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Calan Adverse Events Reported to the FDA Over Time

How are Calan adverse event reports trending over time?

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

Most Common Calan Adverse Events Reported to the FDA

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

Completed Suicide
991 (6.05%)
Hypotension
397 (2.43%)
Bradycardia
340 (2.08%)
Drug Interaction
291 (1.78%)
Overdose
240 (1.47%)
Dizziness
210 (1.28%)
Death
208 (1.27%)
Drug Ineffective
196 (1.2%)
Drug Toxicity
192 (1.17%)
Cardiac Arrest
181 (1.11%)
Metabolic Acidosis
168 (1.03%)
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Nausea
165 (1.01%)
Dyspnoea
159 (.97%)
Intentional Overdose
158 (.97%)
Atrial Fibrillation
141 (.86%)
Asthenia
125 (.76%)
Vomiting
124 (.76%)
Cardiogenic Shock
123 (.75%)
Headache
119 (.73%)
Somnolence
112 (.68%)
Suicide Attempt
109 (.67%)
Loss Of Consciousness
107 (.65%)
Renal Failure Acute
104 (.64%)
Shock
99 (.6%)
Hypertension
98 (.6%)
Blood Pressure Increased
97 (.59%)
Medication Error
97 (.59%)
Blood Pressure Decreased
95 (.58%)
Syncope
95 (.58%)
Atrioventricular Block Complete
93 (.57%)
Hyperkalaemia
90 (.55%)
Malaise
90 (.55%)
Hallucination
89 (.54%)
Pulmonary Oedema
89 (.54%)
Renal Failure
89 (.54%)
Fatigue
88 (.54%)
Chest Pain
87 (.53%)
Poisoning
83 (.51%)
Respiratory Arrest
77 (.47%)
Heart Rate Decreased
74 (.45%)
Multiple Drug Overdose
72 (.44%)
Depressed Level Of Consciousness
70 (.43%)
Anuria
69 (.42%)
Diarrhoea
69 (.42%)
Cough
67 (.41%)
Hyperhidrosis
66 (.4%)
Cardio-respiratory Arrest
65 (.4%)
Confusional State
64 (.39%)
Palpitations
64 (.39%)
Cardiac Failure
62 (.38%)
Hyperglycaemia
62 (.38%)
Multiple Drug Overdose Intentional
62 (.38%)
Abdominal Pain
61 (.37%)
Rhabdomyolysis
59 (.36%)
Coma
57 (.35%)
Circulatory Collapse
56 (.34%)
Nodal Rhythm
56 (.34%)
Blood Creatine Phosphokinase Increa...
55 (.34%)
Blood Creatinine Increased
55 (.34%)
Atrioventricular Block
54 (.33%)
Atrioventricular Block First Degree
53 (.32%)
Intentional Drug Misuse
53 (.32%)
Abdominal Discomfort
52 (.32%)
Anxiety
52 (.32%)
Blood Glucose Increased
52 (.32%)
Pulse Absent
50 (.31%)
Decreased Appetite
48 (.29%)
Feeling Abnormal
48 (.29%)
Oedema Peripheral
48 (.29%)
Constipation
47 (.29%)
Depression
47 (.29%)
Haemodialysis
47 (.29%)
Toxic Epidermal Necrolysis
46 (.28%)
Acute Respiratory Distress Syndrome
45 (.27%)
Condition Aggravated
45 (.27%)
Heart Rate Increased
45 (.27%)
Multi-organ Failure
45 (.27%)
Cardiomegaly
44 (.27%)
Pyrexia
43 (.26%)
Dehydration
42 (.26%)
Hypoglycaemia
42 (.26%)
Hypokalaemia
42 (.26%)
Hypoxia
41 (.25%)
Off Label Use
41 (.25%)
Orthostatic Hypotension
41 (.25%)
Sinus Bradycardia
41 (.25%)
Blood Pressure Inadequately Control...
40 (.24%)
Torsade De Pointes
40 (.24%)
Arrhythmia
39 (.24%)
Atrioventricular Block Second Degre...
39 (.24%)
Lethargy
39 (.24%)
Muscle Spasms
39 (.24%)
Alanine Aminotransferase Increased
38 (.23%)
Convulsion
38 (.23%)
Migraine
38 (.23%)
Renal Impairment
38 (.23%)
Weight Increased
38 (.23%)
Acute Myocardial Infarction
37 (.23%)
Arthralgia
37 (.23%)
Myalgia
37 (.23%)
Tachycardia
37 (.23%)

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

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

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

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

Hypertension
2118
Drug Use For Unknown Indication
894
Product Used For Unknown Indication
809
Atrial Fibrillation
464
Blood Pressure
206
Arrhythmia
156
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Migraine
153
Cardiac Disorder
126
Supraventricular Tachycardia
108
Tachycardia
101
Ill-defined Disorder
87
Blood Pressure Increased
57
Angina Pectoris
55
Heart Rate Irregular
52
Blood Pressure Abnormal
51
Palpitations
50
Essential Hypertension
49
Suicide Attempt
46
Cluster Headache
44
Migraine Prophylaxis
30
Headache
28
Intentional Overdose
26
Heart Rate Increased
25
Tachyarrhythmia
25
Prophylaxis
21
Coronary Artery Disease
21
Atrial Flutter
20
Atrial Tachycardia
20
Mitral Valve Prolapse
19
Cardiomyopathy
19
Overdose
16
Hypertrophic Cardiomyopathy
16
Cardiac Failure
13
Arteriospasm Coronary
13
Myocardial Ischaemia
13
Ventricular Tachycardia
12
Sinus Tachycardia
12
Heart Rate
12
Heart Rate Abnormal
10
Depression
10
Ventricular Extrasystoles
9
Supraventricular Extrasystoles
9
Chest Pain
9
Completed Suicide
9
Arrhythmia Supraventricular
9
Angina Unstable
8
Extrasystoles
8
Cardiac Murmur
8
Maternal Exposure Timing Unspecifie...
8
Cardiovascular Disorder
8
Raynauds Phenomenon
7

Drug Labels

LabelLabelerEffective
Calan SrG.D. Searle LLC Division of Pfizer Inc02-SEP-10
CalanG.D. Searle LLC Division of Pfizer Inc18-OCT-11

Calan Case Reports

What Calan 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 Calan. 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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