ProHance

Side Effects
Interactions

SIDE EFFECTS

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

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

Read the ProHance (gadoteridol injection solution) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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.

Side Effects
Interactions
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