DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Omniscan (Gadodiamide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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

Clinical Studies Experience (Adults)

In clinical studies 1160 patients were exposed to OMNISCAN. The most frequent adverse reactions were nausea, headache, and dizziness that occurred in 3% or less of the patients. The majority of these adverse reactions were of mild to moderate intensity.

The following adverse reactions occurred in 1% or less of patients:

Application Site Disorders: Injection site reaction.

Autonomic Nervous System Disorders: Vasodilation.

Body as a Whole-General Disorders: Anaphylactoid reactions (characterized by cardiovascular, respiratory, and cutaneous symptoms), fever, hot flushes, rigors, fatigue, malaise, pain, syncope.

Cardiovascular Disorders: Cardiac failure, rare arrhythmia and myocardial infarction resulting in death in patients with ischemic heart disease, flushing, chest pain, deep thrombophlebitis.

Central and Peripheral Nervous System Disorders: Convulsions including grand mal, ataxia, abnormal coordination, parethesia, tremor, aggravated multiple sclerosis (characterized by sensory and motor disturbances), aggravated migraine.

Gastrointestinal System Disorders: Abdominal pain, diarrhea, eructation, dry mouth/vomiting, melena.

Hearing and Vestibular Disorders: Tinnitus.

Liver and Biliary System Disorders: Abnormal hepatic function.

Musculoskeletal System Disorders: Arthralgia, myalgia.

Respiratory System Disorders: Rhinitis, dyspnea.

Skin and Appendage Disorders: Pruritus, rash, erythematous rash, sweating increased, urticaria.

Special Senses, Other Disorders: Taste loss, taste perversion.

Urinary System Disorders: Acute reversible renal failure.

Vision Disorders: Abnormal vision.

Clinical Studies Experience (Pediatrics)

In the 97 pediatric patients in CNS studies with OMNISCAN [ see Clinical Studies ] and the 144 pediatric patients in published literature, the adverse reactions were similar to those reported in adults.

Postmarketing Experience

Because postmarketing 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.

The following adverse reactions have been identified during the postmarketing use of OMNISCAN:

Nervous System Disorders: Inadvertent intrathecal use causes seizures, coma, paresthesia, paresis.



REPORTS OF SUSPECTED OMNISCAN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Omniscan 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 Omniscan 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 Omniscan 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 Omniscan side effect reports >>

Drug label data at the top of this Page last updated: 2007-09-05

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012