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.
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
- Nausea
Nausea
1,462 reports
- Chronic Kidney Disease
Chronic Kidney Disease
1,202 reports
- Diarrhoea
Diarrhoea
1,195 reports
- Renal Failure
Renal Failure
1,142 reports
- Vomiting
Vomiting
1,092 reports
- Dyspnoea
Dyspnoea
1,066 reports
- Acute Kidney Injury
Acute Kidney Injury
1,026 reports
- Fatigue
Fatigue
1,026 reports
- Death
Death
902 reports
- Drug Hypersensitivity
Drug Hypersensitivity
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) 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?
What pregnancy or breastfeeding source fields are listed for calcitriol?
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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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for calcitriol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 20,452.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 13.14%.
- spironolactone Δ 0.02 pts · 133,996 reports · Potassium-Sparing Diuretic / Aldosterone Antagonist 13.16%death share
- cyclosporine Δ 0.03 pts · 106,440 reports · Calcineurin Inhibitor (Immunosuppressant) 13.12%death share
- febuxostat Δ 0.03 pts · 16,005 reports · Xanthine Oxidase Inhibitor 13.11%death share
- zoledronic acid Δ 0.06 pts · 38,197 reports · Bisphosphonate (IV) 13.09%death share
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Understanding Drug Interactions
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FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 18, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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