Applies to edetate calcium disodium: parenteral injection.
Warning
-
Fatality Risk
- Risk of potentially fatal toxic effects.b (See Fatality Risk and also see Renal Effects under Cautions.)
- Possible lethal increase in intracranial pressure following IV infusion in patients with lead encephalopathy and cerebral edema.b Manufacturer recommends IM administration in this patient population.b If administered IV, avoid rapid infusion.b (See Administration under Dosage and Administration and see Fatality Risk under Cautions.)
- Follow dosage schedule; do not exceed recommended daily dose.b
-
Encephalopathy Risk
- Lead encephalopathy occurs rarely in adults; occurs more often in pediatric patients, in whom encephalopathy may be incipient and overlooked and results in high mortality rate.b
Side effects include:
Injection site pain.
For Healthcare Professionals
Applies to edetate calcium disodium: compounding powder, injectable solution.
Metabolic
Frequency not reported: Anorexia, zinc deficiency, hypercalcemia, hyperuricemia[Ref]
Cardiovascular
Frequency not reported: Hypotension, cardiac rhythm irregularities, transient drop in systolic and diastolic blood pressure, thrombophlebitis[Ref]
Gastrointestinal
Frequency not reported: Cheilosis, nausea, vomiting, diarrhea, circumoral paresthesia[Ref]
Genitourinary
Frequency not reported: Glycosuria, proteinuria, microscopic hematuria, large epithelial cells in urinary sediment[Ref]
Renal
Frequency not reported: Acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli, nephrotoxicity, damage to the reticuloendothelial system with hemorrhagic tendencies (from excessive dosages)[Ref]
Hematologic
Frequency not reported: Transient bone marrow depression, anemia[Ref]
Hepatic
Increases in SGOT and SGPT usually return to normal within 48 hours after treatment discontinuation.[Ref]
Common (1% to 10%): Mild increases in SGOT and SGPT[Ref]
Nervous system
Frequency not reported: Tremors, headache, tingling, numbness[Ref]
Dermatologic
Frequency not reported: Rash, exfoliative dermatitis and other toxic skin and mucus membrane reactions[Ref]
Other
Frequency not reported: Fever, malaise, fatigue, febrile reactions[Ref]
Musculoskeletal
Frequency not reported: Chills, myalgia, arthralgia[Ref]
Immunologic
Frequency not reported: Histamine-like reactions (sneezing, nasal congestion, lacrimation)[Ref]
Local
Frequency not reported: Pain at intramuscular injection site[Ref]
