"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
Hectorol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Hectorol (doxercalciferol liquid filled capsule) is used to reduce elevated intact parathyroid hormone (iPTH) levels in the treatment of secondary hyperparathyroidism in patients undergoing chronic renal dialysis. It is a form of Vitamin D. This medication is available in generic form. Common side effects include headache, upset stomach, constipation, nausea, vomiting, or tiredness.
The recommended initial adult dose of Hectorol is 10 mcg administered three times weekly at dialysis (approximately every other day). The maximum recommended dose is 20 mcg administered three times a week at dialysis for a total of 60 mcg per week. Hectorol may interact with antacids containing magnesium, digoxin, vitamin D supplements, mineral oil, or cholestyramine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant before using Hectorol. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.
Our Hectorol (doxercalciferol) 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.
Hectorol in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop taking doxercalciferol and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
- an irregular heartbeat;
- increased nighttime urination; or
- abdominal pain.
Contact your doctor if you experience any of the following side effects:
- nausea, vomiting, or decreased appetite;
- dry mouth;
- a metallic taste;
- muscle or bone pain;
- increased thirst or urination;
- shortness of breath; or
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Hectorol (Doxercalciferol Liquid Filled Capsule)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Hectorol Overview - Patient Information: 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: bone/joint/muscle pain, loss of appetite, increased thirst, increased urination, fast/slow/irregular heartbeat, mental/mood changes (e.g., drowsiness, disturbed/irrational thoughts or beliefs), metallic taste in mouth, weakness, unexplained weight gain or loss.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Hectorol (Doxercalciferol Liquid Filled Capsule)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hectorol FDA Prescribing Information: Side Effects
Hectorol (doxercalciferol liquid filled capsule) has been evaluated for safety in clinical studies in 165 patients with chronic kidney disease on hemodialysis. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 2.9% of 138 patients treated with Hectorol (doxercalciferol liquid filled capsule) for four to six months (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in 3.3% of 61 patients treated with placebo for two months. Adverse events occurring in the Hectorol (doxercalciferol liquid filled capsule) group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3 below:
Table 3: Adverse Events Reported by ≥ 2% of Hectorol® (doxercalciferol liquid filled capsule) Treated
Patients and More Frequently Than Placebo During the Double-blind Phase of Two
|Adverse Event|| Hectorol®
|Body as a Whole|
|Metabolic and Nutritional|
|A patient who reported the same medical term more than once was counted only once for that medical term.|
Hectorol (doxercalciferol liquid filled capsule) has been evaluated for safety in clinical studies in 55 patients (27 active and 28 placebo) with chronic kidney disease, Stages 3 or 4. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in one (3.7%) of 27 patients treated with Hectorol (doxercalciferol liquid filled capsule) for 24 weeks (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in three (10.7%) of 28 patients treated with placebo for 24 weeks. Adverse events occurring in the Hectorol (doxercalciferol liquid filled capsule) group at a frequency of 5% or greater and more frequently than in the placebo group are as follows: Body as a Whole - Infection, Chest Pain; Digestive System - Constipation, Dyspepsia; Hematologic and Lymphatic - Anemia; Metabolic and Nutritional - Dehydration; Nervous System - Depression, Hypertonia, Insomnia, Paresthesia; Respiratory System - Cough increased, Dyspnea, Rhinitis.
Potential adverse effects of Hectorol (doxercalciferol liquid filled capsule) are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:
Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated serum aspartate transaminase (AST) and alanine transaminase (ALT), ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.
Read the entire FDA prescribing information for Hectorol (Doxercalciferol Liquid Filled Capsule)
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Report Problems to the Food and Drug Administration
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