Mannitol
Active ingredient · 5 therapeutic classes
Sold as Osmitrol · Bronchitol · ARIDOL
- Drug class
- Osmotically Acting Laxatives
- Availability
- Prescription only
- Routes
- Inhalation, Intravenous
- Markets covered
- 4
- Products on record
- 14
- FDA reports (12 mo)
- 254
Overview
Mannitol is an active pharmaceutical ingredient in the Osmotically Acting Laxatives group (A06AD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 6 | March 13, 2026 |
| CA Canada | Health Canada | 6 | July 25, 2025 |
| US United States | FDA | 1 | August 26, 2025 |
| EU European Union | EMA | 1 | February 17, 2026 |
GBUnited Kingdom· MHRA
6 products
Uses
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.
How to take
CACanada· Health Canada
6 products
How to take
For Intravenous Injection General Recommendations:
Give Mannitol Injection, USP only intravenously. The total dosage, concentration and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement and urinary output. Usual adult dosage ranges from 50 to 200 g in 24 hours, but in most instances, an adequate response will be achieved at a dosage of approximately 100 g in 24 hours.
The rate is usually adjusted to maintain an adequate urine flow (at least 30 to 50 mL / hr).
Test Dose:
In marked oliguria or inadequate renal function, a test dose of mannitol should be given. 2 g / kg (about 50 mL of a 25% solution) infused in three to five minutes to produce an adequate urine flow (at least 30 to 50 mL / hr). If urine flow does not increase within two or three hours, a second test dose may be given.
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE 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.
( 1 ) • elevated intraocular pressure. ( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
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.
How to take
Drug interactions
Known interactions involving Mannitol. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB506080002 · revised October 18, 2024
- [2]Health Canada (DPD) · 02243176 · revised March 22, 2025
- [3]FDA DailyMed · 0d914965-7001-45… · revised August 26, 2025 [PDF]
- [4]European Medicines Agency · EMEA/H/C/001252 · revised February 17, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.