Furosemide

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
Furosemide
Generic name
FUROSEMIDE
Manufacturer
AvKARE
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
d4c532be-1f3f-60d3-e053-2995a90a98be
SPL ID
485d7945-6751-e159-e063-6294a90a27ce
Version
3
Effective date
2026-01-14
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:29:50
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNING Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs (see DOSAGE AND ADMINISTRATION ).

warnings

WARNINGS In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) (see PRECAUTIONS: Drug Interactions ).

Adverse reactions cross-check#

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Adverse reactions sections page 2 of 2 · 7 matching rows.

adverse reactions table

<table width="100%"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr><td valign="top"><list listType="ordered"><item>1. aplastic anemia</item></list></td><td valign="top"><list listType="ordered"><item>5. leukopenia</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>2. thrombocytopenia</item></list></td><td valign="top"><list listType="ordered"><item>6. anemia</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>3. agranulocytosis</item></list></td><td valign="top"><list listType="ordered"><item>7. eosinophilia</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>4. hemolytic anemia</item></list></td><td valign="top"/></tr></tbody></table>

adverse reactions table

<table width="100%"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr><td valign="top"><list listType="ordered"><item>1. toxic epidermal necrolysis</item></list></td><td valign="top"><list listType="ordered"><item>7. bullous pemphigoid</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>2. Stevens-Johnson Syndrome</item></list></td><td valign="top"><list listType="ordered"><item>8. purpura</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>3. erythema multiforme</item></list></td><td valign="top"><list listType="ordered"><item>9. fever</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>4. drug rash with eosinophilia and systemic symptoms</item></list></td><td valign="top"><list listType="ordered"><item>10. rash</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>5. acute generalized exanthematous pustulosis</item></list></td><td valign="top"><list listType="ordered"><item>11. pruritus</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>6. exfoliative dermatitis</item></list></td><td valign="top"><list listType="ordered"><item>12. urticaria</item></list></td></tr></tbody></table>

adverse reactions table

<table width="100%"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr><td valign="top"><list listType="ordered"><item>1. hyperglycemia</item></list></td><td valign="top"><list listType="ordered"><item>6. restlessness</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>2. glycosuria</item></list></td><td valign="top"><list listType="ordered"><item>7. urinary bladder spasm</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>3. hyperuricemia</item></list></td><td valign="top"><list listType="ordered"><item>8. thrombophlebitis</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>4. muscle spasm</item></list></td><td valign="top"><list listType="ordered"><item>9. fever</item></list></td></tr><tr><td valign="top"><list listType="ordered"><item>5. weakness</item></list></td><td valign="top"/></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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