Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Calcitriol
Drug ID BADD_D00337
Description Calcitriol is an active metabolite of vitamin D with 3 hydroxyl (OH) groups and is commonly referred to as 1,25-dihydroxycholecalciferol, or 1alpha,25-dihydroxyvitamin D3, 1,25-dihydroxyvitamin D3. It is produced in the body after series of conversion steps of 7-dehydrocholesterol from exposure to UV light. 7-dehydrocholesterol is converted to [DB00169] (vitamin D3) in the skin, which is then converted to [DB00146] in the liver and kidneys. [DB00146] undergoes hydroxylation to form calcitriol via 1α-hydroxylase (CYP27B1) activity [A26353]. Calcitriol is considered to be the most potent metabolite of vitamin D in humans [A3366]. Renal production of calcitriol is stimulated in response to PTH, low calcium and low phosphate [A26353]. Calcitriol plays a role in plasma calcium regulation in concert with parathyroid hormone (PTH) by enhancing absorption of dietary calcium and phosphate from the gastrointestinal tract, promoting renal tubular reabsorption of calcium in the kidneys, and stimulating the release of calcium stores from the skeletal system. In addition to promoting fatty acid synthesis and inhibiting lipolysis, calcitriol has been demonstrated to increase energy efficiency by suppressing UCP2 expression, which is modulated by signaling pathways of classical nuclear receptors (nVDR), where calcitriol acts as a natural ligand [A175615]. There is also evidence that calcitriol modulates the action of cytokines and may regulate immune and inflammatory response, cell turnover, cell differentiation [A26353]. Administered orally and intravenously, calcitriol is commonly used as a medication in the treatment of secondary hyperparathyroidism and resultant metabolic bone disease, hypocalcemia in patients undergoing chronic renal dialysis, and osteoporosis. It is also available in topical form for the treatment of mild to moderate plaque psoriasis in adults. Calcitriol is marketed under various trade names including Rocaltrol (Roche), Calcijex (Abbott) and Decostriol (Mibe, Jesalis).
Indications and Usage Used to treat vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. Also used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis.
Marketing Status approved; nutraceutical
ATC Code A11CC04; D05AX03
DrugBank ID DB00136
KEGG ID D00129
MeSH ID D002117
PubChem ID 5280453
TTD Drug ID D0T2PL
NDC Product Code 73309-261; 62135-611; 63629-8742; 68308-665; 71335-2095; 10888-8107; 55361-0001; 56161-202; 0093-7352; 62756-967; 72266-251; 72789-058; 45408-001; 43353-138; 64980-447; 0054-0007; 0299-2012; 63304-240; 54239-004; 17478-831; 23155-662; 62756-968; 63629-2445; 10888-5032; 55361-0007; 58272-125; 17478-931; 12869-329; 63415-0046; 17478-932; 43353-998; 51407-170; 63304-239; 63304-241; 71335-1594; 71335-1782; 71610-521; 10888-8106; 11014-0013; 51927-0194; 51407-169; 63629-8741; 65162-576; 69452-207; 0054-3120; 71610-468; 10888-8111; 10888-8112; 11014-0021; 66499-0003; 62135-610; 65162-519; 69452-208; 68083-316; 11014-0012; 51927-0033; 23155-663; 0093-7353; 45802-608
UNII FXC9231JVH
Synonyms Calcitriol | 1, 25-(OH)2D3 | 1,25-Dihydroxycholecalciferol | 1,25 Dihydroxycholecalciferol | 1,25-Dihydroxyvitamin D3 | 1,25 Dihydroxyvitamin D3 | D3, 1,25-Dihydroxyvitamin | 1 alpha,25-Dihydroxycholecalciferol | 1 alpha,25-Dihydroxyvitamin D3 | 1 alpha,25 Dihydroxyvitamin D3 | D3, 1 alpha,25-Dihydroxyvitamin | Bocatriol | Calcijex | Calcitriol KyraMed | KyraMed, Calcitriol | Calcitriol-Nefro | Calcitriol Nefro | Decostriol | MC1288 | MC-1288 | MC 1288 | Osteotriol | Renatriol | Rocaltrol | Silkis | Sitriol | Soltriol | Tirocal | 20-epi-1alpha,25-dihydroxycholecaliferol | 1,25-dihydroxy-20-epi-Vitamin D3 | 1,25 dihydroxy 20 epi Vitamin D3 | D3, 1,25-dihydroxy-20-epi-Vitamin | 1,25(OH)2-20epi-D3 | 1 alpha, 25-dihydroxy-20-epi-Vitamin D3
Chemical Information
Molecular Formula C27H44O3
CAS Registry Number 32222-06-3
SMILES CC(CCCC(C)(C)O)C1CCC2C1(CCCC2=CC=C3CC(CC(C3=C)O)O)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.000223%-
Abdominal distension07.01.04.0010.000223%
Abdominal pain07.01.05.0020.000447%
Abdominal pain upper07.01.05.003--
Abortion spontaneous18.01.04.0010.000223%-
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001---
Anaphylactic shock10.01.07.002; 24.06.02.0040.000223%-
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.0010.000335%-
Anxiety19.06.02.0020.000491%
Apathy19.04.04.002---
Arrhythmia02.03.02.001---
Arthralgia15.01.02.0010.000447%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.000670%-
Blister12.01.06.002; 23.03.01.001---
Blood calcium increased13.11.01.003---
Blood creatinine increased13.13.01.004--
Blood urea increased13.13.01.006---
Body temperature increased13.15.01.001---
Bone pain15.02.01.0010.000603%
Bradycardia02.03.02.0020.000223%-
Calcification metastatic08.03.04.006; 14.04.01.011---
Calcinosis08.03.04.0020.000447%-
Calcium intoxication05.04.02.002; 14.04.01.001---
Cardiac amyloidosis02.04.01.013; 10.02.05.0020.000223%-
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Coma17.02.09.0010.000335%-
Condition aggravated08.01.03.0040.000335%-
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ADReCS-Target
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