calcitriol
Brand names: Rocaltrol
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.
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).
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.
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.
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.
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 11,208 FDA adverse event reports.
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
Death-Related Reports
2,688
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 |
| 5 | OFF LABEL USE | 1,097 |
| 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 |
| 12 | DRUG INEFFECTIVE | 787 |
| 13 | HEADACHE | 764 |
| 14 | END STAGE RENAL DISEASE | 761 |
| 15 | ASTHENIA | 757 |
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 11,208 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.
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