pharmacopeia
GET
/api/v1/drug/furosemide
2D structure
4-chloro-2-(furan-2-ylmethylamino)-5-sulfamoylbenzoic acid
SMILES C1=COC(=C1)CNC2=CC(=C(C=C2C(=O)O)S(=O)(=O)N)Cl
InChIKey ZZUFCTLCJUWOSV-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium Potassium Chloride Symporter Inhibitors.

Sodium Potassium Chloride Symporter

Indications

Sourced from openFDA
  • Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired.ICD-10: I50.9, R60.9

Contraindications

Sourced from openFDA
  • Furosemide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.contraindicated

Dosage & administration

Sourced from openFDA

Edema Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Adults: The usual initial dose of furosemide tablets is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of furosemide tablets may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states. Edema may be most efficiently and safely mobilized by giving furosemide tablets on 2 to 4 consecutive days each week. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS: Laboratory Tests ). Geriatric Patients: In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use ). Pediatric Patients: The usual initial dose of oral furosemide in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose.

Warnings & precautions

Sourced from openFDA

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 ).

Adverse reactions

Sourced from openFDA

Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. hepatic encephalopathy in patients with hepatocellular insufficiency 2. pancreatitis 3. jaundice (intrahepatic cholestatic jaundice) 4. increased liver enzymes 5. anorexia 6. oral and gastric irritation 7. cramping 8. diarrhea 9. constipation 10. nausea 11. vomiting Systemic Hypersensitivity Reactions 1. severe anaphylactic or anaphylactoid reactions (e.g., with shock) 2. systemic vasculitis 3. interstitial nephritis 4. 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 2. thrombocytopenia 3. agranulocytosis 4. hemolytic anemia 5. leukopenia 6. anemia 7. eosinophilia Dermatologic-Hypersensitivity Reactions 1. toxic epidermal necrolysis 2. Stevens-Johnson Syndrome 3. erythema multiforme 4. drug rash with eosinophilia and systemic symptoms 5. acute generalized exanthematous pustulosis 6. exfoliative dermatitis 7. bullous pemphigoid 8. purpura 9. photosensitivity 10. rash 11. pruritus 12. urticaria 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 2. glycosuria 3. hyperuricemia 4. muscle spasm 5. weakness 6. restlessness 7. urinary bladder spasm 8. thrombophlebitis 9.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category C: Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human dose. There are no adequate and well-controlled studies in pregnant women. Furosemide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights. The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. Furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (2 times the maximal recommended human dose of 600 mg/day). In another study, a dose of 50 mg/kg (4 times the maximal recommended human dose of 600 mg/day) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived a dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths.

Overdosage

Sourced from openFDA

The principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD 50 exceeded 1000 mg/kg body weight, while the intravenous LD 50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluids associated with toxicity or death is not known. Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Hemodialysis does not accelerate furosemide elimination.

Approval history

Sourced from openFDA
  • Jul 1, 1966NDANDA016273Validus Pharms
  • May 19, 1981NDANDA018267Hikma
  • Oct 19, 1981NDANDA018569Epic Pharma Llc
  • May 28, 1982NDANDA018667Hospira
  • Nov 10, 1983NDANDA018823Hikma
  • Nov 30, 1983NDANDA018413Chartwell Rx
  • May 22, 1984NDANDA018902Fresenius Kabi Usa
  • Oct 7, 2022NDANDA209988Scpharmaceuticals

