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Isoptin Adverse Events Reported to the FDA Over Time

How are Isoptin adverse event reports trending over time?

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

Most Common Isoptin Adverse Events Reported to the FDA

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

Completed Suicide
966 (5.3%)
Hypotension
477 (2.62%)
Bradycardia
419 (2.3%)
Drug Interaction
360 (1.98%)
Overdose
269 (1.48%)
Drug Toxicity
214 (1.17%)
Death
209 (1.15%)
Dizziness
209 (1.15%)
Cardiac Arrest
200 (1.1%)
Dyspnoea
191 (1.05%)
Drug Ineffective
183 (1%)
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Metabolic Acidosis
182 (1%)
Nausea
176 (.97%)
Atrial Fibrillation
163 (.89%)
Vomiting
153 (.84%)
Cardiogenic Shock
146 (.8%)
Intentional Overdose
146 (.8%)
Asthenia
144 (.79%)
Suicide Attempt
142 (.78%)
Hyperkalaemia
137 (.75%)
Renal Failure Acute
132 (.72%)
Renal Failure
130 (.71%)
Shock
127 (.7%)
Atrioventricular Block Complete
122 (.67%)
Syncope
118 (.65%)
Loss Of Consciousness
113 (.62%)
Headache
106 (.58%)
Somnolence
106 (.58%)
Malaise
96 (.53%)
Blood Pressure Decreased
94 (.52%)
Pulmonary Oedema
93 (.51%)
Hallucination
90 (.49%)
Fatigue
89 (.49%)
Chest Pain
87 (.48%)
Atrioventricular Block
85 (.47%)
Confusional State
85 (.47%)
Poisoning
85 (.47%)
Cardiac Failure
83 (.46%)
Hypertension
81 (.44%)
Abdominal Pain
80 (.44%)
Respiratory Arrest
80 (.44%)
Blood Pressure Increased
79 (.43%)
Cardio-respiratory Arrest
77 (.42%)
Cough
77 (.42%)
Depressed Level Of Consciousness
77 (.42%)
Anuria
76 (.42%)
Hyperhidrosis
76 (.42%)
Medication Error
76 (.42%)
Blood Creatinine Increased
75 (.41%)
Palpitations
74 (.41%)
Diarrhoea
73 (.4%)
Hyperglycaemia
69 (.38%)
Heart Rate Decreased
68 (.37%)
Rhabdomyolysis
68 (.37%)
Atrioventricular Block First Degree
67 (.37%)
Dehydration
66 (.36%)
Nodal Rhythm
66 (.36%)
Multiple Drug Overdose
65 (.36%)
Constipation
63 (.35%)
Circulatory Collapse
62 (.34%)
Coma
62 (.34%)
Hypokalaemia
62 (.34%)
Pyrexia
61 (.33%)
Orthostatic Hypotension
58 (.32%)
Blood Creatine Phosphokinase Increa...
57 (.31%)
Multiple Drug Overdose Intentional
57 (.31%)
Haemodialysis
56 (.31%)
Pulse Absent
56 (.31%)
Multi-organ Failure
55 (.3%)
Sinus Bradycardia
55 (.3%)
Toxic Epidermal Necrolysis
55 (.3%)
Cardiomegaly
54 (.3%)
Condition Aggravated
54 (.3%)
Fall
54 (.3%)
Depression
53 (.29%)
Intentional Drug Misuse
53 (.29%)
Pruritus
51 (.28%)
Hypoxia
50 (.27%)
Blood Glucose Increased
49 (.27%)
Decreased Appetite
49 (.27%)
Arrhythmia
48 (.26%)
Oedema Peripheral
48 (.26%)
Acute Respiratory Distress Syndrome
47 (.26%)
Atrioventricular Block Second Degre...
46 (.25%)
Hypoglycaemia
46 (.25%)
Off Label Use
46 (.25%)
General Physical Health Deteriorati...
45 (.25%)
Alanine Aminotransferase Increased
44 (.24%)
Anxiety
44 (.24%)
Electrocardiogram Qt Prolonged
44 (.24%)
Renal Impairment
44 (.24%)
Tachycardia
44 (.24%)
Torsade De Pointes
43 (.24%)
Heart Rate Increased
41 (.23%)
Hyponatraemia
41 (.23%)
Lethargy
39 (.21%)
Oedema
39 (.21%)
International Normalised Ratio Incr...
38 (.21%)
Myalgia
38 (.21%)
Convulsion
37 (.2%)
Urinary Incontinence
37 (.2%)

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

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

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

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

Hypertension
2067
Drug Use For Unknown Indication
1131
Product Used For Unknown Indication
817
Atrial Fibrillation
548
Arrhythmia
186
Blood Pressure
182
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Migraine
144
Tachycardia
139
Cardiac Disorder
132
Supraventricular Tachycardia
127
Essential Hypertension
79
Ill-defined Disorder
76
Angina Pectoris
67
Suicide Attempt
62
Blood Pressure Increased
59
Cluster Headache
58
Palpitations
53
Heart Rate Irregular
50
Blood Pressure Abnormal
44
Atrial Flutter
40
Tachycardia Paroxysmal
32
Tachyarrhythmia
30
Migraine Prophylaxis
28
Headache
27
Hypertrophic Cardiomyopathy
27
Intentional Overdose
27
Coronary Artery Disease
25
Myocardial Ischaemia
24
Heart Rate Increased
22
Prophylaxis
22
Cardiomyopathy
19
Cardiac Failure
19
Atrial Tachycardia
18
Overdose
17
Mitral Valve Prolapse
16
Arteriospasm Coronary
13
Ventricular Tachycardia
12
Heart Rate
12
Chest Pain
11
Sinus Tachycardia
11
Supraventricular Extrasystoles
11
Heart Rate Abnormal
10
Completed Suicide
10
Arrhythmia Supraventricular
9
Ventricular Extrasystoles
9
Ischaemic Cardiomyopathy
9
Cardiac Fibrillation
9
Acute Myocardial Infarction
9
Depression
9
Maternal Exposure Timing Unspecifie...
8
Cardiac Murmur
8

Isoptin Case Reports

What Isoptin 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 Isoptin. 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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