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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the prescribing information: Nephrogenic Systemic Fibrosis [see Contraindications ( 4 ), Boxed Warning and Warnings and Precautions ( 5.1 )] Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence >2%) are: headache, vasodilatation, taste perversion, dizziness, nausea and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS contact Liebel- Flarsheim Company LLC at 1-855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 6.2 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 General Disorders and Administration Site Conditions: Adverse events with variable onset and duration have been reported after GBCA administration [see Warnings and Precautions ( 5.3 )] . These include heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems, fatigue, asthenia, pain syndromes, and gadolinium retention. Skin: Gadolinium associated plaques