ProHance

Last reviewed on RxList: 1/5/2021
ProHance Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is ProHance?

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.

What Are Side Effects of ProHance?

Common side effects of ProHance include:

  • nausea
  • unusual or unpleasant taste in your mouth
  • itching
  • flushing (warmth, redness, or tingly feeling)
  • headache
  • dizziness
  • numbness/burning pain/tingling in your hands or feet, or
  • injection site reactions (cold feeling, warmth, pain, bruising, swelling, or burning)

Tell your doctor if you have serious side effects of ProHance including urinating less than usual or not at all, drowsiness, confusion, mood changes, increased thirst, loss of appetite, swelling, weight gain, shortness of breath, fast or uneven heart rate, seizures (convulsions), or feeling like you might pass out.

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.

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ProHance Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects of gadoteridol may occur up to several days after injection.

Gadoteridol can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

  • burning, itching, swelling, scaling, and tightening or hardening of your skin;
  • muscle weakness;
  • joint stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • trouble moving; or
  • skin redness or discoloration.

Also call your doctor at once if you have:

  • kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
  • a seizure (convulsions); or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • nausea; or
  • unusual or unpleasant taste in your mouth.

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.

Read the entire detailed patient monograph for ProHance (Gadoteridol Injection Solution)

ProHance Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the prescribing information:

  • Nephrogenic systemic fibrosis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse events described in this section were observed in clinical trials involving 1,251 patients (670 males and 581 females). Adult patients ranged in age from 18 to 91 yrs. Pediatric patients ranged from 2 to 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 less 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

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of ProHance that were not observed in the clinical trials. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General Disorders and Administration Site ConditionsAdverse events with variable onset and duration have been reported after GBCA administration [see WARNINGS AND PRECAUTIONS]. These include fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems.

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: Gadolinium associated plaques, Sweating; and Cyanosis

Special Senses: Voice Alteration; Transitory Deafness

Urogenital: Urinary Incontinence

Read the entire FDA prescribing information for ProHance (Gadoteridol Injection Solution)

© ProHance Patient Information is supplied by Cerner Multum, Inc. and ProHance Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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