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OptiMARK

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OptiMARK

OptiMARK Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

OptiMARK 0.5 mmol/mL (gadoversetamide) Injection is a paramagnetic agent used with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues, and to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomography. Common side effects include headache, widening of blood vessels, changes in taste, dizziness, nausea, and tingling sensation.

OptiMARK Injection is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection. OptiMARK may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, OptiMARK should be used only if prescribed. OptiMARK passes into breast milk. Women should discontinue nursing and discard breast milk up to 72 hours after receiving OptiMARK Injection. Consult your doctor before breastfeeding.

Our OptiMARK 0.5 mmol/mL (gadoversetamide) 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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

OptiMARK in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath; or
  • fast, uneven heart rate.

Less serious side effects may include:

  • headache, dizziness;
  • nausea, diarrhea;
  • flushing (warmth, redness, or tingly feeling);
  • unusual or unpleasant taste in your mouth;
  • numbness, burning pain, or tingling in your hands or feet; or
  • cold feeling, warmth, pain, bruising, swelling, or burning where the medicine was injected.

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 OptiMARK (Gadoversetamide Injection) »

What is Prescribing information?

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

OptiMARK FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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 reactions described in this section were observed in a total of 1,309 subjects (24 healthy volunteers and 1,285 patients in clinical trials). Patients ranged in age from 12 to 85 years (mean age of 50 years) and 680 subjects (52%) were men. The ethnic distribution was 84% White, 9% Black, 3% Asian, and 4% other.

Overall, 460 subjects (35%) reported at least one adverse reaction. Most adverse reactions were mild or moderate in severity. The most commonly noted adverse reactions were: injection associated discomfort (26%), headache (9.4%), vasodilatation (6.4%), taste perversion (6.2%), dizziness (3.7%), nausea (3.2%), and paresthesia (2.2%). Table 2 lists adverse reactions reported in 1% or greater of patients.

Table 2 : Adverse Reactions Experienced by ≥ 1% of Patients

Body System or Event OptiMARK
(N = 1309)
Injection associated discomfort 26.4%
Headache 9.4%
Vasodilatation 6.4%
Taste Perversion 6.2%
Dizziness 3.7%
Nausea 3.2%
Paresthesia 2.2%
Diarrhea 1.9%
Pain Abdomen 1.8%
Asthenia 1.5%
Injection Site Reaction 1.5%
Rhinitis 1.5%
Dyspepsia 1.2%
Pain Back 1.2%
Pain 1.0%

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

Body as a W hole: allergic reaction, facial edema, fever, malaise, neck rigidity, neck pain, pelvic pain, increased sweating

Cardiovascular: arrhythmia, chest pain, hypertension, hypotension, pallor, palpitation, syncope, tachycardia, vasospasm

Digestive: anorexia, constipation, dry mouth, dysphagia, eructation, increased salivation, thirst, vomiting

Metabolic and Nutritional: increased creatinine, edema, hypercalcemia

Musculoskeletal: arthralgia, leg cramps, myalgia, spasm

Nervous System: agitation, anxiety, confusion, diplopia, dystonia, hypertonia, hypesthesia, somnolence, tremor, vertigo

Respiratory System: cough, dyspnea, laryngismus, pharyngitis, sinusitis, voice alteration

Skin and Appendages: erythema multiforme, pruritus, rash, thrombophlebitis, urticaria

Special Senses: parosmia, tinnitus

Urogenital: oliguria

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of OptiMARK. 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 OptiMARK.

  • Nephrogenic Systemic Fibrosis (NSF)
  • Hypersensitivity reactions
  • Seizures

Read the entire FDA prescribing information for OptiMARK (Gadoversetamide Injection) »

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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.


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