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Adenoscan (Adenosine) - Side Effects and Adverse Reactions

 
 



Adverse Reactions

The following reactions with an incidence of at least 1% were reported with intravenous Adenoscan among 1421 patients enrolled in controlled and uncontrolled U.S. clinical trials. Despite the short half-life of adenosine, 10.6% of the side effects occurred not with the infusion of Adenoscan but several hours after the infusion terminated. Also, 8.4% of the side effects that began coincident with the infusion persisted for up to 24 hours after the infusion was complete. In many cases, it is not possible to know whether these late adverse events are the result of Adenoscan infusion.

Flushing44%
Chest discomfort40%
Dyspnea or urge to breathe deeply28%
Headache18%
Throat, neck or jaw discomfort15%
Gastrointestinal discomfort13%
Lightheadedness/dizziness12%
Upper extremity discomfort4%
ST segment depression3%
First-degree AV block3%
Second-degree AV block3%
Paresthesia2%
Hypotension2%
Nervousness2%
Arrhythmias1%

Adverse experiences of any severity reported in less than 1% of patients include:

Body as a Whole

Back discomfort; lower extremity discomfort; weakness

Cardiovascular System

Nonfatal myocardial infarction; life-threatening ventricular arrhythmia; third-degree AV block; bradycardia; palpitation; sinus exit block; sinus pause; sweating; T-wave changes; hypertension (systolic blood pressure > 200 mm Hg)

Central Nervous System

Drowsiness; emotional instability; tremors

Genital/Urinary System

Vaginal pressure; urgency

Respiratory System

Cough

Special Senses

Blurred vision; dry mouth; ear discomfort; metallic taste; nasal congestion; scotomas; tongue discomfort

Post Marketing Experience (see WARNINGS)

The following adverse events have been reported from marketing experience with Adenoscan. Because these events are reported voluntarily from a population of uncertain size, are associated with concomitant diseases and multiple drug therapies and surgical procedures, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, (3) strength of causal connection to the drug, or a combination of these factors.

Body as a Whole

Injection site reaction

Central Nervous System

Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness

Digestive

Nausea and vomiting

Respiratory

Respiratory arrest

OVERDOSAGE

The half-life of adenosine is less than 10 seconds and side effects of Adenoscan (when they occur) usually resolve quickly when the infusion is discontinued, although delayed or persistent effects have been observed. Methylxanthines, such as caffeine and theophylline, are competitive adenosine receptor antagonists and theophylline has been used to effectively terminate persistent side effects. In controlled U.S. clinical trials, theophylline (50-125 mg slow intravenous injection) was needed to abort Adenoscan side effects in less than 2% of patients.



REPORTS OF SUSPECTED ADENOSCAN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Adenoscan. The information is not vetted and should not be considered as verified clinical evidence.

Possible Adenoscan side effects / adverse reactions in 76 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-21

Patient: 76 year old male

Reactions: Anaphylactic Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Adenoscan



See index of all Adenoscan side effect reports >>

Drug label data at the top of this Page last updated: 2006-08-04

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