Home FDA labels ee0b407e-d04b-41b4-a9e1-f1c9878db024 FDA label ee0b407e-d04b-41b4-a9e1-f1c9878db024 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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SPL set ID a10def90-97c4-43dc-9312-496b8ad89dab
SPL ID ee0b407e-d04b-41b4-a9e1-f1c9878db024
Version 16
Effective date 2025-12-04
Source export date 2026-10-12
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/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
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Import run 20261013T011858Z
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warnings WARNING Furosemide USP 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 4. dizziness 2. paresthesias 5. headache 3. vertigo 6. blurred vision 7. xanthopsia Hematologic Reactions 1. aplastic anemia 2. thrombocytopenia 5. leukopenia 3. agranulocytosis 6. anemia 4. hemolytic anemia 7. eosinophilia 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.
adverse reactions table <table width="100%"><col width="49%"/><col width="49%"/><tbody><tr><td colspan="2" styleCode="Botrule Toprule " valign="top"><paragraph><content styleCode="bold">Gastrointestinal System Reactions </content></paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 1. hepatic encephalopathy in patients with</paragraph><paragraph> hepatocellular insufficiency </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 6. oral and gastric irritation</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 2. pancreatitis </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 7. cramping</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 3. jaundice (intrahepatic cholestatic jaundice) </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 8. diarrhea</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 4. increased liver enzymes</paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 9. constipation</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 5. anorexia </paragraph></td><td styleCode="Botrule " valign="top"><paragraph>10. nausea</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"/><td styleCode="Botrule " valign="top"><paragraph>11. vomiting</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td colspan="2" styleCode="Botrule " valign="top"><paragraph><content styleCode="bold">Systemic Hypersensitivity Reactions</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock)</paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 3. interstitial nephritis </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 2. systemic vasculitis </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 4. necrotizing angiitis</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td colspan="2" styleCode="Botrule " valign="top"><paragraph><content styleCode="bold">Central Nervous System Reactions</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 1. tinnitus and hearing loss </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 4. dizziness </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 2. paresthesias </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 5. headache </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 3. vertigo </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 6. blurred vision </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 7. xanthopsia </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td colspan="2" styleCode="Botrule " valign="top"><paragraph><content styleCode="bold">Hematologic Reactions</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 1. aplastic anemia </paragraph></td><td styleCode="Botrule " valign="top"/></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 2. thrombocytopenia </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 5. leukopenia </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 3. agranulocytosis</paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 6. anemia </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 4. hemolytic anemia</paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 7. eosinophilia </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"/><td styleCode="Botrule " valign="top"/></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Dermatologic - Hypersensitivity Reactions</content></paragraph></td><td styleCode="Botrule " valign="top"><paragraph> </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 1. toxic epidermal necrolysis</paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 7. bullous pemphigoid </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 2. Stevens-Johnson Syndrome </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 8. purpura</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 3. erythema multiforme </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 9. photosensitivity</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 4.drug rash with eosinophilia and systemic symptoms</paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 10. rash</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 5. acute generalized exanthematous pustulosis</paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 11. pruritis</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 6. exfoliative dermatitis </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 12. urticaria</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"/><td styleCode="Botrule " valign="top"/></tr><tr><td colspan="2" styleCode="Botrule " valign="top"><paragraph><content styleCode="bold">Cardiovascular Reaction</content></paragraph></td></tr><tr><td colspan="2" styleCode="Botrule " valign="top"><paragraph>1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.</paragraph><paragraph>2. Increase in cholesterol and triglyceride serum levels.</paragraph></td></tr><tr><td colspan="2" styleCode="Botrule " valign="top"/></tr><tr><td colspan="2" styleCode="Botrule " valign="top"><paragraph><content styleCode="bold">Other Reactions</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 1. hyperglycemia </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 6. restlessness </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 2. glycosuria </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 7. urinary bladder spasm </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 3. hyperuricemia </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 8. thrombophlebitis </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 4. muscle spasm </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> 9. fever </paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph> 5. weakness </paragraph></td><td styleCode="Botrule " valign="top"><paragraph> </paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.