Droperidol

Overview

A butyrophenone with general properties similar to those of haloperidol. It is used in conjunction with an opioid analgesic such as fentanyl to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. It is also used as a premedicant, as an antiemetic, and for the control of agitation in acute psychoses. (From Martindale, The Extra Pharmacopoeia, 29th ed, p593)

Indication

Droperidol is used to produce tranquilization and to reduce the incidence of nausea and vomiting in surgical and diagnostic procedures.

Associated Conditions

Agitation
Delirium
Nausea and vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Assessment of Drug Liking In Peri-procedural Clinical Settings	2025/06/11	NCT07015528	Early Phase 1	Not yet recruiting	Stanford University
Droperidol and QTc Interval Changes in ED Patients	2024/12/10	NCT06726811	N/A	Recruiting	CHRISTUS Health
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery	2022/06/02	NCT05401058	Not Applicable	Recruiting	RenJi Hospital
Droperidol on Prevention of Cannabis Hyperemesis Syndrome	2022/02/17	NCT05244460	Phase 3	Recruiting	Mercy Health Ohio
Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis	2021/10/04	NCT05065567	Phase 3	Terminated	Spectrum Health - Lakeland
Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital	2020/06/02	NCT04411069	Phase 2	Completed	Instituto do Cancer do Estado de São Paulo
Gender Influence on Torsadogenic Actions of Droperidol.	2019/05/09	NCT03944681	Not Applicable	Completed	Medical University of Gdansk
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery	2016/04/20	NCT02744495	Phase 3	Completed	Hôpital Privé de Parly II - Le Chesnay
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis	2015/12/09	NCT02625181	Not Applicable	Completed	Vanderbilt University
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)	2015/11/09	NCT02600741	N/A	Completed	Janssen Scientific Affairs, LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Droperidol	American Regent, Inc.	0517-9702	INTRAMUSCULAR, INTRAVENOUS	2.5 mg in 1 mL	3/20/2023
DROPERIDOL	Hikma Pharmaceuticals USA Inc.	0143-9515	INTRAMUSCULAR, INTRAVENOUS	2.5 mg in 1 mL	6/8/2022
DROPERIDOL	Hikma Pharmaceuticals USA Inc.	0143-9514	INTRAMUSCULAR, INTRAVENOUS	2.5 mg in 1 mL	6/8/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DROPERIDOL 2.5 mg/1 mL MEDICIANZ droperidol 2.5 mg/1 mL solution for injection ampoule	353871	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021
DROPERIDOL PANPHARMA droperidol 5 mg/2 mL solution for injection, ampoule	238347	Panpharma Australia Pty Ltd	Medicine	A	5/17/2016
DROPERIDOL PANPHARMA droperidol 2.5 mg/1 mL solution for injection, ampoule	238342	Panpharma Australia Pty Ltd	Medicine	A	5/17/2016
DROPERIDOL LUPIN droperidol 5 mg/2 mL solution for injection glass ampoule	256892	Southern Cross Pharma Pty Ltd	Medicine	A	3/6/2017
DROLEPTAN droperidol 2.5mg/1mL injection	46841	Phebra Pty Ltd	Medicine	A	11/1/1993
DROPERIDOL 2.5 mg/1 mL MEDSURGE droperidol 2.5 mg/1 mL solution for injection ampoule	353872	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021
DROPERIDOL PANPHARMA droperidol 1.25 mg/2.5 mL solution for injection, ampoule	238346	Panpharma Australia Pty Ltd	Medicine	A	5/17/2016
DROPERIDOL 1.25 mg/1 mL MEDSURGE droperidol 1.25 mg/1 mL solution for injection ampoule	353873	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021
DROPERIDOL AJS droperidol 2.5 mg/1 mL solution for injection glass ampoule	256872	Southern Cross Pharma Pty Ltd	Medicine	A	3/6/2017
DROPERIDOL 1.25 mg/1 mL MEDICIANZ droperidol 1.25 mg/1 mL solution for injection ampoule	353874	Medsurge Pharma Pty Ltd	Medicine	A	12/8/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
INNOVAR INJ	janssen pharmaceutica, division of janssen-ortho inc.	00554243	Liquid - Intramuscular , Intravenous	2.5 MG / ML	12/31/1982
DROPERIDOL INJECTION	novopharm limited	02232449	Liquid - Intramuscular , Intravenous	2.5 MG / ML	4/20/1998
INAPSINE INJ 2.5MG/ML	janssen pharmaceutica, division of janssen-ortho inc.	00554251	Liquid - Intramuscular , Intravenous	2.5 MG / ML	12/31/1982
DROPERIDOL INJECTION USP 2.5MG/ML	Sandoz Canada, Inc.	02167832	Solution - Intravenous , Intramuscular	2.5 MG / ML	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DROPERIDOL KALCEKS 2,5 MG/ML SOLUCION INYECTABLE EFG	Kalceks As	86009	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
DROPERIDOL KALCEKS 1,25 MG/ML SOLUCION INYECTABLE	Kalceks As	86008	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
DROPERIDOL HIKMA 2,5 MG/ML SOLUCION INYECTABLE EFG	Hikma Farmaceutica (Portugal) S.A.	82997	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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