ADVERSE REACTIONS
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 |
| Special Senses: | Tinnitus |
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 |
| Respiratory: | Apnea; Wheezing |
| Skin and Appendages: | Sweating; and Cyanosis |
| Special Senses: | Voice Alteration; Transitory Deafness |
| Urogenital: | Urinary Incontinence |
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