1 INDICATIONS AND USAGE FUROSEMIDE INJECTION is a loop diuretic indicated for: • The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease ( 1.1 ) • Acute pulmonary edema as adjunctive therapy ( 1.2 ) 1.1 Edema Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.

1.2 Acute Pulmonary Edema Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema.

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Fluid, Electrolyte, and Metabolic Abnormalities [see Warnings and Precautions (5.1) ] • Ototoxicity [see Warnings and Precautions (5.3) ] The following adverse reactions associated with the use of furosemide were identified in clinical studies or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

Gastrointestinal System Reactions: 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, thrombocytopenia, agranulocytosis, hemolytic anemia, leukopenia, anemia, eosinophilia.

Dermatologic-Hypersensitivity Reactions: toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, drug rash with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, exfoliative dermatitis, bullous pemphigoid, purpura, photosensitivity, rash.

Cardiovascular Reactions: orthostatic hypotension, increase in cholesterol and triglyceride serum levels.

Other Reactions: glycosuria, muscle spasm, weakness, restlessness, urinary bladder spasm, thrombophlebitis, transient injection site pain following intramuscular injection, fever.

Most common adverse reactions are related to fluid and electrolyte imbalance ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.

at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.