FDA label f7eee0f5-ce28-4fca-8c56-5176ab7fd50e

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)

SPL set ID
74e9108e-8540-4442-82bc-4f46c6bdd334
SPL ID
f7eee0f5-ce28-4fca-8c56-5176ab7fd50e
Version
3
Effective date
2019-02-14
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:05:11

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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 adequate 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 pre-existing 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 sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Reactions are infrequent and may include: 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, 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.