FDA label 32031b77-6231-4e93-a5cd-c412cc72f306
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- dc676bc5-f3f7-4755-92e1-1814498c1f4f
- SPL ID
- 32031b77-6231-4e93-a5cd-c412cc72f306
- Version
- 10
- Effective date
- 2018-10-30
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:30:51
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 32031b77-6231-4e93-a5cd-c412cc72f306 | id | |
| spl set id | dc676bc5-f3f7-4755-92e1-1814498c1f4f | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Overdosage of any form of vitamin D, including Hectorol, is dangerous (see OVERDOSAGE ). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. The serum calcium times serum phosphorus (Ca X P) product should be maintained at < 55 mg 2 /dL 2 in patients with chronic kidney disease. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. Since doxercalciferol is a precursor for 1α,25-(OH) 2 D 2 , a potent metabolite of vitamin D 2 , pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol treatment to avoid possible additive effects and hypercalcemia. Oral calcium-based or other non-aluminum-containing phosphate binders and a low phosphate diet should be used to control serum phosphorus levels in patients with chronic kidney disease. Uncontrolled serum phosphorus exacerbates secondary hyperparathyroidism and can lessen the effectiveness of Hectorol in reducing blood PTH levels. If hypercalcemia occurs after initiating Hectorol therapy, the dose of Hectorol and/or calcium-containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating Hectorol, the dose of Hectorol should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for Hectorol under DOSAGE AND ADMINISTRATION section.) Magnesium-containing antacids and Hectorol should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Dialysis: Hectorol 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 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 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 ® 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 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 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 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 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.
adverse reactions table
<table ID="ff04940d-8f7e-4c51-b4f8-71e1bf45befe"> <caption>Table 3: Adverse Events Reported by ≥ 2% of Hectorol<sup>®</sup> Treated Patients and More Frequently Than Placebo During the Double-blind Phase of Two Clinical Studies </caption> <colgroup> <col align="left" valign="bottom"/> <col align="center" valign="bottom"/> <col align="center" valign="bottom"/> </colgroup> <thead styleCode="Lrule Rrule Toprule Botrule"> <tr> <th styleCode="Lrule Rrule Toprule Botrule" align="left">Adverse Event</th> <th styleCode="Lrule Rrule Toprule Botrule" align="center">Hectorol<sup>®</sup> (n=61) % </th> <th styleCode="Lrule Rrule Toprule Botrule" align="center">Placebo (n=61) % </th> </tr> </thead> <tbody> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Body as a Whole</content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Abscess</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">3.3</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">0.0</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Headache</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">27.9</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">18.0</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Malaise</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">27.9</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">19.7</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Cardiovascular System </content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Bradycardia</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">6.6</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">4.9</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Digestive System</content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Anorexia</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">4.9</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">3.3</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Constipation</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">3.3</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">3.3</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Dyspepsia</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">4.9</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">1.6</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Nausea/Vomiting</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">21.3</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">19.7</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Musculoskeletal System </content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Arthralgia</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">4.9</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">0.0</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Metabolic and Nutritional </content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Edema</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">34.4</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">21.3</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Weight increase</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">4.9</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">0.0</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Nervous System</content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Dizziness</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">11.5</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">9.8</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Sleep disorder</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">3.3</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">0.0</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Respiratory System</content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Dyspnea</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">11.5</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">6.6</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <content styleCode="bold"> <content styleCode="emphasis">Skin </content> </content> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left">Pruritus</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">8.2</td> <td styleCode="Lrule Rrule Toprule Botrule" align="center">6.6</td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left" colspan="3">A patient who reported the same medical term more than once was counted only once for that medical term.</td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.