What the label lists and what reports show
Calcifediol side effects
Calcifediol's FDA label: “The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.” FAERS holds 2,421 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 acute kidney injury (116 reports).
- No generic listed
Check it at the source: the calcifediol FDA label on DailyMed (effective January 19, 2024, OPKO Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.
Table 1. Common Adverse Reactions in Placebo-controlled Trials Reported in ≥1.4% of RAYALDEE-Treated Subjects
| Adverse Reaction | Placebo N=144 % | RAYALDEE N=285 % |
|---|---|---|
| Anemia | 3.5 | 4.9 |
| Nasopharyngitis | 2.8 | 4.9 |
| Blood creatinine increased | 1.4 | 4.9 |
| Dyspnea | 2.8 | 4.2 |
| Cough | 2.1 | 3.5 |
| Cardiac failure congestive | 0.7 | 3.5 |
| Constipation | 2.8 | 3.2 |
| Bronchitis | 0.7 | 2.8 |
| Hyperkalemia | 0.7 | 2.5 |
| Osteoarthritis | 0.7 | 2.1 |
| Hyperuricemia | 0.7 | 1.8 |
| Contusion | 0.0 | 1.8 |
| Pneumonia | 0.7 | 1.4 |
| Chronic obstructive pulmonary disease | 0.0 | 1.4 |
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, continuedThe following important adverse reactions are discussed in greater detail in other sections of the label: • Hypercalcemia [ see Warnings and Precautions ( 5.1 ) ] • Adynamic Bone Disease [ see Warnings and Precautions ( 5.3 ) ] The most common adverse reactions (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact OPKO Pharmaceuticals, LLC at 1-844-729-2539 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The data in Table 1 are derived from two pivotal studies described below [ see Clinical Studies ( 14 ) ]. These data reflect exposure of 285 subjects to RAYALDEE 30 or 60 mcg daily for up to 6 months (mean 24 weeks, range 1 to 31 weeks). The mean age of the study population was 66 years old (range 25-85 years). Half of the subjects were male, 65% were White, and 32% were African-American or Black. …
Source: FDA drug label, NDA208010 (Eirgen), as published by OPKO Pharmaceuticals LLC, effective January 19, 2024 (SPL set 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,421 reports list calcifediol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 356 are coded as a death and 1,228 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 20 reactions below, 6 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.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Calcifediol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions