Mannitol

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Mannitol
Generic name
MANNITOL
Manufacturer
Fresenius Kabi USA, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
c395e13d-6ea1-4104-8b37-669cfb982f04
SPL ID
fe8beed4-a8db-400e-834e-b5efe2f5af1c
Version
4
Effective date
2023-03-16
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:24:10
Harmonized routes table
Harmonized routes
INTRAVENOUS

Warnings cross-check#

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warnings

WARNINGS In severe impairment of renal function a test dose should be given (see DOSAGE AND ADMINISTRATION ). A second test dose may be given if there is an inadequate response. No more than two test doses should be attempted. Excessive loss of water and electrolytes may lead to serious imbalances. Serum sodium and potassium should be carefully monitored during mannitol therapy. The diuresis after rapid infusion of mannitol may increase preexisting hemoconcentration. With continued use of mannitol a loss of water in excess of electrolytes can cause hypernatremia. Shift of sodium-free intracellular fluid into the extracellular compartment after mannitol infusion may lower serum sodium concentration and aggravate preexisting hyponatremia. Closely monitor the urine output and discontinue mannitol infusion promptly if output is low. Inadequate urine output results in accumulation of mannitol, expansion of extracellular fluid volume and could result in water intoxication or congestive heart failure. Renal function must be closely monitored during mannitol infusion. Mannitol solution must be used with caution in patients with significant cardiopulmonary or renal dysfunction. Irrigating solutions used in transurethral prostatectomy have been shown to enter the systemic circulation in relatively large volumes, exert a systemic effect and may significantly alter cardiopulmonary and renal dynamics.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Reactions are infrequent and may include: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Metabolic: fluid and electrolyte imbalance, acidosis, dehydration. Gastrointestinal: dryness of mouth, nausea, vomiting, diarrhea. Genitourinary: osmotic nephrosis, urinary retention. Central Nervous System: headache, convulsions, dizziness. Special Senses: Blurred vision, rhinitis. Cardiovascular: pulmonary edema, edema, hypotension, hypertension, tachycardia, angina-like chest pains. Dermatologic: skin necrosis, thrombophlebitis. Hypersensitivity: urticaria. Miscellaneous: thirst, arm pain, chills, fever.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.