Home FDA labels a504ee4b-3995-45f2-898c-91116dd81d19 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 Aurobindo Pharma Limited
Product type HUMAN PRESCRIPTION DRUG
SPL set ID a504ee4b-3995-45f2-898c-91116dd81d19
SPL ID a504ee4b-3995-45f2-898c-91116dd81d19
Version 1
Effective date 2025-07-19
Source export date 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
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Import run 20261013T011858Z
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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 ).
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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 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. toxic epidermal necrolysis 7. bullous pemphigoid 2. Stevens-Johnson Syndrome 8. purpura 3. erythema multiforme 9. photosensitivity 4. drug rash with eosinophilia and systemic symptoms 10. rash 5. acute generalized exanthematous pustulosis 11. pruritis 6. exfoliative dermatitis 12. urticaria 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 spasm 9. fever 5. weakness Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="96%"><colgroup><col width="50.4302832244009%"/><col width="49.5697167755991%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top"><content styleCode="bold">Gastrointestinal System Reactions</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">1. hepatic encephalopathy in patients with hepatocellular insufficiency </td><td styleCode="Rrule" valign="top">6. oral and gastric irritation </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">2. pancreatitis </td><td styleCode="Rrule" valign="top">7. cramping </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">3. jaundice (intrahepatic cholestatic jaundice) </td><td styleCode="Rrule" valign="top">8. diarrhea </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">4. increased liver enzymes </td><td styleCode="Rrule" valign="top">9. constipation </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">5. anorexia </td><td styleCode="Rrule" valign="top">10. nausea </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top"/><td styleCode="Rrule" valign="top">11. vomiting </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top"><content styleCode="bold">Systemic Hypersensitivity Reactions</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock) </td><td styleCode="Rrule" valign="top">3. interstitial nephritis </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">2. systemic vasculitis </td><td styleCode="Rrule" valign="top">4. necrotizing angiitis </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top"><content styleCode="bold">Central Nervous System Reactions</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">1. tinnitus and hearing loss </td><td styleCode="Rrule" valign="top">5. headache </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">2. paresthesias </td><td styleCode="Rrule" valign="top">6. blurred vision </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">3. vertigo </td><td styleCode="Rrule" valign="top">7. xanthopsia </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">4. dizziness </td><td styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top"><content styleCode="bold">Hematologic Reactions</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">1. aplastic anemia </td><td styleCode="Rrule" valign="top">5. leukopenia </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">2. thrombocytopenia </td><td styleCode="Rrule" valign="top">6. anemia </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">3. agranulocytosis </td><td styleCode="Rrule" valign="top">7. eosinophilia </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">4. hemolytic anemia </td><td styleCode="Rrule" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top"><content styleCode="bold">Dermatologic-Hypersensitivity Reactions</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">1. toxic epidermal necrolysis </td><td styleCode="Rrule" valign="middle">7. bullous pemphigoid </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">2. Stevens-Johnson Syndrome </td><td styleCode="Rrule" valign="middle">8. purpura </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">3. erythema multiforme </td><td styleCode="Rrule" valign="middle">9. photosensitivity </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">4. drug rash with eosinophilia and systemic symptoms </td><td styleCode="Rrule" valign="middle">10. rash </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">5. acute generalized exanthematous pustulosis </td><td styleCode="Rrule" valign="middle">11. pruritis </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">6. exfoliative dermatitis </td><td styleCode="Rrule" valign="middle">12. urticaria </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="middle"><content styleCode="bold">Cardiovascular Reaction</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top">1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics. </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top">2. Increase in cholesterol and triglyceride serum levels </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="2" valign="top"><content styleCode="bold">Other Reactions</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">1. hyperglycemia </td><td styleCode="Rrule" valign="top">6. restlessness </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">2. glycosuria </td><td styleCode="Rrule" valign="top">7. urinary bladder spasm </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">3. hyperuricemia </td><td styleCode="Rrule" valign="top">8. thrombophlebitis </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="top">4. muscle spasm </td><td styleCode="Rrule" valign="top">9. fever </td></tr><tr><td styleCode="Lrule Rrule" valign="top">5. weakness </td><td styleCode="Rrule" valign="top"> </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.