OptiMARK Side Effects Center

Last updated on RxList: 1/22/2021
OptiMARK Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is OptiMARK?

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.

What Are Side Effects of OptiMARK?

Common side effects of OptiMARK include:

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

Dosage for OptiMARK

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.

What Drugs, Substances, or Supplements Interact with OptiMARK?

OptiMARK may interact with other drugs. Tell your doctor all medications and supplements you use.

OptiMARK During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

About how much does an adult human brain weigh? See Answer
OptiMARK 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 gadoversetamide may occur up to several days after injection.

Gadoversetamide 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
  • fast, uneven heart rate.

Common side effects may include:

  • headache, dizziness;
  • nausea;
  • flushing (warmth, redness, or tingly feeling);
  • unusual or unpleasant taste in your mouth; or
  • numbness, burning pain, or tingling in your hands or feet.

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)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
OptiMARK Professional Information

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 Whole

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 including bronchospasm and laryngeal/pharyngeal edema
  • Seizures

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

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

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