The following adverse reactions are discussed in greater detail in other sections of the label:
- Nephrogenic systemic fibrosis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
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 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, paresthesia, 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.
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 convulsions, coma, paresthesia, paresis. Convulsions have been reported with intravenous use in patients with and without a history of convulsions or brain lesions. General Disorders: Nephrogenic Systemic Fibrosis (NSF) [see WARNINGS AND PRECAUTIONS]. Renal and Urinary System Disorders: In patients with pre-existing renal insufficiency: acute renal failure, renal impairment, blood creatinine increased [see WARNINGS AND PRECAUTIONS].