What the label lists and what reports show
Calcitriol side effects
Calcitriol's FDA label lists its adverse reactions in its own words. FAERS holds 20,167 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 nausea (1,462 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the calcitriol FDA label on DailyMed (effective October 23, 2024, Amneal Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VECTICAL Ointment?VECTICAL Ointment may cause serious side effects, including: Too much calcium in your blood (hypercalcemia) may occur with VECTICAL Ointment. Your healthcare provider may tell you to stop using VECTICAL Ointment until your calcium levels become normal. The most common side effects of VECTICAL Ointment include increased urine calcium level, itching, and skin discomfort. These are not all of the possible side effects of VECTICAL Ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.
Source: FDA drug label (Vectical), Galderma Laboratories, L.P., effective October 24, 2024 (SPL set a1567da9-af74-4afd-9ac5-8b53ec5d7cbf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsSince calcitriol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, i.e., hypercalcemia syndrome or calcium intoxication, depending on the severity and duration of hypercalcemia (see WARNINGS ). Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalization of elevated serum calcium within a few days of treatment withdrawal, ie, much faster than in treatment with vitamin D 3 preparations. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include: Early: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache. …
Source: FDA drug label, Amneal Pharmaceuticals LLC, effective October 23, 2024 (SPL set b1fef137-63c5-4662-8cd9-b9e8b12bacb6), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,167 reports list calcitriol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,661 are coded as a death and 8,520 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 21 reactions below, 5 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?
- Calcitriol: 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