Doxercalciferol Side Effects

Not all side effects for doxercalciferol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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

General

Studies of intravenous doxercalciferol did not include a placebo group and adverse effects reported are from placebo-controlled studies of oral doxercalciferol. The intravenous formulation was evaluated in 70 patients with chronic renal disease on hemodialysis previously treated with oral doxercalciferol.

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.

Metabolic side effects have frequently included hypercalcemia, hyperphosphatemia, and hypercalciuria. Metabolic side effects of doxercalciferol in relation to placebo therapy have included edema (34.4% vs. 21.3%) and weight gain (4.9% vs. 0%).

Endocrine

Endocrine side effects have included oversuppression of parathyroid hormone.

Oversuppression of iPTH may result in adynamic bone syndrome.

Cardiovascular

Cardiovascular side effects of doxercalciferol in relation to placebo therapy have included bradycardia (6.6% vs. 4.9%).

Gastrointestinal

Gastrointestinal side effects of doxercalciferol in relation to placebo therapy have included anorexia (4.9% vs. 3.3%), constipation(3.3% vs. 3.3%), dyspepsia (4.9% vs. 1.6%), and nausea/vomiting (21.3% vs. 19.7%).

Gastrointestinal side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included constipation and dyspepsia.

Musculoskeletal

Musculoskeletal side effects of doxercalciferol in relation to placebo therapy have included arthralgia (4.9% vs. 0%).

Nervous system

Nervous system side effects of doxercalciferol in relation to placebo therapy have included dizziness (11.5% vs. 9.8%) and sleep disorders (3.3% vs. 0%).

Nervous system side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included hypertonia, insomnia, and paresthesia.

Dermatologic

Dermatologic side effects of doxercalciferol in relation to placebo therapy have included pruritus (8.2% vs. 6.6%).

Respiratory

Respiratory side effects of doxercalciferol in relation to placebo therapy have included dyspnea (11.5% vs. 6.6%).

Respiratory side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included increased cough, dyspnea, and rhinitis.

Other

Other side effects of doxercalciferol in relation to placebo therapy have included abscess (3.3% vs. 0%), headache (27.9% vs. 18%), and malaise (27.9% vs. 19.7%).

Other side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included infection, chest pain, and dehydration.

Hematologic

Hematological side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included anemia.

Psychiatric

Psychiatric side effects associated with the use of oral doxercalciferol in the treatment of predialysis patients have frequently included depression.

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