FDA label 20d401b2-74c1-52b1-e063-6294a90a63d2

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
b39ad6b3-401d-4aba-a0a9-6d56fcfa0ac9
SPL ID
20d401b2-74c1-52b1-e063-6294a90a63d2
Version
7
Effective date
2024-08-29
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 06:24:36

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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 arenter. 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 arenteral 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).

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 2 · 7 matching rows.

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 6. Oral and gastric irritation hepatocellular insufficiency 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 3. Interstitial nephritis reactions (e.g. with shock) 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 9. Transient injection site pain following 4. Muscle spasms 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="ID40" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td align="justify" valign="top"><content styleCode="bold">Gastrointestinal </content><content styleCode="bold">System </content><content styleCode="bold">Reactions</content><content styleCode="bold"> </content></td><td align="justify" valign="top"> </td></tr><tr><td align="justify" valign="top">1. Hepatic encephalopathy in patients with </td><td align="justify" valign="top">6. Oral and gastric irritation </td></tr><tr><td align="justify" valign="top"> hepatocellular insufficiency </td><td align="justify" valign="top">7. Cramping </td></tr><tr><td align="justify" valign="top">2. Pancreatitis </td><td align="justify" valign="top">8. Diarrhea </td></tr><tr><td align="justify" valign="top">3. Jaundice (intrahepatic cholestatic jaundice) </td><td align="justify" valign="top">9. Constipation </td></tr><tr><td align="justify" valign="top">4. Increased liver enzymes </td><td align="justify" valign="top">10. Nausea </td></tr><tr><td align="justify" valign="top">5. Anorexia </td><td align="justify" valign="top">11. Vomiting </td></tr></tbody></table>

adverse reactions table

<table ID="ID41" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td align="justify" valign="top"><content styleCode="bold">Systemic </content><content styleCode="bold">Hypersensitivity </content><content styleCode="bold">Reactions</content><content styleCode="bold"> </content></td><td align="justify" valign="top"> </td></tr><tr><td align="justify" valign="top">1. Severe anaphylactic or anaphylactoid </td><td align="justify" valign="top">3. Interstitial nephritis </td></tr><tr><td align="justify" valign="top"> reactions (e.g. with shock) </td><td align="justify" valign="top">4. Necrotizing angiitis </td></tr><tr><td align="justify" valign="top">2. Systemic vasculitis </td><td align="justify" valign="top"> </td></tr></tbody></table>

adverse reactions table

<table ID="ID42" width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td align="justify" valign="top"><content styleCode="bold">Central </content><content styleCode="bold">Nervous </content><content styleCode="bold">System </content><content styleCode="bold">Reactions</content><content styleCode="bold"> </content></td><td align="justify" valign="top"> </td></tr><tr><td align="justify" valign="top">1. Tinnitus and hearing loss </td><td align="justify" valign="top">5. Headache </td></tr><tr><td align="justify" valign="top">2. Paresthesias </td><td align="justify" valign="top">6. Blurred vision </td></tr><tr><td align="justify" valign="top">3. Vertigo </td><td align="justify" valign="top">7. Xanthopsia </td></tr><tr><td align="justify" valign="top">4. Dizziness </td><td align="justify" valign="top"> </td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.