Furosemide
Regulatory sources consulted
- AEMPS-CIMA-ft-64140
- EMA-EPAR-EMEA/H/C/006617
- CredibleMeds.org
- Clinical Pharmacology Knowledge
- AEMPS CIMA · nº registro 64140 ↗
- EMA EPAR · EMEA/H/C/006617 ↗
- RxNorm rxcui 4603 ↗
Approved indications
- Treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease (including nephrotic syndrome). Treatment of acute pulmonary edema. Treatment of hypertension, alone or in combination with other antihypertensive agents.
- Treatment of oedema of cardiac or renal origin, oedema of hepatic origin, and hypertension in patients with chronic kidney disease (pediatric population from birth to less than 18 years of age).
Contraindications
Absolute
- Hypersensitivity to furosemide or sulfonamides.
- Renal failure with anuria not responding to furosemide.
- Hypovolemia or dehydration.
- Severe hypokalemia or hyponatremia.
- Pre-comatose and comatose states associated with hepatic encephalopathy.
Clinical warnings
- Boxed 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. — FDA
- Major warning · Risk of ototoxicity (tinnitus, hearing impairment, deafness), especially with high doses, rapid IV infusion, severe renal impairment, and concomitant use of other ototoxic drugs. — AEMPS CIMA
Drug interactions
- ModerateDigoxinC01AA05
Mechanism: Furosemide-induced hypokalemia and hypomagnesemia increase myocardial sensitivity to digoxin, increasing the risk of digitalis toxicity (arrhythmias).
Recommendation: Closely monitor serum potassium, magnesium levels, and cardiac function (ECG). Correct electrolyte imbalances before and during treatment.
AEMPS CIMA
- HighAminoglycosides (e.g., Gentamicin)J01GB03
Mechanism: Increased risk of ototoxicity and nephrotoxicity. Furosemide can potentiate the ototoxic effects of aminoglycosides.
Recommendation: Avoid concomitant use whenever possible. If unavoidable, strict monitoring of auditory and renal function is required.
AEMPS CIMA
- ModerateNSAIDs (e.g., Ibuprofen)M01AE01
Mechanism: NSAIDs can reduce the diuretic, natriuretic, and antihypertensive effect of furosemide. In dehydrated patients, it may precipitate acute renal failure.
Recommendation: Monitor blood pressure, diuresis, and renal function. Ensure adequate hydration. A dose adjustment of furosemide may be necessary.
AEMPS CIMA
Adverse events
Common (≥1%)
hypokalemia · hyponatremia · hypomagnesemia · hypotension · dehydration · hyperuricemia · dizziness
Rare but serious
ototoxicity (deafness) · pancreatitis · interstitial nephritis · agranulocytosis · aplastic anemia · Stevens-Johnson syndrome (SJS) · toxic epidermal necrolysis (TEN)
Pregnancy and lactation
FDA category: C
Crosses the placental barrier. Use only if the potential benefit justifies the potential risk to the fetus (may cause fetal electrolyte disturbances). It is excreted in breast milk and may inhibit lactation; caution or avoiding breastfeeding is recommended.