Note: This document contains side effect information about calcitriol. Some dosage forms listed on this page may not apply to the brand name Rocaltrol.
Summary
Common side effects of Rocaltrol 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]
