Rocaltrol Side Effects

Generic Name: calcitriol

Please note - some side effects for Rocaltrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rocaltrol - for the Consumer

Rocaltrol

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Rocaltrol. Seek medical attention right away if any of these SEVERE side effects occur when using Rocaltrol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; bone pain; constipation; decreased sex drive; diarrhea; difficult or painful urination; dizziness; drowsiness; dry mouth; eye redness or irritation; fever; flushing; frequent urination; headache; increased body temperature; increased thirst; irregular heartbeat; loss of appetite; mental or mood changes; metallic taste; muscle pain; nausea; runny nose; sensitivity of the eyes to sunlight; stomach pain or cramps; unexplained weight loss; unusual thinking; vomiting; weakness.

Rocaltrol Solution

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Rocaltrol Solution. Seek medical attention right away if any of these SEVERE side effects occur when using Rocaltrol Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; bone pain; constipation; decreased sex drive; diarrhea; difficult or painful urination; dizziness; drowsiness; dry mouth; eye redness or irritation; fever; flushing; frequent urination; headache; increased body temperature; increased thirst; irregular heartbeat; loss of appetite; mental or mood changes; metallic taste; muscle pain; nausea; runny nose; sensitivity of the eyes to sunlight; stomach pain or cramps; unexplained weight loss; unusual thinking; vomiting; weakness.

Rocaltrol Side Effects - for the Professional

Rocaltrol

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. 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.

In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine.

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.

Side Effects by Body System

Metabolic

Early signs and symptoms of hypercalcemia include headache, anorexia, nausea, vomiting, metallic taste, constipation, abdominal cramps, dry mouth, weakness, fatigue, muscle and bone pain, ataxia, tinnitus, abdominal pain, and vertigo. Later hypercalcemia may result in pruritus, mental confusion, coma, elevated hepatic transaminase levels, hypertension, cardiac arrhythmias, seizures, metastatic calcification, and renal insufficiency manifested by polyuria, nocturia, polydipsia, and proteinuria and elevated BUN.

In one study, the incidence of hypercalcemia was lower (50% vs 80%) when calcitriol was administered at night as opposed to morning administration. Hypercalcemia also appears to occur more commonly in patients receiving intermittent vs. continuous therapy and in oral vs. intravenous therapy.

Patients with renal failure are more prone to the development of hypercalcemia because the urinary excretion of calcium cannot compensate for increases in serum calcium.

Increased phosphate absorption may be detrimental in patients with chronic renal failure and hyperphosphatemia.

Metabolic side effects have included hypercalcemia and increased phosphate absorption.

Hypersensitivity

Hypersensitivity side effects have included rare cases of hypersensitivity reactions, including anaphylaxis. A single case of erythema multiform has been reported. Another case involving a single patient experiencing an allergic reaction including total body hives and swelling of the lips has also been reported.

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