Prescription medicine
Mannitol Brand names: Osmitrol, Aridol
Mannitol (Osmitrol) is a prescription medicine with an FDA approval on record since 1964. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the mannitol FDA label on DailyMed (effective August 26, 2025, Baxter Healthcare Company); the NDA 13684 record on Drugs@FDA; every mannitol label on DailyMed.
Highlights of the record
FDA label of August 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOSMITROL is indicated for:
The reduction of intracranial pressure and treatment of cerebral edema;
Forms and strengths
- 10 g/100ml
- 12.5 g/50ml
- 20 g/100ml
- 250 mg/ml
Injection (solution); kit.
On the market
- Earliest approval on file
- June 8, 1964 Osmitrol 20% In Water In Plastic Container, Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first August 11, 1972; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 2 under generic applications, 7 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,912 through July 30, 2026
What is mannitol used for?
From the label: indications and usageOSMITROL 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.
Conditions named in the indications of mannitol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Osmotic Diuretic.
Source: FDA drug label (Osmitrol), Baxter Healthcare Company, effective August 26, 2025 (SPL set 0d914965-7001-45cb-ba51-d7c5964b05bc), via openFDA; the full label on DailyMed
Is there a generic for mannitol (Osmitrol)?
The FDA approved the first generic mannitol on August 11, 1972. 6 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mannitol from 2 labelers under a generic (ANDA) application and from 7 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1964 earliest approval on file
- 1972 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the mannitol label say about other medicines?
The mannitol label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | Concomitant administration of nephrotoxic drugs (e.g., cyclosporine, aminoglycosides) increases the risk of renal failure following administration of mannitol. |
| Digoxin | drug interactions | Affected by Electrolyte Imbalances The development of electrolyte imbalances (e.g., hyperkalemia, hypokalemia) associated with mannitol administration may result in cardiac adverse reactions in patients receiving drugs that are sensitive to such imbalances (e.g., digoxin, drugs that prolong the QT interval … |
| Lithium | drug interactions | However, concomitant use of mannitol and lithium may increase risk of lithium toxicity. |
Source: FDA drug label (Osmitrol), Baxter Healthcare Company, effective August 26, 2025 (SPL set 0d914965-7001-45cb-ba51-d7c5964b05bc), via openFDA; the full label on DailyMed
What do FAERS reports show for mannitol?
The FDA Adverse Event Reporting System holds 4,912 reports that list mannitol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,410 are coded as a death and 2,144 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mannitol?
1 other medicine is given the same way (intravenous) and in the same FDA class as mannitol or labeled mainly for the same use (edema (fluid retention)), the same class first. Edema (fluid retention) lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ethacrynic acid | Edema (fluid retention) | 2 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other osmotic diuretics
- the pharmacologic class, with prices and generics
- Mannitol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other