ProHance

ProHance Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

ProHance (gadoteridol) Injection is a nonionic contrast medium for magnetic resonance imaging (MRI) used to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues, and to visualize lesions in the head and neck. Common side effects include nausea and changes in taste.

The recommended dose of ProHance Injection for adults is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus ( > 60 mL/min). The recommended dose of ProHance for children 2-18 years is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus ( > 60 mL/min). ProHance may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, ProHance should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our ProHance (gadoteridol) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

ProHance FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for ProHance (Gadoteridol Injection Solution) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.