FDA label 997354c8-0112-c9dd-e053-2a95a90a3071

openFDA label record#

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SPL set ID
3a0919fa-3ff5-43d9-bf37-2da671c34bf2
SPL ID
997354c8-0112-c9dd-e053-2a95a90a3071
Version
5
Effective date
2019-12-11
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:42:32

Warnings cross-check#

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warnings

WARNINGS Overdosage of any form of vitamin D, including doxercalciferol, 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 doxercalciferol 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 doxercalciferol in reducing blood PTH levels. If hypercalcemia occurs after initiating doxercalciferol therapy, the dose of doxercalciferol and/or calcium-containing phosphate binders should be decreased. If hyperphosphatemia occurs after initiating doxercalciferol therapy, the dose of doxercalciferol should be decreased and/or the dose of phosphate binders increased. (See dosing recommendations for doxercalciferol under DOSAGE AND ADMINISTRATION section.) Magnesium-containing antacids and doxercalciferol 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#

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adverse reactions

ADVERSE REACTIONS Dialysis Doxercalciferol 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 doxercalciferol 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 doxercalciferol 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 Doxercalciferol Treated Patients and More Frequently Than Placebo During the Double-Blind Phase of Two Clinical Studies Adverse Event Doxercalciferol (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 Doxercalciferol 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 doxercalciferol 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 doxercalciferol 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 doxercalciferol 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 width="100%" ID="_RefID0EZGAG"> <caption>Table 3: Adverse Events Reported by &#x2265;2% of Doxercalciferol Treated Patients and More Frequently Than Placebo During the Double-Blind Phase of Two Clinical Studies</caption> <colgroup> <col width="44%"/> <col width="32%"/> <col width="24%"/> </colgroup> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Adverse Event</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Doxercalciferol (N=61) % </content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Placebo (N=61) % </content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Body as a Whole</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Abscess</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Headache</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>27.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>18.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Malaise</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>27.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>19.7</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Cardiovascular System</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Bradycardia</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>6.6</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.9</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Digestive System</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Anorexia</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Constipation</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Dyspepsia</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>1.6</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Nausea/Vomiting</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>21.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>19.7</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Musculoskeletal System</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Arthralgia</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Metabolic and Nutritional</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Edema</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>34.4</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>21.3</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Weight Increase</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>4.9</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Nervous System</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Dizziness</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>11.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>9.8</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Sleep Disorder</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.3</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Respiratory System</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>Dyspnea</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>11.5</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>6.6</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Skin</content> </paragraph> </td> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Lrule Botrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Pruritus</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>8.2</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>6.6</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.