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Calcitriol Adverse Events Reported to the FDA Over Time

How are Calcitriol adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Calcitriol, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Calcitriol is flagged as the suspect drug causing the adverse event.

Most Common Calcitriol Adverse Events Reported to the FDA

What are the most common Calcitriol adverse events reported to the FDA?

Hypercalcaemia
40 (4.06%)
Acute Myeloid Leukaemia
18 (1.83%)
Cardiovascular Disorder
16 (1.62%)
Nausea
15 (1.52%)
Dizziness
14 (1.42%)
Nephrolithiasis
13 (1.32%)
Asthenia
12 (1.22%)
Vomiting
12 (1.22%)
Abdominal Pain
11 (1.12%)
Confusional State
9 (.91%)
Death
9 (.91%)
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Milk-alkali Syndrome
9 (.91%)
Pain
9 (.91%)
Pain In Extremity
9 (.91%)
Blood Calcium Increased
8 (.81%)
Diarrhoea
8 (.81%)
Drug Ineffective
8 (.81%)
Hypocalcaemia
8 (.81%)
Nephrocalcinosis
8 (.81%)
Pyrexia
8 (.81%)
Renal Failure Acute
8 (.81%)
Adverse Event
7 (.71%)
Blood Urine Present
7 (.71%)
Coma
7 (.71%)
Convulsion
7 (.71%)
Enterococcal Infection
7 (.71%)
Renal Failure
7 (.71%)
Respiratory Distress
7 (.71%)
Staphylococcal Infection
7 (.71%)
Urinary Tract Infection
7 (.71%)
Weight Increased
7 (.71%)
Aplasia Pure Red Cell
6 (.61%)
Blood Alkaline Phosphatase Increase...
6 (.61%)
Decreased Appetite
6 (.61%)
Epistaxis
6 (.61%)
Headache
6 (.61%)
Hypertension
6 (.61%)
Infection
6 (.61%)
Paraesthesia
6 (.61%)
Syncope
6 (.61%)
Thrombosis
6 (.61%)
Arthritis
5 (.51%)
Blood Calcium Decreased
5 (.51%)
Blood Creatinine Increased
5 (.51%)
Blood Potassium Decreased
5 (.51%)
Bone Pain
5 (.51%)
Developmental Delay
5 (.51%)
Diabetes Mellitus
5 (.51%)
Fluid Retention
5 (.51%)
Haemorrhage
5 (.51%)
Hypoaesthesia
5 (.51%)
Lithotripsy
5 (.51%)
Neoplasm Malignant
5 (.51%)
Tinnitus
5 (.51%)
Transplant Rejection
5 (.51%)
Wheezing
5 (.51%)
Aspiration
4 (.41%)
Calciphylaxis
4 (.41%)
Chest Pain
4 (.41%)
Condition Aggravated
4 (.41%)
Continuous Positive Airway Pressure
4 (.41%)
Endometrial Disorder
4 (.41%)
Endometrial Hyperplasia
4 (.41%)
Femur Fracture
4 (.41%)
Medication Error
4 (.41%)
No Therapeutic Response
4 (.41%)
Oxygen Supplementation
4 (.41%)
Packed Red Blood Cell Transfusion
4 (.41%)
Post Herpetic Neuralgia
4 (.41%)
Product Taste Abnormal
4 (.41%)
Rash
4 (.41%)
Swelling
4 (.41%)
Thrombocytopenia
4 (.41%)
Thyroid Cancer
4 (.41%)
Weight Decreased
4 (.41%)
Abdominal Pain Upper
3 (.3%)
Alanine Aminotransferase Increased
3 (.3%)
Anaemia
3 (.3%)
Anxiety
3 (.3%)
Aspartate Aminotransferase Increase...
3 (.3%)
Bronchopneumonia
3 (.3%)
Calcinosis
3 (.3%)
Constipation
3 (.3%)
Device Related Infection
3 (.3%)
Electrocardiogram Pr Prolongation
3 (.3%)
Erythema
3 (.3%)
Fatigue
3 (.3%)
Haemoglobin Decreased
3 (.3%)
Haemolytic Anaemia
3 (.3%)
Hypercalciuria
3 (.3%)
Hypomagnesaemia
3 (.3%)
Leukopenia
3 (.3%)
Liver Function Test Abnormal
3 (.3%)
Muscle Spasms
3 (.3%)
Neutropenia
3 (.3%)
Oedema
3 (.3%)
Overdose
3 (.3%)
Pollakiuria
3 (.3%)
Pruritus
3 (.3%)
Renal Impairment
3 (.3%)
Repetitive Strain Injury
3 (.3%)

