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Prohance (Gadoteridol) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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



REPORTS OF SUSPECTED PROHANCE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Prohance. The information is not vetted and should not be considered as verified clinical evidence.

Possible Prohance side effects / adverse reactions in 58 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05

Patient: 58 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus, Scab, Skin Burning Sensation, Skin Hyperpigmentation, Joint Stiffness, Anhedonia, Skin Swelling, Peau D'orange, Pain in Extremity, Skin Disorder, Muscular Weakness, Nephrogenic Systemic Fibrosis, Skin Induration, Skin Hypertrophy, Livedo Reticularis, Anxiety, Scar, Mobility Decreased, Skin Fibrosis

Suspect drug(s):
Magnevist
    Indication: Imaging Procedure
    Start date: 2005-05-26
    End date: 2005-05-26

Contrast Media
    Indication: Angiogram

Prohance
    Indication: Imaging Procedure

Magnevist
    Dosage: 15 ml, unk
    Indication: Nuclear Magnetic Resonance Imaging Brain
    Start date: 2006-05-30

Contrast Media
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-12-20
    End date: 2003-12-20

Omniscan
    Indication: Imaging Procedure

Optimark
    Indication: Imaging Procedure

Multihance
    Indication: Imaging Procedure

Other drugs received by patient: Phoslo; Folbee; Epogen; Colchicine; Calcitriol; Sensipar; Klonopin; Midodrine Hydrochloride; Plavix; Synthroid; Iron Supplement; Coumadin; Aspirin; Norvasc; Zemplar; Corticosteroids; Steroid Antibacterials; Levothyroxine Sodium; Nephrocaps; Renagel; Robaxin; Immunosuppressive Agents; Hormones and Related Agents; Neurontin; Gabapentin; Immunosuppressive Agents; Antithrombotic Agents



Possible Prohance side effects / adverse reactions in 31 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-06

Patient: 31 year old female weighing 59.8 kg (131.6 pounds)

Reactions: Pruritus, Pain, Joint Contracture, Skin Burning Sensation, Joint Stiffness, Generalised Oedema, Hand Deformity, Myalgia, Joint Range of Motion Decreased, Skin Discolouration, Oedema Peripheral, Musculoskeletal Stiffness, Skin Swelling, Pain in Extremity, DRY Skin, Nephrogenic Systemic Fibrosis, Skin Hypertrophy, Stress, Skin Tightness, Anxiety, Arthralgia, Exfoliative Rash, Gait Disturbance, Atrophy

Suspect drug(s):
Magnevist
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Magnevist
    Dosage: unk
    Indication: Angiogram
    Start date: 2007-01-18
    End date: 2007-01-18

Optimark
    Indication: Angiogram

Prohance
    Indication: Angiogram

Omniscan
    Dosage: unk
    Indication: Angiogram
    Start date: 2003-01-10
    End date: 2003-01-10

Omniscan
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2003-09-22
    End date: 2003-09-22

Multihance
    Indication: Angiogram

Optimark
    Indication: Nuclear Magnetic Resonance Imaging Brain

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Dilantin; Metoprolol Tartrate; Amlodipine; Phenytoin; Morphine; Renagel; Promethazine; Aspirin; Vitamin K TAB; Diazepam; Lovenox; Labetalol HCL; Lidocaine; Ibuprofen; Plendil; Coumadin; Heparin; Methadone HCL; Norvasc; Accupril; Vicodin; Depakote; Amiodarone HCL; Pravastatin; Enoxaparin; Cardura; Cardizem; Lamictal; Clonidine; Prednisone; Elavil



Possible Prohance side effects / adverse reactions in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-10

Patient: 43 year old male weighing 118.0 kg (259.6 pounds)

Reactions: Pain in Extremity, General Physical Health Deterioration, Skin Induration, Nephrogenic Systemic Fibrosis, Deformity, Skin Tightness, Emotional Distress, Anxiety, Skin Discolouration, Depression, Fibrosis, Mobility Decreased, Scar

Adverse event resulted in: disablity

Suspect drug(s):
Magnevist
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Dosage: 20 ml, once
    Start date: 2006-05-21
    End date: 2006-05-21

Prohance
    Indication: Nuclear Magnetic Resonance Imaging

Omniscan
    Dosage: 20 ml, once
    Indication: Nuclear Magnetic Resonance Imaging
    Start date: 2006-04-25
    End date: 2006-04-25

Multihance
    Indication: Nuclear Magnetic Resonance Imaging

Optimark
    Indication: Nuclear Magnetic Resonance Imaging

Other drugs received by patient: Insulin [insulin]; Zemplar; Cardizem; Losartan Potassium; Albumin (Human); Aranesp; Phoslo; Catapres; Nephrocaps; Procardia XL; Procrit; Aldactone



See index of all Prohance side effect reports >>

Drug label data at the top of this Page last updated: 2008-12-24

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