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Rocaltrol

Last reviewed on RxList: 10/18/2016
Rocaltrol Side Effects Center

Last reviewed on RxList 10/28/2016

Rocaltrol (calcitriol) is a synthetic version of Vitamin D3 used to treat calcium deficiency with hypoparathyroidism (decreased functioning of the parathyroid glands) and metabolic bone disease in people with chronic kidney failure. Rocaltrol does not usually have side effects. Your doctor may check your calcium and phosphate blood levels and adjust your dose if you have side effects. Tell your doctor if you experience rare side effects of Rocaltrol including:

  • increased thirst,
  • urinating more than usual or changes in the amount of urine,
  • lower back pain,
  • heart rate changes (fast, slow, or uneven),
  • headache,
  • drowsiness,
  • changes in behavior,
  • bone pain,
  • muscle pain or weakness,
  • loss of height,
  • nausea,
  • vomiting,
  • stomach or abdominal pain,
  • constipation,
  • loss of appetite,
  • weight loss,
  • dry mouth or a metallic taste,
  • changes in behavior,
  • slow growth (in a child taking Rocaltrol),
  • severe pain in your upper stomach spreading to your back,
  • eye pain or redness,
  • eye sensitivity to light,
  • diarrhea, or
  • sleepiness.

Rocaltrol is dosed for each individual patient, and may be given in either capsule or oral solution form. Some medications that may adversely interact with Rocaltrol include digoxin, cholestyramine, sevelamer, ketoconazole, lanthanum, seizure medication, steroids, and diuretics (water pills). During pregnancy, Rocaltol should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Rocaltrol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rocaltrol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using calcitriol and call your doctor at once if you have a serious side effect such as:

  • weakness, headache, drowsiness;
  • nausea, vomiting, stomach pain, constipation;
  • loss of appetite;
  • dry mouth, increased thirst;
  • metallic taste in your mouth;
  • urinating more than usual;
  • fast, slow, or uneven heart rate;
  • changes in behavior;
  • muscle pain, bone pain, muscle weakness, loss of height;
  • slow growth (in a child taking calcitriol); or
  • severe pain in your upper stomach spreading to your back.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rocaltrol (Calcitriol)

Rocaltrol Professional Information

SIDE EFFECTS

Since Rocaltrol (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 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.

Read the entire FDA prescribing information for Rocaltrol (Calcitriol)

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© Rocaltrol Patient Information is supplied by Cerner Multum, Inc. and Rocaltrol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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