Osseka Adverse Reactions

The most commonly reported adverse reaction was hypercalcaemia.
The ADRs listed in the table as follows 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). (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 normalisation 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 infections.
In concurrent hypercalcaemia and hyperphosphataemia 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 increase.