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
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).
Digestive: Increased Salivation; Dysphagia
Nervous System: Stupor; Tremor; Loss of Consciousness
Skin and Appendages: Sweating; and Cyanosis
Special Senses: Voice Alteration; transitory deafness
Urogenital: Urinary Incontinence
Read the ProHance (gadoteridol injection solution) Side Effects Center for a complete guide to possible side effects
No information provided.
Last reviewed on RxList: 7/13/2012
This monograph has been modified to include the generic and brand name in many instances.
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