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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.

Flushing 44%
Chest discomfort 40%
Dyspnea or urge to breathe deeply 28%
Headache 18%
Throat, neck or jaw discomfort 15%
Gastrointestinal discomfort 13%
Lightheadedness/dizziness 12%
Upper extremity discomfort 4%
ST segment depression 3%
First-degree AV block 3%
Second-degree AV block 3%
Paresthesia 2%
Hypotension 2%
Nervousness 2%
Arrhythmias 1%

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

Cardiovascular System

Fatal and nonfatal cardiac arrest, myocardial infarction, ventricular arrhythmia

Central Nervous System

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

Digestive

Nausea and vomiting

Respiratory

Respiratory arrest, throat tightness