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adenosine Injection, USP Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

Fatal Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction [see Warnings and Precautions (5.1)]
Sinoatrial and Atrioventricular Nodal Block [see Warnings and Precautions (5.2)]
Bronchoconstriction [see Warnings and Precautions (5.3)]
Hypotension [see Warnings and Precautions (5.4)]
Cerebrovascular Accident [see Warnings and Precautions (5.5)]
Seizures [see Warnings and Precautions (5.6)]
Hypersensitivity [see Warnings and Precautions (5.7)]
Atrial fibrillation [see Warnings and Precautions (5.8)]
Hypertension [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following adverse reactions, with an incidence of at least 1%, were reported with adenosine injection among 1,421 patients in clinical trials. 11% of the adverse reactions occurred several hours after adenosine injection administration. 8% of the adverse reactions began with adenosine infusion and persisted for up to 24 hours.

The most common (incidence ≥10%) adverse reactions to adenosine injection are flushing, chest discomfort, shortness of breath, headache, throat, neck or jaw discomfort, gastrointestinal discomfort, and dizziness (Table 2).

Table 2 Adverse Reactions in Clinical Trials (Frequency ≥1%)

Adverse Reactions

Adenosine Injection
N=1,421

Flushing

44%

Chest discomfort

40%

Dyspnea

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 reactions to adenosine injection of any severity reported in less than 1% of patients include:

Body as a Whole:

back discomfort, lower extremity discomfort, weakness

Cardiovascular System:

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

Respiratory System:

cough

Central nervous System:

drowsiness, emotional instability, tremors

Genital/Urinary System:

Vaginal pressure, urgency

Special Senses:

blurred vision, dry mouth, ear discomfort, metallic taste, nasal congestion, scotomas, tongue discomfort

6.2 Post-Marketing Experience

The following adverse reactions have been reported from marketing experience with adenosine injection. Because these reactions 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.

Cardiac Disorders:

cardiac arrest, atrial fibrillation, cardiac failure, myocardial infarction, tachycardia, ventricular arrhythmia

Gastrointestinal Disorders:

nausea and vomiting

General Disorders and Administration Site Conditions:

chest pain, injection site reaction, infusion site pain

Immune System Disorders:

hypersensitivity

Nervous System Disorders:

cerebrovascular accident including intracranial hemorrhage, seizure activity including tonic-clonic (grand mal) seizures, loss of consciousness

Respiratory, Thoracic and Mediastinal Disorders:

bronchospasm, respiratory arrest, throat tightness

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