Home FDA labels 7d5e6c3e-5c5e-455a-903f-618aa6709043 FDA label 7d5e6c3e-5c5e-455a-903f-618aa6709043 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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SPL set ID cc6e8707-2e6b-4cb8-bf93-117a0ae2559d
SPL ID 7d5e6c3e-5c5e-455a-903f-618aa6709043
Version 11
Effective date 2013-05-17
Source export date 2026-10-12
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
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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 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). 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 ).
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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. pancreatitis 5. cramping 2. jaundice (intrahepatic cholestatic jaundice) 6. diarrhea 7. constipation 3. anorexia 8. nausea 4. oral and gastric irritation 9. vomiting Systemic Hypersensitivity Reactions 1. systemic vasculitis 3. necrotizing angiitis 2. interstitial nephritis 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 (rare) 4. hemolytic anemia 2. thrombocytopenia 5. leukopenia 3. agranulocytosis (rare) 6. anemia Dermatologic-Hypersensitivity Reactions 1. exfoliative dermatitis 5. urticaria 2. erythema multiforme 6. rash 3. purpura 7. pruritus 4. photosensitivity Cardiovascular Reaction Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics. Other Reactions 1. hyperglycemia 7. urinary bladder spasm 2. glycosuria 8. thrombophlebitis 3. hyperuricemia 9. transient injection site pain following intramuscular injection 4. muscle spasm 5. weakness 6. restlessness 10. fever Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
adverse reactions table <table> <tbody> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">Gastrointestinal System Reactions</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>1. pancreatitis</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>5. cramping</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="2" valign="top"> <paragraph>2. jaundice (intrahepatic cholestatic jaundice)</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>6. diarrhea</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>7. constipation</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>3. anorexia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>8. nausea</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>4. oral and gastric irritation</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>9. vomiting</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">Systemic Hypersensitivity Reactions</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>1. systemic vasculitis</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="2" valign="top"> <paragraph>3. necrotizing angiitis</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>2. interstitial nephritis</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">Central Nervous System Reactions</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>1. tinnitus and hearing loss</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>5. headache</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>2. paresthesias</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>6. blurred vision</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>3. vertigo</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="2" valign="top"> <paragraph>7. xanthopsia</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>4. dizziness</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">Hematologic Reactions</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>1. aplastic anemia (rare) </paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>4. hemolytic anemia</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>2. thrombocytopenia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>5. leukopenia </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>3. agranulocytosis (rare)</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>6. anemia</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">Dermatologic-Hypersensitivity Reactions</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>1. exfoliative dermatitis</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>5. urticaria</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>2. erythema multiforme</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>6. rash</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>3. purpura</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="2" valign="top"> <paragraph>7. pruritus</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>4. photosensitivity</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">Cardiovascular Reaction</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph>Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics.</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" colspan="2" valign="top"> <paragraph> <content styleCode="bold"> <content styleCode="emphasis">Other Reactions</content> </content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>1. hyperglycemia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>7. urinary bladder spasm</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>2. glycosuria</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>8. thrombophlebitis</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>3. hyperuricemia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" rowspan="3" valign="top"> <paragraph>9. transient injection site pain following intramuscular injection</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>4. muscle spasm</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>5. weakness</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>6. restlessness</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" valign="top"> <paragraph>10. fever</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.