Drug Information for Furosemide Tablets, USP (Sandoz Inc): ADVERSE REACTIONS

Adverse reactions are categorized below by organ system and listed by decreasing severity.

Gastrointestinal System Reactions

• hepatic encephalopathy in patients with hepatocellular insufficiency
• pancreatitis
• jaundice (intrahepatic cholestatic jaundice)
• increased liver enzymes
• anorexia
• oral and gastric irritation
• cramping
• diarrhea
• constipation
• nausea
• vomiting

Systemic Hypersensitivity Reactions

• severe anaphylactic or anaphylactoid reactions (e.g. with shock)
• systemic vasculitis
• interstitial nephritis
• necrotizing angiitis

Central Nervous System Reactions

• tinnitus and hearing loss
• paresthesias
• vertigo
• dizziness
• headache
• blurred vision
• xanthopsia

Hematologic Reactions

• aplastic anemia (rare)
• thrombocytopenia
• agranulocytosis (rare)
• hemolytic anemia
• leukopenia
• anemia
• eosinophilia

Dermatologic-Hypersensitivity Reactions

• exfoliative dermatitis
• bullous pemphigoid
• erythema multiforme
• purpura
• photosensitivity
• urticaria
• rash
• pruritus

Cardiovascular Reaction

• Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.
• Increase in cholesterol and triglyceride serum levels.

Other Reactions

• hyperglycemia
• glycosuria
• hyperuricemia
• muscle spasm
• weakness
• restlessness
• urinary bladder spasm
• thrombophlebitis
• fever

In premature infants furosemide may precipitate nephrocalcinosis/nephrolithiasis.

If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.

Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.