Mannitol

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.

• 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.ICD-10: R60.9

• OSMITROL is contraindicated in patients with: • Known hypersensitivity to mannitol [see Warnings and Precautions (5.1) ] • Anuria [see Warnings and Precautions (5.2) ] • Severe hypovolemia [see Warnings and Precautions (5.4) ] • Pre-existing severe pulmonary vascular congestion or pulmonary edema [see Warnings and Precautions (5.5) ] • Active intracranial bleeding except during craniotomy • Known hypersensitivity to mannitol. ( 4 , 5.1 ) • Anuria.contraindicated

Administration Instructions ( 2.1 ): • 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 ( 2.2 ) : • 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. 2.1 Important Preparation and Administration Instructions • OSMITROL is for intravenous infusion preferably into a large central vein [see Warnings and Precautions (5.5) , Description (11) ]. • Prior to administration of OSMITROL, evaluate renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances [see Dosage and Administration (2.2) ]. • Do not administer OSMITROL simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. Preparation 1. Tear overwrap down side at slit and remove solution container. 2. Visually inspect the container. Do not administer unless solution is clear and seal is intact. o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

• Hypersensitivity Reactions, including anaphylaxis : Stop infusion immediately if hypersensitivity reactions develop. ( 5.1 ) • 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. ( 5.2 , 8.6 ) • 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. ( 5.3 ) • 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. ( 5.4 ) • Monitoring/Laboratory Tests : Monitor fluid and electrolytes, serum osmolarity and renal, cardiac and pulmonary function. Discontinue if toxicity develops. ( 5.5 ) • Infusion Site Reactions : May include irritation and inflammation, as well as severe reactions (compartment syndrome) when associated with extravasation. ( 5.6 ) • Interference with Laboratory Tests : High concentrations of mannitol may cause false low results of inorganic phosphorus blood concentrations. Mannitol may produce false positive results for blood ethylene glycol.

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. [see Warnings and Precautions (5.1) ] • Renal Failure : acute kidney injury, osmotic nephrosis, azotemia, anuria, hematuria, oliguria, polyuria [see Warnings and Precautions (5.2) ] • CNS Toxicity : coma, seizures, confusion, lethargy; rebound increase in intracranial pressure; dizziness [see Warnings and Precautions (5.3) ] • Fluid and Electrolyte Imbalances : hypovolemia, hypervolemia, peripheral edema, dehydration, hyponatremia, hypernatremia, hyperkalemia, hypokalemia; metabolic acidosis [see Warnings and Precautions (5.4) ] • Infusion Site Reactions : phlebitis, inflammation, pain, rash, erythema, pruritus; compartment syndrome and swelling associated with extravasation [see Warnings and Precautions (5.6) ] • Cardiac and Respiratory Disorders : congestive cardiac failure, pulmonary edema, palpitations • Gastrointestinal Disorders : thirst, dry mouth • General Disorders : asthenia, malaise The most common adverse reactions are hypersensitivity reactions, renal failure, CNS toxicity, hypo/hypervolemia, hypo…

8.1 Pregnancy Risk Summary The available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see Data) . No adverse developmental effects from mannitol were reported in published animal studies; however, fluid shifts occurred in fetal ewes in response to maternal infusion of mannitol. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Published literature reports the presence of mannitol in amniotic fluid when mannitol is administered to pregnant women during the third trimester of pregnancy. 8.2 Lactation Risk Summary There are no data on the presence of mannitol in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

Metabolism

Distribution Mannitol distributes largely in the extracellular space in 20 to 40 minutes after intravenous administration. The volume of distribution of mannitol is approximately 17 L in adults.

Signs and symptoms of overdose with OSMITROL include renal failure and AKI, hypo/hypervolemia, hyperosmolarity and electrolyte imbalances, CNS toxicity (e.g., coma, seizures), some of which can be fatal [see Warnings and Precautions (5.2 , 5.3 , 5.4 )]. Management of overdosage with OSMITROL is symptomatic and supportive. Discontinue the infusion and institute appropriate corrective measures with particular attention to renal, cardiac and pulmonary systems . Correct fluid and electrolyte imbalances. OSMITROL is dialyzable (hemodialysis and peritoneal dialysis), hemodialysis may increase OSMITROL elimination.

• Jun 8, 1964NDANDA013684Baxter Hlthcare
• Dec 22, 1967NDANDA016269Hospira
• Aug 11, 1972ANDAANDA080677Fresenius Kabi Usa
• Feb 22, 1980NDANDA018316Otsuka Icu Medcl
• Jan 8, 1987NDANDA019603Otsuka Icu Medcl
• Jul 26, 1993NDANDA020006B Braun
• Oct 5, 2010NDANDA022368Pharmaxis Europe

1. 1Pain61813%
2. 2Renal Failure59312%
3. 3Anxiety50610%
4. 4Injury49610%
5. 5Unevaluable Event4719.8%
6. 6Drug Ineffective4579.5%
7. 7Stress4499.3%
8. 8Fear4318.9%
9. 9Death4268.8%
10. 10Renal Impairment3938.1%
11. 11Emotional Distress3878.0%
12. 12Renal Injury3837.9%
13. 13Off Label Use3597.4%
14. 14Nausea3246.7%
15. 15Anhedonia3136.5%

Recent PubMed references pinned to Mannitol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Insights into the Fucoidan and Mannitol Biosynthetic Pathways in the Brown Seaweed Padina Tetrastromatica Based on Draft Genome and Transcriptome Analysis.
  Marine biotechnology (New York, N.Y.) · 2026 · Phakatkar SS, Parab AS, Naik SS, et al.
  PMID 42240916DOI 10.1007/s10126-026-10649-8
• Thermo-acoustic and computational studies for the mixture of drug (NSAIDs) and D-mannitol in an aqueous system: Implications for pharmaceutical formulation.
  Pakistan journal of pharmaceutical sciences · 2026 · Shoukat S, Asghar Jamal M, Ahmed F, et al.
  PMID 42170961DOI 10.36721/PJPS.2026.39.7.184.1
• Comparing the efficacy of dextrose, mannitol, and saline solutions in male rabbits' chemical castration.
  Animal models and experimental medicine · 2026 · Gholizadeh MJ, Azargoun R, Shalizar-Jalali A, et al.
  PMID 42117338DOI 10.1002/ame2.70179
• Stem Shading Promotes Mannitol Accumulation in the Bark of Fraxinus ornus and Prevents Sucrose Transport in Roots Under Drought.
  Physiologia plantarum · 2026 · Gargiulo S, Natale S, Pichierri A, et al.
  PMID 42010452DOI 10.1111/ppl.70894
• Mannitol concentration is a determinant of the mycorrhizal infectivity of the Laccaria trichodermophora mycelium produced in liquid culture.
  Fungal biology · 2026 · Campos-López A, Valdez-Cruz NA, Garibay-Orijel R, et al.
  PMID 42000306DOI 10.1016/j.funbio.2026.101738
• Clearance of mannitol for assessment of glomerular filtration rate in chronic kidney disease: A validation against iohexol clearance.
  Clinical physiology and functional imaging · 2026 · Kiss K, Saeed A, Ricksten SE, et al.
  PMID 41930677DOI 10.1111/cpf.70059
• Delayed-type anaphylactic shock to mannitol: a case report and review of the literature.
  Journal of medical case reports · 2026 · Hu G, Li J, Fu L, et al.
  PMID 41888951DOI 10.1186/s13256-026-05896-1
• Standardizing Intestinal Permeability Assessment: Optimization of Gluten Dose and Urine Collection Times for u-GIP and Lactulose:Mannitol Ratio in Healthy Volunteers.
  International journal of molecular sciences · 2026 · Rodríguez-Ramírez R, Fernández Peralbo MA, Cebolla Á, et al.
  PMID 41828523DOI 10.3390/ijms27052286

The 10 most recently updated of 513 ClinicalTrials.gov registrations naming Mannitol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
  Recruiting · Phase 2 · Phase 3 · Interventional · 2,250 enrolled · Global Coalition for Adaptive Research
  NCT03970447updated 2026-06-12
• The Effect of Mannitol Volume With Changes in Osmolarity in Traumatic Brain Injury
  Completed · Phase 3 · Interventional · 64 enrolled · Universitas Diponegoro
  NCT06846307updated 2026-06-11
• Key Diagnostic & Therapeutic Technologies for Severe Acute High Altitude Disease (SAHAD): Integration and Application
  Not yet recruiting · Interventional · 3,035 enrolled · Tibet Autonomous Region People's Hospital
  NCT07639931updated 2026-06-10
• Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
  Not yet recruiting · Phase 2 · Interventional · 52 enrolled · Muhammad N Aslam, MD
  NCT07501078updated 2026-06-08
• EFFECT OF AYURVEDA TREATMENT IN ALLERGIC RHINITIS
  Not yet recruiting · Interventional · 104 enrolled · Amrita Vishwa Vidyapeetham
  NCT07626099updated 2026-06-04
• Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness
  Completed · Phase 2 · Interventional · 822 enrolled · University of Arizona
  NCT02148796updated 2026-06-02
• Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
  Recruiting · Phase 1 · Phase 2 · Interventional · 54 enrolled · Northwell Health
  NCT01269853updated 2026-06-01
• Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
  Recruiting · Phase 2 · Interventional · 60 enrolled · Shirley Ryan AbilityLab
  NCT07434492updated 2026-06-01
• Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
  Recruiting · Phase 1 · Phase 2 · Interventional · 33 enrolled · Northwell Health
  NCT02861898updated 2026-06-01
• Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma
  Suspended · Phase 1 · Phase 2 · Interventional · 54 enrolled · Northwell Health
  NCT01386710updated 2026-06-01

Frequently asked questions

How does Mannitol work?

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.

What is Mannitol used for?

According to FDA labeling, Mannitol carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mannitol?

Mannitol is classified as Mucolytics, Osmotically acting laxatives, Other diagnostic agents, Other irrigating solutions, Solutions producing osmotic diuresis, Osmotic Diuretic, Osmotic Activity, Increased Diuresis, Increased Glomerular Filtration Pressure, Increased Renal Ion Excretion.

What are the brand names for Mannitol?

Mannitol is marketed under brand names including Bronchitol, Osmitrol.

What are the contraindications for Mannitol?

Mannitol labeling lists contraindications including: OSMITROL is contraindicated in patients with: • Known hypersensitivity to mannitol [see Warnings and Precautions (5.1) ] • Anuria [see Warnings and Precautions (5.2) ] • Severe hypovolemia [see Warnings and Precautions (5.4) ] • Pre-existing severe pulmonary vascular congestion or pulmonary edema [see Warnings and Precautions (5.5) ] • Active intracranial bleeding except during craniotomy • Known hypersensitivity to mannitol. ( 4 , 5.1 ) • Anuria.. Always consult the full prescribing information and a clinician.