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ROCALTROL

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Rocaltrol Adverse Events Reported to the FDA Over Time

How are Rocaltrol adverse event reports trending over time?

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

Most Common Rocaltrol Adverse Events Reported to the FDA

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

Hypercalcaemia
57 (6.42%)
Drug Ineffective
14 (1.58%)
Renal Failure
14 (1.58%)
Renal Failure Acute
14 (1.58%)
Drug Interaction
13 (1.46%)
Aspartate Aminotransferase Increase...
11 (1.24%)
Decreased Appetite
10 (1.13%)
Renal Impairment
10 (1.13%)
Blood Creatinine Increased
9 (1.01%)
Blood Parathyroid Hormone Increased
9 (1.01%)
Death
9 (1.01%)
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Pruritus
9 (1.01%)
Anaemia
8 (.9%)
Condition Aggravated
8 (.9%)
Hypocalcaemia
8 (.9%)
Hypotension
8 (.9%)
Coma
7 (.79%)
Diarrhoea
7 (.79%)
Hepatic Function Abnormal
7 (.79%)
Nausea
7 (.79%)
Rash Morbilliform
7 (.79%)
Altered State Of Consciousness
6 (.68%)
Anaphylactic Shock
6 (.68%)
Blood Urea Increased
6 (.68%)
Cardiac Failure
6 (.68%)
Gamma-glutamyltransferase Increased
6 (.68%)
Hypophagia
6 (.68%)
Muscle Spasms
6 (.68%)
Pain
6 (.68%)
Alanine Aminotransferase Increased
5 (.56%)
Angina Pectoris
5 (.56%)
Anorexia
5 (.56%)
Arthralgia
5 (.56%)
Blood Phosphorus Increased
5 (.56%)
Eosinophilia
5 (.56%)
Heart Rate Decreased
5 (.56%)
Hyperparathyroidism
5 (.56%)
Inflammation
5 (.56%)
Lenticular Opacities
5 (.56%)
Malaise
5 (.56%)
Myalgia
5 (.56%)
Pneumonia
5 (.56%)
Rectal Haemorrhage
5 (.56%)
Transient Ischaemic Attack
5 (.56%)
Abdominal Pain
4 (.45%)
Atrial Fibrillation
4 (.45%)
Blood Creatine Increased
4 (.45%)
Convulsion
4 (.45%)
Dehydration
4 (.45%)
Dialysis
4 (.45%)
Dyspepsia
4 (.45%)
Dysphagia
4 (.45%)
Fall
4 (.45%)
Hypereosinophilic Syndrome
4 (.45%)
International Normalised Ratio Incr...
4 (.45%)
Pancreatitis
4 (.45%)
Parapsoriasis
4 (.45%)
Platelet Count Decreased
4 (.45%)
Pruritus Generalised
4 (.45%)
Rash
4 (.45%)
Somnolence
4 (.45%)
Vomiting
4 (.45%)
White Blood Cell Count Decreased
4 (.45%)
White Blood Cell Count Increased
4 (.45%)
Abasia
3 (.34%)
Anaphylactic Reaction
3 (.34%)
Anuria
3 (.34%)
Aphagia
3 (.34%)
Asthenia
3 (.34%)
Blood Glucose Increased
3 (.34%)
Bone Pain
3 (.34%)
Cerebral Infarction
3 (.34%)
Cerebrovascular Accident
3 (.34%)
Confusional State
3 (.34%)
Disorientation
3 (.34%)
Dizziness
3 (.34%)
Drug Exposure During Pregnancy
3 (.34%)
Ear Pruritus
3 (.34%)
Erythema
3 (.34%)
Erythema Multiforme
3 (.34%)
Fluid Intake Reduced
3 (.34%)
Gait Disturbance
3 (.34%)
Hyperphosphataemia
3 (.34%)
Hypoglycaemia
3 (.34%)
Hypovitaminosis
3 (.34%)
Jaundice
3 (.34%)
Jugular Vein Thrombosis
3 (.34%)
Labyrinthitis
3 (.34%)
Lactose Intolerance
3 (.34%)
Leukopenia
3 (.34%)
Liver Disorder
3 (.34%)
Long Qt Syndrome
3 (.34%)
Lung Disorder
3 (.34%)
Malnutrition
3 (.34%)
Metabolic Acidosis
3 (.34%)
Multiple Fractures
3 (.34%)
Muscular Weakness
3 (.34%)
Nephrolithiasis
3 (.34%)
Nephropathy Toxic
3 (.34%)
Oliguria
3 (.34%)
Osteonecrosis
3 (.34%)

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This graph shows the top adverse events submitted to the FDA for Rocaltrol, 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 Rocaltrol 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 Rocaltrol

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

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This graph shows the top categories of adverse events submitted to the FDA for Rocaltrol, 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 Rocaltrol 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 Rocaltrol According to Those Reporting Adverse Events

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

Osteoporosis
207
Drug Use For Unknown Indication
178
Product Used For Unknown Indication
120
Hyperparathyroidism Secondary
36
Hypocalcaemia
31
Hyperparathyroidism
27
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Osteoporosis Prophylaxis
19
Renal Failure Chronic
18
Hypoparathyroidism
18
Thyroidectomy
13
Renal Osteodystrophy
10
Renal Disorder
8
Nutritional Support
8
Mineral Supplementation
8
Blood Calcium
7
Bone Disorder
7
Osteoporosis Postmenopausal
6
Prophylaxis
6
Hypoparathyroidism Secondary
6
Femur Fracture
6
Blood Calcium Decreased
5
Rheumatoid Arthritis
5
Calcium Deficiency
4
Hypertension
4
Prostate Cancer
4
Nephrogenic Anaemia
4
Myalgia
3
Vitamin D Deficiency
3
Vitamin D
3
Calcium Metabolism Disorder
3
Renal Impairment
3
Bone Density Decreased
3
Ill-defined Disorder
3
Routine Health Maintenance
3
Blood Parathyroid Hormone Increased
3
Diabetic Nephropathy
3
Osteopenia
2
Hyperthyroidism
2
Hepatitis C
2
Morphoea
2
Musculoskeletal Pain
2
Disease Complication
2
Thyroid Disorder
2
Parathyroidectomy
2
Mixed Connective Tissue Disease
2
Prostate Cancer Metastatic
2
Blood Calcium Increased
2
Osteomalacia
2
Osteodystrophy
2
Hypokalaemia
2
Renal Failure
2

Drug Labels

LabelLabelerEffective
RocaltrolValidus Pharmaceuticals LLC01-AUG-10
RocaltrolKAISER FOUNDATION HOSPITALS16-AUG-10
RocaltrolAphena Pharma Solutions - Tennessee, Inc.15-AUG-12

Rocaltrol Case Reports

What Rocaltrol 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 Rocaltrol. 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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