 mg and at a higher rate than placebo in Studies 1 and 2 for the prevention of PONV are shown in Table 1. Table 1. Common Adverse Reactions Reported in at least 2% of patients…

Who shouldn’t take amisulpride

BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride [see Adverse Reactions (6.2) ] . Known hypersensitivity to amisulpride. ( 4 )

Amisulpride drug interactions

7.1 Dopamine Agonists Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS. Avoid using levodopa with BARHEMSYS. 7.2 Drugs Prolonging the QT Interval BARHEMSYS causes dose- and concentration-dependent QT prolongation [see Clinical Pharmacology (12.2) ] . To avoid potential additive effects, avoid use of BARHEMSYS in patients taking droperidol. ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron) [see Warnings and Precautions (5.1) ] .

Every amisulpride product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Barhemsys.

Amisulpride and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Excretion of amisulpride into breastmilk is higher than with other pharmacologically similar drugs. Most information on amisulpride is with continuous oral use as a psychotherapeutic agent. For these uses, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.[1-3] After a single dose for post-operative nausea and vomiting, the manufacturer suggests waiting 48 hours before resuming breastfeeding; however, with a half-life of 4 to 5 hours, a waiting period of 12 to 24 hours should be adequate to avoid large amounts being excreted into breastmilk.

Full LactMed record for amisulpride: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about amisulpride

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 6,210 reports naming amisulpride, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • weight increased438 reports
  • neutropenia401 reports
  • schizophrenia332 reports
  • leukopenia319 reports
  • akathisia312 reports
  • extrapyramidal disorder304 reports
  • electrocardiogram qt prolonged287 reports
  • somnolence280 reports

Read these as a signal, not a rate. A report does not mean amisulpride caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is amisulpride?

The active ingredient of BARHEMSYS is amisulpride, a dopamine-2 (D 2 ) receptor antagonist.

Can you take amisulpride with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run amisulpride against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does amisulpride come in?

Across the brands we track, amisulpride is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic amisulpride?

We do not currently list a generic-labelled amisulpride product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Amisulpride: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/amisulpride
MLA
“Amisulpride: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/amisulpride.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for amisulpride on DailyMed (NIH) ↗.