ADVERSE REACTIONS
Since Rocaltrol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication, depending on the severity and duration of hypercalcemia (see
WARNINGS
). 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, ie, much faster than in treatment with vitamin D3 preparations.
The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:
Early: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache.
Late: polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.
In clinical studies on hypoparathyroidism and pseudohypoparathyroidism, hypercalcemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7 patients. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).
In concurrent hypercalcemia and hyperphosphatemia, soft-tissue calcification may occur; this can be seen radiographically (see
WARNINGS
).
In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine (see
PRECAUTIONS: General
).
Hypersensitivity reactions (pruritus, rash, urticaria, and very rarely severe erythematous skin disorders) may occur in susceptible individuals. One case of erythema multiforme and one case of allergic reaction (swelling of lips and hives all over the body) were confirmed by rechallenge.
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REPORTS OF SUSPECTED ROCALTROL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Rocaltrol. The information is not vetted and should not be considered as verified clinical evidence.
Possible Rocaltrol side effects / adverse reactions in male
Reported by a pharmacist from Italy on 2011-10-24
Patient: male
Reactions: Iatrogenic Injury, Hypercalcaemia
Adverse event resulted in: hospitalization
Suspect drug(s):
Calcium Sandoz
Administration route: Oral
Indication: Hypocalcaemia
Start date: 2009-09-01
End date: 2011-06-15
Rocaltrol
Administration route: Oral
Indication: Hypocalcaemia
Start date: 2009-09-01
End date: 2011-06-15
Omeprazole
Administration route: Oral
Indication: Prophylaxis Against Gastrointestinal Ulcer
Start date: 2009-09-01
End date: 2011-06-15
Other drugs received by patient: MAG 2; Noroxin; Neoral; Laevolac; Kanrenol; Mycophenolate Mofetil (Cellcept); Mircera; Catapresan TTS; Lasix
Possible Rocaltrol side effects / adverse reactions in female
Reported by a physician from Japan on 2011-10-27
Patient: female weighing 0.5 kg (1.1 pounds)
Reactions: LOW Birth Weight Baby, Hypoglycaemia Neonatal, Maternal Drugs Affecting Foetus, Anaemia Neonatal, Caesarean Section, Dyspepsia, Aspiration, Laryngomalacia, White Blood Cell Count Decreased, Apgar Score LOW, Dysphagia, Premature Baby, Vomiting Neonatal, Skin Oedema, Circulatory Failure Neonatal, Aplasia, Poor Sucking Reflex, Laryngeal Cleft, Sepsis Neonatal, Platelet Count Decreased, Poor Weight Gain Neonatal, Blood Pressure Decreased, Inflammation
Adverse event resulted in: hospitalization
Suspect drug(s):
Rocaltrol
Other drugs received by patient: Levothyroxine Sodium
Possible Rocaltrol side effects / adverse reactions in male
Reported by a physician from Italy on 2011-10-31
Patient: male
Reactions: Hypercalcaemia
Adverse event resulted in: hospitalization
Suspect drug(s):
Omeprazole
Administration route: Oral
Indication: Prophylaxis Against Gastrointestinal Ulcer
Start date: 2009-09-01
Rocaltrol
Administration route: Oral
Indication: Hypocalcaemia
Start date: 2009-09-01
End date: 2011-06-15
Calcium Sandoz
Administration route: Oral
Indication: Hypocalcaemia
Start date: 2009-09-01
End date: 2011-06-15
Other drugs received by patient: Catapresan TTS; MAG 2; Neoral; Laevolac; Kanrenol; Lasix; Mircera; Mycophenolate Mofetil (Cellcept); Noroxin
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