Mannitol — uses, dosing, side effects & the brands that sell it · pharmaranks
Mannitol: uses, dosing, side effects & brands
Mannitol is an osmotic diuretic sold in the U.S. under 8 brand and generic names, for anuria, brain edema and ocular hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Osmotic Diuretic
Treats
Anuria, Brain Edema and Ocular Hypertension
Available as
Kit · Powder · Injectable · Solution
Sold as
8 products — Aridol, Aridol Kit and Bronchitol, and others
From the FDA label for Aridol (application NDA022368). Other mannitol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For Oral Inhalation Use Only One ARIDOL test kit contains dry powder mannitol capsules in graduated doses and a single patient use inhaler necessary to perform one bronchial challenge test. ( 2 ) The mannitol capsules supplied in the ARIDOL kit are to be used with the single patient use inhaler device ( 2 ). Discard the inhaler after use. Capsule contents are to be inhaled in increasing dosage until either a positive response (15% reduction in FEV 1 from baseline or a 10% incremental reduction in FEV 1 between consecutive doses) is achieved or all capsules are inhaled (maximum total dose 635mg) ( 2 ) Starting and maximum dose is the same for children (≥6 years old) and adults ( 2 ) 2.1 Bronchial Challenge Test Kit Overview ARIDOL is a bronchial challenge test kit containing the required capsules of dry powder mannitol for oral inhalation in graduated doses with the supplied single patient use inhaler necessary to perform one bronchial challenge test. Do not swallow ARIDOL capsules. The airway response to bronchial challenge testing with ARIDOL is measured using forced expiratory volume in one second (FEV 1 ). Prior to bronchial challenge testing with ARIDOL, standard spirometry should be performed and the reproducibility of the resting FEV 1 established. 2.2 Administration Instructions An overview of the testing procedure can be found below. The ARIDOL bronchial challenge test…
Mannitol side effects
The following clinically significant adverse reaction is described elsewhere in the labeling: • Severe Bronchospasm [ see Warnings and Precautions ( 5.1 )]. Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm, Inc. at 1-866-701-4636 or email at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population for the ARIDOL bronchial challenge test consisted of 1,082 subjects (577 females and 505 males) including patients with asthma, symptoms suggestive of asthma, and healthy individuals from 6 to 83 years of age who participated in the two clinical trials (Studies 1 and 2). The racial distribution of subjects was 84% Caucasian, 5% Asian, 4% Black, and 7% Other. Pediatric and adolescents patients comprised 23% of the total study population with 118 pediatric patients aged 6-11 years and 128 adolescents aged 12-17 years. Adverse reactions were reported at the…
Every mannitol product we track (8)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
D-mannitol (referred to throughout as mannitol), the active ingredient in ARIDOL is a hexahydric alcohol, that is a sugar alcohol, with the following chemical name (2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexol and chemical structure: Mannitol is a white or almost white crystalline powder of free-flowing granules with an empirical formula of C 6 H 14 O 6 and molecular weight of 182.2. Mannitol is freely soluble in water, and very slightly soluble in alcohol. Mannitol shows polymorphism. The ARIDOL Bronchial Challenge Test Kit contains one single patient use dry powder inhaler and 3 consecutively numbered foil blister packs containing a total of 19 capsules of mannitol for oral inhalation. All except the 0 mg printed hard gelatin capsules contain dry powder mannitol for oral inhalation. The accompanying dry powder inhaler is a plastic device used for inhaling the capsules. All doses are to be administered using the same device supplied with each kit without washing or sterilizing the device at anytime during the test. To use the delivery system, a mannitol capsule is placed in the well of the inhaler, and the capsule is pierced by pressing and releasing the buttons ONCE on the side of the device. The mannitol dry powder is dispersed into the air stream when the patient inhales deeply through the mouthpiece. There are no inactive ingredients in the mannitol capsules…
What kind of drug is mannitol?
The FDA classifies mannitol as an osmotic diuretic. Osmotic diuretics like mannitol are sugar-like molecules that the kidney filters but cannot reabsorb, so they stay in the urine and pull water along with them like a magnet. This boosts urine output and can also draw excess fluid out of swollen tissues, such as a swollen brain. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take mannitol with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run mannitol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is mannitol sold under?
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take mannitol
ARIDOL is contraindicated in: Patients with known hypersensitivity to mannitol or to the gelatin used to make the capsules Patients with conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. Some examples include: aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident [ see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to mannitol or to the gelatin used to make the capsules ( 4 ) Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers ( 4 )
Mannitol drug interactions
No formal drug-drug interaction studies were conducted with mannitol, the active ingredient in ARIDOL.
We track 8 mannitol-containing products in the U.S.: Aridol, Aridol Kit, Bronchitol, Mannitol 10% in Plastic Container, Mannitol 15% in Plastic Container, Mannitol 20% in Plastic Container, Mannitol 5% in Plastic Container and Resectisol. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does mannitol come in?
Across the brands we track, mannitol is currently marketed as kit, powder, injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic mannitol?
We do not currently list a generic-labelled mannitol product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has mannitol been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions mannitol. The most recent: Kit for the Preparation of Technetium Tc 99m Sestamibi Injection (Nov 26, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.