Home FDA labels 463ce3e6-a666-9db5-e063-6394a90a91ee Furosemide openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Furosemide
Generic name FUROSEMIDE
Manufacturer ProPharma Distribution
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 38550de1-f099-0cdf-e063-6294a90a9e26
SPL ID 463ce3e6-a666-9db5-e063-6394a90a91ee
Version 4
Effective date 2025-12-18
Source export date 2026-08-08
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-08/ff6f8a7e8311a0dd3c947cd18ca343b8c43f8b6003d238bee8402e80a049f204/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run 20260810T161303Z
Imported at 2026-08-10 17:32:24 Harmonized routes table Harmonized routes INTRAVENOUS
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boxed warning 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 .)
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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).
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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 7. Cramping 2. Pancreatitis 8. Diarrhea 3. Jaundice (intrahepatic cholestatic jaundice) 9. Constipation 4. Increased liver enzymes 10. Nausea 5. Anorexia 11. Vomiting Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid reactions (e.g. with shock) 3. Interstitial nephritis 4. Necrotizing angiitis 2. Systemic vasculitis 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. Stevens-Johnson 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 7. Urinary bladder spasm 2. Glycosuria 8. Thrombophlebitis 3. Hyperuricemia 4. Muscle spasms 9. Transient injection site pain following intramuscular injection 5. Weakness 10. Fever 6. Restlessness Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table <table ID="ID36" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td colspan="2" align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><content styleCode="bold">Gastrointestinal System Reactions</content></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">1. Hepatic encephalopathy in patients with hepatocellular insufficiency </td><td align="left" styleCode="Botrule Rrule" valign="top">6. Oral and gastric irritation 7. Cramping </td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">2. Pancreatitis</td><td align="left" styleCode="Botrule Rrule" valign="top">8. Diarrhea</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">3. Jaundice (intrahepatic cholestatic jaundice)</td><td align="left" styleCode="Botrule Rrule" valign="top">9. Constipation</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">4. Increased liver enzymes</td><td align="left" styleCode="Botrule Rrule" valign="top">10. Nausea</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">5. Anorexia</td><td align="left" styleCode="Botrule Rrule" valign="top">11. Vomiting</td></tr><tr><td colspan="2" align="left" styleCode="Botrule Lrule Rrule" valign="top"><content styleCode="bold"> Systemic Hypersensitivity Reactions</content></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">1. Severe anaphylactic or anaphylactoid reactions (e.g. with shock) </td><td align="left" styleCode="Botrule Rrule" valign="top">3. Interstitial nephritis 4. Necrotizing angiitis </td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">2. Systemic vasculitis</td><td styleCode="Botrule Rrule" valign="top"/></tr><tr><td colspan="2" align="center" styleCode="Botrule Lrule Rrule" valign="top"><content styleCode="bold">Central Nervous System Reactions</content></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">1. Tinnitus and hearing loss</td><td align="left" styleCode="Botrule Rrule" valign="top">5. Headache</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">2. Paresthesias</td><td align="left" styleCode="Botrule Rrule" valign="top">6. Blurred vision</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">3. Vertigo</td><td align="left" styleCode="Botrule Rrule" valign="top">7. Xanthopsia</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">4. Dizziness</td><td styleCode="Botrule Rrule" valign="top"/></tr><tr><td colspan="2" align="center" styleCode="Botrule Lrule Rrule" valign="top"><content styleCode="bold">Hematologic Reactions</content></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">1. Aplastic anemia</td><td align="left" styleCode="Botrule Rrule" valign="top">5. Leukopenia</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">2. Thrombocytopenia</td><td align="left" styleCode="Botrule Rrule" valign="top">6. Anemia</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">3. Agranulocytosis</td><td align="left" styleCode="Botrule Rrule" valign="top">7. Eosinophilia</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">4. Hemolytic anemia</td><td styleCode="Botrule Rrule" valign="top"/></tr><tr><td colspan="2" align="center" styleCode="Botrule Lrule Rrule" valign="top"><content styleCode="bold">Dermatologic-Hypersensitivity Reactions</content></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">1. Exfoliative dermatitis</td><td align="left" styleCode="Botrule Rrule" valign="top">6. Urticaria</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">2. Bullous pemphigoid</td><td align="left" styleCode="Botrule Rrule" valign="top">7. Rash</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">3. Erythema multiforme</td><td align="left" styleCode="Botrule Rrule" valign="top">8. Pruritus</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">4. Purpura</td><td align="left" styleCode="Botrule Rrule" valign="top">9. Stevens-Johnson Syndrome</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">5. Photosensitivity</td><td align="left" styleCode="Botrule Rrule" valign="top">10. Toxic epidermal necrolysis</td></tr><tr><td colspan="2" align="left" styleCode="Botrule Lrule Rrule" valign="top"><content styleCode="bold"> Cardiovascular Reaction</content></td></tr><tr><td colspan="2" align="left" styleCode="Botrule Lrule Rrule" valign="top">1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. 2. Increase in cholesterol and triglyceride serum levels. </td></tr><tr><td colspan="2" align="left" styleCode="Botrule Lrule Rrule" valign="top"><content styleCode="bold"> Other Reactions</content></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">1. Hyperglycemia</td><td align="left" styleCode="Botrule Rrule" valign="top">7. Urinary bladder spasm</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">2. Glycosuria</td><td align="left" styleCode="Botrule Rrule" valign="top">8. Thrombophlebitis</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">3. Hyperuricemia 4. Muscle spasms </td><td align="left" styleCode="Botrule Rrule" valign="top">9. Transient injection site pain following intramuscular injection </td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">5. Weakness</td><td align="left" styleCode="Botrule Rrule" valign="top">10. Fever</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule" valign="top">6. Restlessness</td><td styleCode="Botrule Rrule" valign="top"/></tr></tbody></table>