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This graph shows the top adverse events submitted to the FDA for Calcitriol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Calcitriol is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Calcitriol

What are the most common Calcitriol adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Calcitriol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Calcitriol is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Calcitriol According to Those Reporting Adverse Events

Why are people taking Calcitriol, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
366
Product Used For Unknown Indication
228
Osteoporosis
120
Hyperparathyroidism Secondary
44
Hypocalcaemia
42
Mineral Supplementation
37
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Osteoporosis Prophylaxis
36
Hyperparathyroidism
36
Renal Failure Chronic
34
Anaemia
30
Prophylaxis
23
Supplementation Therapy
22
Hypoparathyroidism
20
Vitamin D Deficiency
16
Bone Disorder
14
Renal Failure
14
Renal Disorder
14
Blood Calcium Decreased
11
Osteopenia
11
Medical Diet
11
Renal Osteodystrophy
10
Vitamin Supplementation
9
Vitamin D Decreased
8
Parathyroid Disorder
8
Vitamin D
7
Ill-defined Disorder
5
Blood Parathyroid Hormone Increased
5
Rickets
5
Renal Impairment
5
Back Pain
4
Hypertension
4
Osteodystrophy
4
Metastases To Bone
4
Osteoporosis Postmenopausal
3
Blood Parathyroid Hormone
3
Prostate Cancer Recurrent
3
Rheumatoid Arthritis
3
Blood Calcium
3
Systemic Sclerosis
2
Routine Health Maintenance
2
Osteoarthritis
2
Osteogenesis Imperfecta
2
Calcium Deficiency
2
Thyroid Disorder
2
Nutritional Support
2
Drug Therapy
2
Hypersensitivity
2
Thyroid Operation
2
Hypophosphataemic Rickets
2
Nephrogenic Anaemia
2
Hyperparathyroidism Primary
1

Drug Labels

LabelLabelerEffective
CalcitriolPhysicians Total Care, Inc.09-MAR-10
CalcitriolWest-ward Pharmaceutical Corp29-APR-10
RocaltrolKAISER FOUNDATION HOSPITALS16-AUG-10
CalcitriolCardinal Health09-JUN-11
CalcitriolPhysicians Total Care, Inc.16-JUN-11
CalcitriolRanbaxy Pharmaceuticals Inc.31-AUG-11
CalcitriolAmerican Regent, Inc.01-SEP-11
CalcitriolAkorn, Inc.14-OCT-11
VecticalGalderma Laboratories, L.P.01-JAN-12
CalcitriolRoxane Laboratories, Inc26-JAN-12
CalcitriolRoxane Laboratories, Inc.26-JAN-12
CalcitriolAmerican Health Packaging15-MAY-12
CalcitriolPerrigo New York Inc10-JUL-12
CalcitriolTeva Pharmaceuticals USA Inc26-JUL-12
CalcijexAbbott Laboratories20-AUG-12
CalcitriolFresenius Kabi USA, LLC13-SEP-12
CalcitriolAphena Pharma Solutions - Tennessee, Inc.13-NOV-12
CalcitriolAkorn, Inc.20-MAR-13

Calcitriol Case Reports

What Calcitriol safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Calcitriol. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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