What the label lists and what reports show
Paricalcitol side effects
Paricalcitol's FDA label: “The most common adverse reactions (> 5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema ( 6 ).” FAERS holds 14,043 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 cardiac disorder (622 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the paricalcitol FDA label on DailyMed (effective August 7, 2024, AbbVie Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (> 5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema ( 6 ).
Table 3. Adverse Reactions Occurring at a Rate of 2% or Greater in Patients with CKD on Dialysis in Four Placebo-Controlled Studies
This table is printed in the Zemplar label published by AbbVie Inc. of August 1, 2024; the label quoted above does not print one.
| Adverse Reaction | Placebo (n = 51) % | ZEMPLAR (n = 62) % |
|---|---|---|
| Nausea | 8 | 13 |
| Vomiting | 6 | 8 |
| Edema | 0 | 7 |
| Gastrointestinal Hemorrhage | 2 | 5 |
| Chills | 2 | 5 |
| Pyrexia | 2 | 5 |
| Pneumonia | 0 | 5 |
| Sepsis | 2 | 5 |
| Influenza | 4 | 5 |
| Arthralgia | 4 | 5 |
| Palpitations | 0 | 3 |
| Dry Mouth | 2 | 3 |
| Malaise | 0 | 3 |
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, continuedBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reactions (> 5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience CKD Stages 3 and 4 Adults The safety of ZEMPLAR capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of ZEMPLAR capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the ZEMPLAR capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3: Table 3.
Source: FDA drug label, AbbVie Inc., effective August 7, 2024 (SPL set 1b27c026-2d60-47b4-2a9c-ded1818f21b5), via openFDA; the full label on DailyMed
What do FAERS reports show?
14,043 reports list paricalcitol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8,428 are coded as a death and 3,640 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. Reports rose sharply in 2016 (1,826, against a median of 268 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 23 reactions below, 10 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?
- Paricalcitol: 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