Skip to content
MedsAcross

Molecule

Mannitol

Osmotic Diuretic
Available on requestOrphanGastroenterology
Presentations
7
Brands
2
Manufacturers
2
Available from stock
0

Mannitol is an osmotic diuretic indicated for the reduction of intracranial pressure and treatment of cerebral edema,, among other approved uses. It is available as injection and kits for intravenous use. MedsAcross supplies Mannitol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Osmotic Diuretic, Osmotic Activity, Increased Diuresis
ATC classification
A06AD16 Mannitol · Hyperosmotic laxativeB05BC01 Mannitol · Osmotic diureticB05CX04 Mannitol · Blood substitutes and infusion solutions, subgroup B05C, subgroup B05CXR05CB16 Mannitol · Mucolytic
US FDA first approval
8 June 1964
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection, Kit
Identifiers
UNII 3OWL53L36ARxCUI 6628CAS 69-65-8DrugBank DB00742Q407646

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

OSMITROL is indicated for: • The reduction of intracranial pressure and treatment of cerebral edema, • The reduction of elevated intraocular pressure. OSMITROL is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. • elevated intraocular pressure.

Source: US FDA prescribing information

How it works

Mannitol, when administered intravenously, exerts its osmotic diuretic effect as a solute of relatively small molecular size being largely confined to the extracellular space. Mannitol hinders tubular reabsorption of water and enhances excretion of sodium and chloride by elevating the osmolarity of the glomerular filtrate. This increase in extracellular osmolarity affected by the intravenous administration of mannitol will induce the movement of intracellular water to the extracellular and vascular spaces. This action underlies the role of mannitol in reducing intracranial pressure, intracranial edema, and intraocular pressure.

Source: US FDA prescribing information

Dosing overview

Administration Instructions: • For intravenous infusion preferably into a large central vein. • Prior to administration, evaluate renal, cardiac and pulmonary status, and correct fluid and electrolyte imbalances. Recommended Dosage: • The dosage, concentration and rate of administration depend on the age, weight and condition of the patient, including fluid requirement, urinary output and concomitant therapy. • Reduction of Intracranial Pressure: 0.25 gram/kg administered every 6 to 8 hours as an intravenous infusion over 30 minutes. • Reduction of Intraocular Pressure: 1.5 to 2 grams/kg of a 15% or 20% w/v solution as a single dose administered intravenously over at least 30 minutes.

Source: US FDA prescribing information

Contraindications

OSMITROL is contraindicated in patients with: • Known hypersensitivity to mannitol • Anuria • Severe hypovolemia • Pre-existing severe pulmonary vascular congestion or pulmonary edema • Active intracranial bleeding except during craniotomy • Known hypersensitivity to mannitol. • Anuria. • Severe hypovolemia. • Pre-existing severe pulmonary vascular congestion or pulmonary edema. • Active intracranial bleeding except during craniotomy.

Source: US FDA prescribing information

Warnings and precautions

• Hypersensitivity Reactions, including anaphylaxis: Stop infusion immediately if hypersensitivity reactions develop. • Renal Complications Including Renal Failure: Risk factors include pre-existing renal failure, concomitant use of nephrotoxic drugs or other diuretics. Avoid use of nephrotoxic drugs. Discontinue OSMITROL if renal function worsens. • Central Nervous System (CNS) Toxicity: Confusion, lethargy and coma may occur during or after infusion. Concomitant neurotoxic drugs may potentiate toxicity. Avoid use of neurotoxic drugs. Discontinue OSMITROL if CNS toxicity develops. • Fluid and Electrolyte Imbalances, Hyperosmolarity: Hypervolemia may exacerbate congestive heart failure, hyponatremia can lead to encephalopathy, hypo/hyperkalemia can result in cardiac adverse reactions in sensitive patients. Discontinue OSMITROL if fluid and/or electrolyte imbalances occur.

Source: US FDA prescribing information

Side effects

The following adverse reactions from voluntary reports or clinical studies have been reported with OSMITROL. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hypersensitivity reactions: cardiac arrest, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, cough, musculoskeletal stiffness, myalgia, urticarial/rash, pruritus, generalized pain, discomfort, nausea, vomiting, and headache.

Source: US FDA prescribing information

Interactions

• Nephrotoxic Drugs and Diuretics: May increase the risk of renal failure, avoid concomitant use. • Neurotoxic Drugs: May potentiate CNS toxicity of mannitol, avoid concomitant use. • Drugs Affected by Electrolyte Imbalances: May result in cardiac adverse reactions, monitor serum electrolytes and discontinue OSMITROL if cardiac status worsens. • Renally Eliminated Agents: Concomitant use may decrease the effectiveness of agents that undergo significant renal elimination. However, concomitant use of mannitol and lithium may increase risk of lithium toxicity. If concomitant use is necessary, frequently monitor lithium concentrations and for signs of toxicity.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

7 presentations of Mannitol, sorted by availability.

MedicineManufacturerRegisterAvailability
Mannitol 12.5 g/50 mL injectionIntravenousGeneric name—US FDAAvailable on request
Mannitol 100 g/500 mL injectionIntravenousGeneric name—US FDAAvailable on request
Mannitol 50 g/250 mL injectionIntravenousGeneric name—US FDAAvailable on request
Aridol Bronchial Challenge Test Kit kitMethapharmUS FDAAvailable on request
Osmitrol 100 g/500 mL injectionIntravenousBaxter HealthcareUS FDAAvailable on request
Osmitrol 50 g/250 mL injectionIntravenousBaxter HealthcareUS FDAAvailable on request
Osmitrol 50 g/500 mL injectionIntravenousBaxter HealthcareUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 8 June 1964Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Mannitol in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Mannitol available for export from India?

Yes, on request. MedsAcross lists 7 presentations of Mannitol and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Mannitol have?

The catalogue lists 2 brand names for Mannitol, including Aridol Bronchial Challenge Test Kit, Osmitrol.

Is Mannitol approved by the US FDA?

Yes. The US FDA first approved Mannitol on 8 June 1964, according to Drugs@FDA.

Is Mannitol authorised in the European Union?

Yes. Mannitol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Mannitol need cold chain shipping?

No listed presentation of Mannitol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Mannitol in?

Mannitol is classified under ATC code A06AD16 (Mannitol).

References

  1. Osmitrol prescribing information (Baxter Healthcare). U.S. National Library of Medicine, DailyMed. Retrieved 26 August 2025
  2. Bronchitol: European public assessment report (EPAR). European Medicines Agency. Retrieved 17 February 2026

Request Mannitol for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.