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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

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#

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Adverse reactions sections page 1 of 2 · 8 matching rows.

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.