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What the label lists and what reports show

Furosemide side effects

Furosemide's FDA label lists its adverse reactions in its own words. FAERS holds 398,354 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (29,961 reports).

  • Generic listed
  • In shortage

Check it at the source: the furosemide FDA label on DailyMed (effective September 30, 2025, Validus Pharmaceuticals LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. hepatic encephalopathy in patients with hepatocellular insufficiency 6. oral and gastric irritation 7. cramping 2. pancreatitis 8. diarrhea 3. jaundice (intrahepatic cholestatic jaundice) 9. constipation 4. increased liver enzymes 10. nausea 5. anorexia 11. vomiting Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock) 3. interstitial nephritis 4. necrotizing angiitis 2. systemic vasculitis 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 5. leukopenia 2. thrombocytopenia 6. anemia 3. agranulocytosis 7. eosinophilia 4. …

Source: FDA drug label, Validus Pharmaceuticals LLC, effective September 30, 2025 (SPL set 2c9b4d8f-0770-482d-a9e6-9c616a440b1a), via openFDA; the full label on DailyMed

What do FAERS reports show?

398,354 reports list furosemide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 61,850 are coded as a death and 195,229 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Dyspnoea29,961
  • Fatigue (named in the label)21,054
  • Diarrhoea (named in the label)20,618
  • Nausea (named in the label)19,257
  • Acute Kidney Injury19,011
  • Death (an outcome recorded in the report)18,746
  • Fall16,523
  • Pneumonia16,480
  • Asthenia15,485
  • Dizziness (named in the label)15,210
  • Hypotension (named in the label)15,153
  • Drug Ineffective (a use or a product term, not a reaction)14,882
  • Off Label Use (a use or a product term, not a reaction)14,779
  • Pain13,914
  • Headache (named in the label)13,590
  • Renal Failure (named in the label)12,989
  • Vomiting (named in the label)12,725
  • Anaemia (named in the label)12,475
  • Cardiac Failure Congestive12,089
  • Malaise11,836
  • Oedema Peripheral11,715
  • Cough10,693
  • Pyrexia10,062
  • Drug Interaction (a use or a product term, not a reaction)10,038
  • Cardiac Failure10,025

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Furosemide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions