Is Ondansetron registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 45 valid registrations of Ondansetron, including DANSETRON 2 mg/ml solution for injection (2 mg/ml, Solution for injection, SAR 78.65); DANSETRON 2MG\ML AMP. FOR I.V INJECTION (2 mg/ml, Solution for injection, SAR 157.35); Emedan 4 mg / 2 ml (2 mg/ml, Solution for injection, SAR 56.10); Emedan 8 mg / 4 ml (2 mg/ml, Solution for injection, SAR 112.25); IMATOX 4 mg/2 ml solution for injection/infusion (2 mg/ml, Solution, SAR 102.15).

Is Ondansetron approved by the US FDA?

Drugs@FDA lists 90 application product lines for Ondansetron, including ONDANSETRON HYDROCHLORIDE (Prescription); ONDANSETRON HYDROCHLORIDE (Prescription); ONDANSETRON HYDROCHLORIDE (Prescription); ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (Prescription); ONDANSETRON HYDROCHLORIDE (Prescription).

Is Ondansetron on the WHO Model List of Essential Medicines?

Yes — 2.3. Medicines for other common symptoms in palliative care (core list): Palliative care.

Are there safety signals or safety updates for Ondansetron?

EMA PRAC: 2 entries; US FDA: 5 entries; MHRA: 2 entries (latest 2025-06-02).

Active substance

Ondansetron

SFDA 54
US FDA 90
Health Canada 61
US price lines 8
NHS prices 9
WHO EML 2
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DANSETRON 2 mg/ml solution for injection	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 78.65	Generic · Prescription	Hikma Pharmaceuticals PLC	Valid
DANSETRON 2MG\ML AMP. FOR I.V INJECTION	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 157.35	Generic · Prescription	Hikma Pharmaceuticals PLC	Valid
Emedan 4 mg / 2 ml	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 56.10	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Emedan 8 mg / 4 ml	2 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 112.25	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
IMATOX 4 mg/2 ml solution for injection/infusion	2 mg/ml	Solution · Intramuscular and intravenous use	5 Ampoule	SAR 102.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
IMATOX 4 mg/2 ml solution for injection/infusion	2 mg/ml	Solution · Intramuscular and intravenous use	5 Ampoule	SAR 157.35	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
IMATOX 4MG FILM COATED TABLETS	4 mg	Film-coated tablet · Oral use	10 Blister	SAR 100.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
IMATOX 8MG FILM COATED TABLETS	8 mg	Film-coated tablet · Oral use	10 Blister	SAR 136.35	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Ivonsan	2 mg/mg	Solution for injection · Intramuscular and intravenous use	5 Ampoule	SAR 56.10	Generic · Prescription	Eva pharma for Industry	Valid
Ivonsan	2 mg/ml	Solution for injection · Intramuscular and intravenous use	5 Ampoule	SAR 112.25	Generic · Prescription	Eva pharma for Industry	Valid
KROMAFINA	8 mg	Film-coated tablet · Oral use	10 Blister	SAR 136.35	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
KROMAFINA	4 mg	Film-coated tablet · Oral use	10 Blister	SAR 99.10	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Kromafina solution 4 mg/5 ml	0.8 mg/ml	Oral solution · Oral use	1 Bottle	SAR 97.95	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Mundell	4 mg	Orodispersible tablet · Oral use	10 Blister	SAR 79.65	Generic · Prescription	Biolab Sanus Farmaceutica Ltda	Valid
Mundell	8 mg	Orodispersible tablet · Oral use	10 Blister	SAR 100.75	Generic · Prescription	Biolab Sanus Farmaceutica Ltda	Valid
ONDA 2 mg/ml Solution for Injection	2 mg/ml	Solution for injection · Intravenous use	1 Ampoule	SAR 22.45	Generic · Prescription	VIANEX S.A	Valid
ONDANION	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Ampoule	SAR 56.10	Generic · Prescription	SPIMACO ADDWAEIH	Valid
ONDANION	2 mg/ml	Solution for injection/infusion · Intravenous use	5 Ampoule	SAR 112.25	Generic · Prescription	SPIMACO ADDWAEIH	Valid
ONDANSETRON MEDIS 8MG F.C.TABLET	8 mg	Film-coated tablet · Oral use	10 Blister	SAR 136.35	Generic · Prescription	LES LABORATOIRES MEDIS	Valid
ONDRON 2MG/ML AMPOULE	2 mg/ml	Solution · Intramuscular and intravenous use	5 Ampoule	SAR 112.25	Generic · Prescription	Accord Healthcare Limited	Valid
ONDRON 2MG/ML AMPOULE	2 mg/ml	Solution · Intramuscular and intravenous use	5 Ampoule	SAR 56.10	Generic · Prescription	Accord Healthcare Limited	Valid
Ondans	8 mg	Film-coated tablet · Oral use	10 Blister	SAR 136.35	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Ondans	4 mg	Film-coated tablet · Oral use	10 Blister	SAR 100.80	Generic · Prescription	SPIMACO	Valid
Ondansetron Kabi 2 MG/ML SOL. FOR INJ	2 mg/ml	Solution for injection · Intramuscular and intravenous use	5 Vial	SAR 56.10	Generic · Prescription	Labesfal Laboratorios Almiro, S.A.	Valid
Ondansetron Kabi 2 MG/ML SOL. FOR INJ	2 mg/ml	Solution for injection · Intramuscular and intravenous use	5 Vial	SAR 112.25	Generic · Prescription	Labesfal Laboratorios Almiro, S.A.	Valid

