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Edetate calcium disodium Side Effects

For the Consumer

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Calcium Disodium Versenate (edetate calcium disodium)." Medicis Pharmaceutical Corporation, Scottsdale, AZ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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