Is Mannitol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Mannitol, including MANNITOL 10% INFUSION (10 %, Solution for infusion, SAR 9.95); MANNITOL 10% W-V INFUSION BOTTLES (10 %, Solution for infusion, SAR 9.95); MANNITOL 20 % I.V INFUSION 500 ML (20 %, Solution for infusion, SAR 10.55); MANNITOL 20% INFUSION (20 %, Solution for infusion, SAR 9.15).

Is Mannitol approved by the US FDA?

Drugs@FDA lists 46 application product lines for Mannitol, including OSMITROL 5% IN WATER (Prescription); OSMITROL 10% IN WATER (Prescription); OSMITROL 20% IN WATER (Prescription); OSMITROL 15% IN WATER (Prescription); OSMITROL 5% IN WATER IN PLASTIC CONTAINER (Prescription).

Is Mannitol authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mannitol: Bronchitol.

Is Mannitol on the WHO Model List of Essential Medicines?

Yes — 16. Diuretics (core list): Ocular hypertension.

Are there safety signals or safety updates for Mannitol?

US FDA: 2 entries (latest 2021-08-13).

Active substance

Mannitol

SFDA 13
US FDA 46
EMA 1
Health Canada 6
NHS prices 1
WHO EML 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
MANNITOL 10% INFUSION	10 %	Solution for infusion · Intravenous use	1 Bag	SAR 9.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
MANNITOL 10% W-V INFUSION BOTTLES	10 %	Solution for infusion · Intravenous use	1 Bottle	SAR 9.95	Generic · Prescription	GULF INJECT	Valid
MANNITOL 20 % I.V INFUSION 500 ML	20 %	Solution for infusion · Intravenous use	1 Bag	SAR 10.55	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
MANNITOL 20% INFUSION	20 %	Solution for infusion · Intravenous use	1 Bottle	SAR 9.15	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
MANNITOL 20% INFUSION	20 %	Solution for infusion · Intravenous use	1 Bottle	SAR 12.40	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
MANNITOL 20% INFUSION	20 %	Solution for infusion · Intravenous use	1 Bottle	SAR 11.10	Generic · Prescription	GULF INJECT	Valid
10% MANNITOL INTRAVENOUS INFUSION BP	10 %	Intravenous infusion · Intravenous use	1 Bottle	SAR 9.95	Generic · Prescription	QATAR PHARMA	Withdrawn by regulatory authority · Not Marketed
MANNITOL	20 %	Solution for infusion · Intravenous use	1 Bottle	SAR 12.40	Generic · Prescription	McGAW	Invalid · Not Marketed
MANNITOL 10% INFUSION	10 %	Solution for infusion · Intravenous use	1 Bottle	SAR 11.05	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Withdrawn by MAH · Not Marketed
MANNITOL 10% INFUSION	10 %	Solution for infusion · Intravenous use	1 Bottle	SAR 8.50	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Withdrawn by MAH · Not Marketed
MANNITOL 20% INJ	20 %	Solution for infusion · Intravenous use	1 Bottle	SAR 9.10	Generic · Prescription	McGAW	Invalid · Not Marketed
OSMITROL 10% INFUSION SOLN.	10 %	Solution for infusion · Intravenous use	1 Bag	SAR 12.00	Generic · Prescription	BAXTER	Withdrawn by MAH · Not Marketed
OSMITROL 10% INFUSION SOLN.	10 %	Solution for infusion · Intravenous use	1 Bag	SAR 10.00	Generic · Prescription	BAXTER	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE LIVER FAILURE - INCREASED INTRACRANIAL PRESSURE/CEREBRAL EDEMA; DIABETIC KETOACIDOSIS; FLUIDS AND VOLUME EXPANDERS-REDUCING ICP; OPEN ANGLE GLUCOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
OSMITROL 5% IN WATER	5GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
OSMITROL 10% IN WATER	10GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
OSMITROL 20% IN WATER	20GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
OSMITROL 15% IN WATER	15GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
OSMITROL 5% IN WATER IN PLASTIC CONTAINER	5GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
OSMITROL 10% IN WATER IN PLASTIC CONTAINER	10GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
OSMITROL 20% IN WATER IN PLASTIC CONTAINER	20GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
OSMITROL 15% IN WATER IN PLASTIC CONTAINER	15GM/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	8 Jun 1964
MANNITOL 25%	12.5GM/50ML	injectable · injection	HOSPIRA	Prescription	22 Dec 1967
MANNITOL 25%	12.5GM/50ML	injectable · injection	FRESENIUS KABI USA	Prescription	11 Aug 1972
MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	injectable · injection	OTSUKA ICU MEDCL	Prescription	8 Jan 1987
MANNITOL 5% IN PLASTIC CONTAINER	5GM/100ML	injectable · injection	B BRAUN	Prescription	26 Jul 1993
MANNITOL 10% IN PLASTIC CONTAINER	10GM/100ML	injectable · injection	B BRAUN	Prescription	26 Jul 1993
MANNITOL 15% IN PLASTIC CONTAINER	15GM/100ML	injectable · injection	B BRAUN	Prescription	26 Jul 1993
MANNITOL 20% IN PLASTIC CONTAINER	20GM/100ML	injectable · injection	B BRAUN	Prescription	26 Jul 1993
ARIDOL KIT	N/A,5MG,10MG,20MG,40MG	powder · inhalation	PHARMAXIS EUROPE	Prescription	5 Oct 2010
ARIDOL	10MG; 20MG; 40MG	powder · inhalation	PHARMAXIS EUROPE	Prescription	5 Oct 2010
BRONCHITOL	40MG	powder · inhalation	PHARMAXIS EUROPE	Prescription	30 Oct 2020
MANNITOL 20%	20GM/100ML	injectable · injection	B BRAUN	Discontinued	30 Jul 1964
MANNITOL 5%	5GM/100ML	injectable · injection	B BRAUN	Discontinued	8 Oct 1965
MANNITOL 10%	10GM/100ML	injectable · injection	B BRAUN	Discontinued	8 Oct 1965
MANNITOL 15%	15GM/100ML	injectable · injection	B BRAUN	Discontinued	8 Oct 1965
MANNITOL 20%	20GM/100ML	injectable · injection	B BRAUN	Discontinued	8 Oct 1965
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%	15GM/100ML	injectable · injection	B BRAUN	Discontinued	8 Oct 1965
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER	10GM/100ML	injectable · injection	B BRAUN	Discontinued	8 Oct 1965

