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Sectral Adverse Events Reported to the FDA Over Time

How are Sectral adverse event reports trending over time?

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

Most Common Sectral Adverse Events Reported to the FDA

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

Malaise
48 (2.35%)
Bradycardia
41 (2.01%)
Fall
36 (1.76%)
Hyperkalaemia
32 (1.57%)
Renal Failure
30 (1.47%)
Hypotension
29 (1.42%)
Loss Of Consciousness
28 (1.37%)
Drug Interaction
24 (1.18%)
Renal Failure Acute
23 (1.13%)
Coma
20 (.98%)
Confusional State
20 (.98%)
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Vomiting
20 (.98%)
Dyspnoea
19 (.93%)
Toxic Skin Eruption
18 (.88%)
Asthenia
17 (.83%)
Cholestasis
17 (.83%)
Diarrhoea
17 (.83%)
Disorientation
17 (.83%)
Pruritus
16 (.78%)
Pyrexia
16 (.78%)
Hypertension
15 (.73%)
Hyponatraemia
15 (.73%)
Headache
14 (.69%)
Antinuclear Antibody Positive
13 (.64%)
General Physical Health Deteriorati...
13 (.64%)
Orthostatic Hypotension
12 (.59%)
Blood Creatinine Increased
11 (.54%)
Dehydration
11 (.54%)
Gait Disturbance
11 (.54%)
Inflammation
11 (.54%)
Miosis
11 (.54%)
Thrombocytopenia
11 (.54%)
Arthritis
10 (.49%)
Creatinine Renal Clearance Decrease...
10 (.49%)
Cytolytic Hepatitis
10 (.49%)
Drug Exposure During Pregnancy
10 (.49%)
Drug Ineffective
10 (.49%)
Interstitial Lung Disease
10 (.49%)
Nausea
10 (.49%)
Oedema Peripheral
10 (.49%)
Osteonecrosis
10 (.49%)
Overdose
10 (.49%)
Agitation
9 (.44%)
Anaemia
9 (.44%)
Haemoglobin Decreased
9 (.44%)
Hepatitis
9 (.44%)
Jaundice
9 (.44%)
Atrioventricular Block Complete
8 (.39%)
Cardiac Arrest
8 (.39%)
Chest Pain
8 (.39%)
Condition Aggravated
8 (.39%)
Dermatitis Bullous
8 (.39%)
Electrocardiogram Qt Prolonged
8 (.39%)
Face Oedema
8 (.39%)
Hepatomegaly
8 (.39%)
Insomnia
8 (.39%)
Lupus-like Syndrome
8 (.39%)
Pulmonary Fibrosis
8 (.39%)
Sepsis
8 (.39%)
Shock
8 (.39%)
Autoimmune Thyroiditis
7 (.34%)
Blood Pressure Systolic Increased
7 (.34%)
Drug Toxicity
7 (.34%)
Electrocardiogram Qrs Complex Prolo...
7 (.34%)
Erythema
7 (.34%)
Fatigue
7 (.34%)
Hepatic Cirrhosis
7 (.34%)
Hypoxia
7 (.34%)
Lactic Acidosis
7 (.34%)
Lung Disorder
7 (.34%)
Multi-organ Failure
7 (.34%)
Pancytopenia
7 (.34%)
Rash Maculo-papular
7 (.34%)
Rhabdomyolysis
7 (.34%)
Somnolence
7 (.34%)
Syncope
7 (.34%)
Tachycardia
7 (.34%)
Tendon Rupture
7 (.34%)
Acute Respiratory Distress Syndrome
6 (.29%)
Arthralgia
6 (.29%)
Blood Glucose Increased
6 (.29%)
Bundle Branch Block Right
6 (.29%)
Cardio-respiratory Arrest
6 (.29%)
Cardiogenic Shock
6 (.29%)
Cognitive Disorder
6 (.29%)
Convulsion
6 (.29%)
Extrapyramidal Disorder
6 (.29%)
Head Injury
6 (.29%)
Hypoalbuminaemia
6 (.29%)
Leukocytosis
6 (.29%)
Nosocomial Infection
6 (.29%)
Optic Neuropathy
6 (.29%)
Pallor
6 (.29%)
Serum Ferritin Increased
6 (.29%)
Skin Exfoliation
6 (.29%)
Visual Impairment
6 (.29%)
Abdominal Pain
5 (.24%)
Abdominal Pain Upper
5 (.24%)
Blood Urea Increased
5 (.24%)
Dermatitis Exfoliative
5 (.24%)
Eczema
5 (.24%)

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

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

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

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

Hypertension
284
Drug Use For Unknown Indication
168
Product Used For Unknown Indication
55
Cardiac Disorder
34
Ill-defined Disorder
29
Essential Hypertension
22
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Myocardial Infarction
21
Atrial Fibrillation
20
Arrhythmia
14
Tachycardia
12
Ischaemic Cardiomyopathy
12
Blood Pressure
11
Coronary Artery Disease
9
Cardiac Failure
7
Coronary Artery Insufficiency
7
Palpitations
6
Heart Rate Irregular
5
Mitral Valve Prolapse
5
Angina Pectoris
5
Blood Pressure Increased
4
Cardiac Flutter
4
Myocardial Ischaemia
4
Atrial Flutter
4
Ventricular Extrasystoles
3
Suicide Attempt
3
Heart Rate Increased
3
Ischaemic Heart Disease Prophylaxis
3
Supraventricular Tachycardia
3
Breast Cancer
3
Prophylaxis
3
Cardiomyopathy
3
Unevaluable Event
3
Tinnitus
3
Intentional Overdose
2
Cardiovascular Event Prophylaxis
2
Migraine
2
Renal Transplant
2
Infarction
2
Ventricular Hypertrophy
2
Wolff-parkinson-white Syndrome
2
Foetal Exposure During Pregnancy
2
Acute Myocardial Infarction
2
Drug Exposure During Pregnancy
2
Multiple Drug Overdose Intentional
2
Toxicity To Various Agents
1
Coronary Artery Stenosis
1
Ventricular Tachycardia
1
Hypertensive Heart Disease
1
Extrasystoles
1
Sick Sinus Syndrome
1
Chest Pain
1

Drug Labels

LabelLabelerEffective
SectralPromius Pharma, LLC12-JAN-12

Sectral Case Reports

What Sectral 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 Sectral. 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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