Doxercalciferol Side Effects

Some side effects of doxercalciferol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to doxercalciferol: oral capsule

If you experience any of the following serious side effects, stop taking doxercalciferol and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• an irregular heartbeat;

• increased nighttime urination; or

• abdominal pain.

Contact your doctor if you experience any of the following side effects:

• nausea, vomiting, or decreased appetite;

• dry mouth;

• constipation;

• weakness;

• headache;

• dizziness;

• a metallic taste;

• muscle or bone pain;

• increased thirst or urination;

• shortness of breath; or

• itching.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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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