"The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/13/2012
Additional ProHance Information
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