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Rocaltrol

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Rocaltrol

Rocaltrol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rocaltrol (calcitriol) is used to treat calcium deficiency with hypoparathyroidism (decreased functioning of the parathyroid glands) and metabolic bone disease in people with chronic kidney failure. Rocaltrol is a synthetic version of Vitamin D3. 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. In rare cases, side effects may include increased thirst, urinating more than usual, lower back pain, heart rate changes, weakness, drowsiness, changes in behavior, bone pain, muscle weakness, nausea, constipation, loss of appetite, weight loss, dry mouth or a metallic taste. Report any of these rare side effects to your doctor.

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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rocaltrol in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rocaltrol Overview - Patient Information: Side Effects

SIDE EFFECTS: Calcitriol 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.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: loss of appetite, back/bone/joint/muscle pain, constipation, dry mouth, eye pain/redness/sensitivity to light, headache, fast/slow/irregular heartbeat, nausea/vomiting/diarrhea, sleepiness, stomach/abdominal pain, increased thirst, change in the amount of urine, weakness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rocaltrol (Calcitriol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rocaltrol FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 - User Reviews

Rocaltrol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Rocaltrol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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