21 more — full table

EMA European Union — centrally authorised medicines

Bronchitol Pharmaxis Europe Limited · Authorised · authorised 13 Apr 2012 · ATC R05CB16

Therapeutic indication (EMA)

Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ARIDOL	02489562	20 MG / CAP; 10 MG / CAP; 40 MG / CAP; 5 MG / CAP	KIT; POWDER · INHALATION	PHARMAXIS EUROPE LIMITED
MANNITOL INJECTION USP	00038016	20 %	SOLUTION · INTRAVENOUS	ICU MEDICAL CANADA INC
MANNITOL INJECTION USP	00038024	25 %	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
MANNITOL INJECTION, USP	02243176	25 %	SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD
OSMITROL INJECTION 10%	00060410	10 %	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
OSMITROL INJECTION 20%	00060437	20 %	SOLUTION · INTRAVENOUS	BAXTER CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Mannitol 40mg inhalation powder capsules with two devices	£231.66	280 capsule	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)

16. Diuretics · core
Ocular hypertension
Parenteral > General injections > IV: 10% solution; 20% solution
16. Diuretics · core (EML); complementary (EMLc)
Cerebral oedema
Parenteral > General injections > IV: 10% solution; 20% solution

Safety signals and safety-related labeling changes

US FDA 13 Aug 2021 ARIDOL — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Aug 2021 ARIDOL KIT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for mannitol →

Combinations containing Mannitol

Mannitol + sorbitol

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.