Summary

Commonly reported side effects of calcitriol include: hypercalcemia, hypercalciuria, and increased serum creatinine. Continue reading for a comprehensive list of adverse effects.

Applies to calcitriol: oral capsules, oral solution, parenteral injection.

Side effects include:

Excessive vitamin D intake (early manifestations): Weakness, headache, somnolence, nausea, dry mouth, constipation, muscle or bone pain, metallic taste, anorexia, abdominal pain, epigastric distress.

Excessive vitamin D intake (late manifestations): Polyuria, polydipsia, anorexia, weight loss, nocturia, calcific conjunctivitis, pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated AST, elevated ALT, ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections.

For Healthcare Professionals

Applies to calcitriol: injectable solution, oral capsule, oral liquid.

General

Early signs of excessive vitamin D intake include weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, anorexia, abdominal pain, or stomach ache. Late signs include polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated AST and ALT, ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and rarely, overt psychosis.^[Ref]

Adverse events were similar to those of excessive vitamin D intake, hypercalcemia syndrome or calcium intoxication.^[Ref]

Metabolic

Very common (10% or more): Hypercalcemia

Uncommon (0.1% to 1%): Decreased appetite

Frequency not reported: Polydipsia, dehydration, weight loss, thirst, hyperphosphatemia, anorexia, hypercholesterolemia^[Ref]

Genitourinary

Common (1% to 10%): Hypercalciuria, urinary tract infection

Frequency not reported: Polyuria, nocturia, albuminuria^[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Sensory disturbance, somnolence, metallic taste

Postmarketing reports: Seizure^[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction, hypersensitivity (including rash, erythema, pruritus, and urticaria)

Postmarketing reports: Anaphylaxis^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea

Uncommon (0.1% to 1%): Vomiting

Frequency not reported: Constipation, abdominal pain upper, paralytic ileus, dry mouth, pancreatitis, epigastric discomfort, diarrhea^[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Urticaria, erythema, pruritus, erythema multiforme^[Ref]

Cardiovascular

Frequency not reported: Cardiac arrhythmias, cardiac arrest, hypertension^[Ref]

Hepatic

Frequency not reported: Elevated AST, elevated ALT^[Ref]

Other

Frequency not reported: Calcinosis, pyrexia, weakness, hyperthermia, ectopic calcification, dystrophy

Postmarketing reports: Chest pain^[Ref]

Renal

Uncommon (0.1% to 1%): Blood creatinine increased

Frequency not reported: Elevated BUN, nephrocalcinosis, impairment of renal function^[Ref]

Musculoskeletal

Frequency not reported: Muscular weakness, growth retardation, muscle pain, bone pain^[Ref]

Psychiatric

Frequency not reported: Apathy, psychiatric disturbances, decreased libido, overt psychosis^[Ref]

Local

Frequency not reported: Pain on injection

Postmarketing reports: Bleeding at the venipuncture site^[Ref]

Hematologic

Postmarketing reports: Hemolysis^[Ref]

Oncologic

Postmarketing reports: Brown tumor, non-malignant tumor on the ribs^[Ref]

Ocular

Frequency not reported: Conjunctivitis (calcific), photophobia^[Ref]

Respiratory

Frequency not reported: Rhinorrhea^[Ref]