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
Medical Purchasing Solutions, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
d8a064cc-c741-8b80-e053-2a95a90a364c
SPL ID
facb5297-bc02-ea41-e053-6394a90a840c
Version
4
Effective date
2023-05-03
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:52:56
Harmonized routes table
Harmonized routes
INTRAMUSCULAR, INTRAVENOUS

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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 ). Pediatric Use: In premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA), possibly through a prostaglandin-E-mediated process. Literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity. Hearing loss in neonates has been associated with the use of furosemide injection (see WARNINGS , above).

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 2 · 8 matching rows.

adverse reactions

ADVERSE REACTIONS: Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. Hepatic encephalopathy in patients with hepatocellular insufficiency 6. Oral and gastric irritation 2. Pancreatitis 7. Cramping 3. Jaundice (intrahepatic cholestatic jaundice) 8. Diarrhea 4. Increased liver enzymes 9. Constipation 5. Anorexia 10. Nausea 11. Vomiting Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid reactions (e.g. with shock) 3. Interstitial nephritis 2. Systemic vasculitis 4. Necrotizing angiitis Central Nervous System Reactions 1. Tinnitus and hearing loss 5. Headache 2. Paresthesias 6. Blurred vision 3. Vertigo 7. Xanthopsia 4. Dizziness Hematologic Reactions 1. Aplastic anemia 5. Leukopenia 2. Thrombocytopenia 6. Anemia 3. Agranulocytosis 7. Eosinophilia 4. Hemolytic anemia Dermatologic-Hypersensitivity Reactions 1. Exfoliative dermatitis 6. Urticaria 2. Bullous pemphigoid 7. Rash 3. Erythema multiforme 8. Pruritus 4. Purpura 9. Stevens­Johnson Syndrome 5. Photosensitivity 10. Toxic epidermal necrolysis Cardiovascular Reaction 1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. 2. Increase in cholesterol and triglyceride serum levels. Other Reactions 1. Hyperglycemia 6. Restlessness 2. Glycosuria 7. Urinary bladder spasm 3. Hyperuricemia 8. Thrombophlebitis 4. Muscle spasms 9. Transient injection site pain following intramuscular injection 5. Weakness 10. Fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

adverse reactions table

<table ID="ID24" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td align="center" colspan="2" valign="top"><content styleCode="bold">Gastrointestinal System Reactions </content></td></tr><tr><td align="justify" valign="top">1. Hepatic encephalopathy in patients with hepatocellular insufficiency </td><td align="justify" valign="top">6. Oral and gastric irritation </td></tr><tr><td align="justify" valign="top">2. Pancreatitis </td><td align="justify" valign="top">7. Cramping </td></tr><tr><td align="justify" valign="top">3. Jaundice (intrahepatic cholestatic jaundice) </td><td align="justify" valign="top">8. Diarrhea </td></tr><tr><td align="justify" valign="top">4. Increased liver enzymes </td><td align="justify" valign="top">9. Constipation </td></tr><tr><td align="justify" valign="top">5. Anorexia </td><td align="justify" valign="top">10. Nausea </td></tr><tr><td align="justify" valign="top"> </td><td align="justify" valign="top">11. Vomiting </td></tr></tbody></table>

adverse reactions table

<table ID="ID25" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td align="center" colspan="2" valign="top"><content styleCode="bold">Systemic Hypersensitivity Reactions </content></td></tr><tr><td align="justify" valign="top">1. Severe anaphylactic or anaphylactoid reactions (e.g. with shock) </td><td align="justify" valign="top">3. Interstitial nephritis </td></tr><tr><td align="justify" valign="top">2. Systemic vasculitis </td><td align="justify" valign="top">4. Necrotizing angiitis </td></tr></tbody></table>

adverse reactions table

<table ID="ID26" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td align="center" colspan="2" valign="top"><content styleCode="bold">Central Nervous System Reactions </content></td></tr><tr><td align="justify" valign="top">1. Tinnitus and hearing loss </td><td align="justify" valign="top">5. Headache </td></tr><tr><td align="justify" valign="top">2. Paresthesias </td><td align="justify" valign="top">6. Blurred vision </td></tr><tr><td align="justify" valign="top">3. Vertigo </td><td align="justify" valign="top">7. Xanthopsia </td></tr><tr><td align="justify" valign="top">4. Dizziness </td><td align="justify" valign="top"> </td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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