FUROSEMIDE, Vial and Syringe U.S. Physician Prescribing Information Adverse Reactions (furosemide injection, USP)

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 (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 eosinophila 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 Reactions

(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) Transient injection site pain following intramuscular injection (10) Fever.

Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

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