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Hectorol Side Effects

Generic Name: doxercalciferol

Note: This document contains side effect information about doxercalciferol. Some of the dosage forms listed on this page may not apply to the brand name Hectorol.

For the Consumer

Applies to doxercalciferol: oral capsules, parenteral injection

Side effects include:

In dialysis patients: edema, headache, malaise, nausea/vomiting, dizziness, dyspnea, pruritus, bradycardia.

In predialysis patients with stage 3 or 4 CKD: infection, chest pain, constipation, dyspepsia, anemia, dehydration, depression, hypertonia, insomnia, paresthesia, increased cough, dyspnea, rhinitis.

Excessive vitamin D intake (early manifestations): weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, bone pain, metallic taste, anorexia.

Excessive vitamin D intake (late manifestations): polyuria, polydipsia anorexia, weight loss, nocturia, calcific conjunctivitis, pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, increased BUN, albuminuria, hypercholesterolemia, increased serum AST and ALT concentrations, ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, growth arrest, urinary tract infections.

For Healthcare Professionals

Applies to doxercalciferol: injectable solution, oral capsule

Metabolic

Early signs and symptoms of hypercalcemia have included weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia.

Prolonged hypercalcemia may result in polyuria, polydipsia, anorexia, weight loss, nocturia conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated serum aspartate transaminase (AST) and alanine transaminase (ALT), ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.

Hyperphosphatemia may exacerbate hyperparathyroidism.

Hypercalciuria may accelerate the onset of renal failure.[Ref]

Very common (10% or more): Edema (34.4%)
Common (1% to 10%): Anorexia, weight increase, dehydration
Frequency not reported: Hypercalcemia, hyperphosphatemia, hypercalciuria[Ref]

Endocrine

Oversuppression of iPTH may result in adynamic bone syndrome.[Ref]

Frequency not reported: Oversuppression of parathyroid hormone[Ref]

Cardiovascular

Common (1% to 10%): Bradycardia, chest pain[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (21.3%)
Common (1% to 10%): Dyspepsia, constipation[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia[Ref]

Nervous system

Very common (10% or more): Headache (27.9%), dizziness (11.5%)
Common (1% to 10%): Hypertonia, paresthesia[Ref]

Dermatologic

Common (1% to 10%): Pruritus[Ref]

Respiratory

Very common (10% or more): Dyspnea (11.5%)
Common (1% to 10%): Cough increased, rhinitis[Ref]

Other

Very common (10% or more): Malaise (27.9%)
Common (1% to 10%): Abscess[Ref]

Psychiatric

Common (1% to 10%): Sleep disorder, depression
Uncommon (0.1% to 1%): Insomnia[Ref]

Immunologic

Common (1% to 10%): Infection

Hypersensitivity

Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue, and airway), hypotension, unresponsiveness, chest discomfort, shortness of breath, cardiopulmonary arrest, pruritus, and skin burning sensation. These reactions may occur separately or together.

Postmarketing reports: Hypersensitivity reactions (including fatal outcome)

Hematologic

Common (1% to 10%): Anemia[Ref]

References

1. "Product Information. Hectorol (doxercalciferol)" Genzyme Corporation, Cambridge, MA.

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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