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First Adult Injection in US of Dotarem® (gadoterate meglumine) Performed at Winthrop-University Hospital in New York
Date:9/5/2013

ter than or equal to 0.2% patients who received DOTAREM.

Table 1: Adverse Reactions in Clinical Trials
Reaction    Rate (%) n = 2813

Nausea     0.6%
Headache     0.5%
Injection Site Pain    0.4%
Injection Site Coldness    0.2%
Burning Sensation    0.2%

Adverse reactions that occurred with a frequency less than 0.2% in patients who received DOTAREM include: feeling cold, rash, somnolence, fatigue, dizziness, vomiting, pruritus, paresthesia, dysgeusia, pain in extremity, anxiety, hypertension, palpitations, oropharyngeal discomfort, serum creatinine increased and injection site reactions, including site inflammation, extravasation, pruritus, and warmth.

Adverse Reactions in Pediatric Patients
During clinical trials, 141 pediatric patients (7 aged less than 24 months, 33 aged 2 - 5 years, 58 aged 6 - 11 years and 43 aged 12 - 17) received DOTAREM. Overall, 6 pediatric patients (4.3%) reported at least one adverse reaction following DOTAREM administration. The most frequently reported adverse reaction was headache (1.5%). Most adverse events were mild in severity and transient in nature, and all patients recovered without treatment.

6.2 Postmarketing Experience
The following additional adverse reactions have been identified during postmarketing use of DOTAREM. 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 drug exposure.

  • bradycardia, tachycardia, arrhythmia
  • hypersensitivity / anaphylactoid reactions including cardiac arrest, respiratory arrest, cyanosis, pharyngeal edema, laryngospasm, bronchospasm, angioedema, conjunctivitis, ocular hyperemia, eyelid edema, lacrimation increase
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