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CINACALCET

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Cinacalcet Adverse Events Reported to the FDA Over Time

How are Cinacalcet adverse event reports trending over time?

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

Most Common Cinacalcet Adverse Events Reported to the FDA

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

Nausea
207 (3.4%)
Blood Parathyroid Hormone Increased
140 (2.3%)
Vomiting
138 (2.26%)
Death
100 (1.64%)
Hypocalcaemia
100 (1.64%)
Convulsion
93 (1.53%)
Diarrhoea
92 (1.51%)
Hypercalcaemia
82 (1.35%)
Hospitalisation
81 (1.33%)
Dizziness
76 (1.25%)
Dyspnoea
72 (1.18%)
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Blood Calcium Increased
60 (.98%)
Blood Calcium Decreased
59 (.97%)
Drug Ineffective
54 (.89%)
Pruritus
51 (.84%)
Paraesthesia
49 (.8%)
Abdominal Discomfort
45 (.74%)
Dysphagia
44 (.72%)
Rash
44 (.72%)
Asthenia
43 (.71%)
Headache
43 (.71%)
Decreased Appetite
42 (.69%)
Hypotension
41 (.67%)
Therapeutic Response Decreased
41 (.67%)
Muscle Spasms
37 (.61%)
Weight Decreased
36 (.59%)
Malaise
35 (.57%)
Enteral Nutrition
34 (.56%)
Arthralgia
33 (.54%)
Bone Pain
33 (.54%)
Blood Parathyroid Hormone Decreased
32 (.52%)
Myocardial Infarction
32 (.52%)
Fatigue
31 (.51%)
Myalgia
31 (.51%)
Abdominal Pain
29 (.48%)
Hypoaesthesia
29 (.48%)
Tremor
29 (.48%)
Blood Parathyroid Hormone Abnormal
27 (.44%)
Haemoglobin Decreased
27 (.44%)
Abdominal Pain Upper
26 (.43%)
Sepsis
26 (.43%)
Cardiac Failure
25 (.41%)
Cerebrovascular Accident
25 (.41%)
Condition Aggravated
25 (.41%)
Fall
25 (.41%)
Syncope
25 (.41%)
Anaemia
24 (.39%)
Hypersensitivity
24 (.39%)
Pyrexia
24 (.39%)
Anxiety
23 (.38%)
Calciphylaxis
23 (.38%)
Loss Of Consciousness
23 (.38%)
Treatment Noncompliance
22 (.36%)
Feeling Abnormal
21 (.34%)
Muscular Weakness
21 (.34%)
Dehydration
20 (.33%)
Drug Interaction
20 (.33%)
Muscle Twitching
20 (.33%)
Pain In Extremity
20 (.33%)
Blood Alkaline Phosphatase Increase...
19 (.31%)
Depression
19 (.31%)
Gastrointestinal Disorder
19 (.31%)
Hyperphosphataemia
19 (.31%)
Hypertension
19 (.31%)
Palpitations
19 (.31%)
Blood Creatinine Increased
18 (.3%)
Blood Phosphorus Increased
18 (.3%)
Blood Pressure Decreased
18 (.3%)
Insomnia
18 (.3%)
Oedema Peripheral
18 (.3%)
Pain
18 (.3%)
Parathyroidectomy
18 (.3%)
Pneumonia
18 (.3%)
Alopecia
17 (.28%)
Chest Pain
17 (.28%)
Electrocardiogram Qt Prolonged
17 (.28%)
Gastrointestinal Tube Insertion
17 (.28%)
Hyperparathyroidism
17 (.28%)
Hypoglycaemia
17 (.28%)
Hyponatraemia
17 (.28%)
Inappropriate Antidiuretic Hormone ...
17 (.28%)
Lethargy
17 (.28%)
Liver Disorder
17 (.28%)
Urticaria
17 (.28%)
Pleural Effusion
16 (.26%)
Atrial Fibrillation
15 (.25%)
Constipation
15 (.25%)
Haemorrhage
15 (.25%)
Hallucination
15 (.25%)
Blood Calcium Abnormal
14 (.23%)
Cardiac Failure Congestive
14 (.23%)
Chills
14 (.23%)
Hyperkalaemia
14 (.23%)
Nephrolithiasis
14 (.23%)
Renal Failure Acute
14 (.23%)
Renal Haemorrhage
14 (.23%)
Ventricular Extrasystoles
14 (.23%)
Ventricular Tachycardia
14 (.23%)
Drug Intolerance
13 (.21%)
Gastrointestinal Haemorrhage
13 (.21%)
General Physical Health Deteriorati...
13 (.21%)

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

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

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

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

Hyperparathyroidism Secondary
1706
Drug Use For Unknown Indication
462
Product Used For Unknown Indication
442
Hyperparathyroidism
110
Hyperparathyroidism Primary
108
Renal Failure Chronic
55
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Dialysis
37
Parathyroid Disorder
28
Parathyroid Tumour Malignant
17
Hypercalcaemia
15
Secondary Hyperthyroidism
14
Renal Failure
14
Blood Calcium Increased
12
Blood Parathyroid Hormone Increased
10
Mineral Supplementation
9
Blood Calcium
9
Thyroid Disorder
9
Hyperthyroidism
8
Blood Phosphorus Increased
8
Calciphylaxis
4
Nephropathy
4
Blood Calcium Decreased
4
Phosphorus Metabolism Disorder
3
Pre-existing Disease
3
Parathyroid Tumour Benign
3
Blood Parathyroid Hormone
3
Blood Calcium Abnormal
3
Hyperparathyroidism Tertiary
3
Renal Impairment
3
Addisons Disease
2
Abscess Intestinal
2
Drug Therapy
2
Hyperphosphataemia
2
Blood Parathyroid Hormone Abnormal
2
Electrolyte Imbalance
2
Blood Thyroid Stimulating Hormone I...
2
Calcium Metabolism Disorder
2
Calcium Ionised Decreased
2
Pain In Extremity
1
Dependence On Enabling Machine Or D...
1
Hypovitaminosis
1
Hypermagnesaemia
1
Blood Phosphorus
1
Renal Transplant
1
Hypoparathyroidism Secondary
1
Renal Disorder
1
Skin Disorder
1
Fatigue
1
Renal Osteodystrophy
1
Hypothyroidism
1
Pseudohypoparathyroidism
1

Drug Labels

LabelLabelerEffective
SensiparState of Florida DOH Central Pharmacy08-JUN-10
SensiparAmgen, Inc02-AUG-11
SensiparPhysicians Total Care, Inc.01-MAY-12
SensiparAmgen Inc25-MAR-13
SensiparREMEDYREPACK INC. 01-APR-13
SensiparCardinal Health10-APR-13

Cinacalcet Case Reports

What Cinacalcet 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 Cinacalcet. 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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