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What the label lists and what reports show

Doxercalciferol side effects

Doxercalciferol's FDA label: “The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia.” FAERS holds 167 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (13 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the doxercalciferol FDA label on DailyMed (effective October 23, 2025, Eugia US LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia.

Table 2: Adverse Reactions Occurring in ≥2% Doxercalciferol Capsule-Treated Patients with CKD on Dialysis and Greater than Placebo in Two Double-Blind Clinical Studies

Adverse Reaction*Doxercalciferol (n=61) %Placebo (n=61) %
Edema3421
Malaise2820
Headache2818
Nausea/Vomiting2120
Dizziness1210
Dyspnea127
Pruritus87
Bradycardia75
Anorexia53
Dyspepsia52
Arthralgia50
Weight increase50
Abscess30
Sleep disorder30

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed in greater detail in another section of the label: Hypercalcemia [see Warnings and Precautions (5.1) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Adynamic Bone Disease [see Warnings and Precautions (5.4) ] The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Doxercalciferol Capsules Adverse reactions in patients with CKD on dialysis Doxercalciferol capsules have been evaluated in two placebo-controlled, double-blind studies in patients with CKD on hemodialysis. Patients were treated with doxercalciferol capsules (n=61) or placebo (n=61). After randomization to two groups, eligible patients underwent an 8-week washout period during which no vitamin D derivatives were administered to either group. …

Source: FDA drug label, Eugia US LLC, effective October 23, 2025 (SPL set 3376536b-043d-478a-b129-7ce11ec94e3e), via openFDA; the full label on DailyMed

What do FAERS reports show?

167 reports list doxercalciferol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 56 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Dyspnoea (named in the label)13
  • Acute Kidney Injury12
  • Fatigue12
  • Renal Failure12
  • End Stage Renal Disease11
  • Vomiting (named in the label)11
  • Chronic Kidney Disease (a use or a product term, not a reaction)10
  • Drug Hypersensitivity10
  • Nausea (named in the label)9
  • Pain9
  • Anxiety8
  • Asthenia8
  • Diarrhoea8
  • Unresponsive To Stimuli8
  • Chest Pain7
  • Malaise (named in the label)7
  • Blood Pressure Increased6
  • Nephrogenic Anaemia6
  • Pneumonia6
  • Pruritus (named in the label)6
  • Death (an outcome recorded in the report)5
  • Dialysis (a use or a product term, not a reaction)5
  • Hyperparathyroidism Secondary5
  • Oedema Peripheral5
  • Off Label Use (a use or a product term, not a reaction)5

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Doxercalciferol: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions