Home FDA labels 414d2cef-c3a6-7fdb-e063-6394a90a01d1 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 NuCare Pharmaceuticals, Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 20eecc36-dfb7-0060-e063-6394a90a9d0b
SPL ID 414d2cef-c3a6-7fdb-e063-6394a90a01d1
Version 2
Effective date 2025-10-16
Source export date 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:29:25 Harmonized routes table Harmonized routes ORAL
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warnings and cautions 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 4mg 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 (eg., 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 2. stevens-johnson syndrome 3. erythema multiforme 4. drug rash with eosinophilia and systemic symptoms 5. acute generalized exanthematous pustulosis 6. exfoliative dermatitis 7. bullous pemphigoid 8. purpura 9. photosensitivity 10. rash 11. pruritis 12. urticaria Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics. 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 5. weakness 9. fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table <table ID="ID19" width="100%" styleCode="Noautorules"><caption/><col/><col/><tbody><tr><td align="left" valign="top">1.hepatic encephalopathy in patients with hepatocellular insufficiency </td><td align="left" valign="top">6. oral and gastric irritation </td></tr><tr><td align="left" valign="top">2. pancreatitis </td><td align="left" valign="top">7. cramping </td></tr><tr><td align="left" valign="top">3. jaundice (intrahepatic cholestatic jaundice) </td><td align="left" valign="top">8. diarrhea </td></tr><tr><td align="left" valign="top">4. increased liver enzymes </td><td align="left" valign="top">9. constipation </td></tr><tr><td align="left" valign="top">5. anorexia </td><td align="left" valign="top">10. nausea </td></tr><tr><td valign="top"/><td align="left" valign="top">11. vomiting </td></tr></tbody></table>
adverse reactions table <table ID="ID21" width="555" styleCode="Noautorules"><caption/><col width="312"/><col width="37"/><col width="206"/><tbody><tr><td align="left" valign="top">1. severe anaphylactic or anaphylactoid reactions (eg., with shock) </td><td valign="top"/><td align="left" valign="top">3. interstitial nephritis </td></tr><tr><td align="left" valign="top">2. systemic vasculitis </td><td valign="top"/><td align="left" valign="top">4. necrotizing angiitis </td></tr></tbody></table>
adverse reactions table <table ID="ID23" width="100%" styleCode="Noautorules"><caption/><col/><col/><col/><tbody><tr><td align="left" valign="top">1. tinnitus and hearing loss </td><td valign="top"/><td align="left" valign="top">5. headache </td></tr><tr><td align="left" valign="top">2. paresthesias </td><td valign="top"/><td align="left" valign="top">6. blurred vision </td></tr><tr><td align="left" valign="top">3. vertigo </td><td valign="top"/><td align="left" valign="top">7. xanthopsia </td></tr><tr><td align="left" valign="top">4. dizziness </td><td valign="top"/><td valign="top"/></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.