Rocaltrol Adverse Reactions

Clinical Trials: The adverse reactions listed as follows reflect the experience from investigational studies of Calcitriol (Rocaltrol), and the post-marketing experience.
The most commonly reported adverse reaction was hypercalcaemia.
The ADRs listed in the table are presented by system organ class and frequency categories, defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See table.)

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Since calcitriol exerts vitamin D activity, adverse effects may occur which are similar to those found when an excessive dose of vitamin D is taken, i.e. hypercalcaemia syndrome or calcium intoxication (depending on the severity and duration of hypercalcaemia). (See Dosage & Administration and Precautions). Occasional acute symptoms include decreased appetite, headache, nausea, vomiting, abdominal pain or abdominal pain upper and constipation.
Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalization of elevated serum calcium within a few days of treatment withdrawal, i.e. much faster than in treatment with vitamin D₃ preparations.
Chronic effects may include muscular weakness, weight decreased, sensory disturbances, pyrexia, thirst, polydipsia, polyuria, dehydration, apathy, growth retardation and urinary tract infection.
In concurrent hypercalcaemia and hyperphosphatemia of >6 mg/100 ml or >1.9 mmol/l, calcinosis may occur; this can be seen radiographically.
Hypersensitivity reactions including rash, erythema, pruritus, and urticaria may occur in susceptible individuals.
Laboratory Abnormalities: In patients with normal renal function, chronic hypercalcaemia may be associated with a blood creatinine increased.
Post Marketing: The number of adverse effects reported from clinical use of Calcitriol (Rocaltrol) over a period of 15 years in all indications is very low with each individual effect, including hypercalcaemia, occurring at a rate of 0.001% or less.