Home FDA labels 53d55ac1-9c2c-4591-8334-cc970a02d6cc FDA label 53d55ac1-9c2c-4591-8334-cc970a02d6cc 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 d10cc602-6bb6-4fbe-989d-8307d37eb252
SPL ID 53d55ac1-9c2c-4591-8334-cc970a02d6cc
Version 2
Effective date 2019-10-11
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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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.
adverse reactions table <table ID="ID36" width="100%"> <col width="50%"/> <col width="50%"/> <tbody> <tr> <td align="center" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Gastrointestinal </content> <content styleCode="bold">System </content> <content styleCode="bold">Reactions</content> </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">1. Hepatic encephalopathy in patients with hepatocellular insufficiency </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">6. Oral and gastric irritation 7. Cramping </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">2. Pancreatitis </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">8. Diarrhea </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">3. Jaundice (intrahepatic cholestatic jaundice) </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">9. Constipation </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">4. Increased liver enzymes </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">10. Nausea </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">5. Anorexia </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">11. Vomiting </td> </tr> <tr> <td align="left" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Systemic </content> <content styleCode="bold">Hypersensitivity </content> <content styleCode="bold">Reactions</content> </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">1. Severe anaphylactic or anaphylactoid reactions (e.g. with shock) </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">3. Interstitial nephritis 4. Necrotizing angiitis </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">2. Systemic vasculitis </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="center" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Central </content> <content styleCode="bold">Nervous </content> <content styleCode="bold">System </content> <content styleCode="bold">Reactions</content> </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">1. Tinnitus and hearing loss </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">5. Headache </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">2. Paresthesias </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">6. Blurred vision </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">3. Vertigo </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">7. Xanthopsia </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">4. Dizziness </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="center" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Hematologic </content> <content styleCode="bold">Reactions</content> </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">1. Aplastic anemia </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">5. Leukopenia </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">2. Thrombocytopenia </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">6. Anemia </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">3. Agranulocytosis </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">7. Eosinophilia </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">4. Hemolytic anemia </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="center" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Dermatologic</content> <content styleCode="bold">-</content> <content styleCode="bold">Hypersensitivity </content> <content styleCode="bold">Reactions</content> </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">1. Exfoliative dermatitis </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">6. Urticaria </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">2. Bullous pemphigoid </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">7. Rash </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">3. Erythema multiforme </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">8. Pruritus </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">4. Purpura </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">9. Stevens-Johnson Syndrome </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">5. Photosensitivity </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">10. Toxic epidermal necrolysis </td> </tr> <tr> <td align="left" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Cardiovascular </content> <content styleCode="bold">Reaction</content> </td> </tr> <tr> <td align="left" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule">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 align="left" valign="top" colspan="2" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Other </content> <content styleCode="bold">Reactions</content> </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">1. Hyperglycemia </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">7. Urinary bladder spasm </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">2. Glycosuria </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">8. Thrombophlebitis </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">3. Hyperuricemia 4. Muscle spasms </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">9. Transient injection site pain following intramuscular injection </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">5. Weakness </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">10. Fever </td> </tr> <tr> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule">6. Restlessness </td> <td align="left" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.