Home FDA labels 77e48621-aef7-4db3-9c70-8d0d64b207b2 FDA label 77e48621-aef7-4db3-9c70-8d0d64b207b2 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 a87ca064-4121-4428-9cde-bff1c288b12c
SPL ID 77e48621-aef7-4db3-9c70-8d0d64b207b2
Version 5
Effective date 2018-05-30
Source export date 2026-09-28
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
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Import run 20260929T050834Z
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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> <col width="65%"/> <col width="28%"/> <tbody> <tr> <td colspan="2" styleCode="Botrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Gastrointestinal System Reactions </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 2. pancreatitis </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 7. cramping</paragraph> </td> </tr> <tr> <td styleCode="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 4. increased liver enzymes</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 9. constipation</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 5. anorexia </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph>10. nausea</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Botrule " valign="top"> <paragraph>11. vomiting</paragraph> </td> </tr> <tr> <td styleCode="Lrule 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="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 2. systemic vasculitis </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 4. necrotizing angiitis</paragraph> </td> </tr> <tr> <td styleCode="Lrule 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="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 2. paresthesias </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 5. headache </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 3. vertigo </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 6. blurred vision </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 7. xanthopsia </paragraph> </td> </tr> <tr> <td styleCode="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 1. aplastic anemia </paragraph> </td> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 2. thrombocytopenia </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 5. leukopenia </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 3. agranulocytosis</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 6. anemia </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 4. hemolytic anemia</paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 7. eosinophilia </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"/> <td styleCode="Botrule " valign="top"/> </tr> <tr> <td styleCode="Lrule 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="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 2. Stevens-Johnson Syndrome </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 8. purpura</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 3. erythema multiforme </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 9. photosensitivity</paragraph> </td> </tr> <tr> <td styleCode="Lrule 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="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 6. exfoliative dermatitis </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 12. urticaria</paragraph> </td> </tr> <tr> <td styleCode="Lrule 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="Lrule Botrule " valign="top"> <paragraph> 1. hyperglycemia </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 6. restlessness </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 2. glycosuria </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 7. urinary bladder spasm </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 3. hyperuricemia </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 8. thrombophlebitis </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph> 4. muscle spasm </paragraph> </td> <td styleCode="Botrule " valign="top"> <paragraph> 9. fever </paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule " 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.