Note: This document contains side effect information about parathyroid hormone. Some dosage forms listed on this page may not apply to the brand name Natpara.
Summary
Common side effects of Natpara include: decreased serum calcium, diarrhea, hypercalcemia, increased serum calcium, increased urine calcium excretion, vomiting, and hypocalcemia. Continue reading for a comprehensive list of adverse effects.
Applies to parathyroid hormone: parenteral powder for injection.
Warning
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Potential Risk of Osteosarcoma
- Increased incidence of osteosarcoma observed in rats.1 Relevance to humans not known.1 (See Osteosarcoma under Cautions.)
- Use only in patients who cannot be well controlled on calcium and activated forms of vitamin D alone and for whom potential benefits outweigh such potential risk.1
- Do not use in patients with an increased baseline risk of osteosarcoma (e.g., patients with Paget's disease of the bone or unexplained increases in serum alkaline phosphatase concentrations, pediatric or young adult patients with open epiphyses, patients with hereditary disorders predisposing them to osteosarcoma, patients who have received prior external beam or implant radiation therapy involving the skeleton).1
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Restricted Distribution Program
- Available only through the Natpara® REMS program.1 (See Restricted Distribution Program under Dosage and Administration.)
REMS:
FDA approved a REMS for parathyroid hormone to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of parathyroid hormone and consists of the following: elements to assure safe use and implementation system. See the FDA REMS page ([Web]).
Side effects include:
Paresthesia, hypocalcemia, headache, hypercalcemia, nausea, hypoesthesia, diarrhea, vomiting, arthralgia, hypercalciuria, extremity pain, upper respiratory tract infection, upper abdominal pain, sinusitis, decreased 25-hydroxycholecalciferol concentration, hypertension, facial hypoesthesia, neck pain.
For Healthcare Professionals
Applies to parathyroid hormone: subcutaneous powder for injection.
General
The more commonly reported adverse reactions have included paresthesia, hypocalcemia, headache, hypercalcemia, nausea, hypoesthesia, diarrhea, vomiting, arthralgia, hypercalciuria, and extremity pain.
Metabolic
Hypocalcemia combines reported events of hypocalcemia and blood calcium decreased; hypercalciuria combines reported events of hypercalciuria and urine calcium increased; and hypercalcemia combines reported events of hypercalcemia and blood calcium increased.
During clinical trials, 3 patients receiving this drug required IV fluids to correct hypercalcemia. In the postmarketing period, seizures due to hypocalcemia have been reported. The risk of hypocalcemia increases when this drug is withdrawn.[Ref]
Very common (10% or more): Hypocalcemia (27%), hypercalcemia (19%); hypercalciuria (11%)[Ref]
Nervous system
Very common (10% or more): Paresthesia (31%), headache (25%), hypoesthesia (14%)
Common (1% to 10%): Facial hypoesthesia
Postmarketing reports: Seizures due to hypocalcemia[Ref]
Hypersensitivity
Postmarketing reports: Hypersensitivity reactions including anaphylaxis, dyspnea, angioedema, urticaria, rash
Cardiovascular
Common (1% to 10%): Hypertension[Ref]
Gastrointestinal
Very common (10% or more): Nausea (18%), diarrhea (12%), vomiting (12%)
Common (1% to 10%): Upper abdominal pain[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (11%), pain in extremity (10%)
Common (1% to 10%): Neck pain[Ref]
Immunologic
Common (1% to 10%): Immunogenicity[Ref]
Genitourinary
Common (1% to 10%): Blood 25-hydroxycholecalciferol decreased[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection, sinusitis[Ref]
