FDA label a8b39d24-5efb-421a-b173-8a5b9d82e2c1
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
- SPL set ID
- b75e6570-c96a-4362-b1e6-2690b859816a
- SPL ID
- a8b39d24-5efb-421a-b173-8a5b9d82e2c1
- Version
- 2
- Effective date
- 2007-06-30
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:05
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | a8b39d24-5efb-421a-b173-8a5b9d82e2c1 | id | |
| spl set id | b75e6570-c96a-4362-b1e6-2690b859816a | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 alteration 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 have been reported. Usually, reports indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, doses exceeding several times the usual recommended dose, 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).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. pancreatitis 2. jaundice (intrahepatic cholestatic jaundice) 3. anorexia 4. oral and gastric irritation 5. cramping 6. diarrhea 7. constipation 8. nausea 9. vomiting Systemic Hypersensitivity Reactions 1. systemic vasculitis 2. interstitial nephritis 3. necrotizing angiitis Central Nervous System Reactions 1. tinnitus and hearing loss 2. paresthesias 3. vertigo 4. dizziness 5. headache 6. blurred vision 7. xanthopsia Hematologic Reactions 1. aplastic anemia (rare) 2. thrombocytopenia 3. agranulocytosis (rare) 4. hemolytic anemia 5. leukopenia 6. anemia Dermatologic-Hypersensitivity Reactions 1. exfoliative dermatitis 2. erythema multiforme 3. purpura 4. photosensitivity 5. urticaria 6. rash 7. pruritus Cardiovascular Reaction Orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics. Other Reactions 1. hyperglycemia 2. glycosuria 3. hyperuricemia 4. muscle spasm 5. weakness 6. restlessness 7. urinary bladder spasm 8. thrombophlebitis 9. fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.