The adverse events described in this section were observed in clinical trials involving 1251 patients (670 males and 581 females). Adult patients ranged in age from 18-91 yrs. Pediatric patients ranged from 2-17 years. The racial breakdown was 83% Caucasian, 8% Black, 3% Hispanic, 2% Asian, and 1% other. In 2% of the patients, race was not reported.
The most commonly noted adverse experiences were nausea and taste perversion with an incidence of 1.4%. These events were mild to moderate in severity.
The following additional adverse events occurred in fewer than 1% of the patients:
|Body as a Whole:||Facial Edema; Neck Rigidity; Pain; Pain at Injection Site; Injection Site Reaction; Chest Pain; Headache; Fever; Itching; Watery Eyes; Abdominal Cramps; Tingling Sensation in Throat; Laryngismus; Flushed Feeling; Vasovagal Reaction; Anaphylactoid Reactions (characterized by cardiovascular, respiratory and cutaneous symptoms)|
|Cardiovascular:||Prolonged P-R Interval; Hypotension; Elevated Heart Rate; A-V Nodal Rhythm|
|Digestive:||Edematous and/or itching tongue; Gingivitis; Dry Mouth; Loose Bowel; Vomiting|
|Nervous System:||Anxiety; Dizziness; Paresthesia; Mental Status Decline; Loss of Coordination in Arm; Staring Episode; Seizure; Syncope|
|Respiratory System:||Dyspnea; Rhinitis; Cough|
|Skin and Appendages: ||Pruritus; Rash; Rash Macular Papular; Urticaria; Hives; Tingling Sensation of Extremity and Digits; Sweating; and Cyanosis|
The following adverse drug reactions have also been reported:
|Body as a Whole:||Generalized Edema; Laryngeal Edema; Malaise; Anaphylactoid Reactions (characterized by cardiovascular, respiratory and cutaneous symptoms, and rarely resulting in Death)|
|Cardiovascular:||Cardiac Arrest; Bradycardia; Hypertension; and Death in association with pre-existing cardiovascular disorders|
|Digestive:||Increased Salivation; Dysphagia|
|Nervous System:||Stupor; Tremor; Loss of Consciousness|
|Skin and Appendages:||Sweating; and Cyanosis|
|Special Senses:||Voice Alteration; Transitory Deafness|