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Furosemide, Injection, 10 mg/1 mL (NDC 16729-500-08)Active
    Sponsor: Accord Healthcare Inc. · Reason: Requirements related to complying with good manufacturing practices
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 16729-501-43)Active
    Sponsor: Accord Healthcare Inc. · Reason: Requirements related to complying with good manufacturing practices
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 16729-502-43)Active
    Sponsor: Accord Healthcare Inc. · Reason: Requirements related to complying with good manufacturing practices
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 23155-473-41)Active
    Sponsor: Avet Pharmaceuticals, Inc.
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 23155-473-42)Active
    Sponsor: Avet Pharmaceuticals, Inc. · Reason: Other
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 23155-473-44)Active
    Sponsor: Avet Pharmaceuticals, Inc. · Reason: Other
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-02)Active
    Sponsor: Gland Pharma Limited · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-02)To be discontinued
    Sponsor: Gland Pharma Limited
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-04)Active
    Sponsor: Gland Pharma Limited · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-04)To be discontinued
    Sponsor: Gland Pharma Limited
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-10)Active
    Sponsor: Gland Pharma Limited · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 25021-311-10)To be discontinued
    Sponsor: Gland Pharma Limited
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 36000-282-25)Active
    Sponsor: Baxter Healthcare
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 36000-283-25)Active
    Sponsor: Baxter Healthcare
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 36000-284-25)Active
    Sponsor: Baxter Healthcare
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 63323-280-02)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 63323-280-04)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 63323-280-10)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 71288-203-05)Active
    Sponsor: Meitheal Pharmaceuticals, Inc.
    Updated
  • Furosemide, Injection, 10 mg/1 mL (NDC 71288-203-11)Active
    Sponsor: Meitheal Pharmaceuticals, Inc.
    Updated
  • Furosemide, Injection, 10 mg/mL, 2 mL (NDC 71288-205-03)Active
    Sponsor: Meitheal Pharmaceuticals, Inc.
    Updated
  • Furosemide, Injection, 100 mg/ 10mL (10 mg/1 mL) (NDC 0409-6102-10)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Furosemide, Injection, 100 mg/ 10mL (10 mg/1 mL) (NDC 0409-6102-27)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Furosemide, Injection, 100 mg/10 mL (NDC 55150-324-25)Active
    Sponsor: Eugia US LLC
    Updated
  • Furosemide, Injection, 20 mg/2 mL (10 mg/1 mL) (NDC 0409-6102-02)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Furosemide, Injection, 20 mg/2 mL (10 mg/1 mL) (NDC 0409-6102-25)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Furosemide, Injection, 20 mg/2 mL (NDC 55150-322-25)Active
    Sponsor: Eugia US LLC · Reason: Demand increase for the drug
    Updated
  • Furosemide, Injection, 40 mg/4 mL (10 mg/1 mL) (NDC 0409-6102-04)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Furosemide, Injection, 40 mg/4 mL (10 mg/1 mL) (NDC 0409-6102-26)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Furosemide, Injection, 40 mg/4 mL (NDC 55150-323-25)Active
    Sponsor: Eugia US LLC
    Updated
  • Furosemide, Oral Solution, 10 mg/1 mL (NDC 0054-3294-46)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Shortage of an inactive ingredient component
    Updated
  • Furosemide, Oral Solution, 10 mg/1 mL (NDC 0054-3294-50)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Shortage of an inactive ingredient component
    Updated
  • Furosemide, Oral Solution, 40 mg/5 mL (NDC 0054-3298-63)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Shortage of an inactive ingredient component
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
393,083 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dyspnoea29,5007.5%
  2. 2Fatigue20,7275.3%
  3. 3Diarrhoea20,2565.2%
  4. 4Nausea18,9724.8%
  5. 5Acute Kidney Injury18,7584.8%
  6. 6Death18,5404.7%
  7. 7Fall16,3184.2%
  8. 8Pneumonia16,2484.1%
  9. 9Asthenia15,3353.9%
  10. 10Dizziness14,9653.8%
  11. 11Hypotension14,9283.8%
  12. 12Drug Ineffective14,6233.7%
  13. 13Off Label Use14,4523.7%
  14. 14Pain13,7123.5%
  15. 15Headache13,2323.4%

Literature

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Recent PubMed references pinned to Furosemide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 426 ClinicalTrials.gov registrations naming Furosemide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Furosemide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • ADD1CPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Furosemide work?
Mechanism-of-action class: Sodium Potassium Chloride Symporter Inhibitors.
What is Furosemide used for?
According to FDA labeling, Furosemide carries indications including: Edema Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Furosemide?
Furosemide is classified as Sulfonamides, plain, Loop Diuretic, Sodium Potassium Chloride Symporter Inhibitors, Decreased Blood Pressure, Decreased Intravascular Volume, Increased Diuresis at Loop of Henle, Increased Loop of Henle Ca++ Excretion, Increased Loop of Henle Cl- Excretion, Increased Loop of Henle K+ Excretion, Increased Loop of Henle Mg++ Excretion, Increased Loop of Henle Na+ Excretion.
What are the brand names for Furosemide?
Furosemide is marketed under brand names including Disal, Furoscix, Lasix, Salix - substance.
What are the contraindications for Furosemide?
Furosemide labeling lists contraindications including: Furosemide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.. Always consult the full prescribing information and a clinician.
Note. Data for furosemide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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