ADENOSCAN SIDE EFFECTS
- Generic Name: adenosine injection
- Brand Name: Adenoscan
- Drug Class: Antidysrhythmics, V
SIDE EFFECTS
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
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
Respiratory
Respiratory arrest, throat tightness
SRC: NLM .
