FDA label 74abbe63-3364-4d66-b9be-39fa5bdcaa44
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
- 2e708746-f551-4b70-b933-4b8d9eacf15d
- SPL ID
- 74abbe63-3364-4d66-b9be-39fa5bdcaa44
- Version
- 2
- Effective date
- 2011-01-20
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:31:31
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 | 74abbe63-3364-4d66-b9be-39fa5bdcaa44 | id | |
| spl set id | 2e708746-f551-4b70-b933-4b8d9eacf15d | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 ”.)
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 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 REACTION Adverse reactions are categorized below by organ system and listed by decreasing severity.
adverse reactions
Gastrointestinal System Reactions 1. pancreatitis 4. Oral and gastric irritation 7. constipation 2. jaundice (intrahepatic cholestatic jaundice 5. cramping 8. nausea 3. a norexia 6. diarrhea 9. vomiting Systemic Hypersensitivity Reactions 1. Systemic vasulitis 2. interstitial nephritis 3. necrotizing angiitis Central Nervous System Reactions 1. tinnitus and hearing loss 4. dizziness 6. blurred vision 2. paresthesias 5. headache 7. xanthopsia 3. vertico Hematologic Reactions 1. aplastic anemia (rare) 3. agranulocytosis (rare) 5. leukopenia 2. thrombocytopenia 4. hemolytic anemia 6. anemia Dermatologic-Hypersensitivity Reactions 1. exfoliative dermatits 4. photosensitivity 7. pruritus 2. erythema multiforme 5. urticaria 3. purpura 6. rash Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. Other Reactions 1. hyperglycemia 4. muscle spasm 7. urinary bladder spasm 2. glycosuria 5. weakness 8. thrombophlebitis 3. hyperuricemia 6. restlessness 9. fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
adverse reactions table
<table ID="i21a04683-e1bf-4e47-8465-26f012cb8f53" width="735"> <tbody> <tr> <td>1. pancreatitis </td> <td>4. Oral and gastric irritation </td> <td>7. constipation </td> </tr> <tr> <td>2. jaundice (intrahepatic cholestatic jaundice </td> <td>5. cramping </td> <td>8. nausea </td> </tr> <tr> <td>3. a<content styleCode="underline">norexia </content> </td> <td>6. diarrhea </td> <td>9. vomiting </td> </tr> </tbody> </table>
adverse reactions table
<table ID="ib8a1df5f-2770-43b7-82a0-2fbf9f7e84ad" width="732"> <tbody> <tr> <td>1. Systemic vasulitis </td> <td>2. interstitial nephritis </td> <td>3. necrotizing angiitis </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.