29 more — full table

Indications — CHI Daman Drug Formulary

INFECTIOUS BACTERIAL DIARRHEA- ANCILLARY TREATMENT; NAUSEA AND VOMITING IN CANCER; POSTOPERATIVE NAUSEA AND VOMITING; VIRAL GASTROENTERITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE; EQ 4MG BASE	tablet · oral	DR REDDYS LABS LTD	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	solution · oral	HIKMA PHARMS	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	26 Dec 2006
ONDANSETRON	16MG; 24MG; 4MG; 8MG	tablet, orally disintegrating · oral	CHARTWELL MOLECULES	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	injectable · injection	HOSPIRA	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	injectable · injection	HOSPIRA	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	injectable · injection	WOCKHARDT BIO AG	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	injectable · injection	WOCKHARDT BIO AG	Prescription	26 Dec 2006
ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE; EQ 8MG BASE; EQ 24MG BASE	tablet · oral	CHARTWELL MOLECULES	Prescription	25 Jun 2007
ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE; EQ 8MG BASE	tablet · oral	GLENMARK PHARMS LTD	Prescription	25 Jun 2007
ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE; EQ 8MG BASE	tablet · oral	NATCO PHARMA LTD	Prescription	25 Jun 2007
ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	solution · oral	PHARM ASSOC	Prescription	25 Jun 2007
ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	injectable · injection	SANDOZ	Prescription	27 Jun 2007
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	injectable · injection	SANDOZ	Prescription	27 Jun 2007
ONDANSETRON	4MG; 8MG	tablet, orally disintegrating · oral	GLENMARK PHARMS LTD	Prescription	27 Jun 2007
ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE; EQ 8MG BASE	tablet · oral	AUROBINDO PHARMA	Prescription	31 Jul 2007
ONDANSETRON	4MG; 8MG	tablet, orally disintegrating · oral	SUN PHARM INDS	Prescription	2 Aug 2007
ONDANSETRON	4MG; 8MG	tablet, orally disintegrating · oral	SANDOZ	Prescription	13 Aug 2007
ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	solution · oral	AUROBINDO PHARMA	Prescription	28 Nov 2007
ONDANSETRON	4MG/2ML	injectable · injection	AM REGENT	Prescription	18 Nov 2008

65 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACCEL-ONDANSETRON	02478927	4 MG	TABLET · ORAL	ACCEL PHARMA INC
ACCEL-ONDANSETRON	02478935	8 MG	TABLET · ORAL	ACCEL PHARMA INC
ACCEL-ONDANSETRON ODT	02535319	4 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	ACCEL PHARMA INC
ACCEL-ONDANSETRON ODT	02535327	8 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	ACCEL PHARMA INC
APO-ONDANSETRON	02288184	4 MG	TABLET · ORAL	APOTEX INC
APO-ONDANSETRON	02288192	8 MG	TABLET · ORAL	APOTEX INC
APO-ONDANSETRON	02291967	4 MG / 5 ML	SOLUTION · ORAL	APOTEX INC
AURO-ONDANSETRON INJECTION	02491524	2 MG / ML	SOLUTION · INTRAVENOUS	AURO PHARMA INC
AURO-ONDANSETRON INJECTION	02491532	2 MG / ML	SOLUTION · INTRAVENOUS	AURO PHARMA INC
AURO-ONDANSETRON ODT	02511282	4 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AURO PHARMA INC
AURO-ONDANSETRON ODT	02511290	8 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AURO PHARMA INC
EUGIA-ONDANSETRON INJECTION	02544822	2 MG / ML	SOLUTION · INTRAVENOUS	EUGIA PHARMA INC.
EUGIA-ONDANSETRON INJECTION	02544830	2 MG / ML	SOLUTION · INTRAVENOUS	EUGIA PHARMA INC.
JAMP ONDANSETRON	02490617	4 MG / 5 ML	SOLUTION · ORAL	JAMP PHARMA CORPORATION
JAMP ONDANSETRON ODF	02541351	4 MG	FILM (SOLUBLE) · ORAL	JAMP PHARMA CORPORATION
JAMP ONDANSETRON ODF	02541378	8 MG	FILM (SOLUBLE) · ORAL	JAMP PHARMA CORPORATION
JAMP-ONDANSETRON	02313685	4 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP-ONDANSETRON	02313693	8 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MAR-ONDANSETRON	02371731	4 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-ONDANSETRON	02371758	8 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-ONDANSETRON ODT	02514966	4 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	MARCAN PHARMACEUTICALS INC
MAR-ONDANSETRON ODT	02514974	8 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	MARCAN PHARMACEUTICALS INC
MINT-ONDANSETRON	02305259	4 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-ONDANSETRON	02305267	8 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-ONDANSETRON ODT	02487330	4 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	MINT PHARMACEUTICALS INC

