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Hectorol

Last reviewed on RxList: 11/10/2016
Hectorol Side Effects Center

Last reviewed on RxList 2/18/2016

Hectorol (doxercalciferol liquid filled capsule) is a form of Vitamin D used to reduce elevated intact parathyroid hormone (iPTH) levels in the treatment of secondary hyperparathyroidism in patients undergoing chronic renal dialysis. Hectorol is available in generic form. Common side effects of Hectorol include headache, upset stomach, constipation, nausea, vomiting, or tiredness. Contact your doctor if you experience side effects from Hectorol such as decreased appetite, dry mouth, weakness, dizziness, metallic taste in the mouth, muscle or bone pain, increased thirst or urination, shortness of breath, or itching.

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.

Hectorol Consumer Information

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;
  • constipation;
  • weakness;
  • headache;
  • dizziness;
  • a metallic taste;
  • muscle or bone pain;
  • increased thirst or urination;
  • shortness of breath; or
  • itching.

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)

Hectorol Professional Information

SIDE EFFECTS

Dialysis

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 Clinical Studies

Adverse Event Hectorol®
(n=61) %
Placebo
(n=61) %
Body as a Whole
  Abscess 3.3 0.0
  Headache 27.9 18.0
  Malaise 27.9 19.7
Cardiovascular System
  Bradycardia 6.6 4.9
Digestive System
  Anorexia 4.9 3.3
  Constipation 3.3 3.3
  Dyspepsia 4.9 1.6
  Nausea/Vomiting 21.3 19.7
Musculoskeletal System
  Arthralgia 4.9 0.0
Metabolic and Nutritional
  Edema 34.4 21.3
  Weight increase 4.9 0.0
Nervous System
  Dizziness 11.5 9.8
  Sleep disorder 3.3 0.0
Respiratory System
  Dyspnea 11.5 6.6
Skin
  Pruritus 8.2 6.6
A patient who reported the same medical term more than once was counted only once for that medical term.

Pre-dialysis

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:

Early

Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia.

Late

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

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