Prescription medicine

Amisulpride Brand names: Barhemsys

Amisulpride (Barhemsys) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the amisulpride FDA label on DailyMed (effective June 17, 2026, Acacia Pharma Ltd); the NDA 209510 record on Drugs@FDA; every amisulpride label on DailyMed.

Highlights of the record

FDA label of June 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
BARHEMSYS ® is indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.

Forms and strengths

2.5 mg/ml

Injection (solution).

On the market

Earliest approval on file: February 26, 2020 Barhemsys, Lxo Ireland; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: February 9, 2038 Barhemsys injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 5,989 through July 30, 2026

What is amisulpride used for?

From the label: indications and usage
BARHEMSYS ® is indicated in adults for: prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis. BARHEMSYS is a dopamine-2 (D 2 ) antagonist indicated in adults for: Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. ( 1 ) Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

Conditions named in the indications of amisulpride's FDA labels, with every medicine labeled for each:

Nausea and vomiting

FDA pharmacologic class: Dopamine-2 Receptor Antagonist.

Source: FDA drug label (Barhemsys), NDA209510 (Lxo Ireland), as published by Acacia Pharma Ltd, effective June 17, 2026 (SPL set ab23bc6e-b6a8-165f-e053-2a95a90ab144), via openFDA; the full label on DailyMed

Is there a generic for amisulpride (Barhemsys)?

No generic amisulpride is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Barhemsys injection, the last expiring on February 9, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2020 earliest approval on file
2038 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the amisulpride label say about other medicines?

The amisulpride label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Droperidol	drug interactions	To avoid potential additive effects, avoid use of BARHEMSYS in patients taking droperidol.
Levodopa	drug interactions	DRUG INTERACTIONS 7.1 Dopamine Agonists Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS.
Ondansetron	drug interactions	ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron) [see Warnings and Precautions (5.1) ].

Check amisulpride against other medicines

What do FAERS reports show for amisulpride?

The FDA Adverse Event Reporting System holds 5,989 reports that list amisulpride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 762 are coded as a death and 2,972 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)863
Drug Interaction (a use or a product term, not a reaction)464
Weight Increased443
Toxicity To Various Agents400
Neutropenia394
Schizophrenia339
Off Label Use (a use or a product term, not a reaction)326
Leukopenia315

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as amisulpride?

3 other medicines are given the same way (intravenous) and in the same FDA class as amisulpride or labeled mainly for the same use (nausea and vomiting), the same class first. Nausea and vomiting lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Palonosetron	Nausea and vomiting	14 labelers	n/a	A presentation being discontinued
Granisetron	Nausea and vomiting	4 labelers	n/a	No current entry
Aprepitant	Nausea and vomiting	none listed	n/a	A presentation being discontinued

Every medicine labeled for the same conditions as amisulpride

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to amisulpride: 3 medicines for the same use
Other dopamine-2 receptor antagonists: the pharmacologic class, with prices and generics
Amisulpride side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other