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Calcitriol (Calcitriol) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Since calcitriol 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 D 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.



REPORTS OF SUSPECTED CALCITRIOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Calcitriol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Calcitriol side effects / adverse reactions in 78 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-11-01

Patient: 78 year old female

Reactions: Haemolytic Anaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Depamide (Valpromide)

Coumadin
    Dosage: oral
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2011-06-02

Clonazepam
    Dosage: oral
    Administration route: Oral
    Indication: Epilepsy

Escitalopram
    Dosage: oral
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-06-02
    End date: 2011-07-01

Galantamine Hydrobromide
    Dosage: oral
    Administration route: Oral
    Indication: Dementia Alzheimer's Type

Calcit Vitamine D3 (Calcium Carbonate, Colecalciferol)
    Dosage: oral
    Administration route: Oral
    Indication: Calcium Deficiency

Diosmine (Diosmin)
    Dosage: oral
    Administration route: Oral
    Indication: Sensation of Heaviness

Calcitriol
    Dosage: oral
    Administration route: Oral
    Indication: Vitamin D Deficiency

Memantine Hydrochloride
    Indication: Dementia Alzheimer's Type

Tanakan (Ginkgo Biloba Extract)
    Dosage: oral
    Administration route: Oral
    Indication: Dementia Alzheimer's Type

Other drugs received by patient: Depakine (Valproic Acid)(valproic Acid)



Possible Calcitriol side effects / adverse reactions in 78 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-11-03

Patient: 78 year old female

Reactions: Haemolytic Anaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Galantamine Hydrobromide
    Dosage: oral
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    End date: 2011-07-22

Cacit Vitamine D3 (Calcium Carbonate, Colecalciferol)
    Dosage: oral
    Administration route: Oral
    Indication: Calcium Deficiency
    End date: 2011-07-22

Tanakan (Ginkgo Biloba Extract)
    Dosage: oral
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    End date: 2011-07-22

Clonazepam
    Dosage: oral
    Administration route: Oral
    Indication: Epilepsy

Coumadin
    Dosage: oral
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2011-06-02

Diosmine (Diosmin)
    Dosage: oral
    Administration route: Oral
    Indication: Sensation of Heaviness
    End date: 2011-07-22

Memantine Hydrochloride
    Indication: Dementia Alzheimer's Type
    End date: 2011-07-22

Depamide (Valpromide)
    End date: 2011-07-22

Calcitriol
    Dosage: oral
    Administration route: Oral
    Indication: Vitamin D Deficiency
    End date: 2011-07-22

Other drugs received by patient: Escitalopram (Escitalopram Oxalate) (Tablets) - (Escitalopram Oxalate)



Possible Calcitriol side effects / adverse reactions in 9 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-17

Patient: 9 year old female weighing 17.0 kg (37.4 pounds)

Reactions: Weight Gain Poor, Drug Ineffective, Gingival Hyperplasia, Blood Potassium Decreased, Malnutrition

Adverse event resulted in: hospitalization

Suspect drug(s):
Amlodipine
    Dosage: 12.5 mg
    Indication: Hypertension

Atorvastatin
    Dosage: 10 mg

Epogen

Azathioprine
    Dosage: 50 mg

Labetalol HCL
    Dosage: 200 mg

Calcitriol
    Dosage: 0.25 mcg

Budesonide
    Dosage: 3 mg



See index of all Calcitriol side effect reports >>

Drug label data at the top of this Page last updated: 2012-01-26

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