36 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ONDANSETRON 4 MG/5 ML SOLUTION	$0.28641	per ML	23 Sep 2026
US NADAC	ONDANSETRON 4 MG/5 ML SOLUTION CUP	$0.28641	per ML	23 Sep 2026
US NADAC	ONDANSETRON 40 MG/20 ML VIAL	$0.17297	per ML	23 Sep 2026
US NADAC	ONDANSETRON HCL 4 MG TABLET	$0.05824	per EA	23 Sep 2026
US NADAC	ONDANSETRON HCL 4 MG/2 ML VIAL	$0.17588	per ML	23 Sep 2026
US NADAC	ONDANSETRON HCL 8 MG TABLET	$0.07811	per EA	23 Sep 2026
US NADAC	ONDANSETRON ODT 4 MG TABLET	$0.11992	per EA	23 Sep 2026
US NADAC	ONDANSETRON ODT 8 MG TABLET	$0.16863	per EA	23 Sep 2026
NHS Drug Tariff	Ondansetron 4mg orodispersible films sugar free	£28.50	10 film	1 Oct 2026
NHS Drug Tariff	Ondansetron 4mg orodispersible tablets	£20.21	10 tablet	1 Oct 2026
NHS Drug Tariff	Ondansetron 4mg tablets	£1.37	10 tablet	1 Oct 2026
NHS Drug Tariff	Ondansetron 4mg/2ml solution for injection ampoules	£20.00	10 ampoule	1 Oct 2026
NHS Drug Tariff	Ondansetron 4mg/5ml oral solution sugar free	£5.66	50 ml	1 Oct 2026
NHS Drug Tariff	Ondansetron 8mg orodispersible films sugar free	£57.00	10 film	1 Oct 2026
NHS Drug Tariff	Ondansetron 8mg orodispersible tablets	£71.94	10 tablet	1 Oct 2026
NHS Drug Tariff	Ondansetron 8mg tablets	£2.10	10 tablet	1 Oct 2026
NHS Drug Tariff	Ondansetron 8mg/5ml oral solution sugar free	£139.34	100 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

2.3. Medicines for other common symptoms in palliative care · core
Palliative care
Parenteral > General injections > IV: 2 mg per mL in 2 mL ampoule (as hydrochloride dihydrate); 2 mg per mL in 4 mL ampoule (as hydrochloride dihydrate) | Oral > Liquid: 4 mg per 5 mL (as hydrochloride dihydrate) | Oral > Solid: 4 mg (as hydrochloride dihydrate); 8 mg (as hydrochloride dihydrate)
17.2. Antiemetic medicines · core
Nausea or vomiting
Parenteral > General injections > IV: 2 mg per mL in 2 mL ampoule (as hydrochloride dihydrate); 2 mg per mL in 4 mL ampoule | Oral > Liquid: 4 mg per 5 mL (as hydrochloride dihydrate) | Oral > Solid > dosage form: 4 mg (as hydrochloride dihydrate); 8 mg (as hydrochloride dihydrate); 24 mg (as hydrochloride dihydrate) (EML)

Safety signals and safety-related labeling changes

US FDA 2 Jun 2025 ZOFRAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2025 ZOFRAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2025 ZOFRAN ODT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Jun 2025 ZOFRAN PRESERVATIVE FREE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Aug 2021 ZUPLENZ — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 27 Jan 2020 Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy
Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.
EMA PRAC 11 Jul 2019 PRAC signal: Signal of birth defects following in-utero exposure during the first trimester of pregnancy arising from recent publications
Action for MAH: update of the product information: Yes
EMA PRAC 15 Mar 2019 PRAC signal: Signal of birth defects following in-utero exposure during the first trimester of pregnancy arising from recent publications
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Ondansetron (Zofran): important new intravenous dose restriction
New maximum single intravenous dose of ondansetron for the management of chemotherapy-induced nausea and vomiting (CINV) restricted due to risk of QTc prolongation.

All safety entries for ondansetron →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.