Prescription medication · Active Vitamin D (1,25-dihydroxy)
calcitriol
Also sold as Rocaltrol. Calcitriol is used to manage secondary hyperparathyroidism and bone disease in people with moderate to severe kidney failure who are not yet on dialysis.
Data updated 2026-05-15
- 20,452
- FDA reportsModerately reported
- In shortage
- FDA status
What the data shows
calcitriol (Rocaltrol) is a prescription Active Vitamin D (1,25-dihydroxy), reported at a middle-of-the-pack volume (20,452 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
calcitriol (Rocaltrol) is a prescription Active Vitamin D (1,25-dihydroxy). Calcitriol is used to manage secondary hyperparathyroidism and bone disease in people with moderate to severe kidney failure who are not yet on dialysis.
Calcitriol is a form of vitamin D that helps your body absorb and use calcium. It is used to treat certain bone conditions related to kidney disease or low calcium levels.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
calcitriol is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc..
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.15/unit
Generic Available
Yes (10 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Calcitriol is used to manage secondary hyperparathyroidism and bone disease in people with moderate to severe kidney failure who are not yet on dialysis.
Common side effects
Weakness, Headache, Sleepiness
Key warnings
Calcitriol can cause high calcium levels in your blood (hypercalcemia).
The sections below are summarized in plain English from calcitriol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Calcitriol is an active form of vitamin D. It helps your body absorb calcium from the food you eat. It also helps to regulate how your body uses calcium to keep your bones healthy.
How to Take It
Take Calcitriol as an oral solution (1 mcg/mL). Your doctor will determine the best daily dose for you. Always start with the lowest possible dose. Your doctor will monitor your calcium levels and adjust your dose as needed. Try to eat at least 600 mg of calcium each day.
This is a plain-language summary of calcitriol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or breastfeeding before taking Calcitriol. It is not known if Calcitriol can harm your unborn baby. Calcitriol may pass into breast milk.
This is a plain-language summary of calcitriol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of calcitriol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Calcitriol Oral Solution at 59° to 86°F (15° to 30°C) and protect it from light.
Side Effects (from patient reports)
Based on 20,452 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for calcitriol, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,460 reports
- Long-term kidney problems
Long-term kidney problems
1,202 reports
- Loose, watery stools
Loose, watery stools
1,195 reports
- Kidney failure
Kidney failure
1,142 reports
- Throwing up
Throwing up
1,094 reports
- Difficulty breathing
Difficulty breathing
1,066 reports
- Sudden kidney damage
Sudden kidney damage
1,026 reports
- Feeling very tired
Feeling very tired
1,025 reports
- Death
Death
902 reports
- Allergic reaction to the medicine
Allergic reaction to the medicine
836 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for calcitriol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where calcitriol sits
calcitriol has more FDA adverse-event reports than 55% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is calcitriol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 20,452 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
20,452
Reports Mentioning Death
2,688
13.1% of reports — not proof of cause
Hospitalization Reports
8,641
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 1,462 |
| 2 | CHRONIC KIDNEY DISEASE | 1,202 |
| 3 | DIARRHOEA | 1,195 |
| 4 | RENAL FAILURE | 1,142 |
| 6 | VOMITING | 1,092 |
| 7 | DYSPNOEA | 1,066 |
| 8 | ACUTE KIDNEY INJURY | 1,026 |
| 9 | FATIGUE | 1,026 |
| 10 | DEATH | 902 |
| 11 | DRUG HYPERSENSITIVITY | 836 |
| 13 | HEADACHE | 764 |
| 14 | END STAGE RENAL DISEASE | 761 |
| 15 | ASTHENIA | 757 |
| 16 | PAIN | 743 |
| 17 | ABDOMINAL PAIN | 735 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Calcitriol can cause high calcium levels in your blood (hypercalcemia). Tell your doctor right away if you have symptoms like weakness, headache, nausea, vomiting, or constipation. If your calcium levels get too high, you may need to stop taking Calcitriol.
Common Questions
What should I do if I experience nausea while taking Calcitriol?
Can I take other vitamin D supplements while taking Calcitriol?
How often will my doctor check my calcium levels?
What is hypercalcemia?
What are the symptoms of hypercalcemia?
Can Calcitriol affect my kidneys?
What should I eat while taking Calcitriol?
Can Calcitriol interact with other medications?
What if I have an allergic reaction to Calcitriol?
Is it okay to drive while taking Calcitriol?
What are the common side effects of calcitriol?
What drug class is calcitriol?
Is calcitriol safe during pregnancy?
Has calcitriol been recalled?
Is calcitriol currently in shortage?
Active Recalls
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
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What the FDA Data Shows for calcitriol
The FDA label for calcitriol (sold under brand names such as Rocaltrol) classifies it as a prescription-only medication in the Active Vitamin D (1,25-dihydroxy) class. Calcitriol is used to manage secondary hyperparathyroidism and bone disease in people with moderate to severe kidney failure who are not yet on dialysis. Official labeling lists 12 commonly reported side effects, including Weakness, Headache, Sleepiness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 20,452 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.15.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: April 18, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages